{"ID":106007,"post_author":"9412100","post_date":"2023-02-11 18:15:20","post_date_gmt":"0000-00-00 00:00:00","post_content":"","post_title":"LIMS Selection Guide for ISO\/IEC 17025 Laboratories","post_excerpt":"","post_status":"draft","comment_status":"closed","ping_status":"closed","post_password":"","post_name":"","to_ping":"","pinged":"","post_modified":"2023-02-11 18:15:20","post_modified_gmt":"2023-02-11 23:15:20","post_content_filtered":"","post_parent":0,"guid":"https:\/\/www.limsforum.com\/?post_type=ebook&p=106007","menu_order":0,"post_type":"ebook","post_mime_type":"","comment_count":"0","filter":"","_ebook_metadata":{"enabled":"on","private":"0","guid":"F192B4E3-6455-4498-8425-54319BA3756A","title":"LIMS Selection Guide for ISO\/IEC 17025 Laboratories","subtitle":"First Edition","cover_theme":"nico_3","cover_image":"https:\/\/www.limsforum.com\/wp-content\/plugins\/rdp-ebook-builder\/pl\/cover.php?cover_style=nico_3&subtitle=First+Edition&editor=Shawn+Douglas&title=LIMS+Selection+Guide+for+ISO%2FIEC+17025+Laboratories&title_image=https%3A%2F%2Fs3.limsforum.com%2Fwww.limsforum.com%2Fwp-content%2Fuploads%2FNuclear_Forensics_02813660_14418120899-scaled.jpg&publisher=LabLynx+Press","editor":"Shawn Douglas","publisher":"LabLynx Press","author_id":"26","image_url":"","items":{"ae534f2f81d36c93e3937beae3c5e2a3_type":"article","ae534f2f81d36c93e3937beae3c5e2a3_title":"6. Closing remarks","ae534f2f81d36c93e3937beae3c5e2a3_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Closing_remarks","ae534f2f81d36c93e3937beae3c5e2a3_plaintext":"\n\nBook:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Closing remarksFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n6. Closing remarks \nThe ISO\/IEC 17025 standard is one of several standards that prescribes quality management and quality systems to entities wishing to improve their operations and have a more positive impact on their customers. In particular, ISO\/IEC 17025 asks analytical, calibration, and sampling laboratories to demonstrate \"competence, impartiality, and consistent operation\" in its activities, enabled by a strong focus on implementing procedural and quality management mechanisms as a means towards meeting those goals. As Chapter 1 points out, laboratories are interwoven throughout our society\u2014conducting analytical, product development, research, and reference and calibration activities\u2014and we expect their resulting data to be timely, accurate, traceable, and secure. These expectations are represented in the ISO\/IEC 17025 standard. Labs benefit in many ways from complying with the standard, as Chapter 2 notes, but not without some sacrifice. However, these labs can benefit from laboratory informatics solutions like the laboratory information management system (LIMS) and their ability to streamline workflows and provide features that make ISO\/IEC 17025 compliance a less painful process.\nChoosing a LIMS for ISO\/IEC 17025 compliance is not necessarily a straightforward task. To be sure, researching business needs, building a list of system requirements, investigating LIMS vendors, and getting the desired LIMS implementation is a complicated process regardless of what industries your lab serves. Adding ISO\/IEC 17025 compliance to your lab's needs can easily add another layer of complication to the LIMS acquisition process, but it doesn't have to. Chapter 3 helps the lab through this process and identifies critical LIMS features that allow for better compliance with the standard, with the help of a freely available requirements specification called LIMSpec. We found that the LIMS with robust sample and method development tools, iron-clad security methods (including role-based access), and support for archiving and retrieving archived data\u2014among other functionality\u2014is critical to the ISO\/IEC 17025 lab. But there's more to consider as well, including cybersecurity, system flexibility, cost, implementation, and warranties. These complexities may be daunting for some lab managers, and Chapter 4 provides additional resources towards being more informed about those nuances. Finally, Chapter 5 walked the reader through how a requirements specification like LIMSpec, requests for information (RFIs), and system demonstrations all further help the lab make its final decisions and better ensure the lab is getting what it needs from the LIMS to better remain ISO\/IEC-compliant.\nAll said, ISO\/IEC 17025 compliance doesn't have to be as daunting a task as it sounds for the laboratory. A consistent and time-tested methodology of understanding the lab's needs, knowing the specifics of the standard, developing a requirements document, investigating LIMS vendors, and following through on a plan of action will do a lot towards meeting your lab's compliance goals. Hopefully this guide has been of use to you in that regard.\n\nCitation information for this chapter \nChapter: 6. Closing remarks\nTitle: LIMS Selection Guide for ISO\/IEC 17025 Laboratories\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: February 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Closing_remarks\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Closing_remarks<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 11 February 2023, at 22:54.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 6 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","ae534f2f81d36c93e3937beae3c5e2a3_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Closing_remarks rootpage-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Closing_remarks skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Closing remarks<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Introduction\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Introduction\" class=\"wiki-link\" data-key=\"dd550e2b577ba2800fc166f51fa74557\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"6._Closing_remarks\">6. Closing remarks<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:IAEA_Clean_Lab_(06410475)_(5113774550).jpg\" class=\"image wiki-link\" data-key=\"5eaa7cfa993b274e8c87117e8c905299\"><img alt=\"IAEA Clean Lab (06410475) (5113774550).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/1\/1f\/IAEA_Clean_Lab_%2806410475%29_%285113774550%29.jpg\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO\/IEC_17025\" title=\"ISO\/IEC 17025\" class=\"wiki-link\" data-key=\"0a89cebb34370dd860cce86881cbf29c\">ISO\/IEC 17025<\/a> standard is one of several standards that prescribes quality management and quality systems to entities wishing to improve their operations and have a more positive impact on their customers. In particular, ISO\/IEC 17025 asks analytical, <a href=\"https:\/\/www.limswiki.org\/index.php\/Reference_laboratory\" title=\"Reference laboratory\" class=\"wiki-link\" data-key=\"f719f408e1660f86b53857eef2f13f32\">calibration<\/a>, and <a href=\"https:\/\/www.limswiki.org\/index.php\/Sample_(material)\" title=\"Sample (material)\" class=\"wiki-link\" data-key=\"7f8cd41a077a88d02370c02a3ba3d9d6\">sampling<\/a> <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratories<\/a> to demonstrate \"competence, impartiality, and consistent operation\" in its activities, enabled by a strong focus on implementing procedural and quality management mechanisms as a means towards meeting those goals. As Chapter 1 points out, laboratories are interwoven throughout our society\u2014conducting analytical, product development, research, and reference and calibration activities\u2014and we expect their resulting data to be timely, accurate, traceable, and secure. These expectations are represented in the ISO\/IEC 17025 standard. Labs benefit in many ways from complying with the standard, as Chapter 2 notes, but not without some sacrifice. However, these labs can benefit from <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solutions like the <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) and their ability to streamline <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflows<\/a> and provide features that make ISO\/IEC 17025 compliance a less painful process.\n<\/p><p>Choosing a LIMS for ISO\/IEC 17025 compliance is not necessarily a straightforward task. To be sure, researching business needs, building a list of system requirements, investigating LIMS vendors, and getting the desired LIMS implementation is a complicated process regardless of what industries your lab serves. Adding ISO\/IEC 17025 compliance to your lab's needs can easily add another layer of complication to the LIMS acquisition process, but it doesn't have to. Chapter 3 helps the lab through this process and identifies critical LIMS features that allow for better compliance with the standard, with the help of a freely available requirements specification called <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec_2022_R2\" title=\"LII:LIMSpec 2022 R2\" class=\"wiki-link\" data-key=\"fcfd093af650d866ae1ed9ed8bbc08f9\">LIMSpec<\/a>. We found that the LIMS with robust <a href=\"https:\/\/www.limswiki.org\/index.php\/Sample_(material)\" title=\"Sample (material)\" class=\"wiki-link\" data-key=\"7f8cd41a077a88d02370c02a3ba3d9d6\">sample<\/a> and method development tools, iron-clad security methods (including role-based access), and support for archiving and retrieving archived data\u2014among other functionality\u2014is critical to the ISO\/IEC 17025 lab. But there's more to consider as well, including <a href=\"https:\/\/www.limswiki.org\/index.php\/Cybersecurity\" class=\"mw-redirect wiki-link\" title=\"Cybersecurity\" data-key=\"ba653dc2a1384e5f9f6ac9dc1a740109\">cybersecurity<\/a>, system flexibility, cost, implementation, and warranties. These complexities may be daunting for some lab managers, and Chapter 4 provides additional resources towards being more informed about those nuances. Finally, Chapter 5 walked the reader through how a requirements specification like LIMSpec, requests for information (RFIs), and system demonstrations all further help the lab make its final decisions and better ensure the lab is getting what it needs from the LIMS to better remain ISO\/IEC-compliant.\n<\/p><p>All said, ISO\/IEC 17025 compliance doesn't have to be as daunting a task as it sounds for the laboratory. A consistent and time-tested methodology of understanding the lab's needs, knowing the specifics of the standard, developing a requirements document, investigating LIMS vendors, and following through on a plan of action will do a lot towards meeting your lab's compliance goals. Hopefully this guide has been of use to you in that regard.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 6. Closing remarks\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for ISO\/IEC 17025 Laboratories<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: February 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230211225444\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.028 seconds\nReal time usage: 0.035 seconds\nPreprocessor visited node count: 10\/1000000\nPost\u2010expand include size: 3383\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 12.654 1 Template:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Closing_remarks\n100.00% 12.654 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14038-0!canonical and timestamp 20230211225454 and revision id 51406. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Closing_remarks\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Closing_remarks<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","ae534f2f81d36c93e3937beae3c5e2a3_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/1\/1f\/IAEA_Clean_Lab_%2806410475%29_%285113774550%29.jpg"],"ae534f2f81d36c93e3937beae3c5e2a3_timestamp":1676157327,"b095c9d6d9726852f649a17288b55101_type":"article","b095c9d6d9726852f649a17288b55101_title":"5.5 LIMSpec in Microsoft Word format","b095c9d6d9726852f649a17288b55101_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/LIMSpec_in_Microsoft_Word_format","b095c9d6d9726852f649a17288b55101_plaintext":"\n\nBook:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/LIMSpec in Microsoft Word formatFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.5 LIMSpec in Microsoft Word format \nMicrosoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\nYou can download a copy of the Microsoft Word version of LIMSpec from LIMSwiki by going to File:LIMSpec 2022R2 v1.0.docx, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widen the response column.\nNote that this downloadable version of LIMSpec is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n\nReferences \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 5. Taking the next step\nTitle: LIMS Selection Guide for ISO\/IEC 17025 Laboratories\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: February 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/LIMSpec_in_Microsoft_Word_format<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 11 February 2023, at 22:55.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 15 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","b095c9d6d9726852f649a17288b55101_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_LIMSpec_in_Microsoft_Word_format rootpage-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_LIMSpec_in_Microsoft_Word_format skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/LIMSpec in Microsoft Word format<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Introduction\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Introduction\" class=\"wiki-link\" data-key=\"dd550e2b577ba2800fc166f51fa74557\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.5_LIMSpec_in_Microsoft_Word_format\">5.5 LIMSpec in Microsoft Word format<\/span><\/h3>\n<p>Microsoft Excel is often used as a tool to document requirements specifications. However, one downside to Microsoft Excel is its inability to handle multiple hyperlinks in the same cell. If you've looked over the LIMSpec, you've likely noticed there are multiple hyperlinks to regulations, specifications, and guidance documents in the first column of the tables. Translating these wiki-based documents to Excel makes for a challenge when trying to maintain those hyperlinks. As they add value to not only your laboratory's requirements research but also to vendors' understanding of the sources for your requirements, it was decided the hyperlinks should be maintained in any portable version. As such, a Microsoft Word version was created.\n<\/p><p>You can download a copy of the Microsoft Word version of LIMSpec from LIMSwiki by going to <a href=\"https:\/\/www.limswiki.org\/index.php\/File:LIMSpec_2022R2_v1.0.docx\" title=\"File:LIMSpec 2022R2 v1.0.docx\" class=\"wiki-link\" data-key=\"6ecc50a09cbc136f1ea678e477ab2dac\">File:LIMSpec 2022R2 v1.0.docx<\/a>, right-clicking the URL under the white box, and selecting \"Save link as...\" (Alternatively, you can just click the link, open the file, and then save it.) A compromise was made between keeping the hyperlinks in the first column readable and leaving enough room in the third column for a vendor to provide a response. This response space admittedly may be a limiting factor for vendors wanting to include screenshots. If this situation arises, you may encourage the vendor to select the entire first column and delete it, then widen the response column.\n<\/p><p>Note that this downloadable version of LIMSpec is released under the same licensing terms as this guide. Please see the first paragraph of the download for more details.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Closing_remarks\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Closing remarks\" class=\"wiki-link\" data-key=\"ae534f2f81d36c93e3937beae3c5e2a3\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 5. Taking the next step\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for ISO\/IEC 17025 Laboratories<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: February 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230211225550\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.031 seconds\nReal time usage: 0.041 seconds\nPreprocessor visited node count: 57\/1000000\nPost\u2010expand include size: 2177\/2097152 bytes\nTemplate argument size: 24\/2097152 bytes\nHighest expansion depth: 7\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 21.001 1 -total\n 67.08% 14.087 1 Template:Reflist\n 31.85% 6.690 1 Template:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/LIMSpec_in_Microsoft_Word_format\n 30.93% 6.495 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14037-0!canonical and timestamp 20230211225553 and revision id 51407. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/LIMSpec_in_Microsoft_Word_format\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/LIMSpec_in_Microsoft_Word_format<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","b095c9d6d9726852f649a17288b55101_images":[],"b095c9d6d9726852f649a17288b55101_timestamp":1676157327,"1396d8d19c4af1734d8a0d4300d4c1b7_type":"article","1396d8d19c4af1734d8a0d4300d4c1b7_title":"5.4 Finalize the requirements specification and choose a vendor","1396d8d19c4af1734d8a0d4300d4c1b7_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor","1396d8d19c4af1734d8a0d4300d4c1b7_plaintext":"\n\nBook:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/Finalize the requirements specification and choose a vendorFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.4 Finalize the requirements specification and choose a vendor \nNow that the demonstrations have been conducted and more questions asked, you should be close to finalizing your requirement specification with one or more vendors. In fact, you may have taken LIMSpec, chosen a few critical requirements from it, added them to a few unique requirements of your own, and included them as part of an RFI or question and answer session with vendors. You then likely took those responses and added them to your wider overall specification, along with your own notes and observations from interacting with the vendor. This may have been repeated for several vendors and their offerings. \nAt this point, you're likely ready to either have those vendors complete the rest of the responses for their corresponding URS, or you may even be ready to narrow down your vendor selection. This all likely depends on what the initial fact finding revealed. How well did the vendors respond to your laboratory's unique set of needs? Were there critical areas that one vendor could address with their off-the-shelf solution but another vendor would have to address with custom coding? Did any of the vendors meet your budget expectations? Have you followed up on any references and customer experiences the vendors provided to you? \nIt may be that several vendors are appealing at this point, meaning it's time to have them respond to the rest of the URS. This makes not only for good due diligence, to better ensure most requirements can be met, but also a reviewable option for any \"tie-breaker\" you have between vendors. In reality, this tie-breaker scenario would rarely come up; more often, some other aspect of the software, company, or pricing will be a stronger limiter. However, you still want to get all those vendor responses, even if you've early on filtered your options down to one vendor.\nUltimately, your specification document may look similar to LIMSpec, or it may have a slightly different format. Many prospective buyers will develop a requirement specification in Microsoft Excel, but that has a few minor disadvantages. Regardless of format, you'll want to give plenty of space for vendors to submit a response to each requirement. (See the next section concerning a Microsoft Word version of LIMSpec.)\nAdditionally, remember that often is the case that after the URS is completed and final questions asked, no single vendor can meet all your needs. Be ready for this possibility, whether it be a functionality requirement or a budget issue. Know ahead of time where your laboratory is willing to be flexible, and how much flex you have. After all of your lab's preparation, and with a little luck, you've found a vendor that fits the bill, even if a few minor compromises had to be made along the way.\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 11 February 2023, at 22:57.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 9 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","1396d8d19c4af1734d8a0d4300d4c1b7_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_Finalize_the_requirements_specification_and_choose_a_vendor rootpage-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_Finalize_the_requirements_specification_and_choose_a_vendor skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/Finalize the requirements specification and choose a vendor<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Introduction\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Introduction\" class=\"wiki-link\" data-key=\"dd550e2b577ba2800fc166f51fa74557\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.4_Finalize_the_requirements_specification_and_choose_a_vendor\">5.4 Finalize the requirements specification and choose a vendor<\/span><\/h3>\n<p>Now that the demonstrations have been conducted and more questions asked, you should be close to finalizing your requirement specification with one or more vendors. In fact, you may have taken LIMSpec, chosen a few critical requirements from it, added them to a few unique requirements of your own, and included them as part of an RFI or question and answer session with vendors. You then likely took those responses and added them to your wider overall specification, along with your own notes and observations from interacting with the vendor. This may have been repeated for several vendors and their offerings. \n<\/p><p>At this point, you're likely ready to either have those vendors complete the rest of the responses for their corresponding URS, or you may even be ready to narrow down your vendor selection. This all likely depends on what the initial fact finding revealed. How well did the vendors respond to your laboratory's unique set of needs? Were there critical areas that one vendor could address with their off-the-shelf solution but another vendor would have to address with custom coding? Did any of the vendors meet your budget expectations? Have you followed up on any references and customer experiences the vendors provided to you? \n<\/p><p>It may be that several vendors are appealing at this point, meaning it's time to have them respond to the rest of the URS. This makes not only for good due diligence, to better ensure most requirements can be met, but also a reviewable option for any \"tie-breaker\" you have between vendors. In reality, this tie-breaker scenario would rarely come up; more often, some other aspect of the software, company, or pricing will be a stronger limiter. However, you still want to get all those vendor responses, even if you've early on filtered your options down to one vendor.\n<\/p><p>Ultimately, your specification document may look similar to LIMSpec, or it may have a slightly different format. Many prospective buyers will develop a requirement specification in Microsoft Excel, but that has a few minor disadvantages. Regardless of format, you'll want to give plenty of space for vendors to submit a response to each requirement. (See the next section concerning a Microsoft Word version of LIMSpec.)\n<\/p><p>Additionally, remember that often is the case that after the URS is completed and final questions asked, no single vendor can meet all your needs. Be ready for this possibility, whether it be a functionality requirement or a budget issue. Know ahead of time where your laboratory is willing to be flexible, and how much flex you have. After all of your lab's preparation, and with a little luck, you've found a vendor that fits the bill, even if a few minor compromises had to be made along the way.\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230211225750\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.007 seconds\nReal time usage: 0.009 seconds\nPreprocessor visited node count: 5\/1000000\nPost\u2010expand include size: 2836\/2097152 bytes\nTemplate argument size: 0\/2097152 bytes\nHighest expansion depth: 3\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 0\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 3.837 1 Template:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\n100.00% 3.837 1 -total\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14036-0!canonical and timestamp 20230211225755 and revision id 51410. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Finalize_the_requirements_specification_and_choose_a_vendor<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","1396d8d19c4af1734d8a0d4300d4c1b7_images":[],"1396d8d19c4af1734d8a0d4300d4c1b7_timestamp":1676157327,"b0113b071d3b314fec8ddec27cc5cb66_type":"article","b0113b071d3b314fec8ddec27cc5cb66_title":"5.3 Respond to or open dialogue with vendors","b0113b071d3b314fec8ddec27cc5cb66_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors","b0113b071d3b314fec8ddec27cc5cb66_plaintext":"\n\nBook:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/Respond to or open dialogue with vendorsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5.3 Respond to or open dialogue with vendors \nIf you went the route of the RFI, you hopefully received more than a few well-crafted responses. Your RFI presumably included a small but critical set of requirements that needed to be addressed, and the vendors who responded dutifully addressed those critical requirements. Even if you didn't send out an RFI, you at least did your own research about some of the big players in the laboratory informatics space, and you may have even opened an initial dialogue with a few of them. If all has gone well, you're now at the point where you've narrowed down the pool of vendors but still have a basket of them to continue dialogue with. (If you're not comfortably at this point after an RFI or engagements with multiple vendors, you may need to either reconsider the effectiveness of your RFI or engagements or enlist help from a knowledgeable and experienced consultant to help steer you back on-course.)\nAs dialogue continues with vendors, you'll have several points to address:\n1. What do I want their laboratory information management system (LIMS) to do for me?\n2. How does their solution fit into our previously discussed budget?\nRegarding question one, you've already laid some of the groundwork for that with the help of your handful of critical requirements (and the associated research that went into developing them). Outside of those critical requirements, a laboratory informatics solution should also provide clearly definable benefits to how you operate your ISO\/IEC 17025 laboratory. These expected benefits should tie in with your overall business mission and goals. Using a LIMS as an example, here are a few of the benefits a well-developed LIMS can provide to practically any laboratory. Whenever you go through the discovery process with a vendor, you'll be asking how their system provides these and other benefits through its functionality. A quality LIMS can provide[1][2]:\n\nincreased accuracy: the minimization or elimination of transcription and other errors;\nstreamlined processes: ensuring each process step in a protocol\/method is completed in the proper order, with all requirements met, updating sample statuses automatically;\nautomation: integration with instruments, allowing for automatic uploading of samples and returning of results;\nregulatory and standards compliance: functionality that aids with compliance, including reporting results to state and local authorities;\ndata security: role-based, configurable, secure access to data, processes, reporting, etc.;\nflexible reporting: reporting tools that allows for the design and generation of certificates of authority and other reports to lab- and regulation-based specs;\ninstant data retrieval: query tools for finding data instantly according to any criteria (date range, test, product type, etc.); and\nconfigurability and cost-effectiveness: a user-configurable system (as opposed to hard-coded, requiring development for any modifications) that is flexible enough to adapt to rapid changes in test volume and type over time, without breaking the bank.\nAs for the second question, budgeting is always a tricky topic, both internally and when discussing it with vendors. We already mentioned in the previous section that addressing the acquisition and long-term maintenance budget of your solution(s) must be addressed as part of your lab's business considerations. (And we already mentioned some cost considerations in 3.1.6; this discussion will add a few more points.) The fact that laboratory informatics systems like the LIMS come in all kinds of price ranges makes it difficult to judge if a given system, as priced, is appropriate for your lab and its budget. There are some basic cost realities associated with LIMS acquisition[3][4], which will help you understand where the vendor price comes from, and how it figures into your lab's budget (though some of these concepts may also apply to other informatics systems).\n\n1. Vendor pricing is generally based on how many will be using the system. This can be measured in concurrent users (how many will be using the system at any one time) or named users (the number of total users who will ever use the system, by name). Additionally, laboratory informatics vendors increasingly offer the option of a cloud-hosted subscription, which of course has the advantage of not requiring your own IT department, and allowing labs to defray cost over time, with little or no actual license fee. Think about your usage strategy and choose the pricing format that makes the most sense for you.\n2. Most costs are related to the work involved with installing, configuring, and migrating data to the system. Try to choose a solution that has what you need out of the box, as much as possible. The more customized or unique options you ask for up-front, the more it tends to cost, as extra items are a function of the time it takes developers to add them.\n3. \"User-configurable\" beats \"vendor-configurable\" on cost-effectiveness. Some vendors offer a free or low-cost option, but don't be fooled. They are in business to make money, and they are counting on the fact that you'll need to pay them to make things work, add necessary functionality, and provide support and training. If you can find a vendor who offers a genuinely user-configurable system, and whose manuals and other support materials are clearly helpful and available so that you can adjust things the way you want, when you want, then that will go a long way toward budget efficiency and longevity.\n4. Additional interfaces and reporting requirements cost money. If necessary, consider phasing in any additional instrument and software interfaces over time, as revenue eases cash flow. You can go live with your system operations more quickly, entering results manually until you can afford to interface your instruments one-by-one. This goes for reports as well; a simple reporting module that meets regulatory requirements will do. You can make your reports and other exportable documents more attractive later.\nIdeally, your budget has room for roughly $40- to $80,000 minimum (including setup, training, interfaces, etc.) for a quality, full-featured professional LIMS or LIS, with $300 to $900 per month (depending on number of users) for ongoing subscriptions. At around five concurrent users, the economics start to favor purchasing perpetual licenses rather than paying for a subscription. Purchased licenses will also entail ongoing annual or monthly costs as well (e.g., maintenance, support, warranty for updates etc.) Subscriptions (if available) are generally aimed at smaller labs. If you will be growing and scaling up, it may be a great way to get started, but make sure you have the option to switch to perpetual licenses later. \nWith much of this information in hand, you're likely ready to move on to finalizing the requirements specification and choosing a vendor, but not before you've sat through a few highly useful demonstrations.\n\n5.3.1 The value of demonstrations \nParticipating in a demonstration of a laboratory informatics solution is an integral part of making your final decisions. The demo offers a unique and valuable opportunity to see in-person how data and information is added, edited, deleted, tracked, and protected within the context of the application; you can ask about how a function works and see it right then and there. Equally, it is an excellent time to compare notes with the vendor, particularly in regard to the critical requirements that were addressed in your RFI (or through direct communication with the vendor). You can ask the vendor in real-time to answer questions about how a specific task is achieved, or how the system addresses ISO\/IEC 17025 compliance needs, and the vendor can ask you about your lab's system and workflow requirements and how you best envision them being implemented in the system (e.g., does this interface seem intuitive?).\nA demonstration is typically performed online, which is useful for a couple of reasons, COVID-19 notwithstanding. First, it means you can schedule and reschedule at your convenience, with little in the way of logistics to arrange. Second, the demonstration session is likely to be recorded (though be sure to verify this), so everyone is clear on what was promised and what wasn't, how processes were shown to work, etc. Additionally, you can later review parts you may have missed, forgotten, or not quite understood, and you can share it with others, who then also get a look at the proposed system in action.\nBe careful about falling for the temptation of presenting a full URS or other specification document to the vendor during the demonstration. You'll want to wait until after participating in several software demonstrations to consider presenting your full specification document to the vendor, and that's assuming that you've grown enamored with their solution. By waiting to finalize your lab's requirements specification until after the demos, a common error is avoided: too often labs think the first thing they must do is create a requirements list, then sit back and let the informatics vendors tell them how they meet it. Remember that even though most labs thoroughly understand their processes, they likely don't have as strong a grasp on the informatics portion of their processes and workflows. Participating in a demo before finalizing your list of specified requirements\u2014or having only a minimal yet flexible requirements list during the demo\u2014is a great way to later crosscheck the software features you have seen demonstrated to your lab's processes and any initial requirements specification you've made.[5] After all, how can you effectively require specific functions of your laboratory informatics software if you don't fully know what such a system is capable of? After the demonstrations, you may end up adding several requirements to your final specifications document, which you later pass on to your potential vendors of choice for final confirmation.\n\nReferences \n\n\n\u2191 McLelland, A. (1998). \"What is a LIMS - a laboratory toy, or a critical IT component?\" (PDF). Royal Society of Chemistry. p. 1. Archived from the original on 04 October 2013. https:\/\/web.archive.org\/web\/20131004232754\/http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf . Retrieved 11 February 2023 .   \n \n\n\u2191 Joyce, J.R. (2010). \"Industry Insights: Examining the Risks, Benefits and Trade-offs of Today\u2019s LIMS\". Scientific Computing (January\/February 2010): 15\u201323.   \n \n\n\u2191 Rosenberg, H.J. (28 March 2017). \"How Much Does a LIMS Cost? Licensing and Beyond\". SlideShare. https:\/\/www.slideshare.net\/CSolsInc\/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk . Retrieved 11 February 2023 .   \n \n\n\u2191 \"Saving Costs with LIMS\". CSols, Inc. 25 October 2018. https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/ . Retrieved 11 February 2023 .   \n \n\n\u2191 Hammer, S. (27 June 2019). \"How to Get the Most Value from an ERP Software Demo\". The Takeoff. https:\/\/www.striven.com\/blog\/erp-software-demo . Retrieved 11 February 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 11 February 2023, at 22:50.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 5 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","b0113b071d3b314fec8ddec27cc5cb66_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_Respond_to_or_open_dialogue_with_vendors rootpage-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_Respond_to_or_open_dialogue_with_vendors skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/Respond to or open dialogue with vendors<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Introduction\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Introduction\" class=\"wiki-link\" data-key=\"dd550e2b577ba2800fc166f51fa74557\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"5.3_Respond_to_or_open_dialogue_with_vendors\">5.3 Respond to or open dialogue with vendors<\/span><\/h3>\n<p>If you went the route of the RFI, you hopefully received more than a few well-crafted responses. Your RFI presumably included a small but critical set of requirements that needed to be addressed, and the vendors who responded dutifully addressed those critical requirements. Even if you didn't send out an RFI, you at least did your own research about some of the big players in the laboratory informatics space, and you may have even opened an initial dialogue with a few of them. If all has gone well, you're now at the point where you've narrowed down the pool of vendors but still have a basket of them to continue dialogue with. (If you're not comfortably at this point after an RFI or engagements with multiple vendors, you may need to either reconsider the effectiveness of your RFI or engagements or enlist help from a knowledgeable and experienced consultant to help steer you back on-course.)\n<\/p><p>As dialogue continues with vendors, you'll have several points to address:\n<\/p><p>1. What do I want their <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS) to do for me?\n<\/p><p>2. How does their solution fit into our previously discussed budget?\n<\/p><p>Regarding question one, you've already laid some of the groundwork for that with the help of your handful of critical requirements (and the associated research that went into developing them). Outside of those critical requirements, a laboratory informatics solution should also provide clearly definable benefits to how you operate your ISO\/IEC 17025 laboratory. These expected benefits should tie in with your overall business mission and goals. Using a LIMS as an example, here are a few of the benefits a well-developed LIMS can provide to practically any laboratory. Whenever you go through the discovery process with a vendor, you'll be asking how their system provides these and other benefits through its functionality. A quality LIMS can provide<sup id=\"rdp-ebb-cite_ref-McLelland98_1-0\" class=\"reference\"><a href=\"#cite_note-McLelland98-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-SciCompRisksBens_2-0\" class=\"reference\"><a href=\"#cite_note-SciCompRisksBens-2\">[2]<\/a><\/sup>:\n<\/p>\n<ul><li>increased accuracy: the minimization or elimination of transcription and other errors;<\/li>\n<li>streamlined processes: ensuring each process step in a protocol\/method is completed in the proper order, with all requirements met, updating sample statuses automatically;<\/li>\n<li>automation: integration with instruments, allowing for automatic uploading of samples and returning of results;<\/li>\n<li>regulatory and standards compliance: functionality that aids with compliance, including reporting results to state and local authorities;<\/li>\n<li>data security: role-based, configurable, secure access to data, processes, reporting, etc.;<\/li>\n<li>flexible reporting: reporting tools that allows for the design and generation of certificates of authority and other reports to lab- and regulation-based specs;<\/li>\n<li>instant data retrieval: query tools for finding data instantly according to any criteria (date range, test, product type, etc.); and<\/li>\n<li>configurability and cost-effectiveness: a user-configurable system (as opposed to hard-coded, requiring development for any modifications) that is flexible enough to adapt to rapid changes in test volume and type over time, without breaking the bank.<\/li><\/ul>\n<p>As for the second question, budgeting is always a tricky topic, both internally and when discussing it with vendors. We already mentioned in the previous section that addressing the acquisition and long-term maintenance budget of your solution(s) must be addressed as part of your lab's business considerations. (And we already mentioned some cost considerations in 3.1.6; this discussion will add a few more points.) The fact that laboratory informatics systems like the LIMS come in all kinds of price ranges makes it difficult to judge if a given system, as priced, is appropriate for your lab and its budget. There are some basic cost realities associated with LIMS acquisition<sup id=\"rdp-ebb-cite_ref-CSolsHowMuch17_3-0\" class=\"reference\"><a href=\"#cite_note-CSolsHowMuch17-3\">[3]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-CSolsSaving18_4-0\" class=\"reference\"><a href=\"#cite_note-CSolsSaving18-4\">[4]<\/a><\/sup>, which will help you understand where the vendor price comes from, and how it figures into your lab's budget (though some of these concepts may also apply to other informatics systems).\n<\/p>\n<dl><dd>1. Vendor pricing is generally based on how many will be using the system. This can be measured in concurrent users (how many will be using the system at any one time) or named users (the number of total users who will ever use the system, by name). Additionally, laboratory informatics vendors increasingly offer the option of a <a href=\"https:\/\/www.limswiki.org\/index.php\/Cloud_computing\" title=\"Cloud computing\" class=\"wiki-link\" data-key=\"fcfe5882eaa018d920cedb88398b604f\">cloud-hosted<\/a> subscription, which of course has the advantage of not requiring your own IT department, and allowing labs to defray cost over time, with little or no actual license fee. Think about your usage strategy and choose the pricing format that makes the most sense for you.<\/dd><\/dl>\n<dl><dd>2. Most costs are related to the work involved with installing, configuring, and migrating data to the system. Try to choose a solution that has what you need out of the box, as much as possible. The more customized or unique options you ask for up-front, the more it tends to cost, as extra items are a function of the time it takes developers to add them.<\/dd><\/dl>\n<dl><dd>3. \"User-configurable\" beats \"vendor-configurable\" on cost-effectiveness. Some vendors offer a free or low-cost option, but don't be fooled. They are in business to make money, and they are counting on the fact that you'll need to pay them to make things work, add necessary functionality, and provide support and training. If you can find a vendor who offers a genuinely user-configurable system, and whose manuals and other support materials are clearly helpful and available so that you can adjust things the way you want, when you want, then that will go a long way toward budget efficiency and longevity.<\/dd><\/dl>\n<dl><dd>4. Additional interfaces and reporting requirements cost money. If necessary, consider phasing in any additional instrument and software interfaces over time, as revenue eases cash flow. You can go live with your system operations more quickly, entering results manually until you can afford to interface your instruments one-by-one. This goes for reports as well; a simple reporting module that meets regulatory requirements will do. You can make your reports and other exportable documents more attractive later.<\/dd><\/dl>\n<p>Ideally, your budget has room for roughly $40- to $80,000 minimum (including setup, training, interfaces, etc.) for a quality, full-featured professional LIMS or LIS, with $300 to $900 per month (depending on number of users) for ongoing subscriptions. At around five concurrent users, the economics start to favor purchasing perpetual licenses rather than paying for a subscription. Purchased licenses will also entail ongoing annual or monthly costs as well (e.g., maintenance, support, warranty for updates etc.) Subscriptions (if available) are generally aimed at smaller labs. If you will be growing and scaling up, it may be a great way to get started, but make sure you have the option to switch to perpetual licenses later. \n<\/p><p>With much of this information in hand, you're likely ready to move on to finalizing the requirements specification and choosing a vendor, but not before you've sat through a few highly useful demonstrations.\n<\/p>\n<h4><span class=\"mw-headline\" id=\"5.3.1_The_value_of_demonstrations\">5.3.1 The value of demonstrations<\/span><\/h4>\n<div class=\"floatleft\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:ForUM_demo_(2659615090).jpg\" class=\"image wiki-link\" data-key=\"6d24fe10a7ea5ad2ee42e7e70cca00b6\"><img alt=\"ForUM demo (2659615090).jpg\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/55\/ForUM_demo_%282659615090%29.jpg\" decoding=\"async\" width=\"360\" height=\"270\" \/><\/a><\/div><p>Participating in a demonstration of a laboratory informatics solution is an integral part of making your final decisions. The demo offers a unique and valuable opportunity to see in-person how data and information is added, edited, deleted, tracked, and protected within the context of the application; you can ask about how a function works and see it right then and there. Equally, it is an excellent time to compare notes with the vendor, particularly in regard to the critical requirements that were addressed in your RFI (or through direct communication with the vendor). You can ask the vendor in real-time to answer questions about how a specific task is achieved, or how the system addresses ISO\/IEC 17025 compliance needs, and the vendor can ask you about your lab's system and workflow requirements and how you best envision them being implemented in the system (e.g., does this interface seem intuitive?).\n<\/p><p>A demonstration is typically performed online, which is useful for a couple of reasons, COVID-19 notwithstanding. First, it means you can schedule and reschedule at your convenience, with little in the way of logistics to arrange. Second, the demonstration session is likely to be recorded (though be sure to verify this), so everyone is clear on what was promised and what wasn't, how processes were shown to work, etc. Additionally, you can later review parts you may have missed, forgotten, or not quite understood, and you can share it with others, who then also get a look at the proposed system in action.\n<\/p><p>Be careful about falling for the temptation of presenting a full URS or other specification document to the vendor during the demonstration. You'll want to wait until after participating in several software demonstrations to consider presenting your full specification document to the vendor, and that's assuming that you've grown enamored with their solution. By waiting to finalize your lab's requirements specification until after the demos, a common error is avoided: too often labs think the first thing they must do is create a requirements list, then sit back and let the informatics vendors tell them how they meet it. Remember that even though most labs thoroughly understand their processes, they likely don't have as strong a grasp on the informatics portion of their processes and workflows. Participating in a demo before finalizing your list of specified requirements\u2014or having only a minimal yet flexible requirements list during the demo\u2014is a great way to later crosscheck the software features you have seen demonstrated to your lab's processes and any initial requirements specification you've made.<sup id=\"rdp-ebb-cite_ref-HammerHowTo19_5-0\" class=\"reference\"><a href=\"#cite_note-HammerHowTo19-5\">[5]<\/a><\/sup> After all, how can you effectively require specific functions of your laboratory informatics software if you don't fully know what such a system is capable of? After the demonstrations, you may end up adding several requirements to your final specifications document, which you later pass on to your potential vendors of choice for final confirmation.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-McLelland98-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-McLelland98_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">McLelland, A. (1998). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20131004232754\/http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf\" target=\"_blank\">\"What is a LIMS - a laboratory toy, or a critical IT component?\"<\/a> (PDF). Royal Society of Chemistry. p. 1. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf\" target=\"_blank\">the original<\/a> on 04 October 2013<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20131004232754\/http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf\" target=\"_blank\">https:\/\/web.archive.org\/web\/20131004232754\/http:\/\/www.rsc.org\/pdf\/andiv\/tech.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=What+is+a+LIMS+-+a+laboratory+toy%2C+or+a+critical+IT+component%3F&rft.atitle=&rft.aulast=McLelland%2C+A.&rft.au=McLelland%2C+A.&rft.date=1998&rft.pages=p.+1&rft.pub=Royal+Society+of+Chemistry&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20131004232754%2Fhttp%3A%2F%2Fwww.rsc.org%2Fpdf%2Fandiv%2Ftech.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-SciCompRisksBens-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-SciCompRisksBens_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Joyce, J.R. (2010). \"Industry Insights: Examining the Risks, Benefits and Trade-offs of Today\u2019s LIMS\". <i>Scientific Computing<\/i> (January\/February 2010): 15\u201323.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Industry+Insights%3A+Examining+the+Risks%2C+Benefits+and+Trade-offs+of+Today%E2%80%99s+LIMS&rft.jtitle=Scientific+Computing&rft.aulast=Joyce%2C+J.R.&rft.au=Joyce%2C+J.R.&rft.date=2010&rft.issue=January%2FFebruary+2010&rft.pages=15%E2%80%9323&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CSolsHowMuch17-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CSolsHowMuch17_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Rosenberg, H.J. (28 March 2017). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.slideshare.net\/CSolsInc\/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk\" target=\"_blank\">\"How Much Does a LIMS Cost? Licensing and Beyond\"<\/a>. <i>SlideShare<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.slideshare.net\/CSolsInc\/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk\" target=\"_blank\">https:\/\/www.slideshare.net\/CSolsInc\/how-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+Much+Does+a+LIMS+Cost%3F+Licensing+and+Beyond&rft.atitle=SlideShare&rft.aulast=Rosenberg%2C+H.J.&rft.au=Rosenberg%2C+H.J.&rft.date=28+March+2017&rft_id=https%3A%2F%2Fwww.slideshare.net%2FCSolsInc%2Fhow-much-does-a-lims-cost-licensing-and-beyond-pittcon-2017-tech-talk&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-CSolsSaving18-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-CSolsSaving18_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/\" target=\"_blank\">\"Saving Costs with LIMS\"<\/a>. CSols, Inc. 25 October 2018<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/\" target=\"_blank\">https:\/\/www.csolsinc.com\/blog\/saving-costs-with-lims\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Saving+Costs+with+LIMS&rft.atitle=&rft.date=25+October+2018&rft.pub=CSols%2C+Inc&rft_id=https%3A%2F%2Fwww.csolsinc.com%2Fblog%2Fsaving-costs-with-lims%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-HammerHowTo19-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-HammerHowTo19_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hammer, S. (27 June 2019). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.striven.com\/blog\/erp-software-demo\" target=\"_blank\">\"How to Get the Most Value from an ERP Software Demo\"<\/a>. <i>The Takeoff<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.striven.com\/blog\/erp-software-demo\" target=\"_blank\">https:\/\/www.striven.com\/blog\/erp-software-demo<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=How+to+Get+the+Most+Value+from+an+ERP+Software+Demo&rft.atitle=The+Takeoff&rft.aulast=Hammer%2C+S.&rft.au=Hammer%2C+S.&rft.date=27+June+2019&rft_id=https%3A%2F%2Fwww.striven.com%2Fblog%2Ferp-software-demo&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230211225016\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.481 seconds\nReal time usage: 0.744 seconds\nPreprocessor visited node count: 3539\/1000000\nPost\u2010expand include size: 32053\/2097152 bytes\nTemplate argument size: 8276\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 7349\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 88.696 1 -total\n 88.54% 78.533 1 Template:Reflist\n 61.58% 54.617 4 Template:Cite_web\n 53.72% 47.647 5 Template:Citation\/core\n 12.92% 11.459 4 Template:Date\n 11.42% 10.128 1 Template:Cite_journal\n 11.30% 10.022 1 Template:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\n 5.77% 5.116 8 Template:Citation\/make_link\n 3.77% 3.344 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14035-0!canonical and timestamp 20230211225017 and revision id 51402. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Respond_to_or_open_dialogue_with_vendors<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","b0113b071d3b314fec8ddec27cc5cb66_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/5\/55\/ForUM_demo_%282659615090%29.jpg"],"b0113b071d3b314fec8ddec27cc5cb66_timestamp":1676157327,"e99fafc9276c83fe0270540b6a58f93c_type":"article","e99fafc9276c83fe0270540b6a58f93c_title":"5.2 Issue some of the specification as part of a request for information (RFI)","e99fafc9276c83fe0270540b6a58f93c_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)","e99fafc9276c83fe0270540b6a58f93c_plaintext":"\n\nBook:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/Issue some of the specification as part of a request for information (RFI)From LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n 5.2 Issue some of the specification as part of a request for information (RFI) \nIn some cases\u2014particularly if your organization is of significant size\u2014it may make sense to issue a formal RFI or request for proposal (RFP) and have laboratory informatics vendors approach your ISO\/IEC 17025 lab with how they can meet its needs. The RFI and RFP are traditional means towards soliciting bidding interest in an organization's project, containing the organization's specific requirements and vital questions that the bidder should be able to effectively answer. However, even if your organization chooses to skip the RFI or RFP process and do most of the investigative work of researching and approaching informatics vendors, turning to a key set of questions typically found in an RFI is extremely valuable towards your fact finding.\nAn RFI is an ideal means for learning more about a potential solution and how it can solve your problems, or for when you're not even sure how to solve your problem yet. However, the RFI should not be unduly long and tedious to complete for prospective vendors; it should be concise, direct, and honest. This means not only presenting a clear and humble vision of your own organization and its goals, but also asking just the right amount of questions to allow potential vendors to demonstrate their expertise and provide a clearer picture of who they are. Some take a technical approach to an RFI, using dense language and complicated spreadsheets for fact finding. However, as previously noted, you will want to limit the specified requirements in your RFI to those carefully chosen\u2014for example, ISO\/IEC 17025-specific requirements\u2014because they matter to you and your lab the most.[1] \nRemember, an RFI is not meant to answer all of your questions. The RFI is meant as a means to help narrow down your search to a few quality candidates while learning more about each other.[1] Once the pool of potential software vendors is narrowed down, and you then participate in their demonstrations, you then can broadly add more requirements to the original collection of critical requirements from the RFI to ensure those providers meet all or most of your needs. That said, be cognizant that there may be no vendor that can meet each and every need of your lab. Your lab will have to make important decisions about which requirements are non-negotiable and which are more flexible. The vendors you engage with may be able to provide realistic advice in this regard, based upon your lab's requirements and their past experience with labs. As such, those vendors with real-world experience meeting the needs of ISO\/IEC 17025 laboratories may have a strong leg up on other vendors.\nAgain, a comprehensive specifications document like LIMSpec makes for one possible source from which you can draw the requirements that are most critical to be addressed in an RFI. If you have zero experience developing an RFI, you may want to first seek out LIMSpec and other various example RFIs on the internet, as well as some basic advice articles on the topic. Some websites may provide templates to examine for further details. Broadly speaking, if you're conducting a full RFI or RFP, you're going to lead with the standard components of an RFI or RFP, including:\n\na table of contents;\nan honest introduction and overview of your organization, its goals and problems, and the services sought to solve them;\ndetails on how the RFI or RFP evaluation process will be conducted;\nbasis for award (if an RFP);\nthe calendar schedule (including times) for related events;\nhow to submit the document and any related questions about it, including response format; and\nyour organization's background, business requirements, and current technical environment.\nBeing honest about your organization, its informatics requirements, and its current technical environment upfront in the RFI or RFP will also ensure that the time spent on the process is optimized for all involved parties. Before submitting any RFI, your lab will want to conduct thorough internal research ensuring everyone understands what the current technology and processes are, and how you all want to shape that with the introduction or updating of laboratory informatics systems. (If your lab has limited to no experience with adding automation and informatics elements to a laboratory, you may want to read through laboratory informatics veteran Joe Liscouski's The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies for further insight.) You'll also want to answer critical questions such as \"who will be responsible for maintaining the solution and its security?\" and \"how will our processes and procedures change with the introduction or updating of informatics systems?\". These and other questions make up your business considerations, which should also address the:\n\nacquisition and long-term maintenance budget;\ndiversity of laboratory services offered now and into the future;\nlevel of in-house knowledge and experience with informatics systems and automation;\nlevel of in-house, executive buy-in of informatics adoption; and\nneed for additional vendor pre-planning.\nOne other note: make it clear in any issued RFI that it's strictly a request for information and not a guarantee to issue a contract with any respondent.\n\nReferences \n\n\n\u2191 1.0 1.1 Holmes, T.. \"It's a Match: How to Run a Good RFI, RFP, or RFQ and Find the Right Partner\". AllCloud Blog. https:\/\/allcloud.io\/blog\/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner\/ . Retrieved 11 February 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 11 February 2023, at 22:49.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 5 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","e99fafc9276c83fe0270540b6a58f93c_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_Issue_some_of_the_specification_as_part_of_a_request_for_information_RFI rootpage-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_Issue_some_of_the_specification_as_part_of_a_request_for_information_RFI skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/Issue some of the specification as part of a request for information (RFI)<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Introduction\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Introduction\" class=\"wiki-link\" data-key=\"dd550e2b577ba2800fc166f51fa74557\">the beginning<\/a> of this guide-----<\/div>\n<h3><span id=\"rdp-ebb-5.2_Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\"><\/span><span class=\"mw-headline\" id=\"5.2_Issue_some_of_the_specification_as_part_of_a_request_for_information_.28RFI.29\">5.2 Issue some of the specification as part of a request for information (RFI)<\/span><\/h3>\n<p>In some cases\u2014particularly if your organization is of significant size\u2014it may make sense to issue a formal RFI or request for proposal (RFP) and have laboratory informatics vendors approach your ISO\/IEC 17025 lab with how they can meet its needs. The RFI and RFP are traditional means towards soliciting bidding interest in an organization's project, containing the organization's specific requirements and vital questions that the bidder should be able to effectively answer. However, even if your organization chooses to skip the RFI or RFP process and do most of the investigative work of researching and approaching informatics vendors, turning to a key set of questions typically found in an RFI is extremely valuable towards your fact finding.\n<\/p><p>An RFI is an ideal means for learning more about a potential solution and how it can solve your problems, or for when you're not even sure how to solve your problem yet. However, the RFI should not be unduly long and tedious to complete for prospective vendors; it should be concise, direct, and honest. This means not only presenting a clear and humble vision of your own organization and its goals, but also asking just the right amount of questions to allow potential vendors to demonstrate their expertise and provide a clearer picture of who they are. Some take a technical approach to an RFI, using dense language and complicated spreadsheets for fact finding. However, as previously noted, you will want to limit the specified requirements in your RFI to those carefully chosen\u2014for example, ISO\/IEC 17025-specific requirements\u2014because they matter to you and your lab the most.<sup id=\"rdp-ebb-cite_ref-HolmesItsAMatch_1-0\" class=\"reference\"><a href=\"#cite_note-HolmesItsAMatch-1\">[1]<\/a><\/sup> \n<\/p><p>Remember, an RFI is not meant to answer all of your questions. The RFI is meant as a means to help narrow down your search to a few quality candidates while learning more about each other.<sup id=\"rdp-ebb-cite_ref-HolmesItsAMatch_1-1\" class=\"reference\"><a href=\"#cite_note-HolmesItsAMatch-1\">[1]<\/a><\/sup> Once the pool of potential software vendors is narrowed down, and you then participate in their demonstrations, you then can broadly add more requirements to the original collection of critical requirements from the RFI to ensure those providers meet all or most of your needs. That said, be cognizant that there may be no vendor that can meet each and every need of your lab. Your lab will have to make important decisions about which requirements are non-negotiable and which are more flexible. The vendors you engage with may be able to provide realistic advice in this regard, based upon your lab's requirements and their past experience with labs. As such, those vendors with real-world experience meeting the needs of ISO\/IEC 17025 laboratories may have a strong leg up on other vendors.\n<\/p><p>Again, a comprehensive specifications document like LIMSpec makes for one possible source from which you can draw the requirements that are most critical to be addressed in an RFI. If you have zero experience developing an RFI, you may want to first seek out LIMSpec and other various example RFIs on the internet, as well as some basic advice articles on the topic. Some websites may provide templates to examine for further details. Broadly speaking, if you're conducting a full RFI or RFP, you're going to lead with the standard components of an RFI or RFP, including:\n<\/p>\n<ul><li>a table of contents;<\/li>\n<li>an honest introduction and overview of your organization, its goals and problems, and the services sought to solve them;<\/li>\n<li>details on how the RFI or RFP evaluation process will be conducted;<\/li>\n<li>basis for award (if an RFP);<\/li>\n<li>the calendar schedule (including times) for related events;<\/li>\n<li>how to submit the document and any related questions about it, including response format; and<\/li>\n<li>your organization's background, business requirements, and current technical environment.<\/li><\/ul>\n<p>Being honest about your organization, its informatics requirements, and its current technical environment upfront in the RFI or RFP will also ensure that the time spent on the process is optimized for all involved parties. Before submitting any RFI, your lab will want to conduct thorough internal research ensuring everyone understands what the current technology and processes are, and how you all want to shape that with the introduction or updating of laboratory informatics systems. (If your lab has limited to no experience with adding <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_automation\" title=\"Laboratory automation\" class=\"wiki-link\" data-key=\"0061880849aeaca05f8aa27ae171f331\">automation<\/a> and informatics elements to a laboratory, you may want to read through laboratory informatics veteran Joe Liscouski's <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:The_Application_of_Informatics_to_Scientific_Work:_Laboratory_Informatics_for_Newbies\" title=\"LII:The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies\" class=\"wiki-link\" data-key=\"d8b467af534a70312a21f63b61be26cd\"><i>The Application of Informatics to Scientific Work: Laboratory Informatics for Newbies<\/i><\/a> for further insight.) You'll also want to answer critical questions such as \"who will be responsible for maintaining the solution and its security?\" and \"how will our processes and procedures change with the introduction or updating of informatics systems?\". These and other questions make up your business considerations, which should also address the:\n<\/p>\n<ul><li>acquisition and long-term maintenance budget;<\/li>\n<li>diversity of laboratory services offered now and into the future;<\/li>\n<li>level of in-house knowledge and experience with informatics systems and automation;<\/li>\n<li>level of in-house, executive buy-in of informatics adoption; and<\/li>\n<li>need for additional vendor pre-planning.<\/li><\/ul>\n<p>One other note: make it clear in any issued RFI that it's strictly a request for information and not a guarantee to issue a contract with any respondent.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-HolmesItsAMatch-1\"><span class=\"mw-cite-backlink\">\u2191 <sup><a href=\"#cite_ref-HolmesItsAMatch_1-0\">1.0<\/a><\/sup> <sup><a href=\"#cite_ref-HolmesItsAMatch_1-1\">1.1<\/a><\/sup><\/span> <span class=\"reference-text\"><span class=\"citation web\">Holmes, T.. <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/allcloud.io\/blog\/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner\/\" target=\"_blank\">\"It's a Match: How to Run a Good RFI, RFP, or RFQ and Find the Right Partner\"<\/a>. <i>AllCloud Blog<\/i><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/allcloud.io\/blog\/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner\/\" target=\"_blank\">https:\/\/allcloud.io\/blog\/its-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=It%27s+a+Match%3A+How+to+Run+a+Good+RFI%2C+RFP%2C+or+RFQ+and+Find+the+Right+Partner&rft.atitle=AllCloud+Blog&rft.aulast=Holmes%2C+T.&rft.au=Holmes%2C+T.&rft_id=https%3A%2F%2Fallcloud.io%2Fblog%2Fits-a-match-how-to-run-a-good-rfi-rfp-or-rfq-and-find-the-right-partner%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230211224944\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.045 seconds\nReal time usage: 0.058 seconds\nPreprocessor visited node count: 677\/1000000\nPost\u2010expand include size: 11112\/2097152 bytes\nTemplate argument size: 2165\/2097152 bytes\nHighest expansion depth: 14\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 1933\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 49.570 1 -total\n 78.52% 38.920 1 Template:Reflist\n 56.64% 28.078 1 Template:Cite_web\n 44.05% 21.836 1 Template:Citation\/core\n 21.22% 10.519 1 Template:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\n 11.08% 5.493 2 Template:Citation\/make_link\n 7.05% 3.493 1 Template:Column-width\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14034-0!canonical and timestamp 20230211224946 and revision id 51401. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Issue_some_of_the_specification_as_part_of_a_request_for_information_(RFI)<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","e99fafc9276c83fe0270540b6a58f93c_images":[],"e99fafc9276c83fe0270540b6a58f93c_timestamp":1676157327,"924c825b69d18b3a3915a0267176ef0f_type":"article","924c825b69d18b3a3915a0267176ef0f_title":"5.1 Conduct initial research into a specification document tailored to your lab's needs","924c825b69d18b3a3915a0267176ef0f_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs","924c825b69d18b3a3915a0267176ef0f_plaintext":"\n\nBook:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/Conduct initial research into a specification document tailored to your lab's needsFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n5. Taking the next step \nIn section 3.4 of this guide, we briefly discussed how a user requirements specification (URS) fits into the process of purchasing laboratory informatics solutions for your ISO\/IEC 17025 laboratory. The URS has been viewed as a means for the purchaser to ensure their needs are satisfied by the functionality of the software. Traditionally, this has turned into a \"wish list\" for the purchaser, which while somewhat practical still lacks in its finesse. One common problem with this wishlist approach is the risk of \"requirements creep,\" where more functionality than is truly necessary is desired, inevitably leading to a state where no vendor can meet all the wishlisted requirements. This makes selecting a solution even more difficult, particularly without significant prioritization skills.[1][2][3]\nNoting the potential problems with this wishlist approach, LIMSpec\u2014a requirement specification document for laboratory informatics solutions\u2014took a new approach and turned to standards and regulations that drive laboratories of all types, as well as the data they manage. LIMSpec was rebuilt based on ASTM E1578-18 Standard Guide for Laboratory Informatics, as well as dozens of other standards (including ISO\/IEC 17025) and regulations, while still leaving room for a software buyer to add their own custom requirements for their industry or lab. \nThe rest of this chapter examines the research, documentation, and acquisition process that the ISO\/IEC 17025 lab needing laboratory informatics solutions will want to go through, with an emphasis on the utility of a sound requirements specification. While LIMSpec is offered as a solid starting point, you don't strictly need to use LIMSpec to conduct this process; the information in this chapter can largely be applied with or without LIMSpec itself. However, as section 3.1.2 of Chapter 3 pointed out, LIMSpec was built with standards like ISO\/IEC 17025 in mind, making it relevant to the lab using software to better conform to the standard.\n\r\n\n\n 5.1 Conduct initial research into a specification document tailored to your lab's needs \nA specification is \"a detailed precise presentation of something or of a plan or proposal for something.\"[4] This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they \"present\" their use case with the help of a requirements specification, and the vendor \"presents\" their ability (or inability) to comply through documentation and demonstration (more on that later). However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. This is where initial specification research comes into play for the lab.\nYour lab's requirements specification document will eventually be a critical component for effectively selecting a laboratory informatics solution. There are numerous ways to approach the overall development of such a document. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your ISO\/IEC 17025 lab accomplish its goals. LIMSpec makes for one of the more thorough starting points to use, though you could also use other structured documents that have been developed by others. For the purposes of this guide, we'll look at LIMSpec.\nThe LIMSpec 2022 document is divided into five distinct sections, with numerous subsections in each:\n\nPrimary Laboratory Workflow\n1. Sample and experiment registration\n2. Sample management\n3. Core laboratory testing and experiments\n4. Results review and verification\n5. Sample, experiment, and study approval and verification\n6. Reporting\nMaintaining Laboratory Workflow and Operations\n7. Document and records management\n8. Resource management\n9. Compliance management\n10. Instrument and equipment management\n11. Batch and lot management\n12. Scheduled event management\n13. Instrument data capture and control\n14. Standard and reagent management\n15. Inventory management\n16. Investigation and quality management\nSpecialty Laboratory Functions (minus non-relevant industries)\n17. Production management\n18. Statistical trending and control charts\n19. Agriculture and food data management\n20. Environmental data management\n21. Forensic case and data management\n22. Clinical and public health data management\n23. Veterinary data management\n24. Scientific data management\n25. Health information technology\nTechnology and Performance Improvements\n26. Instrument data systems functions\n27. Systems integration\n28. Laboratory scheduling and capacity planning\n29. Lean laboratory and continuous improvement\n30. Artificial intelligence and smart systems\nSecurity and Integrity of Systems and Operations\n31. Data integrity\n32. Configuration management\n33. System validation and commission\n34. System administration\n35. Cybersecurity\n36. Information privacy\nThese sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements. \nDuring the initial research towards your URS, you won't have to include every requirement for when you approach potential vendors. Most vendors appreciate a more inviting approach that doesn't overwhelm, at least initially. You will want to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. In the case of a lab seeking a solution to help them better comply with ISO\/IEC 17025, one might want to make requirements related to the standard the practical starting point. (See Chapter 3, section 3.1.2, Table 1 for the full list.) Wherever you choose to start, you'll likely want to wait until after participating in several software demonstrations before even considering your URS to be complete. (More on that in 5.3.1.) This naturally leads us to a discussion about the request for information (RFI) process.\n\nReferences \n\n\n\u2191 Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1\u20136. doi:10.1109\/ICIET.2010.5625687.   \n \n\n\u2191 Hirsch, J. (22 November 2013). \"10 Steps To Successful Requirements Gathering\". Phase2 Technology, LLC. https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering . Retrieved 11 February 2023 .   \n \n\n\u2191 Burris, E. (2007). \"Requirements Specification\". CS451R, University of Missouri\u2013Kansas City. University of Missouri\u2013Kansas City. Archived from the original on 25 September 2019. https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . Retrieved 11 February 2023 .   \n \n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 11 February 2023 .   \n \n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 11 February 2023, at 22:49.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 4 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","924c825b69d18b3a3915a0267176ef0f_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab_s_needs rootpage-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Taking_the_next_step_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab_s_needs skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Taking the next step\/Conduct initial research into a specification document tailored to your lab's needs<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Introduction\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Introduction\" class=\"wiki-link\" data-key=\"dd550e2b577ba2800fc166f51fa74557\">the beginning<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"5._Taking_the_next_step\">5. Taking the next step<\/span><\/h2>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:Possible_features_in_web_cooperation_platforms_like_wikis.png\" class=\"image wiki-link\" data-key=\"f21b6350889fe6674e91e0e8a9914b63\"><img alt=\"Possible features in web cooperation platforms like wikis.png\" src=\"https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/4f\/Possible_features_in_web_cooperation_platforms_like_wikis.png\" decoding=\"async\" style=\"width: 100%;max-width: 400px;height: auto;\" \/><\/a><\/div><p>In section 3.4 of this guide, we briefly discussed how a user requirements specification (URS) fits into the process of purchasing <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solutions for your <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO\/IEC_17025\" title=\"ISO\/IEC 17025\" class=\"wiki-link\" data-key=\"0a89cebb34370dd860cce86881cbf29c\">ISO\/IEC 17025<\/a> <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a>. The URS has been viewed as a means for the purchaser to ensure their needs are satisfied by the functionality of the software. Traditionally, this has turned into a \"wish list\" for the purchaser, which while somewhat practical still lacks in its finesse. One common problem with this wishlist approach is the risk of \"requirements creep,\" where more functionality than is truly necessary is desired, inevitably leading to a state where no vendor can meet all the wishlisted requirements. This makes selecting a solution even more difficult, particularly without significant prioritization skills.<sup id=\"rdp-ebb-cite_ref-AasemAnalysis10_1-0\" class=\"reference\"><a href=\"#cite_note-AasemAnalysis10-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hirsch10Steps13_2-0\" class=\"reference\"><a href=\"#cite_note-Hirsch10Steps13-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BurrissSoftware07_3-0\" class=\"reference\"><a href=\"#cite_note-BurrissSoftware07-3\">[3]<\/a><\/sup>\n<\/p><p>Noting the potential problems with this wishlist approach, <a href=\"https:\/\/www.limswiki.org\/index.php\/LII:LIMSpec_2022_R2\" title=\"LII:LIMSpec 2022 R2\" class=\"wiki-link\" data-key=\"fcfd093af650d866ae1ed9ed8bbc08f9\">LIMSpec<\/a>\u2014a requirement specification document for laboratory informatics solutions\u2014took a new approach and turned to standards and regulations that drive laboratories of all types, as well as the data they manage. LIMSpec was rebuilt based on <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>, as well as dozens of other standards (including ISO\/IEC 17025) and regulations, while still leaving room for a software buyer to add their own custom requirements for their industry or lab. \n<\/p><p>The rest of this chapter examines the research, documentation, and acquisition process that the ISO\/IEC 17025 lab needing laboratory informatics solutions will want to go through, with an emphasis on the utility of a sound requirements specification. While LIMSpec is offered as a solid starting point, you don't strictly need to use LIMSpec to conduct this process; the information in this chapter can largely be applied with or without LIMSpec itself. However, as section 3.1.2 of Chapter 3 pointed out, LIMSpec was built with standards like ISO\/IEC 17025 in mind, making it relevant to the lab using software to better conform to the standard.\n<\/p><p><br \/>\n<\/p>\n<h3><span id=\"rdp-ebb-5.1_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab's_needs\"><\/span><span class=\"mw-headline\" id=\"5.1_Conduct_initial_research_into_a_specification_document_tailored_to_your_lab.27s_needs\">5.1 Conduct initial research into a specification document tailored to your lab's needs<\/span><\/h3>\n<p>A specification is \"a detailed precise presentation of something or of a plan or proposal for something.\"<sup id=\"rdp-ebb-cite_ref-MWSpec_4-0\" class=\"reference\"><a href=\"#cite_note-MWSpec-4\">[4]<\/a><\/sup> This concept of a specification as a presentation is critical to the laboratory seeking to find laboratory informatics software that fulfills their needs; they \"present\" their use case with the help of a requirements specification, and the vendor \"presents\" their ability (or inability) to comply through documentation and demonstration (more on that later). However, even the most seasoned of presenters at conferences and the like still require quality preparation before the presentation. This is where initial specification research comes into play for the lab.\n<\/p><p>Your lab's requirements specification document will eventually be a critical component for effectively selecting a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> solution. There are numerous ways to approach the overall development of such a document. But why re-invent the wheel when others have already gone down that road? Sure, you could search for examples of such documents on the internet and customize them to your needs, or you and your team could brainstorm how a laboratory informatics solution should help your ISO\/IEC 17025 lab accomplish its goals. LIMSpec makes for one of the more thorough starting points to use, though you could also use other structured documents that have been developed by others. For the purposes of this guide, we'll look at LIMSpec.\n<\/p><p>The <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMSpec_2022_R2\" title=\"Book:LIMSpec 2022 R2\" class=\"wiki-link\" data-key=\"df2e12ebefc2379e95f3f1956aac4400\">LIMSpec 2022<\/a> document is divided into five distinct sections, with numerous subsections in each:\n<\/p>\n<ul><li>Primary Laboratory Workflow\n<ul><li>1. Sample and experiment registration<\/li>\n<li>2. Sample management<\/li>\n<li>3. Core laboratory testing and experiments<\/li>\n<li>4. Results review and verification<\/li>\n<li>5. Sample, experiment, and study approval and verification<\/li>\n<li>6. Reporting<\/li><\/ul><\/li>\n<li>Maintaining Laboratory Workflow and Operations\n<ul><li>7. Document and records management<\/li>\n<li>8. Resource management<\/li>\n<li>9. Compliance management<\/li>\n<li>10. Instrument and equipment management<\/li>\n<li>11. Batch and lot management<\/li>\n<li>12. Scheduled event management<\/li>\n<li>13. Instrument data capture and control<\/li>\n<li>14. Standard and reagent management<\/li>\n<li>15. Inventory management<\/li>\n<li>16. Investigation and quality management<\/li><\/ul><\/li>\n<li>Specialty Laboratory Functions (minus non-relevant industries)\n<ul><li>17. Production management<\/li>\n<li>18. Statistical trending and control charts<\/li>\n<li>19. Agriculture and food data management<\/li>\n<li>20. Environmental data management<\/li>\n<li>21. Forensic case and data management<\/li>\n<li>22. Clinical and public health data management<\/li>\n<li>23. Veterinary data management<\/li>\n<li>24. Scientific data management<\/li>\n<li>25. Health information technology<\/li><\/ul><\/li>\n<li>Technology and Performance Improvements\n<ul><li>26. Instrument data systems functions<\/li>\n<li>27. Systems integration<\/li>\n<li>28. Laboratory scheduling and capacity planning<\/li>\n<li>29. Lean laboratory and continuous improvement<\/li>\n<li>30. Artificial intelligence and smart systems<\/li><\/ul><\/li>\n<li>Security and Integrity of Systems and Operations\n<ul><li>31. Data integrity<\/li>\n<li>32. Configuration management<\/li>\n<li>33. System validation and commission<\/li>\n<li>34. System administration<\/li>\n<li>35. Cybersecurity<\/li>\n<li>36. Information privacy<\/li><\/ul><\/li><\/ul>\n<p>These sections and subsections should be able to address most any requirement you have for your system. Of course, if something isn't covered by LIMSpec, you can always add additional requirements. \n<\/p><p>During the initial research towards your URS, you won't have to include every requirement for when you approach potential vendors. Most vendors appreciate a more inviting approach that doesn't overwhelm, at least initially. You will want to go with a limited yet practical set of requirements carefully chosen because they matter to you and your laboratory the most. In the case of a lab seeking a solution to help them better comply with ISO\/IEC 17025, one might want to make requirements related to the standard the practical starting point. (See Chapter 3, section 3.1.2, Table 1 for the full list.) Wherever you choose to start, you'll likely want to wait until after participating in several software demonstrations before even considering your URS to be complete. (More on that in 5.3.1.) This naturally leads us to a discussion about the request for information (RFI) process.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-AasemAnalysis10-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AasemAnalysis10_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". <i>Proceedings from the 2010 International Conference on Information and Emerging Technologies<\/i>: 1\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FICIET.2010.5625687\" target=\"_blank\">10.1109\/ICIET.2010.5625687<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Analysis+and+optimization+of+software+requirements+prioritization+techniques&rft.jtitle=Proceedings+from+the+2010+International+Conference+on+Information+and+Emerging+Technologies&rft.aulast=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.au=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.date=2010&rft.pages=1%E2%80%936&rft_id=info:doi\/10.1109%2FICIET.2010.5625687&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Hirsch10Steps13-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Hirsch10Steps13_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hirsch, J. (22 November 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">\"10 Steps To Successful Requirements Gathering\"<\/a>. Phase2 Technology, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=10+Steps+To+Successful+Requirements+Gathering&rft.atitle=&rft.aulast=Hirsch%2C+J.&rft.au=Hirsch%2C+J.&rft.date=22+November+2013&rft.pub=Phase2+Technology%2C+LLC&rft_id=https%3A%2F%2Fwww.phase2technology.com%2Fblog%2Fsuccessful-requirements-gathering&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BurrissSoftware07-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurrissSoftware07_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Burris, E. (2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">\"Requirements Specification\"<\/a>. <i>CS451R, University of Missouri\u2013Kansas City<\/i>. University of Missouri\u2013Kansas City. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">the original<\/a> on 25 September 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190925003040\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Requirements+Specification&rft.atitle=CS451R%2C+University+of+Missouri%E2%80%93Kansas+City&rft.aulast=Burris%2C+E.&rft.au=Burris%2C+E.&rft.date=2007&rft.pub=University+of+Missouri%E2%80%93Kansas+City&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190925003040%2Fhttp%3A%2F%2Fsce2.umkc.edu%2FBIT%2Fburrise%2Fpl%2Frequirements%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MWSpec-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWSpec_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">\"specification\"<\/a>. <i>Merriam-Webster<\/i>. Merriam-Webster, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">https:\/\/www.merriam-webster.com\/dictionary\/specification<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=specification&rft.atitle=Merriam-Webster&rft.pub=Merriam-Webster%2C+Inc&rft_id=https%3A%2F%2Fwww.merriam-webster.com%2Fdictionary%2Fspecification&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<!-- \nNewPP limit report\nCached time: 20230211224922\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.542 seconds\nReal time usage: 0.807 seconds\nPreprocessor visited node count: 2784\/1000000\nPost\u2010expand include size: 26309\/2097152 bytes\nTemplate argument size: 7717\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 6601\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 110.813 1 -total\n 90.16% 99.910 1 Template:Reflist\n 61.56% 68.213 4 Template:Citation\/core\n 40.52% 44.903 3 Template:Cite_web\n 35.03% 38.819 1 Template:Cite_journal\n 10.62% 11.765 1 Template:Citation\/identifier\n 9.69% 10.736 1 Template:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab's_needs\n 8.71% 9.652 2 Template:Date\n 4.77% 5.287 7 Template:Citation\/make_link\n 3.08% 3.412 1 Template:Only_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14033-0!canonical and timestamp 20230211224923 and revision id 51400. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Taking_the_next_step\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","924c825b69d18b3a3915a0267176ef0f_images":["https:\/\/upload.wikimedia.org\/wikipedia\/commons\/4\/4f\/Possible_features_in_web_cooperation_platforms_like_wikis.png"],"924c825b69d18b3a3915a0267176ef0f_timestamp":1676157327,"a0e6384db464e8944370e00320674da2_type":"article","a0e6384db464e8944370e00320674da2_title":"4.4 LIMSpec","a0e6384db464e8944370e00320674da2_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec","a0e6384db464e8944370e00320674da2_plaintext":"\n\nBook:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Resources for selecting and implementing informatics solutions\/LIMSpecFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n4.4 LIMSpec \nLIMSpec is an ever-evolving set of software user requirements specifications for laboratory informatics systems, especially the laboratory information management system (LIMS). The specification has grown significantly from its humble origins over a decade ago. Earlier versions of LIMSpec focused on a mix of both regulatory requirements and clients' \"wishlist\" features for a given system. The wishlist items haven't necessarily been ignored by developers, but they do in fact have to be prioritized by the potential buyer as \"nice to have\" or \"essential to system operation,\" or something in between.[1][2][3] This latest version is different, focusing strictly on a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems. \nAt its core, LIMSpec is rooted in ASTM E1578-18 Standard Guide for Laboratory Informatics. With the latest version released in 2018, the standard includes an updated Laboratory Informatics Functional Requirements checklist, which \"covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide.\" It goes on to state that the checklist \"is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system,\" though it is certainly \"not meant to be exhaustive.\"\nLIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources, including ISO\/IEC 17025. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, the LIMSpec should also definitely be considered a continual work in progress, with more to be added as new pertinent regulations, standards, and guidance are discovered.\nIf you've never worked with a user requirements specification document, the concept remains relatively simple to grasp. Merriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"[4] Within this organized \"plan or proposal\" are requirements. A requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level), or it may be specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered.\nAn example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.[5]\nSection 3.1.2 of Chapter 3 took those specific LIMSpec requirements linked to ISO\/IEC 17025 and presented them as a means to demonstrate the critical functionality a LIMS should have in order for a laboratory to more easily comply with the standard. However, there's more to LIMSpec than just those requirements. The requirements span multiple areas of laboratory workflow and practice, from the core functions of a lab to its ancillary operations, specialty functions, technology and performance touch points, and data and security touch points. As of December 2022, LIMSpec is based off more than 130 regulations, standards, guidance documents, and more, proving to be a robust starting point for labs seeking to use a requirements specification to acquire a LIMS.\nThe next chapter discusses the user requirements specification, using LIMSpec as an example. You'll learn how to shape such a specification to your laboratory's needs, how to issue the specification as a request for information (RFI), and how to get the most out of it when getting decision-related information from vendors.\n\nReferences \n\n\n\u2191 Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". Proceedings from the 2010 International Conference on Information and Emerging Technologies: 1\u20136. doi:10.1109\/ICIET.2010.5625687.   \n \n\n\u2191 Hirsch, J. (22 November 2013). \"10 Steps To Successful Requirements Gathering\". Phase2 Technology, LLC. https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering . Retrieved 11 February 2023 .   \n \n\n\u2191 Burris, E. (2007). \"Requirements Specification\". CS451R, University of Missouri\u2013Kansas City. University of Missouri\u2013Kansas City. Archived from the original on 24 July 2019. https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/ . Retrieved 11 February 2023 .   \n \n\n\u2191 \"specification\". Merriam-Webster. Merriam-Webster, Inc. https:\/\/www.merriam-webster.com\/dictionary\/specification . Retrieved 11 February 2023 .   \n \n\n\u2191 Memon, A. (Spring 2010). \"Software Requirements: Descriptions and specifications of a system\" (PDF). University of Maryland. https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf . Retrieved 11 February 2023 .   \n \n\n\n\r\n\n\n-----Go to the next chapter of this guide-----\nCitation information for this chapter \nChapter: 5. Taking the next step\nTitle: LIMS Selection Guide for ISO\/IEC 17025 Laboratories\nEdition: First Edition\nAuthor for citation: Shawn E. Douglas\nLicense for content: Creative Commons Attribution-ShareAlike 4.0 International\nPublication date: February 2023\n\r\n\n\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 11 February 2023, at 22:47.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 6 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","a0e6384db464e8944370e00320674da2_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Resources_for_selecting_and_implementing_informatics_solutions_LIMSpec rootpage-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Resources_for_selecting_and_implementing_informatics_solutions_LIMSpec skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Resources for selecting and implementing informatics solutions\/LIMSpec<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Introduction\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Introduction\" class=\"wiki-link\" data-key=\"dd550e2b577ba2800fc166f51fa74557\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"4.4_LIMSpec\">4.4 LIMSpec<\/span><\/h3>\n<div class=\"floatright\"><a href=\"https:\/\/www.limswiki.org\/index.php\/File:LIMSpec.png\" class=\"image wiki-link\" data-key=\"458080cdb6c7fba72b986707492b5a98\"><img alt=\"LIMSpec.png\" src=\"https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/9\/97\/LIMSpec.png\" decoding=\"async\" width=\"240\" height=\"105\" \/><\/a><\/div><p><a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMSpec_2022_R2\" title=\"Book:LIMSpec 2022 R2\" class=\"wiki-link\" data-key=\"df2e12ebefc2379e95f3f1956aac4400\">LIMSpec<\/a> is an ever-evolving set of software user requirements specifications for <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_informatics\" title=\"Laboratory informatics\" class=\"wiki-link\" data-key=\"00edfa43edcde538a695f6d429280301\">laboratory informatics<\/a> systems, especially the <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory_information_management_system\" title=\"Laboratory information management system\" class=\"wiki-link\" data-key=\"8ff56a51d34c9b1806fcebdcde634d00\">laboratory information management system<\/a> (LIMS). The specification has grown significantly from its humble origins over a decade ago. Earlier versions of LIMSpec focused on a mix of both regulatory requirements and clients' \"wishlist\" features for a given system. The wishlist items haven't necessarily been ignored by developers, but they do in fact have to be prioritized by the potential buyer as \"nice to have\" or \"essential to system operation,\" or something in between.<sup id=\"rdp-ebb-cite_ref-AasemAnalysis10_1-0\" class=\"reference\"><a href=\"#cite_note-AasemAnalysis10-1\">[1]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-Hirsch10Steps13_2-0\" class=\"reference\"><a href=\"#cite_note-Hirsch10Steps13-2\">[2]<\/a><\/sup><sup id=\"rdp-ebb-cite_ref-BurrissSoftware07_3-0\" class=\"reference\"><a href=\"#cite_note-BurrissSoftware07-3\">[3]<\/a><\/sup> This latest version is different, focusing strictly on a regulatory-, standards-, and guidance-based approach to building a specification document for laboratory informatics systems. \n<\/p><p>At its core, LIMSpec is rooted in <a href=\"https:\/\/www.limswiki.org\/index.php\/ASTM_E1578\" title=\"ASTM E1578\" class=\"wiki-link\" data-key=\"74b64479a39bee791aacc4605b78a061\">ASTM E1578-18<\/a> <i>Standard Guide for Laboratory Informatics<\/i>. With the latest version released in 2018, the standard includes an updated Laboratory Informatics Functional Requirements checklist, which \"covers functionality common to the various laboratory informatics systems discussed throughout [the] guide as well as requirements recommended as part of [the] guide.\" It goes on to state that the checklist \"is an example of typical requirements that can be used to guide the purchase, upgrade, or development of a laboratory informatics system,\" though it is certainly \"not meant to be exhaustive.\"\n<\/p><p>LIMSpec borrows from that requirements checklist and then adds more to it from a wide variety of sources, including <a href=\"https:\/\/www.limswiki.org\/index.php\/ISO\/IEC_17025\" title=\"ISO\/IEC 17025\" class=\"wiki-link\" data-key=\"0a89cebb34370dd860cce86881cbf29c\">ISO\/IEC 17025<\/a>. An attempt has been made to find the most relevant regulations, standards, and guidance that shape how a compliant laboratory informatics system is developed and maintained. However, the LIMSpec should also definitely be considered a continual work in progress, with more to be added as new pertinent regulations, standards, and guidance are discovered.\n<\/p><p>If you've never worked with a user requirements specification document, the concept remains relatively simple to grasp. Merriam-Webster defines a \"specification\" as \"a detailed precise presentation of something or of a plan or proposal for something.\"<sup id=\"rdp-ebb-cite_ref-MWSpec_4-0\" class=\"reference\"><a href=\"#cite_note-MWSpec-4\">[4]<\/a><\/sup> Within this organized \"plan or proposal\" are requirements. A requirement typically comes in the form of a statement that begins with \"the system\/user\/vendor shall\/should ...\" and focuses on a provided service, reaction to input, or expected behavior in a given situation. The statement may be abstract (high-level), or it may be specific and detailed to a precise function. The statement may also be of a functional nature, describing functionality or services in detail, or of a non-functional nature, describing the constraints of a given functionality or service and how it's rendered.\n<\/p><p>An example of a functional software requirement could be \"the user shall be able to query either all of the initial set of databases or select a subset from it.\" This statement describes specific functionality the system should have. On the other hand, a non-functional requirement, for example, may state \"the system's query tool shall conform to the ABC 123-2014 standard.\" The statement describes a constraint placed upon the system's query functionality. Once compiled, a set of requirements can serve not only to strengthen the software requirements specification, but the requirements set can also be used for bidding on a contract or serve as the basis for a specific contract that is being finalized.<sup id=\"rdp-ebb-cite_ref-MemonSoftware10_5-0\" class=\"reference\"><a href=\"#cite_note-MemonSoftware10-5\">[5]<\/a><\/sup>\n<\/p><p>Section 3.1.2 of Chapter 3 took those specific LIMSpec requirements linked to ISO\/IEC 17025 and presented them as a means to demonstrate the critical functionality a LIMS should have in order for a <a href=\"https:\/\/www.limswiki.org\/index.php\/Laboratory\" title=\"Laboratory\" class=\"wiki-link\" data-key=\"c57fc5aac9e4abf31dccae81df664c33\">laboratory<\/a> to more easily comply with the standard. However, there's more to LIMSpec than just those requirements. The requirements span multiple areas of laboratory <a href=\"https:\/\/www.limswiki.org\/index.php\/Workflow\" title=\"Workflow\" class=\"wiki-link\" data-key=\"92bd8748272e20d891008dcb8243e8a8\">workflow<\/a> and practice, from the core functions of a lab to its ancillary operations, specialty functions, technology and performance touch points, and data and security touch points. As of December 2022, LIMSpec is based off more than 130 regulations, standards, guidance documents, and more, proving to be a robust starting point for labs seeking to use a requirements specification to acquire a LIMS.\n<\/p><p>The next chapter discusses the user requirements specification, using LIMSpec as an example. You'll learn how to shape such a specification to your laboratory's needs, how to issue the specification as a request for information (RFI), and how to get the most out of it when getting decision-related information from vendors.\n<\/p>\n<h2><span class=\"mw-headline\" id=\"References\">References<\/span><\/h2>\n<div class=\"reflist references-column-width\" style=\"-moz-column-width: 30em; -webkit-column-width: 30em; column-width: 30em; list-style-type: decimal;\">\n<div class=\"mw-references-wrap\"><ol class=\"references\">\n<li id=\"cite_note-AasemAnalysis10-1\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-AasemAnalysis10_1-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation Journal\">Aasem, M.; Ramzan, M.; Jaffar, A. (2010). \"Analysis and optimization of software requirements prioritization techniques\". <i>Proceedings from the 2010 International Conference on Information and Emerging Technologies<\/i>: 1\u20136. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1109%2FICIET.2010.5625687\" target=\"_blank\">10.1109\/ICIET.2010.5625687<\/a>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Analysis+and+optimization+of+software+requirements+prioritization+techniques&rft.jtitle=Proceedings+from+the+2010+International+Conference+on+Information+and+Emerging+Technologies&rft.aulast=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.au=Aasem%2C+M.%3B+Ramzan%2C+M.%3B+Jaffar%2C+A.&rft.date=2010&rft.pages=1%E2%80%936&rft_id=info:doi\/10.1109%2FICIET.2010.5625687&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-Hirsch10Steps13-2\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-Hirsch10Steps13_2-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Hirsch, J. (22 November 2013). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">\"10 Steps To Successful Requirements Gathering\"<\/a>. Phase2 Technology, LLC<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering\" target=\"_blank\">https:\/\/www.phase2technology.com\/blog\/successful-requirements-gathering<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=10+Steps+To+Successful+Requirements+Gathering&rft.atitle=&rft.aulast=Hirsch%2C+J.&rft.au=Hirsch%2C+J.&rft.date=22+November+2013&rft.pub=Phase2+Technology%2C+LLC&rft_id=https%3A%2F%2Fwww.phase2technology.com%2Fblog%2Fsuccessful-requirements-gathering&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-BurrissSoftware07-3\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-BurrissSoftware07_3-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Burris, E. (2007). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">\"Requirements Specification\"<\/a>. <i>CS451R, University of Missouri\u2013Kansas City<\/i>. University of Missouri\u2013Kansas City. Archived from <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">the original<\/a> on 24 July 2019<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/\" target=\"_blank\">https:\/\/web.archive.org\/web\/20190724173601\/http:\/\/sce2.umkc.edu\/BIT\/burrise\/pl\/requirements\/<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Requirements+Specification&rft.atitle=CS451R%2C+University+of+Missouri%E2%80%93Kansas+City&rft.aulast=Burris%2C+E.&rft.au=Burris%2C+E.&rft.date=2007&rft.pub=University+of+Missouri%E2%80%93Kansas+City&rft_id=https%3A%2F%2Fweb.archive.org%2Fweb%2F20190724173601%2Fhttp%3A%2F%2Fsce2.umkc.edu%2FBIT%2Fburrise%2Fpl%2Frequirements%2F&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MWSpec-4\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MWSpec_4-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\"><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">\"specification\"<\/a>. <i>Merriam-Webster<\/i>. Merriam-Webster, Inc<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.merriam-webster.com\/dictionary\/specification\" target=\"_blank\">https:\/\/www.merriam-webster.com\/dictionary\/specification<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=specification&rft.atitle=Merriam-Webster&rft.pub=Merriam-Webster%2C+Inc&rft_id=https%3A%2F%2Fwww.merriam-webster.com%2Fdictionary%2Fspecification&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<li id=\"cite_note-MemonSoftware10-5\"><span class=\"mw-cite-backlink\"><a href=\"#cite_ref-MemonSoftware10_5-0\">\u2191<\/a><\/span> <span class=\"reference-text\"><span class=\"citation web\">Memon, A. (Spring 2010). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf\" target=\"_blank\">\"Software Requirements: Descriptions and specifications of a system\"<\/a> (PDF). University of Maryland<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf\" target=\"_blank\">https:\/\/www.cs.umd.edu\/~atif\/Teaching\/Spring2010\/Slides\/3.pdf<\/a><\/span><span class=\"reference-accessdate\">. Retrieved 11 February 2023<\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Software+Requirements%3A+Descriptions+and+specifications+of+a+system&rft.atitle=&rft.aulast=Memon%2C+A.&rft.au=Memon%2C+A.&rft.date=Spring+2010&rft.pub=University+of+Maryland&rft_id=https%3A%2F%2Fwww.cs.umd.edu%2F%7Eatif%2FTeaching%2FSpring2010%2FSlides%2F3.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\"><span style=\"display: none;\"> <\/span><\/span>\n<\/span>\n<\/li>\n<\/ol><\/div><\/div>\n<p><br \/>\n<\/p>\n<div align=\"center\">-----Go to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Conduct_initial_research_into_a_specification_document_tailored_to_your_lab%27s_needs\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Conduct initial research into a specification document tailored to your lab's needs\" class=\"wiki-link\" data-key=\"6ba34bea66d49f836892b6c628f201b1\">the next chapter<\/a> of this guide-----<\/div>\n<h2><span class=\"mw-headline\" id=\"Citation_information_for_this_chapter\">Citation information for this chapter<\/span><\/h2>\n<p><b>Chapter<\/b>: 5. Taking the next step\n<\/p><p><b>Title<\/b>: <i>LIMS Selection Guide for ISO\/IEC 17025 Laboratories<\/i>\n<\/p><p><b>Edition<\/b>: First Edition\n<\/p><p><b>Author for citation<\/b>: Shawn E. Douglas\n<\/p><p><b>License for content<\/b>: <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/creativecommons.org\/licenses\/by-sa\/4.0\/\" target=\"_blank\">Creative Commons Attribution-ShareAlike 4.0 International<\/a>\n<\/p><p><b>Publication date<\/b>: February 2023\n<\/p><p><br \/>\n<\/p>\n<!-- \nNewPP limit report\nCached time: 20230211225113\nCache expiry: 86400\nDynamic content: false\nComplications: []\nCPU time usage: 0.172 seconds\nReal time usage: 0.199 seconds\nPreprocessor visited node count: 3457\/1000000\nPost\u2010expand include size: 28492\/2097152 bytes\nTemplate argument size: 9236\/2097152 bytes\nHighest expansion depth: 18\/40\nExpensive parser function count: 0\/100\nUnstrip recursion depth: 0\/20\nUnstrip post\u2010expand size: 7946\/5000000 bytes\n-->\n<!--\nTransclusion expansion time report (%,ms,calls,template)\n100.00% 167.799 1 -total\n 92.39% 155.032 1 Template:Reflist\n 67.49% 113.248 5 Template:Citation\/core\n 46.78% 78.492 4 Template:Cite_web\n 33.30% 55.877 1 Template:Cite_journal\n 11.28% 18.930 3 Template:Date\n 10.59% 17.772 1 Template:Citation\/identifier\n 7.50% 12.588 1 Template:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\n 5.43% 9.116 8 Template:Citation\/make_link\n 3.56% 5.980 2 Template:Hide_in_print\n-->\n\n<!-- Saved in parser cache with key limswiki:pcache:idhash:14031-0!canonical and timestamp 20230211225113 and revision id 51397. Serialized with JSON.\n -->\n<\/div><\/div><div class=\"printfooter\">Source: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/LIMSpec<\/a><\/div>\n<!-- end content --><div class=\"visualClear\"><\/div><\/div><\/div><div class=\"visualClear\"><\/div><\/div><!-- end of the left (by default at least) column --><div class=\"visualClear\"><\/div><\/div>\n\n\n\n<\/body>","a0e6384db464e8944370e00320674da2_images":["https:\/\/s3.limswiki.org\/www.limswiki.org\/images\/9\/97\/LIMSpec.png"],"a0e6384db464e8944370e00320674da2_timestamp":1676157326,"36794a21999ad917163b298f2138c7d9_type":"article","36794a21999ad917163b298f2138c7d9_title":"4.3 Other resources","36794a21999ad917163b298f2138c7d9_url":"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources","36794a21999ad917163b298f2138c7d9_plaintext":"\n\nBook:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Resources for selecting and implementing informatics solutions\/Other resourcesFrom LIMSWikiJump to navigationJump to search-----Return to the beginning of this guide-----\n4.3 Other resources \n 4.3.1 ISO\/IEC 17025 accreditation bodies \nWhat follows is a set of examples of accreditation bodies handling ISO\/IEC 17025 accreditation for laboratories around the world. For a more complete list of accreditation bodies, see the International Laboratory Accreditation Cooperation (ILAC) directory of approved bodies. \n\nAccredia, the Italian Accreditation Body (Italy)\nAmerican Association for Laboratory Accreditation (A2LA) (U.S.)\nAmerican Industrial Hygiene Association (AIHA) (U.S.)\nANSI National Accreditation Board (ANAB) (U.S.)\nBureau of Accreditation (BoA) (Vietnam)\nCanadian Association for Laboratory Accreditation (CALA) (Canada)\nComit\u00e9 fran\u00e7ais d'accr\u00e9ditation (Cofrac) (France)\nDeutsche Akkreditierungsstelle (DAkkS) (Germany)\nDutch Accreditation Council (RVA) (Netherlands)\nEgyptian Accreditation Council (EGAC) (Egypt)\nInstitute for Accreditation of B&H (BATA) (Bosnia and Herzegovina)\nInternational Accreditation New Zealand (IANZ) (New Zealand)\nInternational Accreditation Service (IAS) (U.S.)\nIrish National Accreditation Board (INAB) (Ireland)\nKomite Akreditasi Nasional (KAN) (Indonesia)\nKorea Laboratory Accreditation Scheme (KOLAS) (South Korea)\nNational Accreditation Board for Testing and Calibration Laboratories (NABL) (India)\nNational Association of Testing Authorities (NATA) (Australia)\nNational Research Council of Canada (NRC) (Canada)\nNational Voluntary Laboratory Accreditation Program (NVLAP) (U.S.)\nPerry Johnson Laboratory Accreditation (PJLA) (U.S.)\nSpanish Association for Standardization and Certification (AENOR) (Spain)\nStandards Council of Canada (SCC) (Canada)\n 4.3.2 ISO\/IEC 17025 reference and resource library \nGuides:\n\nAssociation of Public Health Laboratories (February 2018). \"Laboratory Costs of ISO\/IEC 17025 Accreditation: A 2017 Survey Report\" (PDF). https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf .   \nDouglas, S.E. (21 February 2022). \"FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors\". LIMSwiki.org. https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors .   \nMehta, B. (2019) (PDF). Implementing ISO\/IEC 17025:2017 (2nd ed.). ASQ Quality Press. ISBN 9780873899802. https:\/\/pasargadabzar.com\/wp-content\/uploads\/2022\/04\/Implementing-ISOIEC-170252017-by-Bob-Mehta.pdf .   \nNational Association of Testing Authorities (April 2018). \"General Accreditation Guidance: ISO\/IEC 17025:2017 Gap analysis\" (PDF). https:\/\/nata.com.au\/files\/2021\/05\/17025-2017-Gap-analysis.pdf .   \nPerry Johnson Consulting, Inc (January 2022). \"ISO\/IEC 17025:2017 Testing and Calibration Laboratories: An Executive Overview\" (PDF). https:\/\/www.pjcinc.com\/Downloads\/ISOIEC17025_exov.pdf .   \nPortuguese Accreditation Institute (10 November 2019). \"Guide for ISO\/IEC 17025 Application\" (PDF). http:\/\/www.ipac.pt\/docs\/publicdocs\/requisitos\/OGC001_GuiaAplicacao17025_v20181231_En_20191110.pdf .   \nVehring, S. (June 2020). \"Tested & Accepted: Implementing ISO\/IEC 17025:2017\" (PDF). United Nations Industrial Development Organization. https:\/\/www.unido.org\/sites\/default\/files\/files\/2020-06\/Guide%20ISO%2017025-2017_online.pdf .   \n\r\n\nJournal articles:\n\nDror, Itiel E.; Pierce, Michal L. (1 May 2020). \"ISO Standards Addressing Issues of Bias and Impartiality in Forensic Work\" (in en). Journal of Forensic Sciences 65 (3): 800\u2013808. doi:10.1111\/1556-4029.14265. ISSN 0022-1198. https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1556-4029.14265 .   \nKrismastuti, Fransiska Sri Herwahyu; Habibie, Muhammad Haekal (1 December 2022). \"Complying with the resource requirements of ISO\/IEC 17025:2017 in Indonesian calibration and testing laboratories: current challenges and future directions\" (in en). Accreditation and Quality Assurance 27 (6): 359\u2013367. doi:10.1007\/s00769-022-01523-w. ISSN 0949-1775. PMC PMC9579603. PMID 36275871. https:\/\/link.springer.com\/10.1007\/s00769-022-01523-w .   \nMandal, Goutam; Ansari, M. A.; Aswal, D. K. (1 September 2021). \"Quality Management System at NPLI: Transition of ISO\/IEC 17025 From 2005 to 2017 and Implementation of ISO 17034: 2016\" (in en). MAPAN 36 (3): 657\u2013668. doi:10.1007\/s12647-021-00490-w. ISSN 0970-3950. PMC PMC8308083. https:\/\/link.springer.com\/10.1007\/s12647-021-00490-w .   \nMiguel, Anna; Moreira, Renata; Oliveira, Andr\u00e9 (2021). \"ISO\/IEC 17025: History and Introduction of Concepts\". Qu\u00edmica Nova. doi:10.21577\/0100-4042.20170726. https:\/\/www.limswiki.org\/index.php\/Journal:ISO\/IEC_17025:_History_and_introduction_of_concepts .   \nMonteiro Bastos da Silva, Juliana; Chaker, Jade; Martail, Audrey; Costa Moreira, Josino; David, Arthur; Le Bot, Barbara (26 January 2021). \"Improving Exposure Assessment Using Non-Targeted and Suspect Screening: The ISO\/IEC 17025: 2017 Quality Standard as a Guideline\" (in en). Journal of Xenobiotics 11 (1): 1\u201315. doi:10.3390\/jox11010001. ISSN 2039-4713. PMC PMC7838891. PMID 33530331. https:\/\/www.mdpi.com\/2039-4713\/11\/1\/1 .   \nNeves, Rodrigo S.; Da Silva, Daniel P.; Galhardo, Carlos E.C.; Ferreira, Erlon H.M.; Trommer, Rafael M.; Damasceno, Jailton C. (22 February 2017), Kounis, Leo D., ed., \"Key Aspects for Implementing ISO\/IEC 17025 Quality Management Systems at Materials Science Laboratories\" (in en), Quality Control and Assurance - An Ancient Greek Term Re-Mastered (InTech), doi:10.5772\/66100, ISBN 978-953-51-2921-9, http:\/\/www.intechopen.com\/books\/quality-control-and-assurance-an-ancient-greek-term-re-mastered\/key-aspects-for-implementing-iso-iec-17025-quality-management-systems-at-materials-science-laborator   \nOkezue, Mercy A.; Adeyeye, Mojisola C.; Byrn, Steve J.; Abiola, Victor O.; Clase, Kari L. (1 December 2020). \"Impact of ISO\/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case study\" (in en). BMC Health Services Research 20 (1): 1065. doi:10.1186\/s12913-020-05934-8. ISSN 1472-6963. PMC PMC7686690. PMID 33228675. https:\/\/bmchealthservres.biomedcentral.com\/articles\/10.1186\/s12913-020-05934-8 .   \nPillai, Segaran; Calvert, Jennifer; Fox, Elizabeth (3 November 2022). \"Practical considerations for laboratories: Implementing a holistic quality management system\". Frontiers in Bioengineering and Biotechnology 10: 1040103. doi:10.3389\/fbioe.2022.1040103. ISSN 2296-4185. PMC PMC9670165. PMID 36406233. https:\/\/www.frontiersin.org\/articles\/10.3389\/fbioe.2022.1040103\/full .   \n\r\n\nOther useful documents:\n\nLIMSpec 2022 R2\nNIST Quality System for Measurement Services\n\n\n\n\nSource: <a rel=\"external_link\" class=\"external\" href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\">https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources<\/a>\nNavigation menuPage actionsBookDiscussionView sourceHistoryPage actionsBookDiscussionMoreToolsIn other languagesPersonal toolsLog inRequest accountNavigationMain pageEncyclopedic articlesRecent changesRandom pageHelp about MediaWikiSearch\u00a0 ToolsWhat links hereRelated changesSpecial pagesPermanent linkPage informationPopular publications\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\n\n\t\r\nPrint\/exportCreate a bookDownload as PDFDownload as PDFDownload as Plain textPrintable version This page was last edited on 11 February 2023, at 22:57.Content is available under a Creative Commons Attribution-ShareAlike 4.0 International License unless otherwise noted.This page has been accessed 10 times.Privacy policyAbout LIMSWikiDisclaimers\n\n\n\n","36794a21999ad917163b298f2138c7d9_html":"<body class=\"mediawiki ltr sitedir-ltr mw-hide-empty-elt ns-208 ns-subject page-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Resources_for_selecting_and_implementing_informatics_solutions_Other_resources rootpage-Book_LIMS_Selection_Guide_for_ISO_IEC_17025_Laboratories_Resources_for_selecting_and_implementing_informatics_solutions_Other_resources skin-monobook action-view skin--responsive\"><div id=\"rdp-ebb-globalWrapper\"><div id=\"rdp-ebb-column-content\"><div id=\"rdp-ebb-content\" class=\"mw-body\" role=\"main\"><a id=\"rdp-ebb-top\"><\/a>\n<h1 id=\"rdp-ebb-firstHeading\" class=\"firstHeading\" lang=\"en\">Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Resources for selecting and implementing informatics solutions\/Other resources<\/h1><div id=\"rdp-ebb-bodyContent\" class=\"mw-body-content\"><!-- start content --><div id=\"rdp-ebb-mw-content-text\" lang=\"en\" dir=\"ltr\" class=\"mw-content-ltr\"><div class=\"mw-parser-output\"><div align=\"center\">-----Return to <a href=\"https:\/\/www.limswiki.org\/index.php\/Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Introduction\" title=\"Book:LIMS Selection Guide for ISO\/IEC 17025 Laboratories\/Introduction\" class=\"wiki-link\" data-key=\"dd550e2b577ba2800fc166f51fa74557\">the beginning<\/a> of this guide-----<\/div>\n<h3><span class=\"mw-headline\" id=\"4.3_Other_resources\">4.3 Other resources<\/span><\/h3>\n<h4><span id=\"rdp-ebb-4.3.1_ISO\/IEC_17025_accreditation_bodies\"><\/span><span class=\"mw-headline\" id=\"4.3.1_ISO.2FIEC_17025_accreditation_bodies\">4.3.1 ISO\/IEC 17025 accreditation bodies<\/span><\/h4>\n<p>What follows is a set of examples of accreditation bodies handling ISO\/IEC 17025 accreditation for laboratories around the world. For a more complete list of accreditation bodies, see the International Laboratory Accreditation Cooperation (ILAC) <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/ilac.org\/signatory-search\/\" target=\"_blank\">directory<\/a> of approved bodies. \n<\/p>\n<ul><li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.accredia.it\/en\/accredited-services\/\" target=\"_blank\">Accredia, the Italian Accreditation Body<\/a> (Italy)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/a2la.org\/\" target=\"_blank\">American Association for Laboratory Accreditation (A2LA)<\/a> (U.S.)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aihaaccreditedlabs.org\/lab-accreditation-programs\" target=\"_blank\">American Industrial Hygiene Association (AIHA)<\/a> (U.S.)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/anab.ansi.org\/laboratory-accreditation\/iso-iec-17025\" target=\"_blank\">ANSI National Accreditation Board (ANAB)<\/a> (U.S.)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.boa.gov.vn\/\" target=\"_blank\">Bureau of Accreditation (BoA)<\/a> (Vietnam)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cala.ca\/accreditation\/fields-of-testing\/\" target=\"_blank\">Canadian Association for Laboratory Accreditation (CALA)<\/a> (Canada)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.cofrac.fr\/en\/\" target=\"_blank\">Comit\u00e9 fran\u00e7ais d'accr\u00e9ditation (Cofrac)<\/a> (France)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.dakks.de\/en\/testing-and-calibration-laboratories.html\" target=\"_blank\">Deutsche Akkreditierungsstelle (DAkkS)<\/a> (Germany)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.rva.nl\/en\/disciplines\/\" target=\"_blank\">Dutch Accreditation Council (RVA)<\/a> (Netherlands)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/egac.gov.eg\/en\/accreditation\/\" target=\"_blank\">Egyptian Accreditation Council (EGAC)<\/a> (Egypt)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.bata.gov.ba\/Default.aspx?langTag=en-US\" target=\"_blank\">Institute for Accreditation of B&H (BATA)<\/a> (Bosnia and Herzegovina)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.ianz.govt.nz\/\" target=\"_blank\">International Accreditation New Zealand (IANZ)<\/a> (New Zealand)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.iasonline.org\/services\/\" target=\"_blank\">International Accreditation Service (IAS)<\/a> (U.S.)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.inab.ie\/inab-services\/\" target=\"_blank\">Irish National Accreditation Board (INAB)<\/a> (Ireland)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"http:\/\/kan.or.id\/index.php\/programs\/sni-iso-iec-17025\" target=\"_blank\">Komite Akreditasi Nasional (KAN)<\/a> (Indonesia)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.knab.go.kr\/\" target=\"_blank\">Korea Laboratory Accreditation Scheme (KOLAS)<\/a> (South Korea)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nabl-india.org\/\" target=\"_blank\">National Accreditation Board for Testing and Calibration Laboratories (NABL)<\/a> (India)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nata.com.au\/accreditation\/laboratory-accreditation-iso-iec-17025\/\" target=\"_blank\">National Association of Testing Authorities (NATA)<\/a> (Australia)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nrc.canada.ca\/en\/certifications-evaluations-standards\/calibration-laboratory-assessment-service\/about-calibration-laboratory-assessment-service\" target=\"_blank\">National Research Council of Canada (NRC)<\/a> (Canada)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.nist.gov\/nvlap\" target=\"_blank\">National Voluntary Laboratory Accreditation Program (NVLAP)<\/a> (U.S.)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pjlabs.com\/accreditation-programs\/isoiec-17025\" target=\"_blank\">Perry Johnson Laboratory Accreditation (PJLA)<\/a> (U.S.)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.en.aenor.com\/certificacion\/analisis-y-ensayos-de-laboratorio\" target=\"_blank\">Spanish Association for Standardization and Certification (AENOR)<\/a> (Spain)<\/li>\n<li><a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.scc.ca\/en\/accreditation\/programs\/laboratories\" target=\"_blank\">Standards Council of Canada (SCC)<\/a> (Canada)<\/li><\/ul>\n<h4><span id=\"rdp-ebb-4.3.2_ISO\/IEC_17025_reference_and_resource_library\"><\/span><span class=\"mw-headline\" id=\"4.3.2_ISO.2FIEC_17025_reference_and_resource_library\">4.3.2 ISO\/IEC 17025 reference and resource library<\/span><\/h4>\n<p><b>Guides<\/b>:\n<\/p>\n<ul><li><span class=\"citation web\">Association of Public Health Laboratories (February 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf\" target=\"_blank\">\"Laboratory Costs of ISO\/IEC 17025 Accreditation: A 2017 Survey Report\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf\" target=\"_blank\">https:\/\/www.aphl.org\/aboutAPHL\/publications\/Documents\/FS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Laboratory+Costs+of+ISO%2FIEC+17025+Accreditation%3A+A+2017+Survey+Report&rft.atitle=&rft.aulast=Association+of+Public+Health+Laboratories&rft.au=Association+of+Public+Health+Laboratories&rft.date=February+2018&rft_id=https%3A%2F%2Fwww.aphl.org%2FaboutAPHL%2Fpublications%2FDocuments%2FFS-2018Feb-ISO-IEC-Accreditation-Costs-Survey-Report.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Douglas, S.E. (21 February 2022). <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors\" data-key=\"db3a91773a3d971ad1c5d4df3a7cfd32\">\"FDA Food Safety Modernization Act Final Rule on Laboratory Accreditation for Analyses of Foods: Considerations for Labs and Informatics Vendors\"<\/a>. <i>LIMSwiki.org<\/i><span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors\" data-key=\"db3a91773a3d971ad1c5d4df3a7cfd32\">https:\/\/www.limswiki.org\/index.php\/LII:FDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods:_Considerations_for_Labs_and_Informatics_Vendors<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=FDA+Food+Safety+Modernization+Act+Final+Rule+on+Laboratory+Accreditation+for+Analyses+of+Foods%3A+Considerations+for+Labs+and+Informatics+Vendors&rft.atitle=LIMSwiki.org&rft.aulast=Douglas%2C+S.E.&rft.au=Douglas%2C+S.E.&rft.date=21+February+2022&rft_id=https%3A%2F%2Fwww.limswiki.org%2Findex.php%2FLII%3AFDA_Food_Safety_Modernization_Act_Final_Rule_on_Laboratory_Accreditation_for_Analyses_of_Foods%3A_Considerations_for_Labs_and_Informatics_Vendors&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation book\">Mehta, B. (2019) (PDF). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/pasargadabzar.com\/wp-content\/uploads\/2022\/04\/Implementing-ISOIEC-170252017-by-Bob-Mehta.pdf\" target=\"_blank\"><i>Implementing ISO\/IEC 17025:2017<\/i><\/a> (2nd ed.). ASQ Quality Press. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\"f64947ba21e884434bd70e8d9e60bae6\">ISBN<\/a> 9780873899802<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/pasargadabzar.com\/wp-content\/uploads\/2022\/04\/Implementing-ISOIEC-170252017-by-Bob-Mehta.pdf\" target=\"_blank\">https:\/\/pasargadabzar.com\/wp-content\/uploads\/2022\/04\/Implementing-ISOIEC-170252017-by-Bob-Mehta.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=book&rft.btitle=Implementing+ISO%2FIEC+17025%3A2017&rft.aulast=Mehta%2C+B.&rft.au=Mehta%2C+B.&rft.date=2019&rft.edition=2nd&rft.pub=ASQ+Quality+Press&rft.isbn=9780873899802&rft_id=https%3A%2F%2Fpasargadabzar.com%2Fwp-content%2Fuploads%2F2022%2F04%2FImplementing-ISOIEC-170252017-by-Bob-Mehta.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">National Association of Testing Authorities (April 2018). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/nata.com.au\/files\/2021\/05\/17025-2017-Gap-analysis.pdf\" target=\"_blank\">\"General Accreditation Guidance: ISO\/IEC 17025:2017 Gap analysis\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/nata.com.au\/files\/2021\/05\/17025-2017-Gap-analysis.pdf\" target=\"_blank\">https:\/\/nata.com.au\/files\/2021\/05\/17025-2017-Gap-analysis.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=General+Accreditation+Guidance%3A+ISO%2FIEC+17025%3A2017+Gap+analysis&rft.atitle=&rft.aulast=National+Association+of+Testing+Authorities&rft.au=National+Association+of+Testing+Authorities&rft.date=April+2018&rft_id=https%3A%2F%2Fnata.com.au%2Ffiles%2F2021%2F05%2F17025-2017-Gap-analysis.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Perry Johnson Consulting, Inc (January 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.pjcinc.com\/Downloads\/ISOIEC17025_exov.pdf\" target=\"_blank\">\"ISO\/IEC 17025:2017 Testing and Calibration Laboratories: An Executive Overview\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.pjcinc.com\/Downloads\/ISOIEC17025_exov.pdf\" target=\"_blank\">https:\/\/www.pjcinc.com\/Downloads\/ISOIEC17025_exov.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=ISO%2FIEC+17025%3A2017+Testing+and+Calibration+Laboratories%3A+An+Executive+Overview&rft.atitle=&rft.aulast=Perry+Johnson+Consulting%2C+Inc&rft.au=Perry+Johnson+Consulting%2C+Inc&rft.date=January+2022&rft_id=https%3A%2F%2Fwww.pjcinc.com%2FDownloads%2FISOIEC17025_exov.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Portuguese Accreditation Institute (10 November 2019). <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ipac.pt\/docs\/publicdocs\/requisitos\/OGC001_GuiaAplicacao17025_v20181231_En_20191110.pdf\" target=\"_blank\">\"Guide for ISO\/IEC 17025 Application\"<\/a> (PDF)<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"http:\/\/www.ipac.pt\/docs\/publicdocs\/requisitos\/OGC001_GuiaAplicacao17025_v20181231_En_20191110.pdf\" target=\"_blank\">http:\/\/www.ipac.pt\/docs\/publicdocs\/requisitos\/OGC001_GuiaAplicacao17025_v20181231_En_20191110.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Guide+for+ISO%2FIEC+17025+Application&rft.atitle=&rft.aulast=Portuguese+Accreditation+Institute&rft.au=Portuguese+Accreditation+Institute&rft.date=10+November+2019&rft_id=http%3A%2F%2Fwww.ipac.pt%2Fdocs%2Fpublicdocs%2Frequisitos%2FOGC001_GuiaAplicacao17025_v20181231_En_20191110.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation web\">Vehring, S. (June 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.unido.org\/sites\/default\/files\/files\/2020-06\/Guide%20ISO%2017025-2017_online.pdf\" target=\"_blank\">\"Tested & Accepted: Implementing ISO\/IEC 17025:2017\"<\/a> (PDF). United Nations Industrial Development Organization<span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.unido.org\/sites\/default\/files\/files\/2020-06\/Guide%20ISO%2017025-2017_online.pdf\" target=\"_blank\">https:\/\/www.unido.org\/sites\/default\/files\/files\/2020-06\/Guide%20ISO%2017025-2017_online.pdf<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Abook&rft.genre=bookitem&rft.btitle=Tested+%26+Accepted%3A+Implementing+ISO%2FIEC+17025%3A2017&rft.atitle=&rft.aulast=Vehring%2C+S.&rft.au=Vehring%2C+S.&rft.date=June+2020&rft.pub=United+Nations+Industrial+Development+Organization&rft_id=https%3A%2F%2Fwww.unido.org%2Fsites%2Fdefault%2Ffiles%2Ffiles%2F2020-06%2FGuide%2520ISO%252017025-2017_online.pdf&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<p><br \/>\n<b>Journal articles<\/b>:\n<\/p>\n<ul><li><span class=\"citation Journal\">Dror, Itiel E.; Pierce, Michal L. (1 May 2020). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1556-4029.14265\" target=\"_blank\">\"ISO Standards Addressing Issues of Bias and Impartiality in Forensic Work\"<\/a> (in en). <i>Journal of Forensic Sciences<\/i> <b>65<\/b> (3): 800\u2013808. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1111%2F1556-4029.14265\" target=\"_blank\">10.1111\/1556-4029.14265<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/0022-1198\" target=\"_blank\">0022-1198<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1556-4029.14265\" target=\"_blank\">https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1556-4029.14265<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=ISO+Standards+Addressing+Issues+of+Bias+and+Impartiality+in+Forensic+Work&rft.jtitle=Journal+of+Forensic+Sciences&rft.aulast=Dror&rft.aufirst=Itiel+E.&rft.au=Dror%2C%26%2332%3BItiel+E.&rft.au=Pierce%2C%26%2332%3BMichal+L.&rft.date=1+May+2020&rft.volume=65&rft.issue=3&rft.pages=800%E2%80%93808&rft_id=info:doi\/10.1111%2F1556-4029.14265&rft.issn=0022-1198&rft_id=https%3A%2F%2Fonlinelibrary.wiley.com%2Fdoi%2F10.1111%2F1556-4029.14265&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Krismastuti, Fransiska Sri Herwahyu; Habibie, Muhammad Haekal (1 December 2022). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/link.springer.com\/10.1007\/s00769-022-01523-w\" target=\"_blank\">\"Complying with the resource requirements of ISO\/IEC 17025:2017 in Indonesian calibration and testing laboratories: current challenges and future directions\"<\/a> (in en). <i>Accreditation and Quality Assurance<\/i> <b>27<\/b> (6): 359\u2013367. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2Fs00769-022-01523-w\" target=\"_blank\">10.1007\/s00769-022-01523-w<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/0949-1775\" target=\"_blank\">0949-1775<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC9579603\/\" target=\"_blank\">PMC9579603<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/36275871\" target=\"_blank\">36275871<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/link.springer.com\/10.1007\/s00769-022-01523-w\" target=\"_blank\">https:\/\/link.springer.com\/10.1007\/s00769-022-01523-w<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Complying+with+the+resource+requirements+of+ISO%2FIEC+17025%3A2017+in+Indonesian+calibration+and+testing+laboratories%3A+current+challenges+and+future+directions&rft.jtitle=Accreditation+and+Quality+Assurance&rft.aulast=Krismastuti&rft.aufirst=Fransiska+Sri+Herwahyu&rft.au=Krismastuti%2C%26%2332%3BFransiska+Sri+Herwahyu&rft.au=Habibie%2C%26%2332%3BMuhammad+Haekal&rft.date=1+December+2022&rft.volume=27&rft.issue=6&rft.pages=359%E2%80%93367&rft_id=info:doi\/10.1007%2Fs00769-022-01523-w&rft.issn=0949-1775&rft_id=info:pmc\/PMC9579603&rft_id=info:pmid\/36275871&rft_id=https%3A%2F%2Flink.springer.com%2F10.1007%2Fs00769-022-01523-w&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Mandal, Goutam; Ansari, M. A.; Aswal, D. K. (1 September 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/link.springer.com\/10.1007\/s12647-021-00490-w\" target=\"_blank\">\"Quality Management System at NPLI: Transition of ISO\/IEC 17025 From 2005 to 2017 and Implementation of ISO 17034: 2016\"<\/a> (in en). <i>MAPAN<\/i> <b>36<\/b> (3): 657\u2013668. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.1007%2Fs12647-021-00490-w\" target=\"_blank\">10.1007\/s12647-021-00490-w<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/0970-3950\" target=\"_blank\">0970-3950<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC8308083\/\" target=\"_blank\">PMC8308083<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/link.springer.com\/10.1007\/s12647-021-00490-w\" target=\"_blank\">https:\/\/link.springer.com\/10.1007\/s12647-021-00490-w<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Quality+Management+System+at+NPLI%3A+Transition+of+ISO%2FIEC+17025+From+2005+to+2017+and+Implementation+of+ISO+17034%3A+2016&rft.jtitle=MAPAN&rft.aulast=Mandal&rft.aufirst=Goutam&rft.au=Mandal%2C%26%2332%3BGoutam&rft.au=Ansari%2C%26%2332%3BM.+A.&rft.au=Aswal%2C%26%2332%3BD.+K.&rft.date=1+September+2021&rft.volume=36&rft.issue=3&rft.pages=657%E2%80%93668&rft_id=info:doi\/10.1007%2Fs12647-021-00490-w&rft.issn=0970-3950&rft_id=info:pmc\/PMC8308083&rft_id=https%3A%2F%2Flink.springer.com%2F10.1007%2Fs12647-021-00490-w&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Miguel, Anna; Moreira, Renata; Oliveira, Andr\u00e9 (2021). <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/Journal:ISO\/IEC_17025:_History_and_introduction_of_concepts\" data-key=\"fb396cfe584e3585e1e5688867a3ec3e\">\"ISO\/IEC 17025: History and Introduction of Concepts\"<\/a>. <i>Qu\u00edmica Nova<\/i>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.21577%2F0100-4042.20170726\" target=\"_blank\">10.21577\/0100-4042.20170726<\/a><span class=\"printonly\">. <a rel=\"nofollow\" class=\"external free wiki-link\" href=\"https:\/\/www.limswiki.org\/index.php\/Journal:ISO\/IEC_17025:_History_and_introduction_of_concepts\" data-key=\"fb396cfe584e3585e1e5688867a3ec3e\">https:\/\/www.limswiki.org\/index.php\/Journal:ISO\/IEC_17025:_History_and_introduction_of_concepts<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=ISO%2FIEC+17025%3A+History+and+Introduction+of+Concepts&rft.jtitle=Qu%C3%ADmica+Nova&rft.aulast=Miguel&rft.aufirst=Anna&rft.au=Miguel%2C%26%2332%3BAnna&rft.au=Moreira%2C%26%2332%3BRenata&rft.au=Oliveira%2C%26%2332%3BAndr%C3%A9&rft.date=2021&rft_id=info:doi\/10.21577%2F0100-4042.20170726&rft_id=https%3A%2F%2Fwww.limswiki.org%2Findex.php%2FJournal%3AISO%2FIEC_17025%3A_History_and_introduction_of_concepts&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation Journal\">Monteiro Bastos da Silva, Juliana; Chaker, Jade; Martail, Audrey; Costa Moreira, Josino; David, Arthur; Le Bot, Barbara (26 January 2021). <a rel=\"external_link\" class=\"external text\" href=\"https:\/\/www.mdpi.com\/2039-4713\/11\/1\/1\" target=\"_blank\">\"Improving Exposure Assessment Using Non-Targeted and Suspect Screening: The ISO\/IEC 17025: 2017 Quality Standard as a Guideline\"<\/a> (in en). <i>Journal of Xenobiotics<\/i> <b>11<\/b> (1): 1\u201315. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.3390%2Fjox11010001\" target=\"_blank\">10.3390\/jox11010001<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Serial_Number\" data-key=\"a5dec3e4d005e654c29ad167ab53f53a\">ISSN<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.worldcat.org\/issn\/2039-4713\" target=\"_blank\">2039-4713<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Central\" data-key=\"c85bdffd69dd30e02024b9cc3d7679e2\">PMC<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC7838891\/\" target=\"_blank\">PMC7838891<\/a>. <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/PubMed_Identifier\" data-key=\"1d34e999f13d8801964a6b3e9d7b4e30\">PMID<\/a> <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/33530331\" target=\"_blank\">33530331<\/a><span class=\"printonly\">. <a rel=\"external_link\" class=\"external free\" href=\"https:\/\/www.mdpi.com\/2039-4713\/11\/1\/1\" target=\"_blank\">https:\/\/www.mdpi.com\/2039-4713\/11\/1\/1<\/a><\/span>.<\/span><span class=\"Z3988\" title=\"ctx_ver=Z39.88-2004&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Improving+Exposure+Assessment+Using+Non-Targeted+and+Suspect+Screening%3A+The+ISO%2FIEC+17025%3A+2017+Quality+Standard+as+a+Guideline&rft.jtitle=Journal+of+Xenobiotics&rft.aulast=Monteiro+Bastos+da+Silva&rft.aufirst=Juliana&rft.au=Monteiro+Bastos+da+Silva%2C%26%2332%3BJuliana&rft.au=Chaker%2C%26%2332%3BJade&rft.au=Martail%2C%26%2332%3BAudrey&rft.au=Costa+Moreira%2C%26%2332%3BJosino&rft.au=David%2C%26%2332%3BArthur&rft.au=Le+Bot%2C%26%2332%3BBarbara&rft.date=26+January+2021&rft.volume=11&rft.issue=1&rft.pages=1%E2%80%9315&rft_id=info:doi\/10.3390%2Fjox11010001&rft.issn=2039-4713&rft_id=info:pmc\/PMC7838891&rft_id=info:pmid\/33530331&rft_id=https%3A%2F%2Fwww.mdpi.com%2F2039-4713%2F11%2F1%2F1&rfr_id=info:sid\/en.wikipedia.org:Book:LIMS_Selection_Guide_for_ISO\/IEC_17025_Laboratories\/Resources_for_selecting_and_implementing_informatics_solutions\/Other_resources\"><span style=\"display: none;\"> <\/span><\/span><\/li><\/ul>\n<ul><li><span class=\"citation\" id=\"rdp-ebb-CITEREFNevesDa_SilvaGalhardoFerreira2017\">Neves, Rodrigo S.; Da Silva, Daniel P.; Galhardo, Carlos E.C.; Ferreira, Erlon H.M.; Trommer, Rafael M.; Damasceno, Jailton C. (22 February 2017), Kounis, Leo D., ed., <a rel=\"external_link\" class=\"external text\" href=\"http:\/\/www.intechopen.com\/books\/quality-control-and-assurance-an-ancient-greek-term-re-mastered\/key-aspects-for-implementing-iso-iec-17025-quality-management-systems-at-materials-science-laborator\" target=\"_blank\">\"Key Aspects for Implementing ISO\/IEC 17025 Quality Management Systems at Materials Science Laboratories\"<\/a> (in en), <i>Quality Control and Assurance - An Ancient Greek Term Re-Mastered<\/i> (InTech), <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/Digital_object_identifier\" data-key=\"ae6d69c760ab710abc2dd89f3937d2f4\">doi<\/a>:<a rel=\"external_link\" class=\"external text\" href=\"http:\/\/dx.doi.org\/10.5772%2F66100\" target=\"_blank\">10.5772\/66100<\/a>, <a rel=\"nofollow\" class=\"external text wiki-link\" href=\"http:\/\/en.wikipedia.org\/wiki\/International_Standard_Book_Number\" data-key=\&qu
