ISO/IEC 17025-2017 Process Approach

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The paradigm shift of ISO/IEC 17025 from 2005 to 2017 version is prescriptive approach to the performance/process-based approach. If the...

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Posted by Dr. Prashant Umare (Discussions: 1, Comments: 3)
Replied on January 2, 2018 12:00 am
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Dr. Umare:

One of the misconceptions about 17025 is that it is a management system standard. It is not. It is a QA / QC standard with some management system components in it.

Most of the processes in a laboratory are not management system ones. They are testing and calibration ones and those have already been defined by the testing and calibration method published by ISO, ITU, IEC, ASTM, CODEX, IEEE, FAO etc.

These are the processes that define the requirements for the work of a lab. The only job of the QMS is to support the work of the people in the lab that perform these other processes. That is why Patrick has mentioned that process principally applies to clause 7 (what used to be clause 5).

The biggest piece of process work in a lab is demonstrating that it can implement the processes contained in the published test methods it uses and produce technically valid results against those methods.

This means that 17025 is based on different principles than 9001
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Posted by Ned Gravel (Discussions: 0, Comments: 49)
Replied on January 4, 2018 7:00 pm
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You're absolutely right Mr. Ned Gravel
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Posted by Tahir Zaidi (Discussions: 0, Comments: 2)
Replied on January 5, 2018 7:00 pm
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I tend to have different approach. Management system provides a laboratory a mechanism for assuring the reliability of test or calibration results. People have been generating test and calibration results prior to introduction of standards from ISO. Does these mean that these results without the use ISO standards were not reliable? certainly not. Analyst in the chemical laboratories have always shown their concern about the reliability (fit for purpose) of their results. QMS is like an umbrella where activities (you may call them processes or whatever) in the laboratories are performed which give assurance to analyst about reliability. Customer does not constitute a part of QMS but its requirements are significant driving force for a laboratory for selection of appropriate test or calibration method. For example a customer needs to know whether the method used provide a result he or she can trust regardless of whether a laboratory has a system of internal audit, management review etc.
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Posted by khalid saeed (Discussions: 1, Comments: 12)
Replied on January 6, 2018 7:00 pm
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Yes Your are right Mr Saeed. If it was sufficient to be well organised to be competent It would be known for a long time.
:-)))
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Posted by Patrick Reposeur (Discussions: 1, Comments: 15)
Replied on January 6, 2018 7:00 pm
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I agree with Ned that ISO /IEC 17025 is not a Management System Standard . It is a standard for managing a laboratory (testing &calibration) in an open and consistent way in order to produce technically valid results using confident analysts in a reliable environment (competence).The new standard provided a sample work flow which can be adapted by any laboratory irrespective of the size to meet the requirements.
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Posted by maryanne adeeko (Discussions: 0, Comments: 12)
Replied on January 10, 2018 7:00 pm
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I agree with Ned Gravel the most important thing is QC/QA, not necessarily a good Management System assures it.
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Posted by Fernando Anaya (Discussions: 0, Comments: 1)
Replied on January 15, 2018 7:00 pm
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Posted by said mostafa (Discussions: 1, Comments: 1)
Replied on January 21, 2018 7:00 pm
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