Practical considerations for laboratories: Implementing a holistic quality management system
The quality management system (QMS) is increasingly a constant in laboratories of all types, lending support for better products and services coming out those labs. However, as technologies change and new challenges arise in research, medical, analytical, and R&D labs, the need for a more robust QMS becomes more obvious. In this 2022 article published in the journal Frontiers in Bioengineering and Biotechnology, Pillai et al. explore the varying frameworks of the QMS, which frameworks are best in which labs, and what implementation considerations should be made. After an informative introduction, the authors define the various laboratory types and match those types to the various QMS frameworks. They then provide a set of three critical recommendations for their implementation and use, concluding that while many frameworks are robust, the modern laboratory may need to incorporate more than one framework in order to fully achieve their quality goals. They add that “a holistic QMS framework complemented with guidance from multiple quality documents can benefit many laboratories that aim to address” the 12 quality system essentials (QSEs) of the Clinical and Laboratory Standards Institute (CLSI).