Certification processes allow the selection of methods whose performance has been characterized and which meet international validation regulations in force. Accreditation of a supplier’s quality control laboratories increases confidence and facilitates the implementation of methods in user laboratories. These two approaches, which complement each other, are a solidification of competitiveness for food and water microbiology labs
Why Are Validations Important?
Consumer demand for food quality and safety takes a prominent place in our society. From a microbiological point of view, the control of risk requires the establishment of acceptance or rejection criteria, involving controls using analytical methods of detection or enumeration of microorganisms.
These methods can be described in international standards or alternative methods. The development of alternative methods meets both the specific needs of certain sectors, such as reducing the time required to deliver results, and more general needs such as optimizing analysis flows or automating laboratories. In order to ensure that these alternative methods have equivalent performance to the reference methods, different benchmarks have been developed, such as ISO 16140-2:2016 or AOAC validations.
Alternative methods that are candidates for validation are characterized on the basis of a set of exhaustive technical criteria in order to demonstrate their equivalence with the reference method. The main criteria evaluated include:
- Sensitivity / Specificity
- Relative limit of detection
- Inclusivity / Exclusivity
- Relative trueness (for quantitative methods)
- Accuracy profile (for qualitative methods)
- Reproducibility in an external / interlaboratory study
In addition to method validation, accreditation allows user laboratories to choose a supplier adapted to their needs. ISO 17025 accreditation is now widely adopted by food and water microbiology laboratories. More recently, the application of this standard by the quality control laboratories of culture media suppliers has become a strong recommendation of some national accreditation bodies. This ISO 17025 approach is demanding and complementary to other supplier certification systems such as ISO 13485 or ISO 9001. Bio-Rad obtained ISO 17025 accreditation of its quality control laboratory from Cofrac.
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