The revision of ISO 16140:2003 – the standard for the validation of alternative (proprietary) microbiological methods is now complete. The standard was revised to provide new insights on the validation of microbiological methods and experience gained from conducting validation studies across the world.
The new multipart standard provides specific protocol and guidelines for the validation of methods, whether proprietary or not.
Two parts of ISO 16140 series have been published. ISO 16140-1:2016, Microbiology of the food chain – Method validation – Part 1: Vocabulary, describes the terminology used in microbial testing, while ISO 16140-2:2016, Microbiology of the food chain – Method validation – Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method, is dedicated to the validation of proprietary microbiological methods.
The standards have been designed to help food and feed testing laboratories, test kit manufacturers, competent authorities, and food and feed business operators to implement microbiological methods. ISO 16140-2 includes two phases – the method comparison study and the interlaboratory study, with separate protocols for the validation of qualitative and quantitative microbiological methods.
“The validation according to ISO 16140-2 will lead to a higher reliability of the alternative method test result and the users will benefit from having microbiological test results available sooner,” explained Paul in ‘t Veld, the Convener of Working Group 3 on method validation (ISO/TC 34/SC 9/WG 3 whose secretariat is held by NEN, ISO member for the Netherlands) that is responsible for the development of the ISO 16140 series. “Most likely, this will contribute to greater food safety.”
The other four new parts of ISO 16140 are still under development with the following topics:
- Protocol for the verification of reference and validated alternative methods implemented in a single laboratory (Part 3 of ISO 16140)
- Protocol for single-laboratory (in-house) method validation (Part 4 of ISO 16140)
- Protocol for factorial interlaboratory validation for non-proprietary methods (Part 5 of ISO 16140)
- Protocol for the validation of alternative (proprietary) methods for microbiological confirmation and typing (Part 6 of ISO 16140)