New ISO standard validates microorganism testing methods

Meat, fish, dairy products, eggs and shellfish contain significant microbial flora which can affect human health. It is important to identify the microorganisms to maintain food safety, but the microbial flora can also affect the quality of food and its shelf life. 

The revision of ISO 16140:2003 for the validation of alternative (proprietary) microbiological methods has created a multipart standard providing a specific protocol and guidelines for the validation of methods both proprietary (commercial) or not.

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. They are 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.

Over a hundred alternative methods have been validated based on the previous version of ISO 16140, and the standard was updated to provide new insights on the validation of microbiological methods and experience gained from conducting validation studies across the world. Today, developers, end users and authorities need a reliable common protocol for the validation of the many alternative methods used to assess the microbiological quality of raw materials and finished food products and monitor the microbiological status of manufacturing processes. Data generated with the new protocol will also provide potential end users with performance data for a given method, thus enabling them to make an informed choice on the adoption of a particular method. This data can also serve as a basis for the certification of a method by an independent organisation.

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)