Application of ISO 16140-3:2021 – Key Concepts and Examples of Verification of Alternative Methods

Verification of the methods routinely used in the laboratory is a requirement for laboratories accredited to the International Organization for Standardization (ISO) standard: ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories.1 A method verification protocol is not specified within the ISO 17025:2017 standard, and until now, laboratories have been required to conduct their verification studies based on protocols either developed in-house, or using locally recognized protocols, such as: NATA Technical Note 17,2 Health Canada Compendium of Methods,3 etc. The publication of ISO 16140-3:2021 Microbiology of the food chain — Method validation — Part 3: Protocol for the verification of reference methods and validated alternative methods in a single laboratory4 now provides an internationally developed and recognized protocol that may be used to fulfill this requirement. An orientation to some of the key concepts within the ISO 16140-3:2021 standard is presented and demonstrated using examples of verification of both a qualitative method (Neogen® Molecular Detection Assay 2 – Salmonella (MDA2 SAL) and a quantitative method Neogen® Petrifilm® Enterobacteriaceae Count Plate (Petrifilm EB Plate).