ISO 16140-3:2021 describes procedures for method verification, a requirement for ISO/IEC 17025 accredited laboratories. The validation status of ISO standardized reference methods developed by ISO/TC 34/SC 9 shall be known before you can apply ISO 16140-3. This overview will help you to verify your methods according to ISO 16140-3.
Many ISO reference methods, standardized by ISO/TC 34/SC 9, are validated, but there are still ISO reference methods that are not validated. SC 9 is working to extend the validation of its methods (see more information about the validation requirements here). The attached table provides a current overview of the validation status of all standardized reference methods. In this table you can determine if a method has been validated or not; and if a method is validated, the food categories and/or additional non-food categories (e.g. feed samples) covered in the validation study. This is an important consideration when carrying out the verification of a reference method upon first use in a given laboratory.
The ISO standard for method verification, ISO 16140-3 (published in January 2021), is intended for the verification of validated methods. However, due to the fact that some ISO methods are not yet validated, a procedure for the verification of non-validated reference methods has been included (ISO 16140-3:2021, Annex F). This procedure is expected to be limited to the transition period, which expires on 31 December 2027 (see the document Transition period for the implementation of ISO 16140-3). After the transition period, a validation study will be required to introduce non-validated methods into a laboratory. For such a validation, ISO 16140-4 can be used. The same requirement applies for (food) categories that are outside the scope of validation of the method.