1 Scope
This Technical Specification defines the principles and specifies the nature of the information to be supplied for acceptance of a method as an annex to ISO 21569, ISO 21570 or ISO 21571. It also specifies the process for adding, amending and retaining methods annexed to these standards. This Technical Specification is necessary in order to attain consistency in methods that are to be employed as part of the standards. It does not cover the specifics of the development of a method or laboratory set-up. The operation of laboratories is covered in ISO/IEC 17025.
Method validation is instrumental in assessing the reliability of a test method. Its central role is to establish numerical values for the performance criteria that are to be established. ISO 24276 includes details on method validation, taking into consideration specific technical issues related to the detection of genetically modified organisms and derived products. Given the attention to, and widespread use of deoxyribonucleic acid-based tests or protein-based tests, and the implications to trade of any discrepancies in test results, a single-laboratory validation is most likely not warranted in this case and a multi-centre method validation could be performed according to the international guidelines.