The NF VALIDATION mark certifies the analytical effectiveness of commercial methods for a defined strain and a defined field of application. It is a third party certification governed by Certification Rules which define the procedure very precisely, from submitting the validation application to obtaining the certificate (or statement of validation).
Methods are evaluated in two stages:
1 – implementation of a complete validation study, by an independent Expert Laboratory qualified by AFNOR Certification, and run according to a standardised protocol (see Certification Rules for conditions of application);
2 – implementation of an audit on the production site of the kit to be validated, in order to check that the quality system in place monitoring production is effective.
In accordance with the Certification Rules, the NF VALIDATION mark is issued for a period of 4 years. In addition, certified kits are monitored by means of regular audits. After this 4-year period, a technical renewal study is carried out.