|The principles of the certification procedure
The method validation study is carried out in 2 phases, according to the current technical protocol.
The objective of the first phase (preliminary study) is to assess its effectiveness by comparing it to the effectiveness of the standardised reference method. This is carried out at the expert laboratory. The diversity of samples tested and the experimental conditions applicable to the study (sufficient number of naturally contaminated samples, application of specific stress protocols for artificial contamination,…) allow the method to be tested under conditions that are close to the real conditions in the field.
The objective of the second phase (or inter-laboratory study) is to compare the efficacy of the method to be validated and the reference method in several laboratories under defined conditions of reproducibility and repeatability.
By combining the results of the 2 phases of the study, it is possible to reach a decision on all of the performance criteria of the method as described in the validation current protocol.
At the same time, AFNOR Certification evaluates the quality assurance procedures on the production site of the method to be validated in order to check their effectiveness.
AFNOR Certification carries out regular monitoring in order to check and guarantee users that validated methods comply at all times with the requirements of the NF VALIDATION mark.