Certification and Validation
Validation occurs according to the EN/ISO 16140 'Microbiology of food and animal feeding stuffs - Protocol for the validation of alternative methods' and certification follows the MicroVal Rules and Certification scheme.
The manufacturer presents his request for the certification of an alternative method to a MCB. Each MCB must establish a MicroVal Technical Committee (MTC). In this committee all interested parties shall be represented. The certification body checks the administrative conformity of the request and selects one method reviewer, one laboratory reviewer (if necessary) and one quality auditor. The MGC selects three additional reviewers (one method and two laboratory reviewer) and one technical auditor.
The independent expert laboratory is in charge of the co-ordination and the supervision of the two phases of the validation procedure:
- A method comparison study of the alternative method against the reference method
- An interlaboratory study of both methods.
The expert laboratory must comply with the requirements of EN/ISO 17025 and be accredited. The expert laboratory is pre-selected by the manufacturer or the MCB from the database of laboratories to be established by the MGC. The qualification "expert laboratory" is only valid for the MicroVal certification of the alternative method it was selected for.
The expert laboratories select the collaborative laboratories. There is no limit to the number of collaborating laboratories; however, a minimum of eight from three different countries is required for the study to be valid. The expert laboratory will report to the Technical Committee of the MCB, which will propose a certification proposal to the MCB. The final decision is taken by the MCB. The secretariat of the MGC is informed of this decision.
The MV Secretariat keeps a record of all MV applications and all (positive or negative) decisions taken. If the certification is not granted, the manufacturer can appeal to the MGC. If the method has already been validated and/or certified by another organisation, specific rules apply in order to consider such results.