Before applying for MicroVal certification, the test kit manufacturer must ensure that the alternative test is ready for production (and thus validation and certification). The scope and procedure must be defined before starting the certifcation procedure.
The certification procedure consists of several steps:
Evaluation of the manufacturers quality management system by a certifying organization
Validation of the test method by a MicroVal accredited expert Lab
Evaluation of the results by the MicroVal Technical Committee
Certification by the certifying organization
The alternative method is then certified by MicroVal and can be used as alternative method per European Commission Regulation 2073. In the USA the Food and Drug Administration also recognize MicroVal validated methods. The Certified Kit can hold the MicroVal certification logo.
In addition to test kits within the scope of ISO16140-2, MicroVal is also able to work on other types of test kit. Decisions on this is made on a case by case basis depending on the expert knowledge held within MicroVal committees and the ability to obtain advice from other acknowledged experts in particular microorganisms, analytes, foods or technologies.
To read more about the certification procedure and the expert labs please choose an item from the submenu.
MicroVal rulesThe MicroVal rules ensure a standardized validation process and evaluation