Certification procedure
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 certification procedure.
The certification procedure consists of several steps:
- Evaluation of the manufacturers’ quality management system by a certified 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 an alternative method per European Commission Regulation 2073. In the USA, the Food and Drug Administration also recognizes MicroVal validated methods. The certified Kit can hold the MicroVal certification logo.
In addition to test kits within the scope of EN-ISO16140-2, MicroVal is also able to work on other types of test kits. Decisions on this are 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, food, beverages and water or technologies.
To read more about the certification procedure and the expert labs, please choose an item from the submenu.
