How to become MicroVal certified

The MicroVal initiative has created the MicroVal Rules and Certification Scheme.

To become MicroVal certified the following steps are required:

  • The manufacturer has to apply for a MicroVal validation / certification by filling in the application form (see download). The manufacturer has to choose a MicroVal Certification Body and a MicroVal Expert laboratory.
  • The validation studies are performed by the MicroVal Expert laboratory. If an audit is required this will be performed by the MicroVal Certification Body.
  • The final certification decision is taken by the MicroVal Certification Body
  • If not granted the manufacturer can appeal to the MicroVal General Committee
  • If the method has already been validated and/or certified by an other organization, specific rules apply in order to consider such results.

Publication

MicroVal certified methods will be published on the MicroVal website (MV Validated Methods) with an abstract of the technical report.

Certification renewal

An auditor may perform a renewal audit on the production site. In sections 11, 12 and Annex K of the MV Rules, the audit schedule and the needed documentation for certificate renewal are explained. The manufacturer has to provide the MicroVal Certification Body with documentation about the alternative method in order to renew the certificate and to show that the method has not changed since the first validation.



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Application form

MicroVal Rules and Certification Scheme

The latest version of the MicroVal Rules and Certification Scheme are available for download:

EU recognition

The MicroVal validation system is approved by the EU as a ISO 16140 validation as prescribed in Commission Regulation 2073/2005.