4. Regulatory certification in the European Union

With its resolution on a new approach to technical harmonization and standardization in 1985, the Council of the European Communities laid the foundations for a policy of organizing the internal market through, among other things, regulation and standardization. The resolution indicated that this policy needed to be completed in the field of conformity assessment, and invited the EEC Commission to give priority to this issue. On December 21, 1989, the Council clarified its position on this point with a new resolution concerning a global approach to conformity assessment, as one of the basic elements of a quality policy.

Based on the EN ISO 9000 and EN 45000 series of European standards, the Council has defined the various modes of proof, or modules of attestation of conformity, that can be used in the regulatory field by any new directive to offer a sufficient level...