KAN Report 47

	Accreditation of conformity assessment bodies, 1/2011, D. Gesmann-Nuissl/J. Ensthaler/R. Edelhäuser (3 MB)
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Summary

The European Single Market and with it a substantial part of prevention activity are founded upon suitable procedures for the testing, certification and ongoing monitoring of product conformity. A study conducted in 2003 on behalf of KAN (KAN Report 30) has already proposed changes to the German and European systems of accreditation and notification which would greater confidence in them.

KAN has commissioned a follow-on study analyzing whether the situation has changed since then, particularly with the introduction of the New Legislative Framework. The study analyzed in detail whether conformity assessment bodies are assessed and accredited on the basis of a complete, uniform and cohesive body of regulations and standards.

As a result of the study, KAN calls for standards to be given a meaningful Annex Z in the course of their adoption as EN standards from which it can be seen to what extent they support the specific, legally binding European requirements. If necessary, this measure must be taken separately for each sector-specific directive. A Consultant should also review the standards for their compliance with the European requirements. If appropriate, the responsible CEN/CLC TC 1 must, in accordance with its mandate, adapt the content of the international standards to the European requirements.

The study has also illustrated that the process and management-related requirements formulated in Article R17 of Decision 768/2008/EC are very vague. The European Commission should in the longer term bring this article into line with current accepted good practice in order for it to meet the standards now generally accepted.