KAN Report 30

	Accreditation of testing and certification bodies, 10/2003, J. Ensthaler/M. Funk/R. Schultze (802 KB)
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Summary

A precondition for a properly functioning European Single Market is the elimination of barriers to trade. The free movement of goods within the European Union can be impaired by differences in national regulations and testing, certification and surveillance procedures. Confidence in the technical competence, capability, impartiality and integrity of bodies performing conformity assessments is of great importance for the Single Market and also for relations between the EU and third countries. This is true both of the area subject to statutory regulation and that not subject to such regulation. The accreditation of bodies conducting examination, calibration, certification (of products, quality systems and personnel) and inspection is to be regarded as a confidence-building measure for industry and public bodies. Accreditation procedures, i.e. the formal and technical assessment and recognition by an authority or for that matter by a private body of the competence to perform special tasks, continue to exhibit substantial differences at national, European and international level. The ongoing development of international standards and their consistent application is therefore of great importance in this area. It must be ensured, however, that the standards do not contravene requirements resulting for example from EU Single Market Directives.

Council Decision 93/465/EEC gives rise to a presumption of conformity with the requirements of the EU directives provided testing/certification bodies meet the requirements of the harmonized standards. At present, the Member States apply supplementary criteria for the designation of bodies, in addition to the EN 45000 series of standards.

In order for the presumption of conformity to be created in fact, standards are therefore required which fully cover the requirements of the directives, are harmonized pursuant to the directives, and are published in the official journal.

In addition, it is desirable for international agreement to be reached with regard to these requirements. Once this has been achieved, the mutual recognition of conformity assessment bodies designated by the Member States enshrined in statute in the agreements between the EU and third countries (MRAs) and the protocols governing the mutual recognition of conformity assessments between the EU and the candidate countries for EU membership (PECAs) could then also be based upon these requirements.

Neither the EN 45000 series of standards nor the relevant ISO/IEC Guides meet these requirements at the present time. Furthermore, the structure of these series of standards and ISO/IEC guides exhibits redundancies which could be eliminated in the course of a revision.

A KAN study clarified the extent to which revision of the international body of ISO/CASCO standards, which is generally adopted unchanged in the EN 45000 ff. series of standards, could have implications for the European/national accreditation and designation system, and which elements of Community law are to be regarded as indispensable requirements for adoption of the standards.