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. KAN has commissioned a review of whether an essential requirement for this procedure is met: are conformity assessment bodies themselves assessed and accredited against a complete, harmonized and inherently consistent body of standards and regulations?
The procedure whereby the compliance of products and production methods with statutory provisions is assessed by means of third parties is sound only when technically competent, impartial and reliable bodies are accredited for this purpose. A study conducted in 2003 on behalf of KAN (KAN Report 30, "Accreditation of testing and certification bodies", 10/2003, J. Ensthaler/M. Funk/R. Schultze (pdf)) has already proposed changes to the German and European systems of accreditation and notification which would instil greater confidence in them. In 2008, the European legislation governing accreditation and conformity assessment was revised within the New Legislative Framework (See KANBrief 2/08). KAN has commissioned a follow-on study (KAN Report 47, "Accreditation of conformity assessment bodies", 01/2011, D. Gesmann-Nuissl/J. Ensthaler/R. Edelhäuser (pdf)) analysing whether the situation has changed significantly.
Standards are now even more important
A key component of the New Legislative Framework is Decision 768/2008/EC, Annex I Article R17 of which contains essential requirements concerning conformity assessment bodies. In addition, Article R18 of the decision introduces a presumption of conformity for standards similar to that familiar from the product directives. The standards are to support the essential requirements by providing detailed provisions for the work and quality of conformity assessment bodies. Where a body demonstrates that it satisfies the criteria of the harmonized standards, it is presumed to comply with the requirements of Article R17 which are covered by the standards concerned. The harmonized standards listed for the first time in the Official Journal of the EU 2009/C/136/08 will however be able to satisfy their new, even more comprehensive function only if they do in fact meet the requirements of the New Legislative Framework, and if this fact is apparent to the users of the standards.
Results of the stud
Standards listed in the Official Journal which are relevant to conformity assessment bodies are developed by international rather than European standards organizations, in order to enable them to be applied uniformly throughout the world. The new study confirms however the fears expressed in 2003 that the support of the legally binding European requirements is to some extent being sacrificed in the interests of worldwide acceptance. The international standards committees are not willing (or able) to give adequate consideration to European requirements, with the result that the content of the standards does not cover the full catalogue of requirements of Article R17, nor do the standards adequately support the individual requirements.
In their structure, too, the standards do not precisely mirror the conformity assessment procedures (modules) of the decision/the individual Single Market Directives. Consequently, the standards still fail to indicate clearly in respect of what exactly their observance gives rise to a presumption of conformity. Descriptions of the same subject-matter which differ both from one standard to another and between the standards and Article R17 also exacerbate comparison of the standards between each other and with the underlying legal conditions.
KAN calls for the standards to be given a mandatory, meaningful Annex Z in the course of their adoption as EN standards from which it can be seen to what extent they support the requirements of each module. Where modules have been adopted with changes in certain directives, this measure must be taken separately for each directive concerned. A Consultant should also review the standards for their compliance with the requirements of Article R17. 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.
Since the study has also illustrated that certain process and management-related requirements in Article R17 fall short of the standards now generally accepted, the European Commission should in the longer term bring this article into line with current accepted good practice.