6.2 認定とは何か

Accreditation is the attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity.

A wide range of products are subject to third party conformity assessment. This includes unregulated products as well as products regulated at national or at EU level. For products regulated at EU level i.e. in the harmonised area, this usually means that nationally designated conformity assessment bodies – notified bodies – test the product and issue an attestation of conformity before the product can be placed on the market.

More precisely, for there to be accreditation, there has to be an accreditable conformity assessment body (regardless of its legal personality) performing a specific conformity assessment activity.

Accreditation is the standards-based activity to ensure and attest that conformity assessment bodies have the technical competence to perform their duties as is required by the relevant regulations and standards. It assesses conformity assessment bodies’ competence to perform their duties in specific fields, as accreditation is always linked to a specific scope of activity of the conformity assessment body. Operating in the public interest, accreditation assesses the technical competence, reliability and integrity of conformity assessment bodies. It does this through a process of transparent and impartial evaluation against internationally recognised standards and other requirements. Regulation (EC) No 765/2008 obliges national accreditation bodies to verify that conformity assessments are carried out in an appropriate manner and that account is taken of the size and structure of undertakings and the degree of complexity of the product technology in question and the nature of the production process.

Accreditation is based on the international standards for conformity assessment bodies that have been harmonised in the New Legislative Framework and the references of which have been published in the Official Journal of the EU. It is the attestation by a national accreditation body that a conformity assessment body meets the requirements set by harmonised standards and where applicable any additional requirements, including those set out in relevant sectoral schemes. With Regulation No 765/2008, only national accreditation bodies are allowed to provide accreditation of conformity assessment bodies.

The reliance on harmonised standards, based on corresponding international standards, is intended to create the necessary level of transparency and confidence in the competence of conformity assessment bodies, and to ensure that the European accreditation system set up by Regulation (EC) No 765/2008 is compatible with the international accreditation system – therefore facilitating international trade.

Given the prominent role in the conformity assessment system that the Regulation has bestowed upon national accreditation bodies, accreditation bodies have to strictly follow the rules of the Regulation when assessing the competence of conformity assessment bodies. The legislator has decided to clearly limit the activities that an accreditation body may perform, keeping a tight control over their remit via the direct reference to harmonised standards. This also means that national authorities may therefore not require and should actively prevent their accreditation bodies from performing assessment services outside the full accreditation process or use conformity assessment standards that are not harmonised.