Conformity Assessment Bodies

Accreditation is the last level of public control in the European conformity assessment system.
It is designed to ensure that conformity assessment bodies (e.g. laboratories, inspection or certification bodies) have the technical capacity to perform their duties.
Used in regulated sectors and voluntary areas, accreditation increases trust in conformity assessment. It reinforces the mutual recognition of products, services, systems, and bodies across the EU.

How does accreditation work?

Accreditation of conformity assessment bodies is based on harmonised standards defining competence criteria for:

  • the national accreditation body and each category of conformity assessment body (such as laboratories or certification bodies)
  • sector-specific requirements
  • guidance drawn up by regional and international organisations of accreditation bodies

Organisation of accreditation in the EU

Requirements for accreditation are set in Regulation 765/2008. The Regulation promotes a uniformly rigorous approach to accreditation across EU countries. This consensus is normally reflected in a CERTIF document on a specific topic. As a result, an accreditation certificate is enough to demonstrate the technical capacity of a conformity assessment body.

The main principles of accreditation are:

  • 1 accreditation body per EU country (it is possible, however, to use another country’s national accreditation body). In Spain this accreditation body is ENAC.
  • accreditation is a public sector activity and a not-for-profit activity
  • there is no competition between national accreditation bodies
  • stakeholders are represented
  • accreditation is the preferred means of demonstrating technical capacity of notified bodies in the regulated area

The European accreditation infrastructure

National accreditation bodies are members of the European co-operation for accreditation (EA) that cooperates with the Commission. EA’s tasks include:

  • setting up and managing a peer evaluation system of national accreditation bodies
  • providing technical assistance to the Commission in accreditation

To provide a framework for cooperation:

  • in 2009, the Commission, the European Free Trade Association (EFTA), EU countries and EA signed general cooperation guidelines to mark their political commitment to working together
  • in 2014, the Commission and EA signed a framework partnership agreement (3 MB) for the period 2014-2017. This framework partnership agreement allows financial support for EA in fulfilling its tasks under the Regulation and meeting the objectives set out in the guidelines

Report on the implementation of the Regulation for accreditation and market surveillance

The report gives an overview of how the accreditation provisions of Regulation (EC) No 765/2008 and CE marking were implemented between 2013 and 2017. It confirms that the accreditation infrastructure created by the Regulation has provided added value, not only for the Single Market but also for international trade. The Regulation has established a trustworthy and stable accreditation system that has wide support from industry and the conformity assessment community. It ensures that products meet the applicable requirements, removes barriers for conformity assessment bodies and helps entrepreneurial activities to flourish in Europe.

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