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)
- 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 2018, the Commission and EA signed a framework partnership agreement for the period 2018-2022. 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
Reports on the implementation of the Regulation (EC) No 765/2008 on accreditation
The Commission adopted the following reports on the implementation of Regulation (EC) No 765/2008 setting out requirements for accreditation
Each report gives an overview of how the accreditation provisions of Regulation (EC) No 765/2008 were implemented during the period covered by the report. All reports confirm that the accreditation infrastructure created by the regulation is providing 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.
More information
More information on accreditation can be found on the website of the European co-operation for accreditation. Consult a consolidated paper of all CERTIF documents (142 kB) adopted up to summer 2014.
2015
- CERTIF 2015-02 REV3 - Notified bodies - consultancy
- CERTIF 2015-01 REV2 – The functioning of NANDO with regard to providing accurate information, objection periods, notification procedures and notified bodies groups (51 kB)
2014
2013
- CERTIF 2013-01 REV3 – ‘Non-national accreditation bodies’ that claim to provide accreditation (150 KB)
- CERTIF 2013-02 – Requirement to seek accreditation in the Member State of establishment (29 kB)
- CERTIF 2013-05 REV1 – Delegating notification to national accreditation bodies (32 kB)
- CERTIF 2013-06 REV2 – Notification and the peer evaluation status of a national accreditation body (35 kB)
- CERTIF 2013-11 REV1 – Time frames for notification of NBs following the entry into force of the Alignment Package (173 kB)
2012
- CERTIF 2012-02 REV4 – Activities of Accreditation bodies that are not accreditation (31 kB)
- CERTIF 2012-03 REV2 - Witnessing for new scopes of accreditation (27 kB)
- CERTIF 2012-04 REV4 – The legal personality of accredited bodies – the case of natural persons (32 kB)
- CERTIF 2012-05 – Published audited annual accounts of accreditation bodies (19 kB)
- CERTIF 2012-06 REV1 – Notified Bodies - The use of the notified bodies number for activities not required by EU legislation (14 kB)
2011
- CERTIF 2011-01 - 2010 NMSPs submitted under article 18(5) of the Regulation 765/2008EC - Evaluation of the current implementation state in MS (441 kB)
- CERTIF 2011-02 - Draft ROADMAP – Enhancing the Market Surveillance enforcement for goods – A multi-annual plan (104 kB)
2010
- CERTIF 2010-01 – CE Marking Information Campaign (21 kB)
- CERTIF 2010-02 - Sanctions foreseen in the National Legislation of Member States against Infringements of the Provisions of Regulation 765/2008/EC (21 kB)
- CERTIF 2010-02 - Annex Penalties - Overview of the information provided by Member States - State of play - as of 19th of February 2010 (17 kB)
- CERTIF 2010–03 - Follow up of Mandate M 417 for the use of Harmonised Standards in support of the new legal framework and Eco-Management and Audit Scheme (EMAS) – Update of the list of Standards (21 kB)
- CERTIF 2010/04 - Risk assessment for market surveillance needs towards a methodology for assessing risks presented by industrial products placed on the EU market in the framework of Regulation 765/2008 (107 kB)
- CERTIF 2010-05 Rev1 - Overview of market surveillance procedures (including safeguard clause mechanism) in the area of harmonised products (92 kB)
- CERTIF doc 2010-06 - Notifications of Notified Bodies in NANDO – requirements of Regulation 765/2008 and Decision 768/2008 (32 kB)
- CERTIF 2010-07 - Link between Rapex notifications and safeguard clause procedures (115 kB)
- CERTIF 2010-08 Rev1 - Notification without accreditation (Art. 5.2 of Regulation 765/2008) (18 kB)
2009
- CERTIF 2009–001 - General Guidelines for Cooperation between the European Co-operation for Accreditation and the European Commission, the European Free Trade Association and the competent national authorities CE Marking information campaign (64 kB)
- CERTIF 2009–03 - Orientations for selecting and implementing the modules (as laid down in Decision 768/2008 of the new legal framework) – SMES specificities (49 kB)
- CERTIF 2009–04 - Introduction to conformity assessment and conformity assessment procedures of the new legal framework (as laid down in Decision 768/2008 of the new legal framework) (151 kB)
- CERTIF 2009-08 - Using standards to assess the competence of conformity assessment bodies in the context of the New Legislative Framework (53 kB)
2008
- Draft CERTIF 2008-001 - Application of the RAPEX system to the Community harmonisation legislation as in the Regulation (EC) No 765/2008 (70 kB)
- CERTIF doc. 2008-002 - Differences between Conformity assessment modules as laid down in new approach (Decision 93/465/EEC - old modules) and as laid down in the new legal framework (Decision 768/2008/EC - new modules) (109 kB)
- CERTIF 2008-03 - Impact of the EU accreditation framework at international level CERTIF 2008-004 - Revision and updating of NANDO (the electronic database for notification of Notified Bodies) as a result of the New Legislative Framework (49 kB)