Role of the European co-operation for Accreditation

Consumers demand confidence in the safety and quality of the products they use, the environment they live in, the reliability of health care services, etc.
It is also important for businesses and regulators to have confidence in the integrity and quality of the services supplied by laboratories, inspection and certification bodies.
It is the independence, competence and impartiality of EA member accreditation bodies that guarantee this confidence.

EA, European co-operation for Accreditation, is a non profit association which was set up in November 1997 and registered as an association in the Netherlands in June 2000 and revised in November 2010 (Articles of Association).
EA is the European network of nationally recognised accreditation bodies located in the European geographical area.

The EA missions consist in:

• defining, harmonizing and building consistency in accreditation as a service in Europe, by ensuring common interpretation of the standards used by its members;
• ensuring transparency of the operations (including assessments) performed and results provided by its members;
• maintaining a multilateral agreement on mutual recognition between accreditation schemes and reciprocal acceptance of accredited conformity assessment services and results;
• managing a peer evaluation system consistent with international practices - EA as a region is a member of ILAC (International Laboratory Accreditation Cooperation) and IAF (International Accreditation Forum);
• acting as a technical resource on matters related to the implementation and operation of the European policies on accreditation.

EA covers accreditation of:

• Laboratories
  • Testing
  • Calibration
• Inspection bodies
• Certification bodies
  • Quality management systems (QMS)
  • Environmental management systems (EMS)
  • Products and services
  • Persons
  • EMAS verifiers according to the European Regulation EMAS (European Management and Audit Scheme)

In compliance with the Regulation 765/2008, EA members:

• develop accreditation as a service of general interest with a public authority status as the last level of control of conformity assessment services in the voluntary and law regulated fields;
• operate at the national level upon suitable mandate of the governments, in full independence and impartiality, on a non-profit-distributing and non competitive basis;
• are fully accountable to accreditation stakeholders and their structure does not allow for predominant interests to take control.

EA and its members are neutral from commercial pressure. EA develops and maintains a high level of service for the benefit of the European economy: the European Commission and EFTA, the European industries, governments and citizens. All interested parties and stakeholders are involved in the EA activities. They can and do contribute to the EA work through membership in the EA Advisory Board, committees and working groups.

EA has been established by the European Commission as the official European accreditation infrastructure. This became effective on 1st April 2009 in Brussels when the Guidelines for Cooperation between the European Commission (EC), the EFTA, EA and the competent national authorities were signed. These Guidelines set out the principles and objectives for the cooperation between EA, EC, EFTA and competent national authorities, and provide criteria for the effective and timely implementation of the reinforced role of EA.

The appointment of EA as the official European accreditation infrastructure follows the adoption of Regulation (EC) no 765/2008 of the European Parliament and the Council of 9 July 2008 establishing a legal framework for accreditation in the EU/EFTA member states. This regulation came into effect as of 1st January 2010.

A Framework Partnership Agreement between EA, EC and EFTA setting out the common cooperation objectives as well as the administrative and financial conditions relating to Community financing granted to EA for the implementation of European accreditation policy and of the new EC Regulation, was signed on 30 June 2010 in Brussels. A similar FPA was specifically signed with EFTA. These Partnership Agreements place EA in the same position as other organizations of major European interest (European Standardization Bodies, for instance).

In practice at the operational level, the relations between EA and the European authorities develop based on:

• the communication processes and channels being established with the EC Directorates and other bodies (coordinating committees, e.g);
• participation in the meetings of the "Accreditation Steering Committee" (ASC) that builds on the inter-service meetings of the Commission;
• EA's participation in the meetings of the Senior Officials Group for Standardization and Conformity Assessment Policy (SOGS).

Regulation (EC) nº 765/2008 reinforces the role of EA in both voluntary and regulated sectors. EA shall support and harmonise the implementation of more stringent rules, in particular for cross-frontier accreditation.

The new European legislation also reinforces the requirements for the notification of conformity assessment bodies. Accreditation shall now be used as the preferred route to demonstrate the competence of CABs in view of their notification. In a policy described in EA-2/17, EA has defined horizontal criteria for CABs seeking accreditation for notification purposes, to be applied with relevant harmonised standards, guidance documents and Community or national requirements.

To achieve consistency throughout Europe, as well as greater transparency and acceptability to all, including national authorities, the peer-evaluation process will need to be tailored to fully accommodate the specific needs of regulatory sectors to strengthen the reassurance of sectoral stakeholders and regulators that the ABs’ technical competence is thoroughly assessed. The new Regulation places an obligation on EU Member States to accept results issued by the CABs accredited by any of the EA MLA signatories - for the relevant technical scope.

To meet such ambitions, 13 directive networks covering 21 “New Approach” Directives have been established to collect, structure and make accessible all technical knowledge required for CABs’ assessment. This wide-ranging task, which reflects the high expectations set by the competent national authorities, is monitored by the EA Horizontal Harmonization Committee.

New responsibilities for EA members

Communication is a pivotal function for the consistent implementation of the new regulation. The latter formalises EA members’ obligations to satisfy the expectations of national authorities and stakeholders, which entrust greater responsibility from their NAB. A Best Practice Guide on Communications with the Regulators has been published to assist EA and its members to develop and strengthen cooperation with both national and European regulators.

New responsibilities for EA

Similarly EA itself shall enhance its communications with the EC: EA shall attend every SOGS meeting dealing with accreditation, as well as meetings of the EC Inter-Service Steering Group for Accreditation in order to discuss the benefits of accreditation with the various EC services; specific projects are underway with DGs Environment, Transport, Health & Consumer and Agriculture.

EA is also required to consult and interact in a more efficient and transparent way with its stakeholders. The EA Advisory Board shall be the “appropriate structure to ensure the effective and balanced involvement of all interested parties”, particularly to manage the increasing number of bodies wishing to become EA stakeholders. Accordingly, the EA Policy for Relations with Stakeholders (EA-1/15) has been adopted in order to formally grant a distinct status with associated rights and obligations to those “EA-Recognized Stakeholders” who wish to become more directly involved in EA’s associative life and have a particular institutional interest in contributing to EA’s technical activities without, however, meeting the criteria for becoming EA full members.

Furthermore, EA is given a prime role to define, harmonise and build consistency in accreditation as a service to trade with third countries, with the aim to reduce barriers to trade and to contribute to protecting health and safety. Following the European Union’s will to have close links with these countries, EA considers that relationships between EA and ABs in countries being part of the EU’s Neighbourhood Policy (1) and potential candidates for EU membership (2) should be strengthened in order to support the work of the EU, to embrace and support the effective development of ABs in these countries, to enable good cooperation with EA, and to facilitate a good understanding of EA’s practices.

EA has already entered into a number of cooperative relationships with ABs from countries that are not members of either the EU or European Free Trade Association (EFTA) based on EA-1/13: EA’s relationship with accreditation bodies of countries not being members of the EU or EFTA. Associate membership is notably offered to the ABs located within countries that are either potential candidate countries to the EU/EFTA or in the European Neighbourhood Policy.

(1) Countries in the EU’s Neighbourhood Policy are: Algeria, Armenia, Azerbaijan, Belarus, Egypt, Georgia, Israel, Jordan, Lebanon, Libya, Moldova, Morocco, The Palestinian Authority, Syria, Tunisia, and Ukraine.

(2) “Potential candidates for EU membership" as stated by the European Council meeting in Feira in June 2000 are Albania, Bosnia and Herzegovina, Kosovo (under UN Security Council Resolution 1244), Montenegro, and Serbia.