For Regulators2018-12-12T09:40:25+00:00

What is accreditation?

Accreditation operates in the public interest across all market sectors. It provides an attestation that accredited bodies offering testing, examination, calibration, certification, inspection and verification services have the technical competence and impartiality to check the conformity of products and services with the relevant standards and regulations.

Accreditation supports the market in facilitating the movement of goods and services where demand for quality and safety is growing. It offers a harmonized, transparent and sustainable approach which:

  • helps fulfil legal requirements at reasonable costs;
  • enables innovation;
  • reduces the need for regulators to use their own resources;
  • builds consumers’ and businesses’ confidence.

The accreditation process provides a cost-effective means of delivering public interest services which:

  • are reliable and of high quality;
  • support regulatory compliance;
  • imply lower administrative burdens and bureaucracy.

Regulation (EC) No 765/2008 – Definition of Accreditation

‘Accreditation’ means an attestation by a National Accreditation Body that a Conformity Assessment Body meets the requirements set by harmonized standards and, where applicable, any additional requirements including those set out in relevant sectoral schemes, to carry out a specific conformity assessment activity.

You can find information about conformity assessment on the ISO CASCO website https://www.iso.org/casco.html

Benefits and value

Accredited bodies performing conformity assessment services meet all required standards, as well as regulatory requirements and sector specific criteria, in terms of:

  • technical competence;
  • independence, impartiality and integrity;
  • risk management;
  • adequate use of human and equipment resources;
  • mechanism for continuous improvement of product and service quality;
  • complaint and appeal system.

Accreditation and the services provided by accredited bodies, used directly by regulators as a reference in regulations, demonstrate effectiveness in:

  • supporting implementation of European or national legislation, providing a “stamp of approval” showing compliance with standards and widely accepted requirements;
  • qualifying suppliers of goods and services, especially on the procurement market;
  • enhancing trade and economic growth;
  • supporting cost efficiency, by reducing the need for regulators to employ their specialized assessment personnel and avoiding duplication of audits;
  • simplifying the procurement process based on demonstrated competence and impartiality as decision-making criteria.

A Briefing for Government and Regulators (2018)

Accreditation – A Tool to support Regulators (2016)

Example: EU Emission Trading System (ETS)

The EU ETS is a cornerstone of the EU’s policy to fight climate change and one of the key tools for reducing greenhouse gas emissions. The monitoring and reporting of greenhouse gas emissions must thereby be robust, transparent, consistent and accurate for EU ETS to operate effectively.

As a result, in 2015, EA extended its Multilateral Agreement (EA MLA) to the new scope “Greenhouse Gas Validation and Verification” after having signed a specific agreement with the Directorate-General Climate Action of the European Commission in August 2013 for the implementation of accreditation and peer evaluation of EA National Accreditation Bodies (NAB) according to EN ISO 14065 and Commission Regulation (EU) No 600/2012.

To date, 24 EA Members are signatories to the EA MLA for the scope GHG Validation and Verification with 145 accreditations valid at the end of 2017 (Source: EA survey – January 2018).

Moreover, to facilitate the collaboration with DG CLIMA, EA has established the EU ETS Network Group to provide regular input to the updates of current regulations in order to enhance the position of National Accreditation Bodies (NAB) so they are more harmonized and effective in initiating improvements. As an example, EA is involved in the discussions regarding the revision of EU ETS Monitoring and Reporting Regulation (MRR: Commission Regulation (EU) No. 601/2012) and EU ETS Accreditation and Verification Regulation (AVR, Commission Regulation (EU) No. 600/2012).

For more examples of benefits, visit the Business Benefits’ website: www.business-benefits.org

How accreditation works?

Accreditation demonstrates compliance with specified requirements for:

  • Competence: experience and technical skills of the staff in the accredited or applicant body are verified by qualified assessors with relevant expertise and specialized knowledge;
  • Independence: accredited bodies that grant certificates or issue test reports for instance shall show independence from the organisations to which their services are provided, in terms of decision-making powers or economic and business relations for instance;
  • Impartiality: accredited bodies shall show absence of or properly manage potential conflicts of interest with the client to whom they provide services. For instance, they shall not share any commercial interests.

To ensure continued compliance, National Accreditation Bodies are regularly re-assessed, through the EA MLA at European level, to ensure they:

  • keep pace with technical and regulatory changes in their area of expertise;
  • maintain their standards of work;
  • demonstrate practical competence and sound judgement.

Accreditation gives confidence to regulators that regulations are implemented effectively for the benefit of businesses and consumers.

The process of accreditation is set out in the international standard ISO/IEC 17011 Conformity assessment — Requirements for National Accreditation Bodies accrediting Conformity Assessment Bodies.

For further information, visit our “The EA MLA” page

FAQ

You will find below some Frequently Asked Questions (FAQ).  If you have a question that isn’t answered here, please contact us.

EA, the European cooperation for Accreditation is a not-for-profit association, registered in the Netherlands. It is formally appointed by the European Commission in Regulation (EC) No 765/2008 to develop and maintain a multilateral agreement of mutual recognition, the EA MLA, based on a harmonized accreditation infrastructure.

The EA MLA exists to facilitate fair trade, ensure product and service quality and reduce technical barriers to trade.

EA currently has 50 Members. The EA Members are National Accreditation Bodies in Europe that are officially recognized by their national governments to assess and verify – against international standards – organizations that carry out conformity assessment activities such as certification, verification, inspection, testing and calibration.

Regulation (EC) No 765/2008 and the standards of the ISO/IEC 17000 series provide the set of rules to be used by EA and its National Accreditation Bodies.

To get more information, visit the “About EA” and “Mutual Recognition” pages.

There is one National Accreditation Body (NAB) per Member State according to Regulation (EC) No 765/2008. As an authoritative body appointed by its national authorities, the National Accreditation Body performs accreditation by assessing Conformity Assessment Bodies against international standards. The accreditation process determines the technical competence and integrity of organizations that offer testing, examination, validation and verification, inspection, calibration, certification and proficiency testing provision services (collectively known as conformity assessment). Accreditation operates in the public interest across all market sectors, providing a transparent and impartial assessment of these services against internationally recognized standards and other national or sectoral requirements.

Conformity Assessment Bodies carry out certification, testing, inspection, verification and calibration services, collectively known as conformity assessment activities.

An accredited body is a body that has successfully undergone accreditation. It means it has been assessed and a positive decision has been taken to grant accreditation for an agreed scope. The accredited body is entitled to use the Accreditation Body mark for the scope(s) for which it has been accredited.

Whereas there is only one AB per Member State, there may be plenty of accredited CABs in the same Member State. The EA NAB maintains a list of accredited bodies on their website. The list is also available on the EA website, “Directory of EA Members and MLA signatories” page.

Together, conformity assessment and accreditation are important parts of a nation’s quality infrastructure, along with metrology and standardization. They build confidence that goods and services, processes, management systems and the work of individuals comply with national and international standards and regulations. They also assist in the risk-management and decision-making of manufacturers and regulators.

To get more information, visit the “Accreditation” page

The EA National Accreditation Body Members provide accreditation of:

  • Laboratories
    • Testing (EN ISO/IEC 17025), Medical examinations (EN ISO 15189)
    • Calibration (EN ISO/IEC 17025)
  • Inspection bodies (EN ISO/IEC 17020)
  • Certification bodies:
    • Certification of Persons (EN ISO/IEC 17024)
    • Management Systems Certification (EN ISO/IEC 17021-1) (quality, environment)
    • Products/Services Certification (EN ISO/IEC 17065)
  • Proficiency Testing Providers (EN ISO/IEC 17043)
  • Validation and Verification Bodies (EN ISO 14065) for GHG emissions
  • Reference Materials Producers (EN ISO 17034)

These are the standards used for accreditation by the EA Members.

The official definition of conformity assessment is: “Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled” (definition in EN ISO/IEC 17000:2004 Conformity assessment – Vocabulary and general principles).

Due to the ever-increasing technical complexity of industry and business, it is becoming more and more important to be able to demonstrate that what is being supplied actually meets the requirements specified or claimed. Such a demonstration is called conformity assessment. Conformity assessment can be applied to a product (including, for these purposes, a service), a process, a system, a body or persons, and includes activities such as testing, inspection and certification.

3rd-party assessment

Third-party assessment is the assessment of an organization performed by an independent body. The organization carrying out the assessment shall be independent of both supplier and customer organizations and deliver an impartial assessment.

Impartiality

In the field of accreditation, the impartiality rule requires that the Accreditation Body be impartial in making a decision on accreditation. It means that the AB shall not have any conflict of interest with the body applying for accreditation, and that the AB shall not be subject to any other pressure of a commercial or financial nature.

This is provided for in Article 8 of the European Commission’s Regulation (EC) 765/2008 relating to the “Requirements for NABs” which states “that a NAB shall be organized in such a manner as to make it independent of the CABs it assesses and of commercial pressures, and to ensure that no conflicts of interest with CABs occur.”

In practice, impartiality also means that the accreditation decision shall be made by persons different from those that conducted the assessment.

Non-profit-making principle

EA and its Accreditation Body Members shall be non-profit-making and -distributing organizations in order to meet their formal obligation to act in the public interest.

As such, accreditation must be operated under the following conditions:

  • at national level, with a recognized mandate from the government
  • with complete independence and impartiality
  • with full accountability towards all interested parties, with no single interest or group of interests predominating
  • as a non-profit-distributing service activity
  • without any competition

Cross-frontier accreditation

Cross-frontier accreditation refers to the principles for cooperation between EA Members in the accreditation process when accreditation is granted by a foreign Accreditation Body i.e. by an Accreditation Body that is not the local Accreditation Body.

According to Regulation 765/2008 and the EA Cross-Border Accreditation Policy and Procedure for Cross-Border Cooperation between EA Members (EA-2/13), each Accreditation Body should primarily provide services to its local market. However, in exceptional cases, an Accreditation Body may provide accreditation in a country or economy of another Accreditation Body. In such cases, the principle of the policy is to encourage cooperation between the foreign Accreditation Bodies and the local Accreditation Bodies, and to support local accreditation by offering the local Accreditation Bodies the opportunity to sub-contract, participate in a joint assessment or observe the assessment.

This lies in Article 7.1 of Regulation (EC) 765/2008 providing that Conformity Assessment Bodies, whether third-party or first-party/in-house bodies, are required to request accreditation by the National Accreditation Body of the Member State in which they are established.

This general rule allows for exceptions. The option for a Conformity Assessment Body to request accreditation with a National Accreditation Body in another Member State is limited to cases where:

  • there is no National Accreditation Body in its own Member State [Art. 7.1(a)]
  • the National Accreditation Body does not offer the requested accreditation service [Art. 7.1(b)]
  • the National Accreditation Body has not received a positive outcome in the peer evaluation in relation to the conformity assessment activity for which accreditation is requested [Article 7.1(c)]

Art. 7.1 Regulation (EC) 765/2008 is a logical consequence of the non-competition principle embodied in Article 6 of the same Regulation. It is important to prevent Conformity Assessment Bodies from shopping around for accreditation certificates, thus creating a “market for accreditation” leading to the commercialization of accreditation which jeopardizes the added value and role of accreditation as a public authority activity and last level of control in the conformity assessment chain.

The EA contact in your country is the National Accreditation Body of your country. To find the relevant Accreditation Body, visit the “Directory of EA Members and MLA Signatories” page

The EA Multilateral Agreement (EA MLA) is a signed agreement between the EA Members whereby the signatories recognize and accept the equivalence of the accreditation systems operated by the signing members, and also the reliability of the conformity assessment results provided by Conformity Assessment Bodies (CABs) accredited by the signing members. It makes the objective ‘Accredited once, accepted everywhere’ effective.

The benefits of the EA MLA for Regulators can be summarized as follow:

  • Supporting implementation of European and national legislations by confirming compliance with standards and applicable requirements;
  • Enhancing trade and economic growth by giving governments confidence in accreditation and competent suppliers of goods and services;
  • Limiting costs and resources by eliminating a number of administrative obligations. The EA MLA reduces the need to employ specialized assessment personnel for regulatory controls and avoids duplication of audits.

Yes but under specific conditions.

According to Regulation (EC) No 765/2008 and EA-2/13 EA Cross-Border Accreditation Policy and Procedure for Cross-Border Cooperation between EA Members, each Accreditation Body should primarily provide services to its local market. However, in exceptional cases, an Accreditation Body may provide accreditation in a country or economy of another Accreditation Body. In such cases, the principle of the policy is to encourage cooperation between the foreign Accreditation Body and the local Accreditation Body, and to support local accreditation by offering the local Accreditation Body the opportunity to sub-contract, participate in a joint assessment or observe the assessment.

This lies in Article 7.1 of Regulation (EC) No 765/2008 providing that Conformity Assessment Bodies, whether third-party or first-party/in-house bodies, are required to request accreditation by the National Accreditation Body of the Member State in which they are established.

This general rule allows for exceptions. The option for a Conformity Assessment Body to request accreditation with a NAB in another Member State is limited to cases where:

  • there is no NAB in its own Member State [Art. 7.1(a)]
  • the NAB does not offer the requested accreditation service [Art. 7.1(b)]
  • the NAB has not received a positive outcome in the peer evaluation in relation to the conformity assessment activity for which accreditation is requested [Article 7.1(c)]

Art. 7.1 Regulation (EC) No 765/2008 is a consequence of the non-competition principle embodied in Article 6 of the same Regulation. It is important to prevent Conformity Assessment Bodies from shopping around for accreditation certificates, thus creating a “market for accreditation” leading to the commercialization of accreditation which jeopardizes the added value and role of accreditation as a public authority activity and last level of control in the conformity assessment chain.

EA encourages the use of its publications and communications materials. EA’s publications and brochures may be printed or distributed in full without need for formal permission from EA. Organizations seeking permission to translate EA publications must contact the EA Secretariat. The request for permission should clearly detail:

  • the EA publication, or part thereof, for which permission is sought;
  • where the translated material will appear and what it will be used for;
  • any other background information that may assist EA in granting permission.

The translated document must contain a statement acknowledging EA’s ownership and copyright.

For further details, contact Amandine Combe – Marketing & Communications Manager (amandine.combe@european-accreditation.org)

Accreditation is a decision made by the National Accreditation Body. Notification is a decision made by the national authorities in the Member States. Accreditation is the technical basis used by national authorities to notify a Conformity Assessment Body. The European Commission maintains the NANDO website which lists all notified organizations across Europe.