What is accreditation?
Accreditation is a third-party evaluation and demonstration of competence. It is the assessment of independence, objectivity and competence of an entity for the performance of defined activities.
Accreditation means increased confidence in the observance of required level of quality of the provided services.
Accreditation is a public authority activity. It is the last level of public authority control. The purpose of accreditation is to provide an authoritative statement of the competence of a body to perform conformity assessment activities.
EU Member States shall not maintain more than one national accreditation body (NAB) and shall
ensure that it is organised in such a way as to safeguard the objectivity and impartiality of its activities. NABs should operate independently of commercial conformity assessment activities. Member States shall ensure that, in performing their tasks, NABs are deemed to exercise public authority, irrespective of their legal status.
In summary, accreditation consists in:
- the formal demonstration of conformity assessment bodies’ (CABs) competence to carry out specific conformity assessment tasks (EN ISO/IEC 17000 series)
- the independent and authoritative attestation of the competence, impartiality and integrity of CABs
- the elimination of technical barriers to trade and contributing to the protection of fundamental rights of people
- the harmonization of accreditation rules and procedures at world-wide level
Key words in terms of accreditation: confidence; competence; supports notification; applies to conformity assessment activities; based on international standards; international dimension; facilitate acceptance beyond the frontiers; save re-assessment; tested once, accepted everywhere.
Get more information about accreditation of conformity assessment bodies and EA on European Commission's website
What accreditation bodies do?
The EA members provide accreditation of:
- Testing (ISO/IEC 17025), Medical examinations (ISO 15189)
- Calibration (ISO/IEC 17025)
- Inspection bodies (ISO/IEC 17020)
- Certification bodies:
- Certification of Persons (ISO/IEC 17024)
- Management Systems Certification (ISO/IEC 17021)
- Product Certification (EN/ISO 17065)
- Proficiency Testing Providers (EN ISO/IEC 17043)
- Validation and Verification (ISO14065)
- Reference Materials Producers (ISO 17034)
These are the standards used for accreditation by the EA members.
The official definition is: “Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled” (definition in BS 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 include activities such as testing, inspection and certification.
Third-party assessment consists in the evaluation of an organisation performed by an independent body. The organisation carrying out the assessment shall be independent of both supplier and customer organisations, and deliver an impartial assessment.
The value and reliability of third-party assessment result from the independence and competence of the third-party evaluation of certification body. Accreditation of a certification body assures the market that a product or service fully complies with relevant standards.
In the field of accreditation, the impartiality rule requires that the accreditation body is 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 political,
commercial, financial, etc. 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 organised 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, this means that availability of accreditation services shall not depend on a turn-over. Nor shall the AB be dependent on government funding to the extent that the day-to-day operations of the AB could be damaged or altered. On the contrary, the European legislation puts a responsibility on governments to ensure that such a situation cannot occur.
Impartiality also means that the decision of accreditation shall be made by persons different from those having conducted the assessment.
EA and its member accreditation bodies are non-profit-making and -distributing organisations to meet their formal obligation to act in the public interest.
EA applies itself to promoting the recognition of the role and use of accreditation as a service of general interest that represents the last authoritative level of control of conformity assessment services delivered in both voluntary (market-driven) and mandatory (law-regulated) spheres.
As such, accreditation must be operated under the following conditions:
- at national level, with a recognised mandate from the government
- in 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 refers to the principles for cooperation between EA members in
the accreditation process when accreditation is granted by a foreign AB.
According to 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 AB 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 AB and the local AB, and to support local accreditation by offering the local AB a possibility for sub-contracting, participating in a joint assessment or observing 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 possibility 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) 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 commercialisation of accreditation which jeopardizes the added value and role of accreditation as a public authority activity and last level of control of the conformity assessment chain.