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Definition, legal and normative framework

Definition, legal and normative framework

Definition

ISO/IEC 17000 specifies the general terms and their definitions relating to conformity assessment, including the accreditation of conformity assessment bodies, and the use of conformity assessment to facilitate trade. Annex A includes a description of the functional approach to conformity assessment, intended to provide additional help for its comprehension among users of the conformity assessment, conformity assessment bodies and their accreditation bodies in contexts at once voluntary and statutory.

The standard ISO/IEC 17000 defines accreditation as an "Attestation issued by a third party related to a conformity assessment body conveying formal recognition of its competence to carry out specific conformity assessment tasks".

This translates as a second level inspection carried out on laboratories, inspection bodies and certification bodies in order to certify their competence to perform calibrations, tests or inspections or to certify products, systems or personnel.

Legal and normative framework

Recourse to accreditation is initially and in essence voluntary in nature. However, increasingly frequently, accreditation tends to be developed within a statutory framework. It is then required by the Public Authorities as a preliminary to future approval (in the majority of cases) for the application of a national regulation or with a view to notification within the framework of a European Directive.

This trend towards recourse to accreditation as a prerequisite to notification has grown since publication of the European regulation of 9 July 2008 on accreditation and market surveillance. The ultimate aim of an accreditation procedure is to establish trust in the service provisions fulfilled and accreditation is required to represent the ultimate level of control of conformity assessment activities in terms of technical competence.

This trust cannot, of course, be established unless the accreditation body is itself beyond reproach and suspicion.

It gives rise to several requirements which accreditation bodies must satisfy, which are expressed in the standard, ISO/IEC 17011: independence, impartiality, transparency and competence.

We can single out three fundamental levels of standards (accreditation, conformity assessment bodies, companies employing the services of accredited entities cf. diagram below).

Accreditors' organisations

The main role of accreditors' organisations is to organise and guarantee the harmonisation of practices. They occasionally take part in related activities such as technical assistance in setting up accreditation bodies in the developing countries.

The harmonisation of accreditation practices involves the drafting of guides on the application and interpretation of standards and the organisation of the peer evaluations on which multilateral recognition agreements are based. These are presented elsewhere. We can single out the global organisations and the so-called regional organisations.

There are two global organisations: ILAC (International Laboratory Accreditation Cooperation) for the accreditation of laboratories and IAF (International Accreditation Forum) for the accreditation of certification bodies and inspection bodies.

These two organisations incorporate bodies from five continents and some of their members (this is the case of the Europeans, for example) are affiliated to both organisations.

The regional organisations are organisations whose radius of influence is geographically limited, such as:

  • EA (European Cooperation for Accreditation) for Europe (European Union, EFTA countries and Turkey) for all types of accreditation;
  • APLAC (Asia Pacific Laboratory Accreditation Cooperation) for the Asia Pacific region for the accreditation of laboratories and inspection bodies;
  • PAC (Pacific Accreditation Cooperation) for the same region (apart from a few countries) for the accreditation of certification bodies and inspection bodies;
  • IAAC (Inter American Accreditation Cooperation) for the Americas for all types of accreditation;
  • SADCA (Southern African Development Community Accreditation) for southern Africa for all types of accreditation.

The regional organisations are relays for the global organisations in that they have developed regional recognition agreements with the result that ILAC and IAF are not required to systematically audit all of their members.