§5.3.2.3 Accreditation under Regulation (EC) No 765/2008

Accreditation, performed according to the EN ISO/IEC 17000 series of standards by nationally recognised accreditation bodies that are members of the European co-operation for Accreditation (EA), is a technical assessment of the competence of the conformity assessment body seeking notification. Although it is not a requirement, it remains an important and favoured instrument for evaluating the competence and integrity of the bodies to be notified. For this reason, accreditation should be considered by national notifying authorities as the most favoured technical basis for the assessment of conformity assessment bodies so as to reduce differences in the criteria applied for notification. The harmonised standards of the EN ISO/IEC 17000 series that can be used to demonstrate the competence of the candidate notified body may vary depending on the specific conformity assessment tasks (modules) and the different products in Union harmonisation legislation. In order to ensure harmonisation of the assessment of competence of candidate notified bodies, the European Cooperation for Accreditation (EA) has developed a recommendation on standards for accreditation for each relevant Union harmonisation legislation and for each conformity assessment module (261). It is intended to apply to all National Accreditation Bodies that assess and accredit conformity assessment bodies for notification purposes, unless the notifying and/or regulating authority - at its own discretion - has officially established and published different requirements. Accreditation provides an authoritative statement of the competence, professional integrity and impartiality of the bodies to be notified to the Commission and the other Member States. For a notification to be considered as accompanied by an accreditation certificate, the accreditation certificate must indicate the competence of the candidate notified in relation to the specific Union harmonisation legislation for which notification is being sought. Accreditation also entails regular monitoring and surveillance of the accredited bodies. Whenever a national accreditation body ascertains that the conformity assessment body to which it has issued an accreditation certificate is no longer competent or does not fulfil its obligations, the accreditation certificate must be withdrawn. In this case the body should be de-notified and no longer allowed to carry out conformity assessment activities under the relevant legislation. The preference given to accreditation is based on the peer evaluation process which ensures that the accreditation body adequately supervises the conformity assessment bodies it accredits. Cases may, however arise where the national accreditation body has not been successfully peer evaluated but may nevertheless have assessed notified bodies (262). If the national accreditation body has not been peer evaluated for the specific accreditation activity in question but still evaluate the competence of a conformity assessment body for this activity, the notification of this conformity assessment body should not be considered as accredited for the purposes of EU harmonisation legislation. If a national accreditation body was successful in a previous peer evaluation for a given activity but has been suspended at a subsequent peer evaluation, new notifications of conformity assessment bodies assessed by this national accreditation body should also be considered as unaccredited. As a principle, accreditation certificates issued up until the point of the suspension of the peer evaluation of the national accreditation body, should continue to be recognised by national authorities. If the grounds for suspension of the national accreditation body result in serious doubts about the competence of the notified bodies, the responsible notifying authority would have to inform the Commission and other Member States of how it intends to ensure the competence of the bodies notified, and of any corrective measures taken, including the de-notification. Although accreditation is the favoured instrument for the verification of competence of conformity assessment bodies, Member States can carry out the evaluation themselves. Following the entry into force of Regulation (EC) No 765/2008 on 1 January 2010, in such cases evidence must be given to the Commission and other Member States that the evaluated body complies with all the applicable regulatory requirements. Further, the notified body must be subject to regular surveillance similar to the practice established by the accreditation organisations.

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Source: EUR-Lex (Cellar) · retrieved 2026-09-07