Regulation (EC) No 765/2008 of the European Parliament and of the CouncilShow full title

CHAPTER II ACCREDITATION

Article 3 Scope

This Chapter shall apply to accreditation, used on a compulsory or voluntary basis, relating to conformity assessment, whether that assessment is compulsory or not, and irrespective of the legal status of the body performing the accreditation.

Article 4 General principles

1. Each Member State shall appoint a single national accreditation body.

2. Where a Member State considers that it is not economically meaningful or sustainable to have a national accreditation body or to provide certain accreditation services, it shall, as far as possible, have recourse to the national accreditation body of another Member State.

3. A Member State shall inform the Commission and the other Member States where, in accordance with paragraph 2, recourse is had to the national accreditation body of another Member State.

4. On the basis of the information referred to in paragraph 3 and Article 12, the Commission shall draw up and update a list of national accreditation bodies which it shall make publicly available.

5. Where accreditation is not operated directly by the public authorities themselves, a Member State shall entrust its national accreditation body with the operation of accreditation as a public authority activity and grant it formal recognition.

6. The responsibilities and tasks of the national accreditation body shall be clearly distinguished from those of other national authorities.

7. The national accreditation body shall operate on a not-for-profit basis.

8. The national accreditation body shall not offer or provide any activities or services that conformity assessment bodies provide, nor shall it provide consultancy services, own shares in or otherwise have a financial or managerial interest in a conformity assessment body.

9. Each Member State shall ensure that its national accreditation body has the appropriate financial and personnel resources for the proper performance of its tasks, including the fulfilment of special tasks, such as activities for European and international accreditation cooperation and activities that are required to support public policy and which are not self-financing.

10. The national accreditation body shall be a member of the body recognised under Article 14.

11. National accreditation bodies shall establish and maintain appropriate structures to ensure the effective and balanced involvement of all interested parties within both their organisations and the body recognised under Article 14.

Article 5 Operation of accreditation

1. A national accreditation body shall, when requested by a conformity assessment body, evaluate whether that conformity assessment body is competent to carry out a specific conformity assessment activity. Where it is found to be competent, the national accreditation body shall issue an accreditation certificate to that effect.

2. When a Member State decides not to use accreditation, it shall provide the Commission and the other Member States with all the documentary evidence necessary for the verification of the competence of the conformity assessment bodies it selects for the implementation of the Community harmonisation legislation in question.

3. National accreditation bodies shall monitor the conformity assessment bodies to which they have issued an accreditation certificate.

4. Where a national accreditation body ascertains that a conformity assessment body which has received an accreditation certificate is no longer competent to carry out a specific conformity assessment activity or has committed a serious breach of its obligations, that accreditation body shall take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate.

5. Member States shall establish procedures for the resolution of appeals, including, where appropriate, legal remedies against accreditation decisions or the absence thereof.

Article 6 Principle of non-competition

1. National accreditation bodies shall not compete with conformity assessment bodies.

2. National accreditation bodies shall not compete with other national accreditation bodies.

3. National accreditation bodies shall be permitted to operate across national borders, within the territory of another Member State, either at the request of a conformity assessment body in the circumstances set out in Article 7(1), or, if they are asked to do so by a national accreditation body in accordance with Article 7(3), in cooperation with the national accreditation body of that Member State.

Article 7 Cross-border accreditation

1. Where a conformity assessment body requests accreditation it shall do so with the national accreditation body of the Member State in which it is established or with the national accreditation body to which that Member State has had recourse in accordance with Article 4(2).

However, a conformity assessment body may request accreditation by a national accreditation body other than those referred to in the first subparagraph in any one of the following situations:

(a) where the Member State in which it is established has decided not to establish a national accreditation body and has not had recourse to the national accreditation body of another Member State in accordance with Article 4(2);

(b) where the national accreditation bodies referred to in the first subparagraph do not perform accreditation in respect of the conformity assessment activities for which accreditation is sought;

(c) where the national accreditation bodies referred to in the first subparagraph have not successfully undergone peer evaluation under Article 10 in respect of the conformity assessment activities for which accreditation is sought.

2. Where a national accreditation body receives a request pursuant to paragraph 1(b) or (c), it shall inform the national accreditation body of the Member State in which the requesting conformity assessment body is established. In such cases, the national accreditation body of the Member State in which the requesting conformity assessment body is established may participate as an observer.

3. A national accreditation body may request another national accreditation body to carry out part of the assessment activity. In such a case, the accreditation certificate shall be issued by the requesting body.

Article 8 Requirements for national accreditation bodies

A national accreditation body shall fulfil the following requirements:

1.

it shall be organised in such a manner as to make it independent of the conformity assessment bodies it assesses and of commercial pressures, and to ensure that no conflicts of interest with conformity assessment bodies occur;

2.

it shall be organised and operated so as to safeguard the objectivity and impartiality of its activities;

3.

it shall ensure that each decision relating to the attestation of competence is taken by competent persons different from those who carried out the assessment;

4.

it shall have adequate arrangements to safeguard the confidentiality of the information obtained;

5.

it shall identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to relevant Community or national legislation and standards;

6.

it shall set up the procedures necessary to ensure efficient management and appropriate internal controls;

7.

it shall have a number of competent personnel at its disposal sufficient for the proper performance of its tasks;

8.

it shall document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence;

9.

it shall establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved;

10.

it shall verify that conformity assessments are carried out in an appropriate manner, meaning that unnecessary burdens are not imposed on undertakings and that due account is taken of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process;

11.

it shall publish audited annual accounts prepared in accordance with generally accepted accounting principles.

Article 9 Compliance with requirements

1. Where a national accreditation body does not meet the requirements of this Regulation or fails to fulfil its obligations hereunder, the Member State concerned shall take appropriate corrective action or shall ensure that such corrective action is taken, and shall inform the Commission thereof.

2. Member States shall monitor their national accreditation bodies at regular intervals in order to ensure that they fulfil the requirements laid down in Article 8 on a continuing basis.

3. Member States shall take the utmost account of the results of peer evaluation under Article 10 when carrying out the monitoring referred to in paragraph 2 of this Article.

4. National accreditation bodies shall have in place the necessary procedures to deal with complaints against the conformity assessment bodies they have accredited.

Article 10 Peer evaluation

1. National accreditation bodies shall subject themselves to peer evaluation organised by the body recognised under Article 14.

2. Stakeholders shall have the right to participate in the system set up for the supervision of peer evaluation activities, but not in individual peer evaluation procedures.

3. Member States shall ensure that their national accreditation bodies regularly undergo peer evaluation as required by paragraph 1.

4. Peer evaluation shall be operated on the basis of sound and transparent evaluation criteria and procedures, in particular concerning structural, human resource and process requirements, confidentiality and complaints. Appropriate appeal procedures against decisions taken as a result of such evaluation shall be provided for.

5. Peer evaluation shall ascertain whether the national accreditation bodies meet the requirements laid down in Article 8, taking into account the relevant harmonised standards referred to in Article 11.

6. The outcome of peer evaluation shall be published and communicated by the body recognised under Article 14 to all Member States and the Commission.

7. The Commission shall, in cooperation with the Member States, oversee the rules and the proper functioning of the peer evaluation system.

Article 11 Presumption of conformity for national accreditation bodies

1. National accreditation bodies that demonstrate conformity with the criteria laid down in the relevant harmonised standard, the reference of which has been published in the Official Journal of the European Union, by having successfully undergone peer evaluation under Article 10 shall be presumed to fulfil the requirements laid down in Article 8.

2. National authorities shall recognise the equivalence of the services delivered by those accreditation bodies which have successfully undergone peer evaluation under Article 10, and thereby accept, on the basis of the presumption referred to in paragraph 1 of this Article, the accreditation certificates of those bodies and the attestations issued by the conformity assessment bodies accredited by them.

Article 12 Information obligation

1. Each national accreditation body shall inform the other national accreditation bodies of the conformity assessment activities in respect of which it operates accreditation and of any changes thereto.

2. Each Member State shall inform the Commission and the body recognised under Article 14 of the identity of its national accreditation body and of all conformity assessment activities in respect of which that body operates accreditation in support of Community harmonisation legislation, and of any changes thereto.

3. Each national accreditation body shall regularly make publicly available information concerning the results of its peer evaluation, the conformity assessment activities in respect of which it operates accreditation and any changes thereto.

Article 13 Requests to the body recognised under Article 14

1. The Commission may, after consulting the Committee set up by Article 5 of Directive 98/34/EC, request the body recognised under Article 14 to contribute to the development, maintenance and implementation of accreditation in the Community.

2. The Commission may also, following the procedure laid down in paragraph 1:

(a) request the body recognised under Article 14 to lay down evaluation criteria and procedures for peer evaluation and to develop sectoral accreditation schemes;

(b) accept any existing scheme that already lays down evaluation criteria and procedures for peer evaluation.

3. The Commission shall ensure that sectoral schemes identify the technical specifications necessary to meet the level of competence required by Community harmonisation legislation in fields with specific requirements relating to technology, health and safety or environment related requirements or any other aspect of public interest protection.

Article 14 European accreditation infrastructure

1. The Commission shall, after consulting the Member States, recognise a body which satisfies the requirements set out in Annex I to this Regulation.

2. A body which is to be recognised pursuant to paragraph 1 shall conclude an agreement with the Commission. That agreement shall specify, inter alia, the detailed tasks of the body, funding provisions and provisions for its supervision. Both the Commission and the body shall be able to terminate the agreement without cause at the expiry of a reasonable period of notice to be defined therein.

3. The Commission and the body shall make the agreement public.

4. The Commission shall communicate the recognition of a body pursuant to paragraph 1 to the Member States and to national accreditation bodies.

5. The Commission may not recognise more than one body at a time.

6. The first body recognised under this Regulation shall be the European cooperation for accreditation, provided that it has concluded an agreement as specified in paragraph 2.