CHAPTER IIACCREDITATION
Article 3Scope
This Chapter F1applies 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.
F2Article 4 UK national accreditation body
(1.
The Secretary of State must by regulations appoint a single UK national accreditation body.
(2.
The appointment of the UK national accreditation body under regulation 3 of the Accreditation Regulations 2009 is to be treated on and after IP completion day as having been made in pursuance of the duty on the Secretary of State to appoint a UK national accreditation body set out in paragraph 1.
(3.
The UK national accreditation body must perform its functions in accordance with the provisions of this Chapter.
(4.
Regulations made under this Article may—
(a)
terminate the appointment of a UK national accreditation body; and
(b)
appoint a different body as the UK national accreditation body
where the Secretary of State considers that a UK national accreditation body is not performing its functions in accordance with this Chapter.
(5.
Regulations made under this Article must establish procedures for the resolution of appeals against accreditation decisions made by the appointed UK national accreditation body.
(6.
Regulation 5 of the Accreditation Regulations 2009 is to be treated as meeting the requirements of paragraph 5.
(7.
The UK national accreditation body must operate on a not-for-profit basis.
(8.
The UK national accreditation body must not—
(a)
offer or provide any activities or services that are provided by conformity assessment bodies,
(b)
provide consultancy services; and
(c)
own shares in, or otherwise have any financial or managerial interest in, a conformity assessment body.
(9.
The UK national accreditation body must establish and maintain appropriate structures to ensure—
(a)
consultation on its activities with interested parties; and
(b)
responses of interested parties to consultation are adequately taken into account.
(10.
The Secretary of State must ensure that the UK national accreditation body has the appropriate financial and personnel resources for the proper fulfilment of its tasks, including—
(a)
the fulfilment of special tasks such as activities related to international accreditation cooperation; and
(b)
activities that are required to support public policy and which are not self-financing.
(11.
Regulations made under this Article must be made by statutory instrument.
(12.
Regulations made under this Article may make such transitional, transitory, consequential or saving provision as the Secretary of State considers appropriate.
(13.
A statutory instrument containing regulations made under this Article is subject to annulment in pursuance of a resolution of either House of Parliament.
Article 5Operation of accreditation
1.
F3The UK national accreditation body must, 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, F4the UK national accreditation body must issue an accreditation certificate to that effect.
F52.
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3.
4.
Where F8the UK 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, F9the UK national accreditation body must take all appropriate measures within a reasonable timeframe to restrict, suspend or withdraw the accreditation certificate.
F105.
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Article 6Principle of non-competition
1.
F11The UK national accreditation body must not compete with conformity assessment bodies.
F122.
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F123.
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F13Article 7Cross-border accreditation
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Article 8Requirements for F14the UK national accreditation body
F15The UK national accreditation body must fulfil the following requirements:
- 1.
it F16must 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 F16must be organised and operated so as to safeguard the objectivity and impartiality of its activities;
- 3.
it F16must 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 F16must have adequate arrangements to safeguard the confidentiality of the information obtained;
- 5.
it F16must identify the conformity assessment activities for which it is competent to perform accreditation, referring, where appropriate, to F17any enactment and standards;
- 6.
it F16must set up the procedures necessary to ensure efficient management and appropriate internal controls;
- 7.
it F16must have a number of competent personnel at its disposal sufficient for the proper performance of its tasks;
- 8.
it F16must document the duties, responsibilities and authorities of personnel who could affect the quality of the assessment and of the attestation of competence;
- 9.
it F16must establish, implement and maintain procedures for monitoring the performance and competence of the personnel involved;
- 10.
it F16must 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 F16must publish audited annual accounts prepared in accordance with generally accepted accounting principles.
Article 9Compliance with requirements
1.
2.
F253.
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4.
F28Article 10Peer evaluation
(1.
The UK national accreditation body must—
(a)
ensure that it is evaluated in accordance with the requirements of this Article by a body which is approved by the Secretary of State;
(b)
set out the results of the evaluation in a report;
(c)
make that report publicly available; and
(d)
provide a copy of that report to the Secretary of State.
(2.
The evaluation referred to in paragraph 1(a) must—
(a)
be based on evaluation criteria and procedures—
i)
agreed between the national accreditation body and the body undertaking the evaluation; and
ii)
approved by the Secretary of State; and
(b)
evaluate whether the UK national accreditation body meets the requirements of Article 8.
(3.
The procedures referred to in paragraph 2(a) must include provision for appeal by the UK national accreditation body against the results of the evaluation.
(4.
The report paragraph (1)(c) must include the evaluation criteria and procedures referred to in paragraph (2)(a).
(5.
The first report under paragraph (1) must be made publicly available before the end of the period of five years beginning on IP completion day.
(6.
After the first report, reports made under this Article are to be made publicly available at intervals not exceeding five years
F29Article 11Presumption of conformity for national accreditation bodies
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F29Article 12Information obligation
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F29Article 13Requests to the body recognised under Article 14
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F29Article 14European accreditation infrastructure
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