The Merchant Shipping (Marine Equipment) Regulations 2016 No. 1025

Regulation 4

[F1 SCHEDULE 3 U.K. Requirements to be met by Conformity Assessment Bodies in order to become Approved Bodies

Textual Amendments

F1 Schs. 2-5 inserted (31.12.2020) by The Merchant Shipping (Marine Equipment) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/470), reg. 1(1), Sch. para. 27(2) (with regs. 5, 6) (as amended by S.I. 2020/1000, regs. 1, 7(2)); 2020 c. 1, Sch. 5 para. 1(1)

1.   In order to be designated as an approved body, a conformity assessment body must meet the requirements set out in paragraphs 2 to 19. U.K.

2.   A conformity assessment body must be established in the United Kingdom and have legal personality. U.K.

3.   A conformity assessment body must be a third party body independent of the organisation or the marine equipment which it assesses. A body belonging to a business association or professional federation representing businesses involved in the design, manufacturing, provision, assembly, use or maintenance of marine equipment which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered a conformity assessment body. U.K.

4.— (1) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be the designer, manufacturer, or an authorised representative of a manufacturer, supplier, installer, purchaser, owner, user or maintainer of the marine equipment which is assessed. U.K.

(2) Sub-paragraph (1) does not preclude the use of products that are necessary for the operations of the conformity assessment body or the use of such products for personal purposes.

5.   A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of that marine equipment, or represent the parties engaged in those activities. They must not engage in any activity (including consultancy services) that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are designated. U.K.

6.   A conformity assessment body must ensure that the activities of its subsidiaries or sub-contractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities. U.K.

7.   A conformity assessment body and its personnel must carry out conformity assessment activities with the highest degree of professional integrity and the requisite competence in the specific field and must be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, particularly with regard to persons or groups of persons who have an interest in the results of those activities. U.K.

8.   A conformity assessment body must be capable of carrying out all of the conformity assessment activities for which it has been designated, whether that assessment is carried out by the body itself or on its behalf and under its responsibility. U.K.

9.   A conformity assessment body must have at its disposal— U.K.

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency of and the ability to reproduce those procedures, and have appropriate policies and procedures in place that distinguish between tasks it carries out as an approved body and other activities;

(c) procedures for the performance of conformity assessment activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the marine equipment technology in question and the mass or serial nature of the production process.

10.   A conformity assessment body must have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to the necessary equipment and facilities. U.K.

11.   The personnel responsible for carrying out conformity assessment must have— U.K.

(a) sound technical and vocational training, covering all conformity assessment activities in relation to which the conformity assessment body has been designated;

(b) satisfactory knowledge of the requirements of the assessments which the conformity assessment body carries out, and adequate authority to carry out those assessments;

(c) appropriate knowledge and understanding of the applicable requirements and testing standards and of the applicable provisions of these Regulations; and

(d) the ability to draw up certificates, records and reports demonstrating that the assessments have been carried out.

12.   A conformity assessment body must be able to demonstrate the impartiality of its top level management and the personnel responsible for carrying out the conformity assessment activities. U.K.

13.   The remuneration of the top level management and the personnel responsible for carrying out the conformity assessment activities must not depend on the number of assessments carried out or on the results of those assessments. U.K.

14.   A conformity assessment body must have, and must satisfy the Secretary of State that it has, adequate civil liability insurance in respect of its activities. U.K.

15.   A conformity assessment body must ensure that its personnel observe professional secrecy with regard to all information obtained in carrying out their tasks in accordance with these Regulations, and that proprietary rights are protected. U.K.

16.   Paragraph 15 does not prevent the personnel from providing the information to the Secretary of State. U.K.

17.   A conformity assessment body must participate in, or ensure that its personnel who are responsible for carrying out the conformity assessment activities, are informed of the relevant standardisation activities and the activities of any approved body co-ordination group that may be established and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group. U.K.

18.   A conformity assessment body must meet the requirements of standard EN ISO/IEC 17065:2012. U.K.

19.   A conformity assessment body must ensure that testing laboratories used for conformity assessment purposes meet the requirements of standard EN ISO/IEC 17025:2017.] U.K.