Regulation 2(1)
1. A conformity assessment body shall be established in Northern Ireland or in Great Britain and have legal personality.
2. A conformity assessment body shall be a third party body independent of the organisation or the product it assesses.
3. A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of products which it assesses is to be a conformity assessment body for the purposes of regulation 44 (Notification) provided that such body can demonstrate—
(a)its independence from such business association or professional federation; and
(b)the absence of any conflict of interest.
4.—(1) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the products, nor the representative of any of those parties.
(2) Sub-paragraph (1) does not preclude the use of assessed products that are necessary for the operations of the conformity assessment body or the use of products for personal purposes.
5. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities shall not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of the products, or represent the parties engaged in those activities.
6. A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities shall not engage in activity that may conflict with their independence of judgment or integrity in relation to conformity assessment activities for which they are notified (including consultancy services).
7. A conformity assessment body shall ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.
8. A conformity assessment body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups of persons who have an interest in the results of those activities.
9. A conformity assessment body shall be capable of carrying out all of the conformity assessment activities for which it has been, or is to be, notified, whether those activities are carried out by the conformity assessment body itself or on its behalf and under its responsibility.
10. A conformity assessment body shall have—
(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 activities are to be 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 a notified 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 product technology in question and the mass or serial nature of the process.
11. A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to the necessary equipment or facilities to enable it to perform those activities.
12. The personnel responsible for carrying out conformity assessment activities shall have—
(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;
(b)satisfactory knowledge of the requirements of the assessments which the personnel carry out and adequate authority to carry out those assessments;
(c)appropriate knowledge and understanding of the essential health and safety requirements, of the applicable harmonised standards and of the ATEX Directive and of these Regulations;
(d)the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.
13. A conformity assessment body shall be able to demonstrate the impartiality of its top level management and the personnel responsible for carrying out the conformity assessment activities.
14. The remuneration of the top level management and the personnel responsible for carrying out the conformity assessment activities shall not depend on the number of assessments carried out or on the results of those assessments.
15. A conformity assessment body shall have, and shall satisfy the Executive that it has, adequate civil liability insurance in respect of its activities.
16. A conformity assessment body shall 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.
17. Paragraph 16 does not prevent the personnel from providing information to the Executive pursuant to these Regulations or under any enactment.
18. A conformity assessment body shall 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 notified body coordination group established under the ATEX Directive and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.