Regulation (EU) 2016/424 of the European Parliament and of the CouncilShow full title

Article 26 U.K. Requirements relating to [F1 approved] bodies

1. For the purposes of [F2 approval], a conformity assessment body shall meet the requirements laid down in [F3 paragraphs 3 to 10].

F4 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3. A conformity assessment body shall be a third-party body independent of the organisation or the subsystem or the safety component it assesses.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of subsystems or safety components which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the subsystems or the safety components which they assess, nor the representative of any of those parties. This shall not preclude the use of assessed subsystems or safety components that are necessary for the operations of the conformity assessment body or the use of such subsystems or safety components for personal purposes.

A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of those subsystems or safety components, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

5. Conformity assessment bodies and their 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 judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6. A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annexes III to VII and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times, and for each conformity assessment procedure and each kind or category of subsystems or safety components in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

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

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall 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 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 subsystem or safety component technology in question and the mass or serial nature of the production process.

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 all necessary equipment or facilities.

7. The personnel responsible for carrying out conformity assessment tasks shall have the following:

(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 they carry out and adequate authority to carry out those assessments;

(c) appropriate knowledge and understanding of the essential requirements set out in Annex II, of the applicable [F5 designated standards and of the relevant provisions of this Regulation and of the Cableway Installations Regulations 2018];

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

8. The impartiality of the conformity assessment bodies, their top-level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top-level management and of the personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out, nor on the results of those assessments.

9. Conformity assessment bodies shall take out liability insurance F6 ....

10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annexes III to VII F7 ..., except in relation to the [F8 Secretary of State or the Executive]. Proprietary rights shall be protected.

F9 11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

F1 Word in Art. 26 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in Art. 26(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(b)(i); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 26(1) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F4 Art. 26(2) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(c); 2020 c. 1, Sch. 5 para. 1(1)

F5 Words in Art. 26(7)(c) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(d); 2020 c. 1, Sch. 5 para. 1(1)

F6 Words in Art. 26(9) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(e); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in Art. 26(10) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(f)(i); 2020 c. 1, Sch. 5 para. 1(1)

F8 Words in Art. 26(10) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(f)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F9 Art. 26(11) omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 33(g); 2020 c. 1, Sch. 5 para. 1(1)