The Pressure Equipment (Safety) Regulations 2016

Regulation 2(1), 56(3)

SCHEDULE 4 Notified body requirements

1.  A notified body or recognised third party organisation must meet the requirements for conformity assessment bodies set out in this Schedule.

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

3.  A conformity assessment body must be a third party body independent of the organisation or the pressure equipment it assesses.

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, supplier, installer, purchaser, owner, user or maintainer of pressure equipment or assemblies, nor the representative of any of those parties.

(2) Subparagraph (1) does not preclude the use of pressure equipment or assemblies that are necessary for the operations of the conformity assessment body or the use of pressure equipment for personal purposes.

5.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be directly involved in the design, manufacture or construction, the marketing, installation, use or maintenance of pressure equipment or assemblies, 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 must 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 must 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 must carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and must 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 with an interest in those activities.

9.  A conformity assessment body must be capable of carrying out all of the conformity assessment activities for which it has been authorised, 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 must have at its disposal—

(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 and the ability of reproduction of 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 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 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 or facilities.

12.  The personnel responsible for carrying out conformity assessment activities must 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 safety requirements, of the applicable harmonised standards and of the Directive and of these Regulations; and

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

13.  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.

14.  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.

15.  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.

16.  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.

17.  Paragraph 16 does not prevent the personnel from providing information to the Secretary of State or an enforcing authority.

18.  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 notified body coordination group established under the Directive and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.