The Pressure Equipment (Safety) Regulations 2016

[F1 PART 2 E+W+S Module A2: Internal production control plus supervised pressure equipment checks at random

Textual Amendments

F1 Sch. 1A inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 24 para. 44 (with Sch. 24 para. 41) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

General E+W+S

6.   Internal production control plus supervised pressure equipment checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 ,4 and 5, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned satisfies the requirements of these Regulations.

Technical documentation E+W+S

7.— (1) The manufacturer shall establish the technical documentation.

(2) The technical documentation shall—

(a) make it possible to assess the conformity of the pressure equipment, or the assembly, to the relevant requirements;

(b) include an adequate analysis and assessment of the risk;

(c) specify the applicable requirements and contain, where applicable—

(i) a general description;

(ii) the conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, and all other relevant parts, to component level;

(iii) descriptions and explanations necessary for an understanding of those drawings and diagrams and the operation of the pressure equipment;

(iv) a list of the designated standards;

(v) results of design calculations made, examinations carried out, and the results of any other relevant calculation or examination;

(vi) test reports;

(vii) manufacture; and

(viii) operation

of the pressure equipment or assembly.

(4) The technical documentation must be kept at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

Manufacturing E+W+S

8.   The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in paragraph 7 and the requirements of these Regulations.

Final assessment and pressure equipment, assembly, checks E+W+S

9.— (1) The manufacturer shall perform a final assessment of the pressure equipment, or assembly, monitored by means of unexpected visits by an approved body chosen by the manufacturer.

(2) The approved body shall carry out, or have carried out for them, product checks which shall—

(a) be carried out at random intervals determined by the approved body;

(b) verify the quality of the internal checks of the pressure equipment, or assembly (taking into account the technological complexity of the equipment, or assembly, and the quantity of production);

(c) establish that the manufacturer performs final assessment in accordance with paragraphs 25 to 28 of Schedule 2 to these Regulations;

(d) take samples of pressure equipment and assemblies at the manufacturing or storage premises in order to conduct checks (the approved body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the samples).

(3) The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment, or assembly, performs within acceptable limits, with a view to ensuring conformity of the pressure equipment, or assembly.

(4) The approved body shall take appropriate measures where an item of pressure equipment or assembly does not conform.

(5) The manufacturer shall, under the responsibility of the approved body, affix the approved body's identification number during the manufacturing process.

UK marking and declaration of conformity E+W+S

10.   The manufacturer shall—

(a) affix the UK marking to each individual pressure equipment, or assembly, that satisfies the applicable requirements of these Regulations;

(b) draw up a written declaration of conformity for the pressure equipment, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up;

(c) make a copy of the declaration of conformity available, to the relevant authorities, on request; and

(d) keep a copy of the declaration of conformity at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

Authorised representative E+W+S

11.   The manufacturer's obligations set out in paragraph 10 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.]