Textual Amendments
F1Sch. 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)
82. Conformity based on unit verification is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 83, 84 and 85, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned, which has been subject to the provisions of paragraph 85, is in conformity with the requirements of these Regulations that apply to it.
83.—(1) The manufacturer shall establish the technical documentation and make it available to the approved body referred to in paragraph 85.
(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 the results of any other relevant calculation or examination;
(vi)test reports; and
(vii)appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with paragraphs 21 and 22 of Schedule 2 to these Regulations.
(3) 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.
84. The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured pressure equipment, or assembly, with the applicable requirements of these Regulations.
85.—(1) An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests, set out in the relevant designated standards or equivalent tests, to check the conformity of the pressure equipment, or assembly, with the appropriate requirements of these Regulations, or have them carried out.
(2) In the absence of such a designated standard the approved body concerned shall decide on the appropriate tests to be carried out applying other technical specifications.
(3) The approved body shall—
(a)examine the technical documentation with respect to the design and manufacturing process;
(b)assess the materials used where these are not in conformity with the relevant designated standards and check the certificate issued by the materials manufacturer in accordance with paragraphs 31(6) to (8) of Schedule 2 to these Regulations;
(c)approve the procedures for the permanent joining of parts and check that they have been previously approved in accordance with paragraph 21 of Schedule 2 to these Regulations;
(d)verify the qualifications and approvals required under paragraphs 21 and 22 of Schedule 2 of these Regulations;
(e)carry out the final inspection referred to in paragraphs 25 to 28 of Schedule 2 of these Regulations and perform or have performed the proof test, referred to in the same paragraphs, and examine safety devices, if applicable.
(4) The approved body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number or have it affixed under its responsibility to each approved item of pressure equipment or assembly.
(5) The manufacturer shall keep certificates of conformity available for inspection by the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.
86. The manufacturer shall—
(a)affix the UK marking and, under the responsibility of the approved body referred to in paragraph 85, the latter's identification number, to each individual item of pressure equipment, or assembly, that satisfies the applicable requirements of these Regulations;
(b)draw up a written declaration of conformity which identifies the pressure equipment model, 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.
87. The manufacturer's obligations set out in paragraphs 83 and 85 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that the responsibilities are specified in the mandate set out between the manufacturer and representative.]