The Pressure Equipment (Safety) Regulations 2016

[F1 PART 6 E+W+S Module D1: Quality assurance of the production process

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

56.   Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 57, 58 and 61, 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

57.— (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 of the individual piece of equipment or the assembly;

(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; and

(vi) test reports.

(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.

Manufacturing E+W+S

58.   The manufacturer shall operate an approved quality system for production, final product inspection and testing of the pressure equipment, or assembly, concerned as specified in paragraph 59 and shall be subject to surveillance as specified in paragraph 60.

Quality system E+W+S

59.— (1) The manufacturer shall lodge an application for assessment of their quality system with the approved body of their choice for the pressure equipment, or assembly, concerned.

(2) The application shall include—

(a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, their name and address as well;

(b) a written declaration that the same application has not been lodged with any other approved body;

(c) all relevant information on the pressure equipment, or assembly, type envisaged;

(d) the documentation concerning the quality system; and

(e) the technical documentation referred to in paragraph 57.

(3) The quality system shall ensure compliance of the pressure equipment, or assembly, with the requirements of these Regulations that apply to it.

(4) All elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records, including—

(a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment or assembly;

(b) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with paragraph 21 of Schedule 2 to these Regulations;

(c) the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(d) the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications and approvals of the personnel concerned, particularly of those of the personnel undertaking the permanent joining of parts and the non-destructive test in accordance with paragraphs 21 and 22 of Schedule 2 to these Regulations; and

(e) the means of monitoring the achievement of the required quality and the effective operation of the quality system.

(5) The approved body shall—

(a) assess the quality system to determine whether it satisfies the requirements referred to in sub-paragraphs (3) and (4);

(b) presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant designated standard;

(c) provide a team with experience in quality management systems; and

(d) ensure that the audit—

(i) is carried out by a team containing at least one member with experience in the relevant pressure equipment, or assembly, field and pressure equipment and assembly technology concerned, and knowledge of the applicable requirements of these Regulations;

(ii) includes an inspection visit to the manufacturer's premises; and

(iii) reviews the technical documentation referred to in paragraph 56, to verify the manufacturer's ability to identify the relevant requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the product with those requirements.

(6) The decision shall—

(a) be notified to the manufacturer;

(b) contain the conclusions of the audit; and

(c) contain a reasoned assessment decision.

(7) The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(8) Where the manufacturer intends to change the quality system—

(a) the manufacturer shall inform the approved body that has approved the quality system informed of the intended change to the quality system;

(b) the approved body shall evaluate the proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in sub-paragraph (5) or whether a reassessment is necessary;

(c) the approved body shall notify the manufacturer of its decision; and

(d) the notification shall contain the conclusions of the examination and the reasoned assessment decision.

Surveillance under the responsibility of the approved body E+W+S

60.— (1) The manufacturer shall—

(a) allow the approved body access to the manufacture, inspection, testing and storage sites for assessment;

(b) provide the quality system documentation;

(c) provide the technical documentation referred to in paragraph 57;

(d) provide the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.;

(e) provide any other information deemed necessary by the approved body.

(2) The approved body shall—

(a) carry our periodic audits to make sure that the manufacturer maintains and applies the quality system;

(b) provide the manufacturer with an audit report;

(c) ensure that the frequency of the periodic audits is such that a full reassessment is carried out every three years.

(3) The approved body may pay unexpected visits to the manufacturer. The need for such additional visits, and their frequency, should be determined on the basis of a visit control system operated by the approved body. The following factors shall be considered in the visit control system—

(a) the category of the pressure equipment or assembly;

(b) the results of previous surveillance visits;

(c) the need to follow up corrective actions;

(d) special conditions linked to the approval of the system, where applicable; and

(e) significant changes in manufacturing organisation, policies or techniques.

(4) During unexpected visits, the approved body—

(a) may carry out product tests or have them carried out, where necessary, in order to verify that the quality system is functioning correctly;

(b) shall provide the manufacturer with a visit report; and

(c) shall, where tests have been carried out, provide the manufacturer with a test report.

UK marking and declaration of conformity E+W+S

61.— (1) The manufacturer shall—

(a) affix the UK marking and, under the responsibility of the approved body referred to in paragraph 58(1), the latter's identification number, to each individual piece of pressure equipment, or assembly, that is in conformity with the type described in the Type examination certificate and 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;

(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;

(e) For a period ending 10 years after the pressure equipment, or assembly, has been placed on the market, keep at the disposal of the national authorities—

(i) the documentation referred to in paragraphs 59(1) and (2);

(ii) the change referred to in paragraph 59(8); and

(iii) the decisions and reports of the approved body referred to in paragraphs 58(8) and 60(2) to (4),

(2) Each approved body shall inform the Secretary of State of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.

(3) Each approved body shall inform the other approved bodies of the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

Authorised representative E+W+S

62.   The manufacturer's obligations set out in paragraphs 59(1), (2) and (8) and paragraph 61 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.]