The Pressure Equipment (Safety) Regulations 2016

[F1 PART 12 E+W+S Module H1: Conformity based on full quality assurance plus design examination

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

94.   Conformity based on full quality assurance plus design examination and special surveillance of the final assessment is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 95 and 99, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned satisfies the requirements of these Regulations that apply to it.

Manufacturing E+W+S

95.   The manufacturer shall operate an approved quality system for design, manufacture, final product inspection and testing of the products concerned as specified in paragraph 96 and shall be subject to surveillance as specified in paragraph 98. The adequacy of the technical design of the pressure equipment, or assembly, shall have been examined in accordance with paragraph 97.

Quality system E+W+S

96.— (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) the technical documentation for one model of each type of pressure equipment, or assembly, intended to be manufactured which shall, wherever applicable, contain—

(i) a general description of the pressure equipment or assembly;

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

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

(iv) a list of the designated standards, applied in part or in full, and descriptions of the solutions adopted to meet the essential safety requirements of these Regulations where those designated standards have not been applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied;

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

(vi) test reports;

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

(d) the documentation concerning the quality system.

(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 design and product quality;

(b) the technical design specifications, including standards, that will be applied and, where the relevant designated standards will not be applied in full, the means that will be used to ensure that the essential requirements of these Regulations that apply to the pressure equipment or assembly will be met;

(c) the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment, or assembly, pertaining to the product type covered, particularly with regard to materials in accordance with Part 4 of Schedule 2 to these Regulations;

(d) 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 with paragraph 21 of Schedule 2 to these Regulations;

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

(f) 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

(g) the means of monitoring the achievement of the required design and pressure equipment 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;

(d) ensure that the audit—

(i) is carried out by a team containing at least one member with knowledge of 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;

(iii) reviews the technical documentation referred to in sub-paragraph (2)(b), 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, or his authorised representative;

(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 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 subparagraph (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.

Design examination E+W+S

97.— (1) The manufacturer shall lodge an application for the examination of the design of each item of pressure equipment, or assembly, not covered by a previous design examination with the approved body referred to in paragraph 96(1).

(2) The application shall make it possible to understand the design, manufacture and operation of the pressure equipment, or assembly, and to assess the conformity with the requirements of these Regulations that apply to it.

(3) The application shall include—

(a) the name and address of the manufacturer;

(b) the technical documentation for one model of each type of pressure equipment, or assembly, intended to be manufactured which shall, wherever applicable, contain—

(i) a general description of the pressure equipment or assembly;

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

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

(iv) a list of the designated standards, applied in part or in full, and descriptions of the solutions adopted to meet the essential safety requirements of these Regulations where those designated standards have not been applied. In the event of partly applied designated standards, the technical documentation shall specify the parts which have been applied;

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

(vi) test reports;

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

(d) the supporting evidence for the adequacy of the technical design. The supporting evidence shall mention any documents that have been used, in particular where the relevant designated standards have not been applied in full, and shall include, where necessary, the results of tests carried out by the appropriate laboratory of the manufacturer or by another testing laboratory on their behalf and under their responsibility.

(4) Where the design meets the requirements of these Regulations the approved body shall issue a design examination certificate.

(5) The design examination certificate—

(a) must include—

(i) the name and address of the manufacturer;

(ii) the conclusions of the examination;

(iii) the conditions (if any) for the validity of the certificate; and

(iv) data necessary for identification of the approved design;

(b) may have one or more annexes attached;

(c) shall contain all relevant information to allow the conformity of manufactured products with the examined design to be evaluated, and to allow for in-service control, where applicable.

(6) Where the design does not satisfy the applicable requirements of these Regulations, the approved body shall refuse to issue a design examination certificate and shall inform the applicant accordingly, giving details for its refusal.

(7) The approved body shall keep itself appraised of any changes in the generally acknowledged state of the art which indicates that the approved design may no longer comply with the applicable requirements of these Regulations, and shall determine whether such changes require further investigation. If so, the approved body shall inform the manufacturer accordingly.

(8) The manufacturer shall inform the approved body that issued the design examination certificate of all modifications to the approved design that may affect the conformity of the pressure equipment, or assembly, with the essential safety requirements of these Regulations or the conditions for validity of the certificate. Such modifications shall require additional approval, from the approved body that issued the design examination certificate, in the form of an addition to the original design examination certificate.

(9) Each approved body shall inform the Secretary of State of the design examination certificates and any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of certificates and any additions thereto refused, suspended or otherwise restricted.

(10) Each approved body shall inform the other approved bodies concerning the design examination certificates and any additions thereto which it has refused, withdrawn, suspended or otherwise restricted and, upon request, concerning the certificates and additions thereto that it has issued.

(11) Other approved bodies may, on request, obtain a copy of the design examination certificate and additions thereto.

(12) The approved body shall keep a copy of the design examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the certificate.

(13) The manufacturer shall keep a copy of the design examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment, or assembly, has been placed on the market.

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

98.— (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 quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests and any other relevant quality records;

(d) provide the quality records provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, and any other relevant quality records; and

(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, will 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.

(5) Final assessment as referred to in paragraphs 25 to 28 of Schedule 2 to these Regulations is subject to increased surveillance in the form of unexpected visits by the approved body. In the course of such visits, the approved body shall conduct examinations on the pressure equipment, or assembly, and provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

UK marking and declaration of conformity E+W+S

99.— (1) The manufacturer shall—

(a) affix the UK marking and, under the responsibility of the approved body referred to in paragraph 96(1), the latter's identification number, to each individual items of pressure equipment, or assembly, that satisfies the applicable requirements of these Regulations;

(b) draw up a written declaration of conformity for the pressure equipment model, 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 concerning the quality system referred to in paragraph 96(2);

(ii) the change referred to in paragraph 96(8); and

(iii) the decisions and reports of the approved body referred to in paragraphs 96(8) and 98(2) and (3),

Authorised representative E+W+S

100.   The manufacturer's authorised representative may lodge the application referred to in paragraphs 96(1) and (2) and fulfil the obligations set out in paragraphs 95(1), (2) and (8), 96(8) and (13) and paragraph 98, on the manufacturer's behalf and under his responsibility, provided that they are specified in the mandate set out between the manufacturer and his representative.]