Legalize / United Kingdom / Statutory-Instrument

The Pressure Equipment (Safety) Regulations 2016

Type Statutory-Instrument

Publication 2016-11-15

Last updated 2024-10-01

State In force

Department King's Printer of Acts of Parliament

Source legislation.gov.uk

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articles Not indexed

Reform history JSON API

(2) Each approved body shall inform the Secretary of State of the quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise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approved body shall inform the other approved bodies of the quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.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

68

The manufacturer's obligations set out in paragraphs 65(1), (2) and (8) and paragraph 67 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate agreed between the manufacturer and representative.

PART 8 — Module E1: Quality assurance of final pressure equipment inspection and testing

General

69

Quality assurance of final pressure equipment inspection and testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 70 (technical documentation), 71 (manufacturing) and 74 (UK marking and declaration of conformity), 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.

Technical documentation

70

(1) The manufacturer shall establish the technical documentation. 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 any risk;

(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; and

(vi) test reports.

(2) 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

71

The manufacturer shall operate an approved quality system for the final product inspection and testing of the pressure equipment, or assembly, concerned as specified in paragraph 72 and shall be subject to surveillance as specified in paragraph 73.

Quality system

72

(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;

(d) the documentation concerning the quality system;

(e) the technical documentation referred to in paragraph 70.

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

(4) Under the quality system, each item of pressure equipment, or assembly, shall be examined and appropriate tests as set out in the designated standards and particularly final assessments as set out in paragraphs 25 to 28 of Schedule 2 shall be carried out in order to ensure its conformity with the requirements of these Regulations.

(5) 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 procedures used for the permanent joining of parts as approved with paragraph 21 of Schedule 2 to these Regulations;

(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.

(6) 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;

(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;

(iii) reviews the technical documentation referred to in paragraph 70, 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.

(7) The decision shall—

(a) be notified to the manufacturer;

(b) contain the conclusions of the audit; and

(8) 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.

(9) 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;

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

Surveillance under the responsibility of the approved body

73

(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;

(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;

(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;

(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

UK marking and declaration of conformity

74

(1) The manufacturer shall—

(a) affix the UK marking and, under the responsibility of the approved body referred to in paragraph 72(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;

(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 70(1) and (2);

(ii) the change referred to in paragraph 72(9); and

(iii) the decisions and reports of the approved body referred to in paragraphs 72(9) and 73(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

75

The manufacturer's obligations set out in paragraphs 72(1), (2) and (9) and paragraphs 70 and 74 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.

PART 9 — Module F: Conformity to type based on pressure equipment verification

General

76

Conformity to type based on pressure equipment verification is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 77 and 80, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned, which has been subject to the provisions of paragraph 78, is in conformity with the type described in the Type examination certificate and satisfies the requirements of these Regulations which apply to it.

Manufacturing

77

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured products with the approved type described in the Type examination certificate and with the requirements of these Regulations which apply to them.

Verification

78

(1) An approved body chosen by the manufacturer shall carry out the appropriate examinations and tests in order to check the conformity of the pressure equipment, or assembly, with the approved type described in the Type examination certificate and with the appropriate requirements of these Regulations.

(2) The examinations and tests to check the conformity of the pressure equipment with the appropriate requirements shall be carried out by examination and testing of every product as specified in paragraph 79.

Verification of conformity by examination and testing of every item of pressure equipment or assembly

79

(1) All pressure equipment, or assemblies, shall be individually examined and appropriate tests set out in the relevant designated standards or equivalent tests shall be carried out in order to verify conformity with the approved type and described in the Type examination certificate and with the appropriate requirements of these Regulations.

(2) In the absence of such a designated standard, the approved body concerned shall decide on the appropriate tests to be carried out.

(3) The approved body shall—

(a) verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with paragraphs 21 and 22 of Schedule 2 to these Regulations;

(b) verify the certificate issued by the materials manufacturer in accordance with paragraphs 31(6) to (8) of Schedule 2 to these Regulations; and

(c) carry out or have carried out the final inspection and proof test referred to in paragraphs 25 to 28 to Schedule 2 of these Regulations.

(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.

UK marking and declaration of conformity

80

The manufacturer shall—

(a) affix the UK marking and, under the responsibility of the approved body referred to in paragraph 78(1), the latter's identification number, to each individual item 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 each pressure equipment model, or assembly, which identifies the pressure equipment model, or assembly, for which it has been drawn up;

(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; and

(e) if the approved body referred to in paragraph 78(1) agrees and under its responsibility, the manufacturer may also affix the approved body's identification number to the pressure equipment, or assembly, during the manufacturing process.

Authorised representative

81

The manufacturer's obligations may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate. An authorised representative may not fulfil the manufacturer's obligation set out in paragraph 77.

PART 10 — Module G: Conformity based on unit verification

General

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.

Technical documentation

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;

(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.

Manufacturing

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.

Verification

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.

UK marking and declaration of conformity

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;

(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

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.

PART 11 — Module H: Conformity based on full quality assurance

General

88

Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 89 and 92, and ensures and declares on their sole responsibility that the pressure equipment, or assembly, concerned satisfies the requirements of these Regulations that apply to them.

Manufacturing

89

The manufacturer shall operate an approved quality system for; the final design, manufacture, final product inspection and testing of the pressure equipment, or assembly concerned; as specified in paragraph 90 and shall be subject to surveillance as specified in paragraph 91.

Quality system

90

(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 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;

(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 the quality of the pressure equipment or assembly;

(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 in accordance 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;

(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 paragraph 90(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

(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;

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

Surveillance under the responsibility of the approved body

91

(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;

(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;

(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

UK marking and declaration of conformity

92

(1) The manufacturer shall—

(a) affix the UK marking and, under the responsibility of the approved body referred to in paragraph 90(1), 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 for the pressure equipment model, or assembly, which identifies the pressure equipment, or assembly, for which it has been drawn up;

(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 paragraph 90(2);

(ii) the documentation concerning the quality system referred to in paragraph 90(4);

(iii) the change referred to in paragraph 90(8); and

(iv) the decisions and reports of the approved body referred to in paragraphs 90(8) and 91(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

93

The manufacturer's obligations set out in paragraphs 90(1), (2) and (8) and paragraph 92 may be fulfilled by their authorised representative, on their behalf and under their responsibility, provided that they are specified in the mandate.

PART 12 — Module H1: Conformity based on full quality assurance plus design examination

General

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

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

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;

(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;

(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

(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;

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

Design examination

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;

(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

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;

(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;

(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

(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

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;

(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

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.

SCHEDULE 1B — Conformity Assessment Tables

1

The references in the tables to categories of modules are the following:

1A

(1) Where in order to mitigate the effects of very serious safety concerns the Secretary of State considers that an item or family of pressure equipment are to be subject to different categories of modules, the Secretary of State may by regulations make such provision.

(2) Regulations made under paragraph (1)—

(a) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament; and

(b) include power—

(i) to make different provision for different cases; and

(ii) to make such supplemental, consequential and transitional provision as the Secretary of State considers appropriate.

2

The safety accessories defined in paragraph 5, are classified in category IV. However, by way of exception, safety accessories manufactured for specific equipment may be classified in the same category as the equipment they protect.

3

(1) The pressure accessories defined in paragraph 6, are classified on the basis of:

(a) their maximum allowable pressure PS;

(b) their volume V or their nominal size DN, as appropriate;

(2) The appropriate table for vessels or piping is to be used to determine the conformity assessment category.

(3) Where both the volume and the nominal size are considered appropriate in subparagraph (1)(b), the pressure accessory shall be classified in the highest category.

4

(1) The demarcation lines in the following conformity assessment tables indicate the upper limit for each category.

(i) Table 1: Vessels for gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure is greater than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 1 with a volume greater than 1L and a product PS and V greater than 25 bar.L, or with a pressure PS greater than 200 bar

(ii) Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of table 1 shall be classified in category III.

(i) Table 2: Vessels for gases, liquefied gases, gases dissolved under pressure, vapours and also those liquids whose vapour pressure is greater than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 2, with a volume greater than 1L and a product of PS and V is greater than 50 bar.L, or a pressure PS greater than 1000bar

(ii) Exceptionally, portable extinguishers and bottles for breathing equipment shall be classified at least in category III.

(c) Table 3: Vessels for liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 1 with a volume greater than 1 L and a product of PS and V greater than 200 bar.L, or with a pressure PS greater than 500 bar

(i) Table 4: Vessels for liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 2 with a pressure PS greater than 10 bar and a product of PS and V greater than 10000 bar.L, or with a pressure PS greater than 1000 bar

(ii) Exceptionally, assemblies intended for generating warm water at temperatures not greater than 110°C which are manually fed with solid fuels and have a PS.V, shall be subject either to a Type examination (Module B — design type) with respect to their conformity with the essential requirements referred to in paragraphs 14, 15, 16, 17 and 30 and subparagraphs 33(2)(a) and (d) of Schedule 2 to these Regulations, or to full quality assurance (Module H).

(i) Table 5: Vessels fired or otherwise heated pressure equipment with the risk of overheating intended for generation of steam or superheated water at temperatures higher than 110°C having a volume greater than 2 L

(ii) Exceptionally, the design of pressure-cookers shall be subject to a conformity assessment procedure equivalent to at least one of the category III modules.

(i) Table 6: Piping intended for gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 1 with a DN greater than 25

(ii) Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of Table 6 shall be classified in category III.

(i) Table 7: Piping intended for gases, liquefied gases, gases dissolved under pressure, vapours and those liquids whose vapour pressure at the maximum allowable temperature is greater than 0.5 bar above normal atmospheric pressure (1013 mbar), and for fluids in Group 2 with a DN greater than 32 and a product of PS and DN greater than 1000 bar

(ii) Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling within category II on the basis of Table 7 shall be classified in category III.

(h) Table 8: Piping intended for liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 1 with a DN greater than 25 and a product of PS and DN greater than 2000 bar

(i) Table 9: Piping intended for liquids having a vapour pressure at the maximum allowable temperature of not more than 0.5 bar above normal atmospheric pressure (1013 mbar) and, for fluids in Group 2 with a PS greater than 10 bar, a DN greater than 200 and a product of PS and DN greater than 5000 bar

5

In this Schedule “safety accessories” are defined as follows—

(a) devices designed to protect pressure equipment against the allowable limits being exceeded, including devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and limiting devices, which either activate the means for correction or provide for shutdown or a shutdown and lockout, such as pressure switched or temperature switches or fluid level switches and safety related measurement control and regulation (SRMCR) devices; and

(b) devices intended for equipment covered in the tables in paragraph 6 including where such equipment is incorporated into an assembly.

6

In this Schedule “pressure accessories” are defined as follows—

(a) devices with an operational function and having pressure-bearing housings; and

(b) devices intended for equipment covered in the tables in paragraph 6 including where such equipment is incorporated into an assembly.

PART 1 — Classification of pressure equipment Classification of pressure equipment before IP completion day

PART 2 — Classification of pressure equipment immediately on or after IP completion day

5

Pressure equipment referred to in regulation 6 (pressure equipment and assemblies subject to essential safety requirements) must be classified by category in accordance with Schedule 1B (conformity assessment tables) to these Regulations according to an ascending level of hazard.

6

(1) In order to determine the appropriate category for classification of pressure equipment coming within regulations 6(a) to (c), the manufacturer must refer to the following tables within Schedule 1B to these Regulations—

(a) for pressure equipment coming within—

(i) regulation 6(a)(i)(aa), table 1;

(ii) regulation 6(a)(i) (bb), table 2;

(iii) regulation 6(a)(ii)(aa), table 3;

(iv) regulation 6(a)(ii)(bb), table 4;

(v) regulation 6(b), table 5;

(vi) regulation 6(c)(i)(aa), table 6;

(vii) regulation 6(c)(i)(bb), table 7;

(viii) regulation 6(c)(ii)(aa), table 8;

(ix) regulation 6(c)(ii)(bb), table 9;

(b) for pressure equipment coming within regulation 6(d), the category must be determined in accordance with paragraphs 2 and 3 of Schedule 1B to these Regulations.

(2) Where a vessel is composed of a number of chambers, it must be classified in the highest category applicable to the individual chambers and, where a chamber contains several fluids, classification must be on the basis of the fluid which requires the highest category.

7

For the purposes of the classification referred to in paragraph (5), fluids shall be divided up into the following groups—

(a) group 1 consisting of substances and mixtures, as defined in points 7 and 8 of Article 2 of Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16th December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EEC, and amending Regulation (EC) No 1907/2006, that are classified as hazardous in accordance with the following physical or health hazard classes laid down in Parts 2 and 3 of Annex 1 to that Regulation—

(i) unstable explosives or explosives of Divisions 1.1. 1.2. 1.3, 1.4 and 1.5;

(ii) flammable gases, category 1 and 2;

(iii) oxidising gases, category 1;

(iv) flammable liquids, categories 1 and 2;

(v) flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint;

(vi) flammable solids, category 1 and 2;

(vii) self-reactive substances and mixtures, type A to F;

(viii) pyrophoric liquids, category 1;

(ix) pyrophoric solids, category 1;

(x) oxidising liquids, category 1, 2 and 3;

(xi) substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3;

(xii) oxidising liquids, category 1, 2 and 3;

(xiii) oxidising solids, category 1, 2 and 3;

(xiv) organic peroxides types A to F;

(xv) acute oral toxicity, category 1 and 2;

(xvi) acute dermal toxicity, category 1, 2 and 3;

(xvii) acute inhalation toxicity, category 1, 2 and 3;

(xviii) specific target organ toxicity – single exposure, category 1;

8

Where a vessel is composed of a number of chambers, it shall be classified in the highest category applicable to the individual changes. Where a chamber contains several fluids, classification shall be on the basis of the fluid which requires the highest category.

... Declaration of conformity (No xxxx)

Further use of the UK marking

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