Regulation (EU) 2016/424 of the European Parliament and of the CouncilShow full title

ANNEX VII U.K. CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE H 1: CONFORMITY BASED ON FULL QUALITY ASSURANCE PLUS DESIGN EXAMINATION

1. Conformity based on full quality assurance plus design examination is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the subsystems or safety components concerned satisfy the requirements of this Regulation that apply to them. U.K.

2. Manufacturing U.K.

The manufacturer shall operate an approved quality system for the design, manufacture and final inspection and testing of subsystems or safety components as specified in point 3 and shall be subject to surveillance as specified in point 4. The adequacy of the technical design of the subsystems or safety components shall have been examined in accordance with point 3.6.

3. Quality system U.K.

3.1. The manufacturer shall lodge an application for assessment of his quality system with the [F1 approved body] of his choice, for the subsystems or safety components concerned. U.K.

Textual Amendments

F1 Words in Annex 7 Point 3.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(a); 2020 c. 1, Sch. 5 para. 1(1)

The application shall include:

(a)

the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

(b)

all necessary information on the subsystems or safety components to be manufactured;

(c)

the technical documentation in accordance with Annex VIII for one representative type of each category of subsystem or safety component to be manufactured;

(d)

the documentation concerning the quality system;

(e)

the address of the premises where the subsystems or safety components are designed, manufactured, inspected and tested;

(f)

a written declaration that the same application has not been lodged with any other [F1 approved body].

3.2. The quality system shall ensure compliance of the subsystems or the safety components with the requirements of this Regulation that apply to them. U.K.

All the 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. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.

It shall, in particular, contain an adequate description of:

(a)

the quality objectives and the organisational structure, responsibilities and powers of the management with regard to the design and product quality;

(b)

the technical design specifications, including standards, that will be applied and, where the relevant [F2 designated standards] will not be applied in full, the means, including other relevant technical specifications, that will be used to ensure that the essential requirements of this Regulation will be met;

(c)

the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystems or the safety components;

(d)

the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(e)

the examinations and tests to 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, qualification reports on the personnel concerned, etc.;

(g)

the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

Textual Amendments

F2 Words in Annex 7 Point 3.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(b); 2020 c. 1, Sch. 5 para. 1(1)

3.3. [F3 The approved body] shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant [F4 designated standard]. U.K.

Textual Amendments

F3 Words in Annex 7 Point 3.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(c)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F4 Words in Annex 7 Point 3.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(c)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

The audit shall include an assessment visit to the premises where the subsystems or the safety components are designed, manufactured, inspected and tested.

In addition to experience in quality management systems, the auditing team shall have at least one member experienced as assessor in the field of cableway installations and in the technology of the subsystems or safety components concerned, and knowledge of the applicable requirements of this Regulation.

The auditing team shall review the technical documentation referred to in point 3.1 to verify the manufacturer's ability to identify the applicable requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or the safety components with those requirements.

[F5 The approved body] shall notify its decision to the manufacturer or his authorised representative. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

Textual Amendments

F5 Words in Annex 7 Point 3.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

3.4. 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. U.K.

3.5. The manufacturer shall keep [F6 the approved body] that has approved the quality system informed of any intended change to the quality system. U.K.

Textual Amendments

F6 Words in Annex 7 Point 3.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(d)(i); 2020 c. 1, Sch. 5 para. 1(1)

[F7 The approved body] shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.

Textual Amendments

F7 Words in Annex 7 Point 3.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(d)(ii); 2020 c. 1, Sch. 5 para. 1(1)

It shall notify the manufacturer or the authorised representative of its decision. The notification shall contain the conclusions of the assessment and the reasoned assessment decision.

3.6. Design examination U.K.

3.6.1. The manufacturer shall lodge an application for examination of the design with the [F8 approved body] referred to in point 3.1. U.K.

Textual Amendments

F8 Words in Annex 7 Point 3.6.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(e); 2020 c. 1, Sch. 5 para. 1(1)

3.6.2. The application shall make it possible to understand the design, manufacture and operation of the subsystem or safety component, and to assess the conformity with the requirements of this Regulation that apply to it. U.K.

It shall include:

(a)

the name and address of the manufacturer;

(b)

a written declaration that the same application has not been lodged with any [F9 other approved body];

(c)

the technical documentation as described in Annex VIII.

Textual Amendments

F9 Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(f); 2020 c. 1, Sch. 5 para. 1(1)

3.6.3. [F10 The approved body] shall examine the application and, where the design meets the requirements of this Regulation that apply to the subsystem or safety component, it shall issue [F11 a design examination] certificate to the manufacturer. That certificate shall give the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the data necessary for identification of the approved design. That certificate may have one or more annexes attached. U.K.

That certificate and its annexes shall contain all relevant information to allow the conformity of manufactured subsystems or safety components with the examined design to be evaluated and to allow for in-service control, where applicable.

Where the design does not satisfy the applicable requirements of this Regulation, [F12 the approved body] shall refuse to issue [F13 a design examination] certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

Textual Amendments

F12 Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(g)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(g)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F10 Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(g)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in Annex 7 Point 3.6.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(g)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

3.6.4. [F14 The approved body] shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved design may no longer comply with the applicable requirements of this Regulation, and shall determine whether such changes require further investigation. If so, [F15 the approved body] shall inform the manufacturer accordingly. U.K.

The manufacturer shall keep [F16 the approved body] that has issued the [F17 design examination] certificate informed of any modification to the approved design that may affect the conformity with the essential requirements of this Regulation or the conditions for validity of the certificate. Such modifications shall require additional approval from [F16 the approved body] that issued the [F17 design examination] certificate in the form of an addition to the original [F17 design examination] certificate.

Textual Amendments

F16 Words in Annex 7 Point 3.6.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(h)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Annex 7 Point 3.6.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(h)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F14 Words in Annex 7 Point 3.6.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(h)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F15 Words in Annex 7 Point 3.6.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(h)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

3.6.5. [F18 Each approved body] shall inform [F19 the Secretary of State] of [F20 the design examination] certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to [F19 the Secretary of State] the list of certificates and/or any additions thereto refused, suspended or otherwise restricted. U.K.

[F21 Each approved body] shall inform the [F22 other approved bodies] of [F23 the design examination] certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of the certificates and/or additions thereto which it has issued.

Textual Amendments

F21 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F22 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(ii)(cc); 2020 c. 1, Sch. 5 para. 1(1)

[F24 The other approved bodies may, on request, obtain a copy of the design examination certificates and any additions thereto.]

Textual Amendments

F24 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(iii); 2020 c. 1, Sch. 5 para. 1(1)

[F25 The approved body] shall keep a copy of [F26 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.

Textual Amendments

F25 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(iv)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F26 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(iv)(bb); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F18 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F20 Words in Annex 7 Point 3.6.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(i)(i)(cc); 2020 c. 1, Sch. 5 para. 1(1)

3.6.6. The manufacturer shall keep a copy of [F27 the design examination] certificate, its annexes and additions together with the technical documentation at the disposal of the [F28 Secretary of State] for 30 years after the subsystem or safety component has been placed on the market. U.K.

Textual Amendments

F27 Words in Annex 7 Point 3.6.6 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(j)(i); 2020 c. 1, Sch. 5 para. 1(1)

F28 Words in Annex 7 Point 3.6.6 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(j)(ii); 2020 c. 1, Sch. 5 para. 1(1)

4. Surveillance under the responsibility of [F29 the approved body] U.K.

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. U.K.

4.2. The manufacturer shall, for assessment purposes, allow [F30 the approved body] access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: U.K.

Textual Amendments

F30 Words in Annex 7 Point 4.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(k)(ii); 2020 c. 1, Sch. 5 para. 1(1)

(a)

the quality system documentation;

(b)

the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;

(c)

the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

4.3. [F31 The approved body] shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. The frequency of periodic audits shall be such that a full reassessment is carried out every three years. U.K.

Textual Amendments

F31 Words in Annex 7 Point 4.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(k)(iii); 2020 c. 1, Sch. 5 para. 1(1)

4.4. In addition, [F32 the approved body] may pay unexpected visits to the manufacturer. U.K.

Textual Amendments

F32 Words in Annex 7 Point 4.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(k)(iv); 2020 c. 1, Sch. 5 para. 1(1)

During such visits, [F32 the approved body] may, if necessary, carry out product tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Textual Amendments

F29 Words in Annex 7 Point 4 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(k)(i); 2020 c. 1, Sch. 5 para. 1(1)

5. [F33 UK marking and declaration] of conformity. U.K.

5.1. The manufacturer shall affix the [F34 UK marking] and, under the responsibility of [F35 the approved body] referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F34 Words in Annex 7 Point 5.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(l)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F35 Words in Annex 7 Point 5.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(l)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

5.2. The manufacturer shall draw up a [F36 written declaration] of conformity for each subsystem or safety component model and keep it at the disposal of the [F37 Secretary of State] for 30 years after the subsystem or the safety component has been placed on the market. [F38 The declaration] of conformity shall identify the subsystem or the safety component model for which it has been drawn up and shall refer to the number of [F39 the design examination] certificate. U.K.

Textual Amendments

F36 Words in Annex 7 Point 5.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(l)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F37 Words in Annex 7 Point 5.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(l)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F38 Words in Annex 7 Point 5.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(l)(iii)(cc); 2020 c. 1, Sch. 5 para. 1(1)

F39 Words in Annex 7 Point 5.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(l)(iii)(dd); 2020 c. 1, Sch. 5 para. 1(1)

[F40 A copy of the declaration of conformity must be made available to the Executive upon request.]

Textual Amendments

F40 Words in Annex 7 Point 5.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(l)(iii)(ee); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F33 Words in Annex 7 Point 5 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(l)(i); 2020 c. 1, Sch. 5 para. 1(1)

6. The manufacturer shall, for a period of 30 years after the subsystem or safety component has been placed on the market, keep at the disposal of the [F41 Secretary of State]: U.K.

Textual Amendments

F41 Words in Annex 7 Point 6 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(m)(i); 2020 c. 1, Sch. 5 para. 1(1)

(a)

the technical documentation referred to in point 3.1(c);

(b)

the documentation concerning the quality system referred to in point 3.1(d);

(c)

the information relating to the change referred to in point 3.5 as approved;

(d)

the decisions and reports of [F42 the approved body] referred to in points 3.3, 3.5, 4.3 and 4.4.

Textual Amendments

F42 Words in Annex 7 Point 6(d) substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(m)(ii); 2020 c. 1, Sch. 5 para. 1(1)

7. [F43 Each approved body] shall inform [F44 the Secretary of State] of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to [F44 the Secretary of State] the list of quality system approvals refused, suspended or otherwise restricted. U.K.

Textual Amendments

F43 Words in Annex 7 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(n)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F44 Words in Annex 7 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(n)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

[F45 Each approved body] shall inform the [F46 other approved bodies] of quality system approvals which it has refused, suspended or withdrawn and, upon request, of quality system approvals which it has issued.

Textual Amendments

F45 Words in Annex 7 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(n)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F46 Words in Annex 7 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(n)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F47 ...

Textual Amendments

F47 Words in Annex 7 Point 7 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(n)(iii); 2020 c. 1, Sch. 5 para. 1(1)

[F48 The approved body] shall keep a copy of the quality system approval decision(s) issued, its annexes and additions, as well as the technical file, for a period of 30 years from the date of their issue.

Textual Amendments

F48 Words in Annex 7 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 57(n)(iv); 2020 c. 1, Sch. 5 para. 1(1)

8. Authorised representative U.K.

The manufacturer's obligations set out in points 3.1, 3.6.4, 3.6.6, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.