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

ANNEX IV U.K. CONFORMITY ASSESSMENT PROCEDURES FOR SUBSYSTEMS AND SAFETY COMPONENTS: MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS

1. Conformity to type based on quality assurance of the production process is the part of a 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 are in conformity with the type described in [F1 the type examination] certificate and satisfy the requirements of this Regulation that apply to them. U.K.

Textual Amendments

F1 Words in Annex 4 Point 1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(a); 2020 c. 1, Sch. 5 para. 1(1)

2. Manufacturing U.K.

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the subsystems or safety components concerned as specified in point 3, and shall be subject to surveillance as specified in point 4.

3. Quality system U.K.

3.1. The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice. U.K.

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)

a written declaration that the same application has not been lodged with any [F2 other approved body];

(c)

all relevant information for the subsystems or safety components approved under module B;

(d)

the documentation concerning the quality system;

(e)

the technical documentation of the approved type and a copy of [F3 the type examination] certificate(s);

(f)

details of the premises where the subsystem or the safety component is manufactured.

Textual Amendments

F2 Words in Annex 4 Point 3.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Annex 4 Point 3.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

3.2. The quality system shall ensure that the subsystems or safety components are in conformity with the type(s) described in [F4 the type examination] certificate(s) and comply 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 product quality;

(b)

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

(c)

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

(d)

the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.;

(e)

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

Textual Amendments

F4 Words in Annex 4 Point 3.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(b)(ii); 2020 c. 1, Sch. 5 para. 1(1)

3.3. [F5 The approved body] shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2. U.K.

It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the [F6 relevant designated standard].

Textual Amendments

F6 Words in Annex 4 Point 3.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(b)(iii)(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 manufactured, inspected and tested.

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation 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 audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.1(e), to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the subsystems or safety components with those requirements.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

Textual Amendments

F5 Words in Annex 4 Point 3.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(b)(iii)(aa); 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 [F7 the approved body] that has approved the quality system informed of any intended change to the quality system. U.K.

[F8 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

F8 Words in Annex 4 Point 3.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(b)(iv)(bb); 2020 c. 1, Sch. 5 para. 1(1)

It shall notify the manufacturer of the outcome of the evaluation. In case of a reassessment, it shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

Textual Amendments

F7 Words in Annex 4 Point 3.5 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(b)(iv)(aa); 2020 c. 1, Sch. 5 para. 1(1)

4. Surveillance under the responsibility of [F9 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 [F10 the approved body] access to the manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular: U.K.

(a)

the quality system documentation;

(b)

the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.

Textual Amendments

F10 Words in Annex 4 Point 4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(c)(ii); 2020 c. 1, Sch. 5 para. 1(1)

4.3. [F11 The approved body] shall carry out periodic audits of at least once every two years to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report. U.K.

Textual Amendments

F11 Words in Annex 4 Point 4.3 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(c)(iii); 2020 c. 1, Sch. 5 para. 1(1)

4.4. In addition, [F12 the approved body] may pay unexpected visits to the manufacturer. During such visits [F12 the approved body] may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. [F13 The approved body] shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report. U.K.

Textual Amendments

F12 Words in Annex 4 Point 4.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(c)(iv)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F13 Words in Annex 4 Point 4.4 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(c)(iv)(bb); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F9 Words in Annex 4 Point 4 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(c)(i); 2020 c. 1, Sch. 5 para. 1(1)

5. [F14 CE marking and EU declaration] of conformity U.K.

5.1. The manufacturer shall affix the [F15 UK marking] and, under the responsibility of [F16 the approved body] referred to in point 3.1, the latter's identification number to each individual subsystem or safety component that is in conformity with the type described in [F17 the type examination] certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F15 Words in Annex 4 Point 5.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(d)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F16 Words in Annex 4 Point 5.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(d)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F17 Words in Annex 4 Point 5.1 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(d)(ii)(cc); 2020 c. 1, Sch. 5 para. 1(1)

5.2. The manufacturer shall draw up a written [F18 declaration of conformity] for each subsystem or safety component model and keep it at the disposal of the [F19 Secretary of State] for 30 years after the subsystem or the safety component has been placed on the market. The [F18 declaration of conformity] shall identify the subsystem or safety component model for which it has been drawn up. U.K.

A copy of the [F18 declaration of conformity] shall be made available to the relevant authorities upon request.

Textual Amendments

F18 Words in Annex 4 Point 5.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(d)(iii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F19 Words in Annex 4 Point 5.2 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(d)(iii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F14 Words in Annex 4 Point 5 heading substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(d)(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 [F20 Secretary of State]: U.K.

Textual Amendments

F20 Words in Annex 4 Point 6 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(e)(i); 2020 c. 1, Sch. 5 para. 1(1)

(a)

the documentation referred to in point 3.1;

(b)

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

(c)

the decisions and reports of the [F21 approved body] referred to in points 3.5, 4.3 and 4.4.

Textual Amendments

F21 Words in Annex 4 Point 6 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(e)(ii); 2020 c. 1, Sch. 5 para. 1(1)

7. [F22 Each approved body] shall inform [F23 the Secretary of State] of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to [F23 the Secretary of State] the list of quality system approvals refused, suspended or otherwise restricted. U.K.

Textual Amendments

F22 Words in Annex 4 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(f)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Annex 4 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(f)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

[F24 Each approved body] shall inform [F25 the other approved bodies] of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, giving the reasons for its decision, and, upon request, of quality system approvals which it has issued.

Textual Amendments

F24 Words in Annex 4 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(f)(ii)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in Annex 4 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(f)(ii)(bb); 2020 c. 1, Sch. 5 para. 1(1)

F26 ...

Textual Amendments

F26 Words in Annex 4 Point 7 omitted (31.12.2020) by virtue of The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(f)(iii); 2020 c. 1, Sch. 5 para. 1(1)

[F27 The approved body] shall keep a copy of each approval decision issued and its annexes and additions.

Textual Amendments

F27 Words in Annex 4 Point 7 substituted (31.12.2020) by The Cableway Installations (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/1347), regs. 1, 54(f)(iv); 2020 c. 1, Sch. 5 para. 1(1)

8. Authorised representative U.K.

The manufacturer's obligations set out in points 3.1, 3.5, 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.