Regulation (EU) 2016/426 of the European Parliament and of the CouncilShow full title

3. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS U.K.

3.1. 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 3.2 and 3.5, and ensures and declares on his sole responsibility that the appliances or fittings concerned are in conformity with the type described in the F1 ... type-examination certificate and satisfy the requirements of this Regulation that apply to them. U.K.

Textual Amendments

F1 Word in Annex 3 para. 3.1 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(o) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.2. Manufacturing U.K.

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the appliances or fittings concerned as specified in point 3.3, and shall be subject to surveillance as specified in point 3.4.

3.3. Quality system U.K.

3.3.1. The manufacturer shall lodge an application for assessment of his quality system with the [F2 approved] body of his choice, for the appliances or fittings concerned. U.K.

Textual Amendments

F2 Word in Annex 3 para. 3.3.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 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)

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

(c)

all relevant information for the appliance or the fitting approved under module B;

(d)

the documentation concerning the quality system;

(e)

the technical documentation of the approved type and a copy of the F3 ... type-examination certificate.

Textual Amendments

F3 Word in Annex 3 para. 3.3.1(e) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(o) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.3.2. The quality system shall ensure that the appliances or fittings are in conformity with the type described in the F4 ... type-examination certificate and comply with the requirements of this Regulation that apply to them. U.K.

Textual Amendments

F4 Word in Annex 3 para. 3.3.2 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(o) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

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 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.

3.3.3. The [F5 approved] body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.3.2. U.K.

Textual Amendments

F5 Word in Annex 3 para. 3.3.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

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 [F6 designated] standard.

Textual Amendments

F6 Word in Annex 3 para. 3.3.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(q) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and the product technology 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 3.3.1(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 appliance or the fitting 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.

3.3.4. 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.

3.3.5. The manufacturer shall keep the [F7 approved] body that has approved the quality system informed of any intended change to the quality system. U.K.

Textual Amendments

F7 Word in Annex 3 para. 3.3.5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

The [F7 approved] body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.3.2 or whether a reassessment is necessary.

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

3.4. Surveillance under the responsibility of the [F8 approved] body U.K.

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

3.4.2. The manufacturer shall, for assessment purposes, allow the [F9 approved] body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular: U.K.

Textual Amendments

F9 Word in Annex 3 para. 3.4.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

(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.

3.4.3. The [F10 approved] body shall carry out periodic audits 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

F10 Word in Annex 3 para. 3.4.3 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.4.4. In addition, the [F11 approved] body may pay unexpected visits to the manufacturer. During such visits the [F11 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. The [F11 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

F11 Word in Annex 3 para. 3.4.4 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F8 Word in Annex 3 para. 3.4 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.5. [F12 UK] marking and F13 ... declaration of conformity U.K.

3.5.1. The manufacturer shall affix the [F14 UK] marking and, under the responsibility of the [F15 approved] body referred to in point 3.3.1, the latter's identification number to each individual appliance or fitting that is in conformity with the type described in the F16 ... type-examination certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F14 Word in Annex 3 para. 3.5.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(r) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F15 Word in Annex 3 para. 3.5.1 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F16 Word in Annex 3 para. 3.5.1 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(o) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.5.2. The manufacturer shall draw up a written F17 ... declaration of conformity for each appliance or fitting model and keep it at the disposal of the [F18 enforcement authority] for 10 years after the appliance or the fitting has been placed on the market. The F17 ... declaration of conformity shall identify the appliance or fitting model for which it has been drawn up. U.K.

Textual Amendments

F17 Word in Annex 3 para. 3.5.2 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(o) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F18 Words in Annex 3 para. 3.5.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(s)(i) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

A copy of the F17 ... declaration of conformity shall be made available to the [F19 enforcement authority] upon request. A copy of the F17 ... declaration of conformity of the fitting shall accompany the fitting or, where applicable, the batch or consignment.

Textual Amendments

F19 Words in Annex 3 para. 3.5.2 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(s)(ii) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F12 Word in Annex 3 para. 3.5 heading substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(r) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F13 Word in Annex 3 para. 3.5 heading omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(o) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.6. The manufacturer shall, for a period ending at least 10 years after the appliance or the fitting has been placed on the market, keep at the disposal of the [F20 enforcement authority]: U.K.

Textual Amendments

F20 Words in Annex 3 para. 3.6 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(t) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

(a)

the documentation referred to in point 3.3.1;

(b)

the information relating to the change referred to in point 3.3.5, as approved;

(c)

the decisions and reports of the [F21 approved] body referred to in points 3.3.5, 3.4.3 and 3.4.4.

Textual Amendments

F21 Word in Annex 3 para. 3.6(c) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

3.7. Each [F22 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 systems approvals refused, suspended or otherwise restricted. U.K.

Textual Amendments

F22 Word in Annex 3 para. 3.7 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(p) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

F23 Words in Annex 3 para. 3.7 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 36 para. 2(46)(u) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)

Each [F22 approved] body shall inform the other [F22 approved] bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of quality system approvals which it has issued.

3.8. Authorised representative U.K.

The manufacturer's obligations set out in points 3.3.1, 3.3.5, 3.5 and 3.6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.