Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance) (c. 425)

ANNEX VIII U.K.

CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF THE PRODUCTION PROCESS (Module D) U.K.

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, 5 and 6, and ensures and declares on his sole responsibility that the PPE concerned is in conformity with the type described in the F1 ... type-examination certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F1 Word in Annex 8 para. 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. 35 para. 3(51)(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 PPE 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 a single [F2 approved] body of his choice. U.K.

Textual Amendments

F2 Word in Annex 8 para. 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. 35 para. 3(51)(d); 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)

the address of the manufacturer's premises where the audits can be carried out;

(c)

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

(d)

the identification of the PPE concerned;

(e)

the documentation concerning the quality system.

Where the chosen body is not the body that has carried out the F3 ... type-examination, the application shall also include the following:

Textual Amendments

F3 Word in Annex 8 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. 35 para. 3(51)(b); 2020 c. 1, Sch. 5 para. 1(1)

(a)

the technical documentation of the PPE described in Annex III;

(b)

a copy of the F3 ... type-examination certificate.

3.2. The quality system shall ensure that the PPE is in conformity with the type described in the F4 ... type-examination certificate and complies with the applicable requirements of this Regulation. U.K.

Textual Amendments

F4 Word in Annex 8 para. 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. 35 para. 3(51)(a); 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.

The quality system documentation 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 and qualification reports on the personnel concerned; and

(e)

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

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

Textual Amendments

F5 Word in Annex 8 para. 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. 35 para. 3(51)(c); 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 8 para. 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. 35 para. 3(51)(e); 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 field of PPE and technology concerned, and knowledge of the applicable essential health and safety requirements. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation of the PPE referred to in point 3.1 to verify the manufacturer's ability to identify the applicable essential health and safety requirements and to carry out the necessary examinations with a view to ensuring conformity of the PPE with those requirements.

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

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 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 8 para. 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. 35 para. 3(51)(d); 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 3.2 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.

3.6. The [F8 approved] body shall authorise the manufacturer to affix the [F8 approved] body's identification number to each individual item of PPE that is in conformity with the type described in the F9 ... type-examination certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F8 Word in Annex 8 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. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)

F9 Word in Annex 8 para. 3.6 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. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)

4. Surveillance under the responsibility of the [F10 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 the [F11 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

F11 Word in Annex 8 para. 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. 35 para. 3(51)(c); 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 and qualification reports on the personnel concerned.

4.3. The [F12 approved] body shall carry out periodic audits, at least once a year, 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

F12 Word in Annex 8 para. 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. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)

4.4. In addition, the [F13 approved] body may pay unexpected visits to the manufacturer. During such visits the [F13 approved] body may, if necessary, carry out examinations or tests of the PPE, or have them carried out, in order to verify that the quality system is functioning correctly. The [F13 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

F13 Word in Annex 8 para. 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. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F10 Word in Annex 8 para. 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. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)

5. [F14 UK ] marking and F15 ... declaration of conformity U.K.

5.1. The manufacturer shall affix the [F16 UK ] marking and, under the responsibility of the [F17 approved] body referred to in point 3.1, the latter's identification number to each individual item of PPE that is in conformity with the type described in the F18 ... type-examination certificate and satisfies the applicable requirements of this Regulation. U.K.

Textual Amendments

F16 Word in Annex 8 para. 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. 35 para. 3(51)(f); 2020 c. 1, Sch. 5 para. 1(1)

F17 Word in Annex 8 para. 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. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)

F18 Word in Annex 8 para. 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. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)

5.2. The manufacturer shall draw up a written F19 ... declaration of conformity for each PPE model and keep it at the disposal of the [F20 enforcement authority] for 10 years after the PPE has been placed on the market. The F19 ... declaration of conformity shall identify the PPE model for which it has been drawn up. U.K.

Textual Amendments

F19 Word in Annex 8 para. 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. 35 para. 3(51)(b); 2020 c. 1, Sch. 5 para. 1(1)

F20 Words in Annex 8 para. 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. 35 para. 3(51)(g)(i); 2020 c. 1, Sch. 5 para. 1(1)

A copy of the F19 ... declaration of conformity shall be made available to the [F21 enforcement authority] upon request.

Textual Amendments

F21 Words in Annex 8 para. 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. 35 para. 3(51)(g)(ii); 2020 c. 1, Sch. 5 para. 1(1)

Textual Amendments

F14 Word in Annex 8 para. 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. 35 para. 3(51)(f); 2020 c. 1, Sch. 5 para. 1(1)

F15 Word in Annex 8 para. 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. 35 para. 3(51)(a); 2020 c. 1, Sch. 5 para. 1(1)

6. The manufacturer shall, for 10 years after the PPE has been placed on the market, keep at the disposal of the [F22 enforcement authority]: U.K.

Textual Amendments

F22 Words in Annex 8 para. 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. 35 para. 3(51)(h); 2020 c. 1, Sch. 5 para. 1(1)

(a)

the documentation referred to in point 3.1;

(b)

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

(c)

the decisions and reports of the [F23 approved] body referred to in points 3.5, 4.3 and 4.4.

Textual Amendments

F23 Word in Annex 8 para. 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. 35 para. 3(51)(c); 2020 c. 1, Sch. 5 para. 1(1)

7. The [F24 approved] body shall inform [F25 the Secretary of State] of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to [F25 the Secretary of State] the list of such quality system approvals refused, suspended or otherwise restricted. U.K.

Textual Amendments

F24 Word in Annex 8 para. 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. 35 para. 3(51)(d); 2020 c. 1, Sch. 5 para. 1(1)

F25 Words in Annex 8 para. 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. 35 para. 3(51)(i); 2020 c. 1, Sch. 5 para. 1(1)

The [F24 approved] body shall inform the other [F24 approved] bodies of quality system approvals which it has refused, suspended, withdrawn or otherwise restricted, and, upon request, of such quality system approvals which it has issued.

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.