Textual Amendments
F1Schs. 17, 18 inserted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 16 para. 35 (with Sch. 16 para. 29) (as amended by S.I. 2020/676, regs. 1(1), 2); 2020 c. 1, Sch. 5 para. 1(1)
16. Conformity to type based on quality assurance of the production process (Module D) is a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 17 and 23, and it is solely the manufacturer's responsibility to ensure and declare that the explosives concerned are in conformity with the type described in the Type examination certificate and satisfy the requirements of these Regulations that apply to them.U.K.
17. A manufacturer must operate an approved quality system for production, final product inspection and testing of the explosives specified in paragraph 18, and which is subject to surveillance as specified in paragraph 22.
18.—(1) A manufacturer must lodge an application for assessment of the manufacturer's quality system with an approved body of the manufacturer's choice.
(2) The application must include—
(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, the name and address of the authorised representative;
(b)a written declaration that the same application has not been lodged with any other approved body;
(c)all relevant information for the explosive category envisaged;
(d)the documentation concerning the quality system;
(e)the technical documentation of the approved type and a copy of the Type examination certificate.
19.—(1) The quality system must ensure that the explosives are in conformity with the type described in the Type examination certificate and comply with the requirements of these Regulations that apply to them.U.K.
(2) All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions.
(3) The quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records and must, 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)quality records, such as inspection reports and test data, calibration data, and qualification reports on the personnel concerned;
(e)the means of monitoring the achievement of the required product quality and the effective operation of the quality system.
20.—(1) The approved body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 19 and, where applicable, it must 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.U.K.
(2) The audit team appointed by the approved body to carry out the audit in paragraph 20(1) (“the audit”) must have experience in quality management systems, with at least one member of the team having experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of these Regulations.
(3) The audit must include an assessment visit to the manufacturer's premises.
(4) The audit team must review the technical documentation referred to in paragraph 18(2)(e) 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 explosive with those requirements.
(5) The decision of the approved body must be notified to the manufacturer and must contain the conclusions of the audit and a reasoned assessment of the decision.
21.—(1) A manufacturer must—U.K.
(a)fulfil the obligations arising out of the quality system as approved and maintain it in an adequate and efficient state; and
(b)keep the approved body that has approved the quality system informed of any intended change to the quality system.
(2) Where the approved body is notified by a manufacturer of any proposed change to the quality system the approved body must—
(a)evaluate such proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 19 or whether a reassessment is necessary; and
(b)notify the manufacturer of its decision and, that notification must contain the conclusions of the examination and a reasoned assessment of the decision.
22.—(1) The approved body must carry out surveillance, the purpose of which is to ensure that a manufacturer fulfils the obligations arising out of the approved quality system.
(2) A manufacturer must, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and must provide the approved body with all necessary information including, in particular—
(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.
(3) The approved body must carry out periodic audits to ensure that a manufacturer maintains and applies the quality system and, following each audit, must provide the manufacturer with an audit report.
(4) The approved body may pay unexpected visits to a manufacturer; during such visits 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; and following such a visit the approved body must provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
23.—(1) A manufacturer must affix the UK marking, and, under the responsibility of the approved body referred to in paragraph 18(1), the latter's identification number to each individual explosive that is in conformity with the type described in the Type examination certificate and which satisfies the applicable requirements of these Regulations.
(2) A manufacturer must draw up a written declaration of conformity for each explosive type and keep it at the disposal of the relevant authorities for 10 years beginning on the day on which the explosive has been placed on the market; the declaration of conformity must identify the explosive type for which it has been drawn up.
(3) A copy of the declaration of conformity must be made available to the relevant authorities upon request.
24. A manufacturer must, for a period of 10 years beginning on the day on which the explosive has been placed on the market, keep at the disposal of the relevant authorities—U.K.
(a)the documentation referred to in paragraph 18(2);
(b)any information relating to the change referred to in paragraph 21(1)(b) and 21(2), as approved;
(c)the decisions and reports of the approved body referred to in paragraphs 21, 22(3) and 22(4).
25. Each approved body must inform the Secretary of State of quality system approvals issued or withdrawn and must, periodically or upon request, make available to the Secretary of State the list of quality system approvals refused, suspended or otherwise restricted.U.K.
26. Each approved body must inform other 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.U.K.
27. A manufacturer's obligations set out in paragraphs 18(1), 18(2), 21(1)(b), 21(2), 23 and 24 may be fulfilled by the manufacturer's authorised representative (if any), on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate by which they were appointed under regulation 46.]