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)
28. Conformity to type based on product quality assurance (Module E) is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 29 and 34, and it is solely the responsibility of the manufacturer 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.
29. A manufacturer must operate an approved quality system for final product inspection and testing of the explosives concerned as specified in paragraphs 30 and 31 and which must be subject to surveillance as specified in paragraph 33.
30.—(1) A manufacturer must lodge an application for assessment of the manufacturer's quality system with an approved body of the manufacturer's choice for the explosives concerned.
(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.
(3) The quality system must ensure compliance of the explosives with the type described in the Type examination certificate and with the applicable requirements of these Regulations.
(4) 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; this quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records and, it 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 examinations and tests that will be carried out after manufacture;
(c)the quality records, such as inspection reports and test data, calibration data and qualification reports on the personnel concerned;
(d)the means of monitoring the effective operation of the quality system.
31.—(1) The approved body must assess the quality system to determine whether it satisfies the requirements referred to in paragraph 30(3) and (4) 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 a relevant designated standard.U.K.
(2) The audit team appointed by the approved body to carry out the audit under paragraph 31(1) (“the audit”) must have experience in quality management systems and have at least one member with 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 30(2)(e), in order 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 the notification must contain the conclusions of the audit and the reasoned assessment for the decision.
32.—(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 any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 30(3) and (4) 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 the reasoned assessment for the decision.
33.—(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 it with all necessary information, 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 the manufacturer; during such visits the approved body may 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, a test report.
34.—(1) A manufacturer must affix the UK marking and, under the responsibility of the approved body referred to in paragraph 30(1), the latter's identification number to each individual explosive that is in conformity with the type described in the Type examination certificate and 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.
(3) A copy of the declaration of conformity must be made available to the relevant authorities upon request.
35. 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 30(1) and 30(2);
(b)the information relating to the change referred to in paragraph 32(1)(b) and 32(2), as approved;
(c)the decisions and reports of the approved body referred to in paragraphs 32(2), 33(3) and 33(4).
36.—(1) 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.
(2) Each approved body must inform the 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.
37. A manufacturer's obligations set out in paragraphs 30(1), 30(2), 32(1)(b), 34 and 35 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.]