# The Merchant Shipping (Marine Equipment) Regulations 1999, Regulation 14: EC production quality assurance and product quality assurance procedures


(1) A manufacturer who decides, in accordance with Merchant Shipping Notice MSN 1734, to apply either the EC production quality assurance procedure or the EC product quality assurance procedure to equipment in respect of which an EC type-examination certificate has been issued, may apply to a notified body for approval of his quality assurance system; and such an application shall be made in writing and shall include–
(a) all relevant information for the equipment category envisaged;
(b) the documentation concerning the system;
(c) the technical documentation of the specimen of the equipment and a copy of the EC type-examination certificate issued in respect of it; and
(d) an undertaking by the manufacturer–
(i) to fulfil the obligations arising from the approved system; and
(ii) to maintain the system as approved so that it remains adequate and efficient.
(2) On an application made to it under paragraph (1) above, the notified body shall evaluate the manufacturer’s quality assurance system to determine whether–
(a) on an application for approval of a system to be used in a production quality assurance procedure, it satisfies the requirements referred to in paragraph 3.2, of the section entitled “Production-Quality Assurance (Module D)”, in Annex B of the Directive and set out in Merchant Shipping Notice 1734; or
(b) on an application for approval of a system to be used in a product quality assurance procedure, it satisfies the requirements referred to in paragraph 3.2, of the section entitled “Product-Quality Assurance (Module E)”, in Annex B of the Directive and set out in Merchant Shipping Notice 1734,
and, if the system implements the relevant harmonised standard, it shall be taken to satisfy the said requirements.
(3) When determining whether a manufacturer’s quality assurance system satisfies the requirements referred to in paragraph (2) above, the notified body shall–
(a) include on the relevant auditing team at least one person with experience of assessment in the equipment technology concerned; and
(b) include within the assessment procedure at least one visit to the manufacturer’s premises.
(4) Where the notified body is satisfied, on an application made to it under paragraph (1) above and after evaluating the manufacturer’s quality assurance system, that the system satisfies the relevant requirements referred to in paragraph (2) above it shall grant to the manufacturer an approval of the system.
(5) In its approval under paragraph (4) above the notified body shall include the conclusions of any examinations and the evaluation carried out by it.
(6) A manufacturer to whom an approval has been granted in respect of a quality assurance system under paragraph (4) above shall have authority to make EC declarations of conformity in accordance with paragraph (13) below.
(7) Where the notified body is not satisfied as is mentioned in paragraph (4) above, it shall inform the manufacturer in writing–
(a) of its decision to refuse to grant an approval in respect of the system; and
(b) the conclusions of any examinations and the evaluation carried out by it.
(8) Where a notified body has granted an approval under paragraph (4) above, it shall periodically carry out audits of the approved system to ensure that the manufacturer maintains and applies the approved system and fulfils his obligations arising out of the approved system.
(9) The notified body shall provide the manufacturer with an audit report in respect of each periodic audit undertaken in accordance with paragraph (8) above.
(10) In addition to the periodic audits referred to in paragraph (8) above, the notified body may make unannounced visits to the manufacturer’s premises for the same purposes, and in the course of such visits may carry out tests, or cause tests to be carried out, if such tests are necessary to check whether the approved system is functioning correctly.
(11) The notified body shall provide the manufacturer–
(a) if it performs a visit as is mentioned in paragraph (10) above, with a visit report; and
(b) if it performs such tests as are mentioned in paragraph (10) above, with a test report.
(12) Where a manufacturer has been granted an approval by a notified body in respect of his quality assurance system, he shall–
(a) ensure and declare that the items of equipment concerned conform to the specimen in respect of which the EC type-examination certificate was issued;
(b) allow the notified body access for purposes of inspection to his premises where the equipment is manufactured, inspected, tested and stored;
(c) provide the notified body with all necessary information to enable it to perform its surveillance functions under these Regulations, in particular:
(i) the documentation relating to the system; and
(ii) the relevant quality records, such as inspection reports and test data, calibration data and qualification reports in relation to the personnel involved in the system; and
(d) maintain, at the disposal of the Secretary of State, for at least 10 years after the last item of equipment to which the system relates has been manufactured, the documentation referred to in–
(i) paragraph (1)(b) above;
(ii) paragraph (13)(c) below; and
(iii) paragraphs (4), (7), (9) and (11) above.
(13) Where a manufacturer has been granted an approval under paragraph (4) above by a notified body, the manufacturer or his authorised representative established within the Community shall–
(a) affix the mark referred to in regulation 18 below to each item of equipment; which mark shall be accompanied by the identification symbol and number of the notified body responsible for the auditing referred to in paragraph (8) above;
(b) draw-up a written declaration of conformity; and
(c) inform the notified body in writing of any intended modification of the system.
(14) Where a notified body is informed under paragraph (13)(c) above that a manufacturer intends to modify an approved system, it shall–
(a) assess the modifications proposed and determine whether the modified system would still satisfy the relevant requirements referred to in paragraph (2) above or whether a reassessment is required; and
(b) inform the manufacturer of its decision in writing, including the conclusions of any examinations and the evaluation carried out.
(15) A notified body shall, on request, provide the flag member State and the other notified bodies with the relevant information concerning the approvals granted by it, including those withdrawn, under paragraph (4) above.

---
Source: https://www.legislation.gov.uk/uksi/1999/1957/regulation/14 (the official version)
Page: https://openlegislation.uk/merchant-shipping-marine-equipment-regulations-1999/regulation-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.