14. Conformity to type based on internal production control plus supervised vessel checks at random intervals is a conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in paragraphs 15 to 17, and it is the manufacturer’s sole responsibility to ensure and declare that the vessels concerned are in conformity with the type described in the EU-type examination certificate and satisfy the applicable requirements of these Regulations.
15.—(1) The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured vessels with the type described in the EU-type examination certificate and with the applicable requirements of these Regulations.
(2) Before commencing manufacture, the manufacturer must provide a notified body of his choice with all necessary information, and in particular—
(a)the technical documentation referred to in paragraph 2(2)(c), together with —
(i)the certificates relating to the suitable qualification of the welding operations and of the welders or welding operators;
(ii)the inspection slip for the materials used in the manufacture of parts and components contributing to the strength of the vessel; and
(iii)a report on the examination and tests performed;
(b)the EU-type examination certificate;
(c)a document describing the manufacturing processes and all of the predetermined systematic measures taken to ensure conformity of the vessels with the type described in the EU-type examination certificate, which document must include—
(i)a description of the means of manufacture and checking appropriate to the construction of the vessels;
(ii)an inspection document describing the appropriate examinations and tests to be carried out during manufacture, together with the procedures in respect thereof and the frequency with which they are to be performed;
(iii)an undertaking to carry out the examinations and tests in accordance with the inspection document and to ensure that a hydrostatic test or, subject to the agreement of the relevant authorities, a pneumatic test is carried out on each vessel manufactured at a test pressure equal to 1.5 times the design pressure; and
(iv)the addresses of the places of manufacture and storage and the date on which manufacture is to commence.
(3) The examinations and tests referred to in paragraph 15(2)(c)(iii) must be—
(i)carried out under the responsibility of qualified staff who are independent of production personnel; and
(ii)the subject of a report.
(4) The notified body must, before the date on which any manufacture begins, examine the documents referred to in paragraphs 15(2)(a) and (c) in order to certify their conformity with the EU-type examination certificate.
16.—(1) The notified body must carry out vessel checks, or ensure that vessel checks are carried out, on random samples at random intervals determined by the body, in order to verify the quality of the internal checks on the vessel, taking into account, inter alia, the technological complexity of the vessels and the quantity of production.
(2) An adequate sample of the final vessels, taken on site by the notified body before their placing on the market, must be examined and appropriate tests as identified by the relevant parts of the harmonised standards, or equivalent tests set out in other relevant technical specifications, must be carried out to check the conformity of the vessel with the type described in the EU-type examination certificate and with the relevant requirements of these Regulations.
(3) The notified body must also ensure that the manufacturer checks series-produced vessels in accordance with paragraph 15(2)(c)(iii).
(4) Where a sample does not conform to the acceptable quality level, the notified body must take appropriate measures.
(5) The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the vessel performs within acceptable limits, with a view to ensuring conformity of the vessel.
(6) The notified body must supply the Secretary of State and, on request, other notified bodies, other Member States and the Commission, with a copy of the inspection report issued by it.
(7) The manufacturer must, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
17.—(1) The manufacturer must affix the CE marking to each individual vessel that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of these Regulations.
(2) The manufacturer must draw up a written EU declaration of conformity for each vessel model and keep it at the disposal of the enforcing authority for a period of 10 years beginning on the day on which the vessel has been placed on the market. The EU declaration of conformity must identify the vessel model for which it has been drawn up.
(3) A copy of the EU declaration of conformity must be made available to the enforcing authority upon request.