Regulation 5(5)
1.—(1) The manufacturer shall make an application in writing for evaluation of his quality system to a notified body.
(2) The application shall be signed by or on behalf of the manufacturer and shall include—
(a)the information and undertakings which are required by paragraph 2 of Schedule 5 to be included in an application under paragraph 1 of that Schedule, other than the information required by paragraph 2(1)(e) of that Schedule so far as it relates to research and development and design;
(b)the technical documentation relating to the approved type and a copy of the EC type-examination certificate.
2.—(1) Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.
(2) Subject to sub-paragraph (3) below, paragraphs 3(3) and (4)(a), (b), (d) and (e), 4 and 5 of Schedule 5 shall apply for the purposes of this Schedule as they apply for the purpoes of that Schedule, but as though any reference to paragraph 3(2) to (4) of that Schedule were a reference to sub-paragraph (1) of this paragraph and paragraphs 3(3) and (4)(a), (b), (d) and (e) of that Schedule.
(3) Paragraph 3(4)(b)(ii) of Schedule 5 shall not apply in respect of the desired quality of design.
3. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system.
4. The manufacturer shall authorise the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:
(a)the documentation relating to the quality system documentation;
(b)the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardisations, calibrations, the qualifications of the staff concerned, etc.
5.—(1) The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report.
(2) In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report.
(3) The notified body shall communicate to the other notified bodies all relevant information concerning approvals of quality systems issued, refused or withdrawn.