15.—(1) Where a manufacturer has made an EC declaration of type conformity under regulation 13, the approved body to which the manufacturer made an application for approval of the quality system shall carry out EC surveillance and in particular—
(a)shall periodically carry out audits in order to ensure that the manufacturer is maintaining and applying the quality system and provide the manufacturer with an audit report; and
(b)shall, from time to time, carry out visits at the places of manufacture, inspection, testing and storage and—
(i)check whether the manufacturer is maintaining and applying the quality system, and
(ii)at its discretion, carry out full or partial audits,
and shall provide the manufacturer with a report on each such visit and on any such audit.
(2) For the purpose of assisting the approved body to carry out the audits and checks specified in paragraph (1) above the manufacturer shall, in respect of each instrument, keep available for inspection by the approved body all necessary information, including—
(a)the documentation of the quality system;
(b)the design documentation of the instrument; and
(c)all related quality records,
and shall inform the approved body of any changes in its quality system.