Regulation 46 Surveillance procedure
The notified body shall carry out surveillance as provided for in the procedure set out in paragraph (2) below (“the full quality assurance surveillance procedure”) and the manufacturer shall permit that notified body to carry out that procedure, and, without prejudice to the generality of the foregoing, he shall—
allow the notified body access for the purpose of inspection to the location of design, manufacture, inspection and testing, and storage;
provide the notified body with such information (including the quality system documentation, the design quality records and the production quality records), facilities and assistance as it may reasonably require in carrying out that procedure.
The purpose of the full quality assurance surveillance procedure is to make sure that the manufacturer duly fulfils the obligations arising out of the full quality assurance approved quality system, and the procedure shall consist of—
the carrying out by the notified body of audits at reasonable intervals to make sure that the manufacturer maintains and applies the approved quality system and the provision of an audit report to the manufacturer; and
should the notified body consider it necessary, the paying of unexpected visits to the manufacturer, during which the notified body may carry out, or cause to be carried out, tests to check the proper functioning of the quality system, and, where such a visit has been paid, the provision of a visit report and a report upon any such tests.
Where it appears to the United Kingdom notified body acting pursuant to paragraph (1) above that one or more of the products checked do not conform with the relevant requirements of the TTE Directive, it shall report the matter—
where the products concerned are to be or have been supplied or put into service or connected to the public telecommunications network in the United Kingdom, to the enforcement authority;
where the products concerned are to be or have been supplied or put into service or connected to a public telecommunications network in a member State other than the United Kingdom, to the appropriate authorities in that other member State; or
where the body is aware that the products concerned are to be or have been connected to a public telecommunications network in the United Kingdom or another member State, to the operator thereof.
If the manufacturer fails to comply with his obligations under paragraph (1)(a) and (b) above the notified body shall suspend the approval of the quality system; and an approval suspended pursuant to this paragraph shall remain suspended until the manufacturer complies with the requirements of paragraph (1)(a) and (b) above.