Division 4 Surveillance under the responsibility of the approved bodyF1F2

The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

The manufacturer shall, for assessment purposes, allow the approved body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

1. (a)

   the quality system documentation;

2. (b)

   the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;

3. (c)

   the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.

The approved body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

In addition, the approved body may pay unexpected visits to the manufacturer. During such visits, the approved body may, if necessary, carry out UA or UAS tests, or have them carried out, in order to check the proper functioning of the quality system. It shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.