Paragraph 4 Surveillance under the responsibility of the approved bodyF1

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

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

The approved body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and must 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 product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The approved body must provide the manufacturer with a visit report and, if tests have been carried out, with a test report.