Paragraph 18 Surveillance under the responsibility of the approved body
The manufacturer must allow the approved body access to the manufacture, inspection, testing and storage sites, and must provide it with all necessary information, in particular—
the quality system documentation;
the quality records, including inspection reports and test data, calibration data and qualification reports on the personnel concerned.
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.
The approved body may make unannounced visits to the manufacturer and, during such visits may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly.
Where the approved body has made an unannounced visit to the manufacturer, the approved body must provide the manufacturer with a visit report and, if tests have been carried out during such a visit, with a test report.