Surveillance under the responsibility of the notified body
4.—4.1. The purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
4.2. The manufacturer shall for inspection purposes allow the notified body access to the inspection, testing and storage premises and shall provide it with all necessary information, in particular:
quality system documentation;
technical documentation;
quality records, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
4.3. The notified body shall periodically carry out audits to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.
4.4. Furthermore, the notified body may pay unexpected visits to the manufacturer. At the time of such visits, the notified body may carry out tests or arrange for tests to be carried out in order to check the proper functioning of the quality system, where necessary; it shall provide the manufacturer with a visit report and, if a test has been carried out, with a test report.