4.
Surveillance under the responsibility of the notified body 4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. 4.2. The manufacturer shall allow the notified body entrance for inspection purposes to the locations of manufacture, inspection and testing, and storage and shall provide it with all necessary information, in particular: the quality system documentation, the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc. 4.3. The notified body shall periodically carry out audits to make sure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer. 4.4. Additionally the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may carry out, or cause to be carried out, tests to verify that the quality system is functioning correctly, if necessary. The notified body shall provide the manufacturer with a visit report and, if a test has taken place, with a test report.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.