12.—(1) The purpose of monitoring is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
(2) The manufacturer shall allow the notified body access for inspection purposes to the inspection, testing and storage premises and provide it with all necessary information, in particular —
(a)the quality system documentation,
(b)the technical documents,
(c)the quality records, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.
(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) Additionally, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out tests or have them carried out to verify that the quality system is functioning correctly; if necessary, the notified body must provide the manufacturer with a visit report and, if a test has been carried out, with a test report.
(5) Each notified body shall forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.