- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made). This item of legislation is currently only available in its original format.
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shall forward to the other notified bodies the relevant information concerning the quality system approvals issued and withdrawn.
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include: