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Commencement Information
I1Sch. 8 in force at 1.7.1997, see reg. 1(1)
(4.1) The purpose of surveillance is to make sure that the manufacturer of the safety components duly fulfils the obligations arising out of the approved quality assurance system.
(4.2) The manufacturer of the safety components must allow the notified body access for inspection purposes to the design, manufacture, inspection and testing, and storage locations, and must provide it with all necessary information, in particular:
the quality assurance system documentation,
the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests, etc.,
the quality records provided for in the manufacturing part of the quality assurance system, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel concerned, etc.
(4.3) The notified body must periodically carry out audits to make sure that the manufacturer of the safety components maintains and applies the quality assurance system and must provide an audit report to the manufacturer of the safety components.
(4.4) Additionally, the notified body may pay unexpected visits to the manufacturer of the safety components. At the time of such visits, the notified body may carry out tests or have them carried out in order to check the proper functioning of the quality assurance system where necessary; it must provide the manufacturer of the safety components with a visit report and, if a test has been carried out, with a test report.