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Dyma’r fersiwn wreiddiol (fel y’i gwnaed yn wreiddiol). This item of legislation is currently only available in its original format.
Surveillance under the responsibility of the notified body
4.2 The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection, testing and storage and provide it with all necessary information, in particular:
the quality 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 system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the staff concerned, etc.
Yn ôl i’r brig