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11. In relation to paragraph 9, a manufacturer must—
(a)allow the notified body access to the locations of manufacture, inspection and testing, and storage;
(b)provide all necessary documentation to the notified body, including—
(i)the documentation concerning the quality system; and
(ii)the quality records, including inspection reports and test data, calibration data and qualification reports of the personnel concerned;
and
(c)in respect of visits by the notified body, carry out or allow the notified body to carry out tests necessary to determine that the quality system is functioning correctly.
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