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[F1SCHEDULE 2AE+W+SConformity Assessment Procedures (Annex II to the Directive)

PART 4E+W+SModule E: Conformity to type based on product quality assurance

4.2.  The manufacturer shall, for assessment purposes, allow the approved body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:E+W+S

(a)the quality system documentation;

(b)the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.]