F1SCHEDULE 2AConformity Assessment Procedures (Annex II to the Directive)

Annotations:

PART 4Module E: Conformity to type based on product quality assurance

4

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:

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.