Division 4.2

The manufacturer shall, for assessment purposes, allow F1the approved body access to the design, manufacture, inspection, testing and storage sites, and shall provide it with all necessary information, in particular:

1. (a)

   the quality system documentation;

2. (b)

   the quality records provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;

3. (c)

   the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.