Sch 1B Pt 11 para 5
The manufacturer shall, for assessment purposes, allow the approved body access to the design, 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 as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.; (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.