anx_III__cpt_1__cpt_12__cpt_5__cpt_2__text_3
the quality system documentation, the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc., 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.
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Source: EUR-Lex (Cellar) · retrieved 2026-11-02 · Text as adopted (Official Journal); later amendments are not incorporated in this text.