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anx_III__cpt_1__cpt_11__cpt_4__item_2__text_2

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