anx_III__cpt_1__cpt_4__cpt_3__cpt_2

4.3.2. The quality system shall ensure compliance of the appliances or the fittings with the type described in the EU type-examination certificate and with the applicable requirements of this Regulation. All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of: the quality objectives and the organisational structure, responsibilities and powers of the management with regard to product quality; the examinations and tests that will be carried out after manufacture; the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.; the means of monitoring the effective operation of the quality system.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-01 · Text as adopted (Official Journal); later amendments are not incorporated in this text.