anx_VII__cpt_1__cpt_3__cpt_2

3.2. The quality system shall ensure compliance of the subsystems or the safety components with the requirements of this Regulation that apply to them. 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 the design and product quality; the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means, including other relevant technical specifications, that will be used to ensure that the essential requirements of this Regulation will be met; the design control and design verification techniques, processes and systematic actions that will be used when designing the subsystems or the safety components; the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; the examinations and tests to be carried out before, during and after manufacture, and the frequency with which they will be carried out; the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.; the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.