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REGULATION (EU) 2023/1230 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC (Text with EEA relevance) · European Union

| 3.2. | The quality system shall ensure compliance of the machinery or related products 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. That 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: (a) the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality; (b) the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards or common specifications adopted by the Commission in accordance with Article 20(3) will not be applied in full, the means, including other technical specifications, that will be used to ensure that the essential health and safety requirements of this Regulation that apply to the machinery or related product will be met; (c) the design control and design verification techniques, processes and systematic actions that will be used when designing the machinery or related product; (d) the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; (e) the examinations and tests that will be carried out before, during and after manufacture and the frequency with which they will be carried out; (f) the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.; (g) 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 2026-08-26 · Text as adopted (Official Journal); later amendments are not incorporated in this text.