anx_VIII__cpt_1__cpt_3__cpt_2

3.2. The quality system shall ensure that the PPE is in conformity with the type described in the EU type-examination certificate and complies 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. The quality system documentation 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 corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used; the examinations and tests that will 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 and qualification reports on the personnel concerned; and the means of monitoring the achievement of the required product quality and 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.