5.2.

The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it. Under the quality system, each item of pressure equipment shall be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 12, or equivalent tests, and particularly final assessment as referred to in point 3.2 of Annex I, shall be carried out in order to ensure its conformity with the requirements of this Directive which apply to it. 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. This 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 quality of the pressure equipment, the procedures used for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I, the examinations and tests that will be carried out after manufacture, the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with point 3.1.2 of Annex I, the means of monitoring the effective operation of the quality system.

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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.