# Directive 2014/68/EU of the European Parliament and of the Council of 15 May 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of pressure equipment (recast) (Text with EEA relevance), Division 3.2: The quality system shall ensure compliance of the pressure equipment with the requirements of this Directive that apply to it.

Extent: E+W+S+N.I.

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:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to 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 that will be used to ensure that the essential requirements of this Directive that apply to the pressure equipment will be met,
the design control and design verification techniques, processes and systematic actions that will be used when designing the pressure equipment, pertaining to the product type covered, particularly with regard to materials in accordance with point 4 of Annex I,
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with point 3.1.2 of Annex I,
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, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with points 3.1.2 and 3.1.3 of Annex I, etc.,
the means of monitoring the achievement of the required design and pressure equipment quality and the effective operation of the quality system.

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Source: https://www.legislation.gov.uk/eudr/2014/68/annex/III/division/11/division/3/division/3.2 (the official version)
Page: https://openlegislation.uk/eu-directive-2014-68/annex-III/division-11/division-3/division-3.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.