Directive 2014/68/EU of the European Parliament and of the CouncilShow full title

2. MODULE A2: INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRESSURE EQUIPMENT CHECKS AT RANDOM INTERVALS

1. Internal production control plus supervised pressure equipment checks at random intervals is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3, 4 and 5, and ensures and declares on his sole responsibility that the pressure equipment concerned satisfy the requirements of this Directive.

2. Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity of the pressure equipment with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the pressure equipment. The technical documentation shall contain, wherever applicable, at least the following elements:

• a general description of the pressure equipment,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for the understanding of those drawings and diagrams and the operation of the pressure equipment,

• a list of the harmonised standards the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the essential safety requirements of this Directive where those harmonised standards have not been applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied,

• results of design calculations made, examinations carried out, etc., and

• test reports.

3. Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured pressure equipment with the technical documentation referred to in point 2 and with the requirements of this Directive that apply to it.

4. Final assessment and pressure equipment checks

The manufacturer shall perform a final assessment of the pressure equipment, monitored by means of unexpected visits by a notified body chosen by the manufacturer.

The notified body shall carry out product checks or have them carried out at random intervals determined by the body, in order to verify the quality of the internal checks of the pressure equipment, taking into account, inter alia, the technological complexity of the pressure equipment and the quantity of production.

During its unexpected visits, the notified body shall:

• establish that the manufacturer actually performs final assessment in accordance with point 3.2 of Annex I.

• take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the pressure equipment samples.

The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process of the pressure equipment performs within acceptable limits, with a view to ensuring conformity of the pressure equipment.

Should one or more of the items of pressure equipment or assembly not conform, the notified body shall take appropriate measures.

The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.

5. CE marking and EU declaration of conformity

5.1. The manufacturer shall affix the CE marking to each individual pressure equipment that satisfies the applicable requirements of this Directive.

5.2. The manufacturer shall draw up a written EU declaration of conformity for the pressure equipment model and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the pressure equipment has been placed on the market. The EU declaration of conformity shall identify the pressure equipment for which it has been drawn up.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6. Authorised representative

The manufacturer’s obligations set out in point 5 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.