Guideline H-04
As a first stage the manufacturer shall determine and record the characteristics, extent, surrounding and circumstances of the intended use of the pressure equipment or the assembly. Next, it is necessary to identify hazards and/or hazardous situations that could occur during the life cycle of the pressure equipment or the assembly in reasonably foreseeable conditions. […]
Guideline D-02
A notified body when approving QA systems according to the modules D, D1, E, E1, H or H1 should take into account that the manufacturer already has ISO 9000 certification particularly if it has been certified by an accredited certifying organisation. However, the notified body has overall responsibility for ensuring that the QA systems satisfy […]
Guideline D-03
There is only one manufacturer taking responsibility for each item of pressure equipment, who chooses one module (or combination of modules). The conformity assessment is related to an item of pressure equipment and not to the parts considered alone. It is the responsibility of the pressure equipment manufacturer to obtain from his sub-contractor the information […]
Guideline D-04
No. As requested by modules B (EU-Type examination – production type or design type) (Annex III, points 6 and 7 of the corresponding modules), the examination certificate shall annex a list of the relevant parts of the technical documentation and any other relevant information, which allow the requirements of the production modules to be applied. […]
Guideline D-06
Yes, by application of Article 14 paragraph 6 (a). For example, the valves can have a module different from that applied to the vessel or the piping on which they are placed.
Guideline D-07
Yes. PED requires the manufacturer to prepare operating instructions (see Annex I section 3.4) and supply them together with the equipment. Appropriate operating instructions are an essential safety requirement (ESR) and shall therefore be part of the conformity assessment procedure. When the Notified Body’s duty includes performing or monitoring final assessment, it shall verify the […]
Guideline D-09
No. Components are not items of pressure equipment, and therefore are not subject to individual conformity assessment procedures. For requirements on components to be used in pressure equipment, see PED Guidelines A-22 and G-19. Note 1:The final inspection including the proof test applies to the complete item of pressure equipment and not to the component […]
Guideline D-10
No Even if different organisations can be involved, the directive clearly indicates that there can be only one manufacturer who is responsible for design, manufacture and conformity assessment of the pressure equipment. The manufacturer may subcontract tasks in relation to design and/or manufacture but must retain overall control and have the necessary competence to take […]
Guideline B-11
Article 14 paragraph 3 states that manufacturers can choose to apply one of the procedures which apply to a higher category if available. The words ‘if available’ make it clear that if an item of pressure equipment was classified as category IV, then a module from a higher category is not available. Even for those […]