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D. Konformitätsbewertungsverfahren |
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Leitlinie |
Akzeptiert |
Frage |
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| Leitlinie D-01 |
15.03.2016 | Is design approval by a notified body required under module G? | ||||||||||||
| Leitlinie D-02 |
08.01.2016 | Can a manufacturer’s existing QA certification which is in accordance with the standards EN ISO 9000 be taken into account by the notified bodies when approving QA systems for modules D, D1, E, E1, H or H1 of the PED? | ||||||||||||
| Leitlinie D-03 |
15.03.2016 | How to apply conformity assessment modules when some parts of an item of pressure equipment or some operations are sub-contracted ? | ||||||||||||
| Leitlinie D-04 |
15.03.2016 | If a manufacturer chooses to apply module B for the design phase, in combination with another module for the production phase, does the manufacturer have to choose the same notified body for the design and production modules? | ||||||||||||
| Leitlinie D-06 |
15.03.2016 | Can an assembly be composed of pressure equipment dealt with using different conformity assessment modules? | ||||||||||||
| Leitlinie D-07 |
15.03.2016 | Shall the manufacturer of pressure equipment submit operating instructions as part of the conformity assessment by a Notified Body, and shall the Notified Body verify the content? | ||||||||||||
| Leitlinie D-09 |
15.03.2016 | Is a manufacturer of components required to include a design examination, proof test and final inspection by a Notified Body if the components are intended for later use in PED equipment ? | ||||||||||||
| Leitlinie D-10 |
08.01.2016 | There are many organisations that design pressure equipment that is subsequently fabricated by another organisation. Is it permissible for the company responsible for the design to obtain an EU-Type examination – design type certificate and the fabricator obtain an appropriate certificate for the manufacturing phase, e.g. Modules F (Conformity to type based on pressure equipment verification)? | ||||||||||||
| Leitlinie D-11 |
15.03.2016 | Should the holder and the bursting disc which combine to produce a bursting disc safety device for use above 0,5 bar carry separate CE marking? | ||||||||||||
| Leitlinie D-12 |
08.01.2016 | What information shall be included in the quality system approval notification document issued by the notified body concerning the scope of products? | ||||||||||||
| Leitlinie D-13 |
08.01.2016 | Is it permissible for the Notified Body to delegate the witnessing of the final inspection and proof test under module F or the proof test under module G to the manufacturer? | ||||||||||||
| Leitlinie D-15 |
15.03.2016 | A manufacturer has equipment in stock manufactured under a QA module (D/D1, E/E1 or H/H1). After expiry of the QA system certification the manufacturer switches from Notified Body “X” to Notified Body “Y” for the new certification. Can the manufacturer deliver equipment with Notified Body number "X" to his customers after the expiry date of the certificate? | ||||||||||||
| Leitlinie D-17 |
31.05.2020 | In the case that serially produced pressure equipment is assessed in accordance with module B (production type) + C2: shall the manufacturer affix the notified body’s identification number to all pressure equipment even though the notified body has tested only a sample of the production? | ||||||||||||
