INT MARKT 12009 , A-L Tyry ANNEX 1: WPG – Questions1

4Evaluation assessment procedures ( March 2005 ?)

Guideline 4/1 / Is design approval by a notified body required under module G ?
Origin of the question : / Question from UK by letter dated 06/98, redrafted by UK and accepted by WPG on 1998.09.18
Accepted by WGP on 1999.01.28
Guideline 4/2 : / 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 ?
Origin of the question : / CLAP 16, ORGALIME 16, transferred by the WPG to the Forum of NB, proposal NBF-SPV 98/017
Accepted by WPG on 1998/10/12
Accepted by WGP on 1999.01.28
Guideline 4/3 / How to apply conformity assessment modules when some parts of an item of pressure equipment or some operations are sub-contracted ?.
Origin of the question : / CLAP 44, ORGALIME 45, comments from Finland by fax dated 1998-08-19, transferred by the WPG to the Forum of NB, proposal from UK on 2000.02 09
Accepted by WPG on 2000-05-04
Accepted by WGP on 2000.06.29, with minor corrections
Guideline 4/4 / Is there any obligation that only one notified body intervene for the two modules of a combination, for example EC-type examination and quality assurance ?
Origin of the question : / CLAP 17, ORGALIME 17, proposal from UK on 2000.02 09
Accepted by WPG on 2000-05-04
Accepted by WGP on 2000.06.29, with editorial correction
Guideline 4/5 / Clauses 3 and 4 of module B1 in Annex III deal with information concerning qualifications or approvals of permanent joining that may not be available at the design stage. What are the minimum requirements in clause 3, last indent, and clause 4.1, 2nd and 3rd indents ?
Origin of the question : / Users, 2000.03.15, CLAP form 19.
WPG proposal on 2001.02.21, proposal by Finland 17 April 2001
Accepted by WPG on 2001.04.23
Accepted by WGP on 2001.06.26
Guideline 4/6 / Can an assembly be composed of pressure equipments dealt with different conformity assessment modules ?
Origin of the question : / CLAP 45, ORGALIME 45
Accepted by WPG on 2000-08.25
Accepted by WGP on 2000.11.07
Guideline 4/7 / 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?
Origin of the question : / NBF, November 2001
Accepted by WPG on 2002.04.10
Accepted by WGP on 2002.05.23
Guideline 4/8 / Are tests by the notified body required for module B1 ?
Origin of the question : / Derived from users proposal of 2000.03.15, proposal by Finland 17 April 2001
Accepted by WPG on 2001.04.23
Accepted by WGP on 2001.06.26
Guideline 4/9 / Is a manufacturer of component required to include a design examination, proof test and final inspection by a Notified Body if the component is intended for later use in PED equipment ?
Origin of the question : / New-108, ORGALIME, November 2002
Accepted by WPG on 2003.03.06
Accepted by WGP on 2003.04.28
Guideline 4/10 / 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 EC design examination certificate (B1) and the fabricator obtain an appropriate certificate for the manufacturing phase, e.g. Product Verification (F).
Origin of the question : / NBF/TRG O4/2, March 03.
Accepted by WPG on 2003-03-25
Accepted by WGP on 2003.04.28
Question : no WPG / Is material used in the manufacture of pressure equipment considered to be a “product” or a “commodity” and can the requirements for conformity assessment be applied to materials under the PED ?
Origin of the question : / Q A.8 of M. CROOKS version 5 disappeared from version 6
No guideline needed
Question : no WPG / The directive defines for each "risk" category a given number of applicable modules.
How are chosen these modules in function of the type of manufacturing (with QS/without QS – series/unit) ?
Must all serially produced equipment be subject to EC type examination (module B) and is the selection of modules H and H1 restricted to unit production only ?
Origin of the question : / CLAP 32, Q E.6 of M. CROOKS version 5 disappeared from version 6
Comments from Finland by fax dated 1998-08-19, proposal from UK on 2000.02 09
No guideline needed
Question no WPG / How is a type defined for module B or B1?
Origin of the question : / Austria, October 1998, discussed on 1999-09-03, interest of manufacturers on this issue to be confirmed. No guideline for the time being, waiting for a proposal
Question no WPG / Which are the documents to be given for a design examination ?
Origin of the question : / CLAP 19, ORGALIME 19, comments from Finland by fax dated 1998-08-19, transferred by the WPG to the Forum of NB ; proposal NBF-SPV 98/018
No guideline needed for the time being
Question :no WPG / Is it possible to apply a module H or H1 when the design and the manufacturing are made by two different entities independent from each other within a same industrial group, each of the entities having a quality system in accordance with the specifications of the directive ?
Origin of the question : / CLAP 15, ORGALIME 15
Covered by 4/3