23 th Meeting of the EUROLAB-CEOC JOINT TECHNICAL COMMITTEE ON PRODUCT TESTING AND CERTIFICATION (JTC PTC) 3 July 2006, Brussels.

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1 European Federation of National Associations of Measurement, Testing and Analytical Laboratories EL_07_04_06_ JTCPTC_06_41 23 th Meeting of the EUROLAB-CEOC JOINT TECHNICAL COMMITTEE ON PRODUCT TESTING AND CERTIFICATION (JTC PTC) 3 July 2006, Brussels Confirmed Minutes Attendance: Guy Jacques, chairman, Annick Carpentier, Eulalia Cirici, Radomir Cevelik, Josef Engels, Astrid Grunert, Daniel Pflumm, Christian Priller, Hinrich Schaub, Anita Schmidt, Hannelore Wessel Apologies: Hervé Berrier Hugo Eberhardt, Catherine Gomy, Herbert Egolf, Vladimir Filiac, Stephan Helmprobst, Hoang Liauw, Bernd Siegemund 1. Opening of the meeting; introduction of members and guests The chairman Guy Jacques opened the meeting and welcomed the participants. Actions 2. Approval of the agenda The agenda (JTCPTC_06_36) was adopted. 3. Approval of the minutes of the JTC PTC meeting in Brussels on Matters arising from the minutes The draft minutes (JTCPTC_06_24) were approved and are now official minutes. All actions therein were fulfilled or were included in this meeting s agenda. 5. Review of the New Approach 5.1 Positions to be taken with regard to the new documents Two important new documents were received shortly before the meting and hence could only be circulated on the Friday prior to the meeting: CEOC / EUROLAB Comments on the EU Commission s Working Documents on the Review of the New Approach - 3 July 2006 (JTCPTC_06_40) Elements for possible articles for a horizontal legislative approach to harmonisation of legislation on products Draft regulation (SOGS N 550 EN) (JTCPTC_06_42) It was agreed to prepare comments on the new draft regulation SOGS N550 instead of forwarding comments on the former documents to the European Commission. As the issues mostly remain the same, it was decided to go through the comments proposed by Guy Jacques and to identify the key topics to be addressed. As far as presentation of the comments is concerned there was a long discussion about the use of prose text and the use of templates. At first sight it appeared more practical to use templates for technical comments proposing modifications and prose for general positions, which are to be read easily, and presented in papers or internet sites. The following issues were identified: Elements from SOGS N549 a) The New Approach is highly dependant on standardisation: JTC PTC warns that the outcome must not be soft regulation due to lack of competence, transparency and representation in the standardisation process. Technical Secretariat BAM Federal Institute for Materials Research and Testing Unter den Eichen Berlin Germany Telephone: Telefax: EUROLAB@bam.de Registered office rue du Luxembourg 3 B-1000, Brussels Belgium

2 b) The importance of transparency of the designation and accreditation processes are supported by EUROLAB and CEOC International. c) It was agreed to delete point 3 on safeguard clauses and information procedures, as this is covered already. d) Point 4: The involvement of third parties in critical issues should not be undermined. e) Editorial: SOGS N569 needs to be replaced with SOGS N549 Elements from SOGS N543 (CERTIF ) f) Some pre-requisites have to be met when accreditation is used in the notification process. g) Transparency of the scopes for the accreditation to directives is needed (so far EA has not provided a concept). The degree of detail must be appropriate in terms of the auditing time needed. h) Flexibility of the scope is needed. At the EUROLAB workshop a comment had been made regarding the problem of competence of the auditors. The basis for the scope needs to be the products rather than the method standards. A list of persons with competence produced by the accreditation bodies is certainly not desirable. i) Monitoring needs to be carried on a out fit-for-purpose basis. JTC PTC: include comment template and to propose use to the Commission Elements from SOGS N 541 (CERTIF ) concerning the modules The discussion was also based on Hinrich Schaub s Comments for VdTÜV (JTCPTC_06_37). It was agreed to include the comment template and to suggest to the Commission to use such templates in the future, as it allows to collect and compare all comments. j) As a general statement, it should be stressed that the activity carried out by national authorities is monitoring, not inspection. k) Concerning the Modules A1, A2, C1 and C2, JTC PTC s first choice would be to delete the modules. These modules are misleading, most of the stakeholders will probably not understand that it goes about in-house bodies. Even accredited they are not third parties as notified bodies and this mixture would undermine the third-party independence concept. An argument in this respect is that Aa s use is very limited, if used at all. l) Concerning Module B, the duty to inform other notified bodies and to provide certificates is over-burdening. While it is acceptable to inform Member States authorities and to provide EC-type certificates to the Commission, other notified bodies should only need to be informed on withdrawn certificates. m) For pragmatic reasons (the standard may be changed soon and hence the regulation would become obsolete), the ISO 9001 reference should be deleted. (In addition, in the footnote the statement that Module D assesses the design is wrong). n) Module D1 and E1 should be deleted for clarification and responsibility reasons. Elements from SOGS N 550 In view of the late distribution of the document to eb discussed at the next SOGS meeting to take place on July 4 th, M. Ayral, DG Enterprise, identified only 6 aspects of the draft regulation for discussion. The issues were also discussed in JTC PTC. 1. The form of a legally binding regulation was supported by JTC PTC members. 2. It will be a political discussion to open the New Approach to other areas and to decide on which sectors to include. 2

3 3. CE marking: Under Article 2 a definition is still missing. There is a definition in Article Marking likely to deceive third parties as to the meaning or form of CE marking shall be prohibited. Editorial: third parties should be replaced by the market. 4. The draft regulation foresees 3 different committees: JTC PTC recommends to avoid overlapping between the activities of these three committees. 5. Development of guidelines: JTC PTC supports the use of the expertise of stakeholders (Article 69) 6. Financial provisions: Article 74 1b) should also allow for financing items according to Article 72 1c) (drafting of guidelines), d) (technical experts for market surveillance)and a) (development of sectoral accreditation programmes). Other aspects of SOGS N550 that were addressed by JTC PTC members: Article 20.4: see discussion above under l). Strangely the duty to inform notified bodies only applies for notified bodies participating in coordination groups. Article 21: JTC PTC prefers the wording: designation shall be based on accreditation instead of shall be supported by accreditation, the latter implying that there will be additional requirements. Article 34: only essential requirements? Article 37.1.e: adequate representation but also voting rights should be ensured. Article 40.2: quality management modules (H, D, E) should replace the words quality assurance. Article 41: For practical reasons (to avoid that the text may soon become obsolete), the reference to standards should be avoided. In addition, it must not mean that under ISO 9001 certified bodies can not be checked anymore by the notified body, which on the other hand will be responsible. (see also Article 20.5) Article 42.1: The CE marking does not materialize conformity: this is not a good expression. Article 42.4: The CE marking is the only marking by which the manufacturer declares that his product conforms to the directives. The conformity is NOT attested by the CE marking itself. On the basis of these comments the chairman will amend the existing documents. They will be distributed for comments to the JTCPTC members and in parallel to the Boards of Eurolab and CEOC. All participants agreed with the fact that, due to short notice, the comments are a very first approach but it is also very clear that the SOGS 550 document is at a very preliminary stage and will shortly amended by the Commission. The important issue is, if possible, to produce a position before the end of July. Chairman: On basis of discussions prepare comments onn550 A.Schmidt inform the EUROLAB Technical Committee accordingly to encourage EUROLAB members to answer the consultation. 5.2 Positions to be taken with regard to the public consultation of the Commission : The Commission has started a public consultation on the Review and Extension of the New Approach (deadline 26 July 2006). JTC PTC went through the questionnaire and tried to agree on common positions. However, as there will be different views of the individual EUROLAB and CEOC International members on some aspects, it was agreed that the national members shall be encouraged to reply to the questionnaire. This will also ensure that as many answers as possible are submitted. 3

4 6. Accreditation issues 6.1 EAAB The minutes of the past EAAB meeting (JTCPTC_06_35) reports on discussion on the role and weight of EAAB. The meeting also opened the discussion as to whether EAAB should get rights in EA and what the future role should be (Role of Steering Committee or purely advisory) With regard to the proposal for an appeal procedure within EA, the proposal was revised by Daniel Pierre, but obviously EA feels that it is not in the position to make an appeal against one of its members, and that it would only be able to issue recommendations. JTC PTC insists, however, that also appeals against EA itself must be possible. 6.2 Scopes of accreditation in the field of European directives The EA Inspection Committee circulated a proposal on the form and content in the form of a table heading to the EAAB (JTCPTC_06_39). EUROLAB and CEOC International stressed, that the last column may only be exemplary and optional. There is no current further activities of the EA IC working group. It was proposed to send to the EAAB the German example of a product pyramid by ZLS and ZLG. JTC PTC supports a CEN mandate for harmonised requirements. A.Schmidt follow the work and send German structure to Guy Jacques. 6.3 Information from the latest EA General Assembly Guy Jacques reported that Mr. McMillan attended the General Assembly. A long discussion took place on issues to be improved within EA and on the concept for the future role of EA as European accreditation infrastructure for both the legally regulated field of the European directives and the non regulatory field. The EA survey on EA s members experience in the field of assessment of notified bodies was presented at the GA. The report written by Malcom Hynd (EA-AB chairman) indicates that the situation looks confused as stated by EAAB. Christian Priller also informed about a letter form the Netherlands to Mr. McMillan, presenting the Dutch position that accreditation should not be seen as a public authority activity. 7. Information from various organisations CEOC: Annick Carpentier reported from the developments within the CEOC International technical committees and from the CEOC International General Assembly held in Bucharest. CEOC International was admitted as stakeholder member in the ILAC Laboratory Committee where currently two problematic issues are handled: new fields of accreditation (PT providers, RM producers) and the discussion on what can be accredited and differences in different regions concerning the number of witness audits required for accreditation of inspection activities, where representatives from APLAC step in for witnessing of all auditors. In this case it was the view of JTC PTC that no MLA for inspection will be needed from the European side at all. EUROLAB: see report (JTCPTC_06_38) CEN Certification Board: The CEN Certification Board has issued a Position paper which is very much 4

5 EFNDT on line with the comments produced by Eurolab and CEOC. The next meeting will take place in Vienna on 27 September 2006 There is a German proposal to CENTC148 in order to define the accreditation requirements for certifications bodies active in the field of certification of non-destructive testing personnel. The document is not in line with the requirements of EN ISO which should be the baseline of accreditation in this field. Even the definition of accreditation differs from the definition included in EN ISO standard. This is perceived as fundamentaly inadequate by CEOC. Hannelore Wessel is not aware of this document and will look for further information on the background. 8. Validation of the members list There were no comments on the list circulated. 9. Any other matters There was no additional matter raised. 10. Dates of next meetings The meeting date of 5 October 2006 was cancelled and shifted to 27 October, 10:00-16:00 in Brussels at the CEOC International office 5