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Senior Officials Group on Standards and Conformity Assessment Policy
(SOGS) – 21 April 2005

ConCAss(2005)09

Summary

Preliminary discussion of Commission papers taking forward the Review of the New Approach (Docs N505, N506 and N507 circulated with
CONCASS(2005)06). Reports of contradictory views on changes to the
conformity assessment modules (N505) but marginal preference for option 1 (ie changes as proposed). General agreement to proposals on EC Declaration of Conformity (N506) and designation of notified bodies (N507). Commission’s work plan agreed but timetable considered ambitious.

Most Member States represented. The Commission represented by Michel Ayral (Chair), Jacques McMillan, Martin Stadler, Georgios Antoniou and Brian Jenkinson. UK represented by Richard Lawson and Malcolm Hynd (both STRD). Next meeting: 7/8 July 2005.

New Approach Review

Follow-up to the Council Resolution of 10 November 2003

Conformity assessment procedures (Doc N505)

Most Member States, including UK, said that they had not completed
consultation on the options put forward by the Commission in Doc N505 but reported that initial comments received were contradictory. Some respondents supported the principle of bringing the modules in line with ISO 9001:2000 (and therefore the deletion of modules D & E). Others supported no change, considering that modules D & E should remain available even if outside the ISO 9001:2000 framework. Overall, there seemed to be a marginal preference, including with the Commission, for option 1 (ie the deletion of modules D & E). UK reported tentative overall support for the deletion of modules D & E but not for the other changes proposed ie the introduction of modules B1 & B2 (although it might be helpful to develop a design examination module – B2 in the Commission’s proposals – eg to use with module F).

The Chair agreed to requests for consultation with industry followed by further development of the two options to be considered by a SOGS working group with knowledge of the operation of ISO 9001:2000.

Declaration of Conformity (Doc N506)

There was general support for the Commission’s proposals in Doc N506 subject to a number of minor drafting suggestions. Some MS, including UK, cautioned against referring too closely to the standard for Suppliers’ Declarations of Conformity (ISO 17050) as this was not developed for use in the regulated area and has a slightly different focus. The Commission will develop further.

Designation of notified bodies: Requirements for notified bodies (Doc N507 Part 1)

General reactions

There was general support for the Commission’s proposals for consolidated ‘minimum requirements’ supported by agreed formal guidance. There was support for a UK proposal to rename ‘minimum requirements’ as ‘essential requirements’. There was also support for the principle that there could be some flexibility in individual directives over the application of the general framework agreed but agreement that the burden of justification for departing from the norm should be stronger. Some Member States wanted stronger reference to the role of accreditation in the assessment of notified bodies.

Independence

It was agreed that independence was a key requirement for notified bodies, in order to ensure impartiality, and that clearer criteria were required, particularly on the question of related bodies. There was some support for the UK suggestion that the criteria should require a high level of independence. Some Member States were less convinced by the suggestion in the paper that political and technical decision making should be separated in Governmental notified bodies.

Technical Competence

Paper generally agreed although some Member States asked for clarification that notified bodies should be required to carry out the majority of work themselves (see also under Sub-contracting below). The Chair asked for information on the technical capabilities required of notified bodies by Member States.

Insurance

There was some support for a UK suggestion that these requirements should be expanded to provide further information on issues such as the type of insurance and geographical scope required. The Chair asked Member States to send in details of national requirements on insurance.

Sub-contracting

There was agreement that sub-contracting needed to be addressed more
specifically and general agreement of the wording proposed in the Commission’s paper. There was further discussion of the amount of work that can be subcontracted and how it should be monitored especially if carried out in third countries. The Commission will develop further but there was general agreement that the decision making process could not be sub-contracted and that notified bodies needed to be competent to assess the sub-contractor and the results.

Quality System

General agreement of the Commission’s proposals.

Exchange of information/coordination

General agreement of the Commission’s proposals and an understanding that notified bodies should keep themselves up to date with developments.

Involvement in Standardisation

Some Member States thought it was important that notified bodies were directly involved in standardisation work but the general view, supported by the UK, was that it was sufficient for them to keep themselves informed.

Further Elements Suggested for Consolidation

There were differing and opposing views on the suitability for inclusion of the other elements set out for consideration. It was suggested that the issues proposed might be better covered in guidance rather than the essential requirements. The Chair asked member States for further comments on these elements and any of the other issues covered to assist the Commission in further developing this paper.

Designation of notified bodies: Requirements for designating authorities
(Doc N507 Part 2)

Most Member States were in general agreement with the proposals in this paper although Germany disagreed with the distinction drawn between accreditation and assessment arguing that any assessment of a conformity assessment body was, by definition, accreditation. The Commission and some other Member States (including the UK) disagreed arguing that the paper set out the overall requirements for the assessment process and accreditation could only be considered as one means of addressing them, albeit an important one.

Other Member States were concerned that the paper did not place enough
emphasis on the use of accreditation to support the designation process. The Commission explained that a further paper, still to be prepared, would go into more detail on this aspect.

Whilst agreeing with the paper in general, the UK suggested that para 2.1.d. on sub-contracting should be brought in line with the references in N507 Part 1, ie the main responsibility for monitoring sub-contractors should rest with the notified bodies not the Member States. UK also suggested that the presumption of conformity for notified bodies designated on the basis of accreditation to the harmonised standards (eg in para 2.2.a.) should be linked more clearly to accreditation ‘by a member of EA’ to ensure transparency and consistency. UK also said, in relation to para 2.2.e. that it had not found annual reports to be necessary or useful. Some Member States disagreed on this last point.

Ongoing Activities

The Commission presented an Information Note setting out a timetable for
continuing the work on the New Approach Review. This proposed papers for the July meeting on: the role of accreditation in the designation process; the European accreditation organisation; market surveillance; and definitions. For the September meeting, it proposed papers on: cooperation between notified bodies; the development of NANDO (electronic notification system); the safeguard clause; marks and marking; and the relationship between the CE marking and other marks. A consolidated paper would then be drawn up for the November
meeting.

Member States supported the Commission’s programme but several commented that the timetable set out was extremely ambitious.

The Chair confirmed that the Commission would be consulting widely on these issues and would make the working documents available on the Commission website (address to be advised).

International Issues

EU/US Regulatory Cooperation

The Commission reported good progress since agreement last year and the President Bush visit in February. They were expecting to consider a work programme at the next meeting in June which could include a proposal for a regulators’ forum.

WTO/Technical Barriers to Trade Agreement

The Commission reported on the last meeting held in March which included a workshop on the use of Suppliers’ Declarations of Conformity. Also discussed was the establishment of a notification system for less developed countries to notify technical assistance needs. There was also preparation for the 4th Triennial review of the Agreement. Proposed topics for consideration included good regulatory practice, conformity assessment, transparency, IPR and standardisation.

DTI/STRD
May 2005

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