Report to IAF TC, Bratislava, September 2003
ISO CASCO WG 18
ISO/IEC 17011 status
Results of the ISO/IEC DIS 17011 ballot
Since the last IAF Annual Meeting September 2002, WG 18 have been considering the voting results and related comments on ISO/IEC DIS 17011 that closed on 2002-09-18. The votes on the DIS were as follows:
RESULT OF VOTING
P-Members voting: 37 in favour out of 46 = 80.43 % (requirement >= 66.66%)
(P-members having abstained are not counted in the vote)
Member bodies voting: 9 negative votes out of 47 = 19.15 % (requirement <= 25%)
These voting results constitute statistical approval for ISO/IEC DIS 17011 to move to the next stage. This means the preparation of a Final Draft International Standard (FDIS) version of 17011 for the final ISO member and IEC national committee ballot.
Preparation of ISO/IEC FDIS 17011
The WG 18 Drafting Group met on 2003-03-24/26 in Geneva to consider the comments received on the DIS and prepare the next draft. Keeping in mind the favourable voting results, the Drafting Group modified the document to accommodate as many comments as possible without changing the document significantly. The Drafting Group considered that the document should move to FDIS stage.
FDIS (Draft 1) was then sent to WG 18 members for their editorial comment and approval on 2003-04-01. Comments were requested from WG 18 members by 2003-05-02.
A number of technical and editorial comments were received from WG 18 members. In addition the CASCO Chairman used his prerogative to require more information about the origin and support of some specific clauses (4.3.6 and 4.3.7) in the text.
In general many comments related to improvement in grammar and punctuation. Other comments lead to a more precise formulation of the requirements, without affecting the intention of the WG when writing the requirement. Substantial comments made by the WG 18 members are referred to below:
· Clause 4.3.6 & 4.3.7 Services provided by accreditation bodies and related bodies
The most important issue was related to what an accreditation body (or its related body) can do and what would affect its impartiality.
FDIS (Draft 1) was forwarded to the entire WG 18 for approval/commenting. This resulted in some fine-tuning of the FDIS text. FDIS (Draft 2) was subsequently released with a modified subclause 4.3.6 and 4.3.7 for WG18 member comment. From this moment the debate was restarted. The IAF/ILAC Committee on Developing Countries was requested to provide input to the subject. The result of these discussions became available on 14 August. Unfortunately it was not conclusive.
Therefore the wording in FDIS Draft 1 (and originally in the DIS) of the clauses 4.3.6 and 4.3.7 should be retained
This would allow for the situation that there may be small developing countries which prefer to have their own accreditation service, but where no CABs are willing to operate every field of conformity assessment, that accreditation bodies could undertake such conformity assessment body services.
IAF and ILAC can interpret when the exception in 4.3.6 applies for those accreditation bodies that want to become signatory.
This approach seems realistic because it is IAF and ILAC’s responsibility to assure that signatories to their mutual recognition arrangements are operating in an equivalent manner, since this is providing the basis for the ‘One stop process’ as referred to in the introduction of the standard.
· Clause 7 Accreditation process
The consideration of DIS comments on clause 7 Accreditation Process, resulted in a review of the ordering of the various requirements in this clause. The proposed FDIS improved the order of the requirements and included modifications proposed within the DIS comments. The result is a more logically ordered Clause 7.
· Subclauses related to onsite assessment and premises that are subject to accreditation
It was suggested that the new wording of 7.7.2 (all premises and selected locations) is in contradiction to 7.5.7 (main or head office and premises with key activities) and creates an unacceptable burden for conformity assessment bodies. This has been considered to be an interpretation issue.
· Subclause 7.8.5 Nonconformities
A change was introduced that requires that all nonconformities be resolved prior to granting of accreditation. The phrase "actions planned to be taken" in reference to planned activities to resolve nonconformities has been removed. Some WG 18 members considered this conflicted with existing IAF and ILAC guidance documents, and national practice, on this subject.
WG18 members have now been requested to consider and approve the present wording in the FDIS (Draft 3) with respect to the above clauses. This will be done at the WG 18 meeting that will take place on 31 October and 1 November 2003 in Geneva.
Report written and amended by J-P Jaunin, based on report provided by CASCO WG 18 Convenor, Dr. Jos Leferink
Jean-Pierre Jaunin
September 09,2003