TC/52/03
Unconfirmed Minutes of IAF Technical Committee Meeting held on 16 to 17 September 2003 in Bratislava
1. Welcomes, Apologies
Mr Brockway welcomed the participants (attendance list attached).
2. Agenda and Objectives of the Meeting (TC/22/03 rev2)
Agreed.
3. Approval of Minutes of 17-19 February 2003 Meeting (TC/21/03 rev1)
Approved.
4. Matters Arising from the Minutes not Elsewhere
Item 5.1 –to activate IAF website for information on the implementation of ISO 19011 including transition arrangements.
(Action: Mr Brockway)
All other items either performed, overtaken by events, or now part of the active work programme of the TC.
4.1 Consultancy within One Organisation (TC/34/03)
In response to Mr Kawaberi’s paper, members confirmed that the combination of clauses 2.1.2 (d) and 2.1.2 (o) or Guide 62 prevent a certification/registration body and a related body providing management systems consultancy from within the same legal entity. (If they are part of the same Organisation, the two functions are considered as being performed by related bodies, and it is this situation that the IAF Guidance addresses with safeguards. The two related bodies, if performing these functions, must, however, be in separate legal entities.)
Members stressed the importance of ISO/IEC 17021 providing clear requirements on this issue.
5. Review of Balloted Items
5.1 WDI (TC/35/03 and TC/36/03)
Mr Brockway advised that although the ballot on this document had received enough votes to be approved as an IAF document, the IAF Executive had asked for the document to be reviewed in the light of the large number of comments received, a number of which raised new issues for consideration.
The current text had been developed by Mr Borzek to take account of these comments.
In discussion, a number of members felt that the document as now presented did not provide clear enough guidance on the issue. It came over as a halfway house between the original “Alternative Method” and conventional IAF Guidance that could be included in the broader IAF Guidance documentation for QMS and EMS CRBs.
The Committee was split on whether to propose the amended document for IAF approval, or to take a fresh look at the issue from the standpoint of providing overall Guidance for the assessment of mature management systems by CRBs and organisations with good track records.
Since a small majority favoured the second route it was agreed to start a new work item to undertake this project, and in the meantime to maintain the current document on the Alternative Method (98/020) as an IAF document.
Mr Kawaberi and Mr Croft agreed to co-chair a WG to develop new Guidance with a view to its eventual inclusion in future IAF Guidance on ISO/IEC 17021. (Action: Mr Kawaberi and Mr Croft)
In response to paper TC/36/03, it was confirmed that the 30% reduction in auditor time provided for in the IAF Guidance on Guide 62 was not applicable to any reductions in time arising from an Alternative Method/WDI approach. This was because the 30% reduction applies to initial audit, whereas WDI guidance is applicable to the maintenance of certification following a minimum of three years in certification/registration.
5.2 Cross Frontier Accreditation (TC/37/03)
This document having been approved, members accepted one minor amendment and recommended it to IAF for publication. They further recommended that it should have an implementation date 6 months following publication. Its implementation would become a major concern of the IAF MLA and there would be need for close bilateral communication between IAF member accreditation bodies. This would have to be achieved on a case-by-case basis.
5.3 Exchange of Documents (TC/38/03)
This Procedure document, having been approved by ballot, was recommended to IAF for publication subject to a few changes. It would be brought into force through the cross reference to it in the Cross Frontier document.
5.4 QMS CB Competence (TC/39/03)
This document having been approved was recommended to IAF for publication as part of the revised Guidance on Guide 62 subject to a few changes.
Members requested that the TC spend time discussing its implementation, including the sharing of experience between CRBs and ABs. It was agreed that this should be on the agenda for the February 2004 meeting of the TC.
(Action: Mr Brockway)
5.5 Revision of Guidance on Guide 62 (TC/40/03)
This document having been approved members agreed to recommend it to IAF for publication subject to a few changes.
5.6 Revision of Guidance on Guide 66 (TC/41/03)
This document having been approved members agreed to recommend it to IAF for publication subject to a few changes.
With respect to both the Guidance on Guide 62 and the Guidance on Guide 66, Mr Dalrymple raised the point that the references to ISO 19011 did not fully reflect the nature of that standard as a Guidelines document addressing a wider range of auditing than that needed in support of third part certification of the registration for QMS, EMS etc. He proposed changes to each of the references to ISO 19011.
After discussion, it was agreed to adopt these changes in a simplified form for inclusion in the documents proposed for publication.
In parallel, Mr Dalrymple would lead a WG to examine ISO 19011 and determine what material from the standards should be made requirements for QMS and EMS certification/registration bodies. This work should be done within the year during which the revised Guidance would enter into force.
The team would consist of Mr Dalrymple, Mr Saelzle, Mr Thione, Mr Keeling, an ENAC representative, an IIOC representative.
(Action: Mr Dalrymple)
In the meantime Mr Brockway would prepare the Guidance documents on Guides 62 and 66 for publication, and would also prepare a revision of the Guidance document on Guide 61 making similar reference to the use of ISO 19011 as had been agreed for the other documents.
(Action: Mr Brockway)
In addition to putting clean versions of the approved documents on the IAF web, Mr Brockway would send members of the TC versions of the documents showing the changes from the currently approved versions.
(Action: Mr Brockway)
The transition for implementation of all the documents would be one year from publication.
Note: It was confirmed during the discussion on ISO 19011 that in the third party certification/registration situation, the “audit client” is the certification/registration body that commissioned the team.
6. Progress Reports
6.1 Product Certification (TC/42/03 and TC/42/03a)
Members discussed Mr Egner’s letter in paper TC/42/03 and those on the Task Force maintained that they were unaware of any movement from within the Task Force to prevent the Guidance addressing the certification of processes and services. They maintained that good work had been done to update the guidance with respect to “conventional” product certification, but that discussions on processes and services had not led to the development of new material. However, those present felt that the issues having been discussed, it was possible and appropriate to provide some form of guidance on these topics to add to the current draft.
Members thought, that while it was desirable to publish the material already produced, an effort should be made to provide guidance on these aspects of the subject, particularly given the discussions that had taken place, and given that process certification would be important for the extension of the IAF MLA into the field of product certification through the GFSI food safety certification programme.
It was agreed that Mr Egner should be invited to reconvene the Task Force soon to make an attempt to complete the document with the available guidance on these subjects as soon as possible.
(Action: Mr Brockway, Mr Egner)
6.2 Certification of Persons (TC/43/03)
Mr Kronvall introduced the document that he had modified in response to about 80 comments received from members of the Technical Committee. Further minor amendments were made to the document and it was then agreed that it should be recommended for approval by IAF members in a 60 day ballot.
(Action: Mr Brockway)
6.3 Inspection
Members noted progress in the joint WG with ILAC, in particular agreement on how to deal with the impartiality of Type A inspection bodies. It was agreed that IAF would not re-open the content of the document agreed in the JWG, but would recommend it for approval by IAF members in a 60-day ballot. (Action: Mr Brockway)
6.4 Computer Assisted Audit Techniques (TC/23/03)
Members noted the report and the subsequent recommendation that the subject be considered at this stage as part of the new “WDI” project.
6.5 ISO 9001 Advisory Group (TC/24/03)
The report was noted.
6.6 Transition to ISO 9001:2000 (TC/25/03 and TC/50/03)
After much discussion, during which there was no dissention over the decision to confirm 15 December 2003 as the final date for accredited certification to ISO 9001/2/3:1994, the text of a simple Communiqué was developed for IAF to issue.
The discussion covered how CRBs might manage the certification/registration of any organisations who were working towards the new standard, but could not achieve certification/registration before 15 December. Members agreed that CRBs were likely to be able to justify bringing such organisations back into accredited certification as and when they could demonstrate conformity with the new standard, without having to undergo full new assessment as if they were a new customer, on the grounds of having maintained the working relationship, including routine surveillance, with such organisations over a continuous period.
6.7 Good Auditing Practice (TC/26/03)
Report noted.
6.8 Temporary Sites (TC/44/03)
Mr Keeling introduced the paper developed by his WG. Mr Sutherland suggested that the Guidance appeared to be too detailed for the subject, noting that the variety of auditing situations addressed may well need a variety of options. Nevertheless, members thought that it would be useful to develop the Guidance for consideration as part of the Guidance on both Guide 62 and Guide 66.
Members were asked to provide Mr Keeling with comments on the documents by 31 October.
(Action: Members)
6.9 Witness Assessments
Item deferred.
6.10 Accreditation Scopes (TC/45/03)
Item deferred.
7. Liaisons
7.1 ISO CASCO WG21-CD 17021 (TC/27/03)
Noted.
7.2 ISO CASCO WG23-Common Elements (TC/28/03)
Noted.
7.3 ISO CASCO Other-ISO/IEC 17011 Project (TC/49/03)
Noted.
7.4 ISO TC 176/SC 2/WG 18/TG 1.15
No report.
7.5 ISO TC 207 WG5 (TC/46/03)
Noted.
7.6 Other
8. Overview of Implementation of IAF Guidance Documents
8.1 Product Details on ISO 9001 Certificates (TC/47/03 and TC/47/03a)
Item deferred.
8.2 Auditor Time: EMS/QMS Discrepancy of Off-site Time
Mr Brockway advised that commentators had asked why the QMS Guidance expected 90% of the auditor time to be on-site while the EMS expected 80% of the time to be on-site. It had been suggested that IAF harmonise these. However, members recalled that the EMS document allowed for more auditor time to be spent off-site on account of the time needed to manage the two-stage process (ie preparation of stage 2 following the findings of stage1).
It was also recalled that the 90% and 80% were never intended to mean that auditors were intended to spend only 10% or 20% of the on-site time performing off-site functions. There were many off-site functions associated with an audit that could take very variable lengths of time. The point of the 90% and 80% was to ensure that actual on-site auditing time should not be reduced because of time spent on non-auditing off-site functions such as preparation, reporting etc.
8.3 Auditor Time: Length of Day
Item deferred.
8.4 Guidance on G62, G.3.7.4 Applicability to Use of Words
Item deferred.
9. Miscellaneous
9.1 Discounting of Fees (TC/29/03)
There was agreement to the conclusion of Mr Keeling’s paper that ABs should not involve themselves in the commercial decisions of CBs so long as these do not undermine the certification/registration service.
9.2 Transition for ISO 13485:2003 Quality Systems for Medical Devices
It was noted that ISO TC 201 was recommending a three-year transition for upgrading current certifications in this field to certification to the new standard based on ISO 9001:2000. IAF needed confirmation from regulators that this would be the accepted approach before it could endorse this.
9.3 Maintaining the Distinction between Accreditation and Certification (TC/51/03)
While members supported the idea that IAF should affirm that accreditors should accredit and certifiers should certify and that these two services should not be mixed, a number of members thought it was difficult to write this down in terms of currently recognised definitions. It would be preferable to simplify the text. In the end, however, it was decided to propose the text to IAF for approval, limiting the intent of the resolution to IAF “not endorsing” the provision by either type of body of the other’s services.
10. EMS
10.1 Transition for New ISO 14001
Item deferred until the final text and proposed date of publication of the new standard are known.
10.2 Guide 66 – Checking Regulatory Compliance (TC/30/03 and TC/48/03)
Mr Brockway noted that there were criticisms of the certification/registration of EMSs in a number of countries. Part of this was because ISO 14001 was now well established enough for it to be relatively easy for people to measure the performance of such companies against other companies. This could lead to examples where ISO 14001 certified/registered companied could be seen to “perform less well” than other companies.
Mr Brockway maintained that this was a problem inherent in EMS certification/registration. The goal being to improve the environmental performance of companies where that would provide maximum benefit to the overall environment. In other words, not necessarily the best performers.
The particular problem highlighted about EMSs was the accusation that a certified/registered EMS does not necessarily result in “regulatory compliance”. If judged against this single criterion, certified/registered EMSs could be seen as failing.
Members agreed that it would be beneficial to make another attempt to manage the expectations of the market, and in particular o regulators, in explaining how EMSs contribute to improvement, including the consistent achievement of regulatory compliance, while a lapse in regulatory compliance may not in itself be cause for withdrawing certification/registration.