IAF Technical Committee

Draft Minutes of the IAF Technical Committee Meeting

Held 15-16October 2009 in Vancouver

1. Welcomes and Apologies

Mr. Dougherty called the meeting to order and thanked CALA for hosting and providing arrangements and facilities for the meeting and for making meeting documents available online.

Those in attendance introduced themselves, and a registration list was circulated for verification of information. (A list of those who attendedthe meeting follows.)

Mr. Dougherty noted the death of Tim Inman and the retirements of Lorenzo Thione from SINCERT and Gro Rodland from Norwegian Accreditation. He said Cecille Gillard Kaplan was no longer representing GFSI, and her successor, Kevin Swoffer, was unable to attend the meeting because of a death in the family. He welcomed back Trevor Nash and welcomed James Galloway, the new chief executive of JAS-ANZ. He also welcomed Jan Welch of U.S. FDA and Bill Burr of CSA International as guests of the Technical Committee (TC).

Mr. Dougherty said his term as chair of the TC had begun in Vancouver and was to endwith this meeting. He recognized Ms. Gamaché for her support as TC secretary during his tenure as chair. He also thanked Ms. Brough-Kerrebyn for serving as vice chair. He introduced Mr. Borzek as his successor as chair of the TC following the conclusion of this meeting.

2. Agenda and Objectives of Meeting (TC-44-09rev4)

Meeting papers had been e-mailed and posted on the meeting site. Additional papers submittedduring the meeting (numbered TC-78-09 and up) are included with these minutes.

3. Minutes of 03-04 March 2009 Meeting in Mumbai (TC-41-09rev1)

Ms. Gamachésaid revisions had been made to the Mumbia meeting minutes in TC-41-09rev1, which was circulated prior to this meeting.As no additional concerns were raised during theVancouver meeting, they were accepted as the approved minutes of the Mumbai meeting.

3.1. Log of Key IAF TC Decisions (TC-02-09rev1, TC-78-09)

Mr. Borzeksaidhe had tried to evaluate TC decisions appropriate for publication and presented a number of decisions for publication in TC-78-09. He asked that members review the coding he proposed and if approved they will relate to publishing TC decisions on the public portion of the IAF site.

4. Standing Groups Progress Reports

4.1. WG for ISO/IEC 17024 (TC-85-09)

Dr. Swift reported on the WG meeting in Vancouver. The WG has always felt that the framework MLA is a necessary foundation but is moving to looking at criteria for schemes. The rationale for schemes is that although the framework MLA process promotes some standardization in accreditation practices, it will not provide assurance that the output (competencies of the certified person) is equivalent and does not facilitate cross border acceptance of the certification body or certified person. An IAF scheme should identify validated competencies by three or more countries, standardize mechanisms to measure competencies, and alleviate the AB from reviewing the validated scheme.

The WG examined what the process would be for a scheme and concluded personnel certification may fit in with PL3. There are Issues with PL3, however: It is designed for industry programs and lacks the specificity needed for approving schemes for persons; IAF would not be involved in the design of a scheme for persons; and an IAF committee would review the scheme to determine if it meets specific pre-determined criteria.

Mr. Jianhua said the current IAF policy for expanding the scope of the MLA defines the general criteria for a scheme to be included in the scope of an MLA.

Mr. Swift said it would be good if the document on scheme criteria could be put forward for comment by the TC. The TC would provide technical review of the criteria and the MLAC would specify the peer evaluation process.Mr. Dougherty said because it had been so long since an MLA was created, the Executive Committee (EC) recognized in Mumbai that PL3 needed to be updated because a process was lacking. The EC recognizes the need to expand its thinking on the types of documents to be published. Mr. Borzek said the EA has a process for endorsed schemes that could be taken into consideration.

Mr. Dougherty said decision was taken in Mumbai to separate definitions of critical locations and definitions of key activities from A5 in the interest of making progress. Voting by IAF and ILAC is needed because A5 is a joint document, regardless of there being portions that do not apply at all for ILAC.

Action item: There was consensus to circulate for 60-day comment to the TC the scheme criteria developed by the WG for ISO/IEC 17024.

Action item:There was consensus to circulate for concurrent 60-day comment by IAF and ILAC the definitions of key activities for accreditation of certifiers of personsdeveloped by the WG for ISO/IEC 17024 for inclusion in A5.

Action item: There was consensus to circulate for concurrent 60-day comment by IAF and ILAC the competencies for AB assessor teams developed by the WG for ISO/IEC 17024 for inclusion in A5.

4.2. WG for PEFC

4.2.1. PEFC-IAF Requirements for Chain of Custody (TC-70-09rev1)

Ms. Rantanensaid the WG had met twice since the Mumbai meeting. The main task of working with PEFC to publish a joint guidance document for chain of custody(COC) for CBs is close to completion. It will be a mandatory document and a joint document of IAF and PEFC. A new revision of the PEFC COC standard will be approved in November 2009. The WG will delay voting on the joint document to be able to include new standard, which is not expected to have any effect on the content of the guidance. The WG considered changing the name from PEFC to a more general name and began drafting terms of reference. It is hoped major efforts can be completed this year and any minor issues by the next meeting of the TC.

4.3. WG for ISO/IEC 20000

4.3.1 IAF Document on the Application of ISO/IEC 20000 (TC-45-09rev1, TC-46-09)

Mr. Nonaka, the new convener of the WG, said the WD2 document had been reviewed and comments discussed at the meeting in Vancouver. The WG agreed to make a WD4 because the title was changed to IAF MD on the Application of ISO/IEC 17021:2006 in the Information Technology Service Management Sector. Some requirements from ISO/IEC 27006 still used Guide 62 wording. After specific requirements for competence of ISO/IEC 20000 certification auditors are discussed, it will be amended. The document will be finalized after the next meeting in Rio de Janeiroand circulated to TC members for comment and then to IAF members.

4.4. WG for Product Certification Accreditation (TC-83-09)

Mr. Moliski said the group had met earlier in the week. They expressed concern about the difficulty of navigating documents on the IAF site.The discussion paper on clause 15 of ISO/IEC Guide 65 was discussed (see agenda item 12.7, below). There was some question as to how interpretations should be handled, and Mr. Dougherty said any question about a standard will be referred to ISO/CASCO now that ISO/CASCO has a process.

The WG encouraged comments on the committee draft of ISO/IEC 17065. Redrafting of GD 5 will be considered after ISO/IEC 17065 is published. There was discussion about how different ABs treat errors determined to be the result of human error or simple mistakes. Mr. Ezrakhovich recommended that AAPG draft a paper on how to write non-conformances.The WG confirmed that product certification should not be included in GD 3.

Mr. Moliski asked the TC to name him a liaison to CASCO WG 32, which is revising ISO/IEC Guide 67 for publication as ISO/IEC 17067).

Action item: There was consensus that Mr. Moliski would serve as an IAF TC liaison to CASCO WG 32.

4.4.1. GFSI

Mr. Swoffer was unable to attend the TC meeting to provide a report.

4.5. WG on ISO 13485 QMS for Medical Devices

4.5.1. IAF Document for Medical Device Conformity Assessment Scheme (MDCAS)

Mr. Ramaley said the WG had completed its documents for comment. The WG created a document to help the medical device community make sense of it all (TC-80-09 shows the cover of the document). It is hoped the ISO 13485 IAF MDCAS document will be used universally as a mandatory requirement. Mr. Dougherty clarified that the WG had been working since the San Franciscomeeting to develop essentially a scheme for the consistent application of ISO 13485 and also Global Harmonization Task Force (GHTF) documents. He suggested a 60-day comment period for TC members as the document is not like most IAF publications. It is one cohesive document describing a global scheme for international conformity assessment of medical devices with IAF in some sense the scheme owner. The informative document describes how the MDCAS works, its constituents, and how it is expected to be used, and there are additional requirements for ABs and CABs to comply with. ABs were encouraged to involve experts on medical devices in reviewing the document.

Action item: There was consensus to circulate the MDCAS documentsto the TC for 60-day comment.

4.5.2. FDA Presentation

Mr. Ramaley introduced Jan Welch of the U.S. Food and Drug Administration (FDA). Ms. Welch saidFDA is looking at ISO 13485 and global harmonization. With only 2,000 auditors (which FDA calls investigators) for medical devices, FDA needs a lot of help because it is unable to visit all the medical device manufacturers and do all of the work needed. FDA has been supportive of harmonization from the beginning and its quality system regulation is 95% harmonized with ISO 13485. FDA was involved in development of ISO 13485 and is closely monitoringthe next revision in anticipation of adopting, implementing, or recognizing – which would be a big step for government. The Food, Drug, and Cosmetic Act was modified recently to ask for voluntary submission of ISO 13485 reports.FDA has been using GHTF documents and partnering with other regulatory agencies. It works closely with Health Canada and has efforts with Australia. The goal of the new administrator at FDA is one inspection in which they can have confidence.

4.6. WG on Food Safety Management Systems (TC-47-09, TC-82-09)

Ms. Sheehan said the WG held its second meeting in Vancouver. Work items from the first meeting included (1) sampling of categories to award accreditation scope, (2) assessor competence, (3) interpretation of ISO/TS 22003 requirements for multi-site certification (regarding sales offices), (4) inclusion of recall requirements in ISO 22000, (5) identification of technical competencies using Table B.2 of the ISO/IEC DIS 17021-2. The WG also discussed MLA documents and competence vs. qualifications.

4.7. WG on Greenhouse Gases

Mr. Shaw said since the last meeting of the WG, comments on CD1 14066, GHG competence requirements for verification and validation teams, had been consolidated and would be reviewed later in the week in Vancouver.

4.8. IAF-ILAC Joint Inspection Group

Ms. Rantanen said it was agreed that the JIG needs to nominate someone to report at TC meetingsbecause there are common areas of interest and Ms. Rantanen was nominated.

4.9. IEC/CAB-IAF Technical Panel

Mr. Dougherty said there would be a detailed report at the Joint General Assembly in Vancouver. The group was looking at disbanding and forming a new IAF-ILAC-IEC panel. IAF membership on the current panel has diminished owing to retirements and resignations.

4.10. ISO 9000 Advisory Group

Mr. Doughertysaid IAG had met earlier in the week. The focus continues to move from what is wrong with ISO 9001 certification to what is right. A brief survey was developed to interview top executives about what ISO 9001 certification is doing for their organizations. IAG decided to meet half of its scheduled time with the reengineering group, which has lost its convener (Dr. Thione) and was potentially to be disbanded. IAG may have its next meeting with the mirror committee in conjunction with TC meeting in Rio de Janeiro.

4.10. APG and AAPG

Mr. Ezrakhovich said APG has published about 35 papers in multiple languages. Mr. Balakrishnan agreed to serve as the IAF convener of APG and AAPG (replacing Dr. Thione). It was noted that IAF representation to APG and AAPG has been eroding and new, knowledgeable members are needed. Anyone active with ISO TC176 was encouraged to join, though membership in TC 176 is not required. Mr. Dougherty recognized Mr. Ezrakhovich for his ongoing contributions to APG and AAPG.

5. Projects – Work Program from Mumbai

5.1. Improving Accredited Certification (Reengineering) (TC-91-09)

Mr. Balakrishnansaid at the meeting the previous week, Mr. Kameyama made a presentation on Japanese initiatives for improving the credibility of accreditation. The future of the group was also discussed. As a result of the reengineering TF, four TFs wereestablished for specific issues and other issues are being handled within IAF. The sense was that TF had served its purpose but the kind of brainstorming done by the TF is still needed. It was recommended that a standing WG be established to discuss and monitor the credibility of accredited management systems certification and provide input to the TC from time to time.

Action item: There was consensus to discontinue the TF on improving accredited certification and to form a WG on management systems certification with Mr. Kameyama () and Mr. Savov () serving as co-conveners. Anyone interested in participating can send e-mail to the conveners and copy Mr. Borzek ().

5.2. Task Force on Sanctions (TC-48-09, TC-88-09)

Mr. Kameyama said the TF had met earlier in the week. There were 37 comments from 12 bodies on the first working draft of the IAF MD for harmonization of sanctions to be applied to CABs. The draft was amended as follows: (1) the introduction was expanded to explain the structure of the document; (2) section 3 on initiation of sanctions was revised to include sanctions could apply to applicant CBs as well as accredited CBs; (3) section 4 on sanctions available was expanded with regard to legal actions; (4) section 5 on specific harmonized sanctions was revised with regard to a CB deliberately violating accreditation rules; and (5) section 6 on communication includes a time frame (after any appeal decision). It was clarified that the communication element of the document applies only to two specific situations.

Action item:There was consensus to circulate the revised document to IAF members for 60-day comment, followed by a 30-day IAF ballot. It will also go to the co-conveners of the A series and the IAF-ILAC Joint Inspection Group (via e-mail to Mary Malmqvist) so they are aware of the document.

5.3. Task Force on Obtaining Feedback from End Users (TC-92-09)

Mr. Balakrishnan, serving as temporary convener, said the group had its second meeting in Vancouver and a draft AAPG paper was used as the basis of discussion. It was agreed that while feedback at all levels is important, the focus should be on the performance of certified organizations. Dr. Croft provided a brief about the UNIDO project and suggested the outcomes be used by the TF. The mechanism in ISO 9001 for monitoring customer perceptions does not seem to be working effectively. There was consensus to develop a draft document based on the AAPG paper for consideration with a focus on how ABs could obtain feedback from the users of certification, with output from the UNIDO to be considered when it is available.

The potential of moving the TF from the TC to the User Advisory Committee was discussed.It was noted the original intent was to publish an informative rather than mandatory document.

Mr. Dougherty noted that the documents on expected outcomes had been published on the IAF and ISO sites and it was necessary to get thedocuments into the hands of CB auditors, for whom they were intended.The IAF strategic plan also called on the TC to develop a plan to deploy the expected outcomes documents and to measure their impact.

Action item: There was consensus to form a TF to plan deployment of the expected outcomes documents within the accredited certification community. Dr. Croft () and Mr. Palmes () will serve as co-conveners.

5.4. Task Force on Indicators of CB Performance (TC-90-09)

Mr. Balakrishnan said after the first meeting inputs were sought from ABs and CBs about measures in place. Some ABs have processes to get information they consider essential for effective surveillance and CBs have some internal measures in place. The TF agreed the indicators should (1) be limited to four or five, (2) not be time-consuming or costly to attain, (3) include a rationale for how they are expected to improve effective monitoring, and (4) reflect a uniform approach among ABs so as not to be burdensome to CBs with multiple accreditations. It was decided that the paper should be mandatory.

The TF decided these could be considered as indicators: number of clients, number of auditors, audit duration (% deviation for audit-day tables), number of transfers accepted, and overdue audits.Another critical consideration is that results should factor into the AB’s oversight – that is, indicators suggesting good practices could result in reduced oversight and indicators suggesting bad practices could require additional oversight.

5.5. Task Force on Accreditation Market Surveillance (TC-49-09, TC-94-09)

Dr. Croft said output of the TF on expected outcomes was an input to this TF, and the work of the TF is expected to be a contentious. The mandate from Stockholm was “to potentially develop a document on validation assessments (that is, direct assessments by the AB of a certified organization) to determine the effectiveness of the certified management system.”

In Mumbai there was consensus to move forward with an informative document linked to ISO/IEC 17011. It would be one tool in the AB toolbox, not be used initially on a routine basis. Assessments would be short (typically a half day to one day), not a repeat of a CB audit, and focus on critical issues. They are intended for use by ABs but could be applied to other interested parties, including CBs, regulators, customers of certified organizations, and sector schemes (most of which do not have to ask permission to do a validation visit). The trigger mechanism could include market information received by the AB,CB, or other interested parties, such as a sudden increase in the number of certificates issued, complaints, negative market perceptions, unilateral intervention from regulators, or unlikely occurrences.

The outputs of the Vancouver meeting will be used as inputs to the UNIDO project to be tested/validated in early 2010. In Rio de Janeiro adraft document based on initial feedback from QuEST Forum and UNIDO experiences will be developed, and TF consensus on an informative document will be sought in October 2010 in hopes of publication by March 2011.

5.6. Document on Competence of Accreditation Assessors/Experts (TC-86-09, TC-87-09)