9104-1 Rewrite Team Report to the RMC RMC Annual Meeting 2008 23 January 2008
Project Description • Justification of 9104-1Project • The rewrite of 9104 is the last step in development of the “Trilogy” series of documents. • The Trilogy will complete the commitment the IAQG and the sectors made to the authorities for a command media package describing the entire process. • The 9104-1 project would be initiated after the publication of 9104-2 and 9104-3. Documents 9104-2 & 9104-3 were published in mid-2007. • The 9104-1 will further define ‘controversial’ or ‘confusing’ text in the existing document, and will add new chapters defining roles of OASIS, resolutions, feedback process, sector management, etc.
9104-1 Team Member Attendance Attended Sent Regrets
Existing Topics(For Revision Into 9104-1) • Multi-site requirements interpretation • Multi-site definition (& expectations) • Sampling • Surveillance requirements • Multi-site frequency • Define OASIS authority, responsibility, accountability • Improvement process • Use and acceptability of Resolutions, process for • OPMT level and sector level • Exact wording for existing resolutions (approx 20+)
New Topics(For Inclusion Into 9104-1) • OPMT Charter – Rules of operation (OPMT 101, etc.) • Client/Supplier Responsibilities • IAQG Member Responsibilities • Use of process flows to improve the structure • Suspensions and withdrawals of CBs, ABs, etc. • Incorporate ISO17011, ISO17021, ISO17024, ISO19011, & IAF Documents • Process for funding and expenditures of ICOP activities • Cross sector activities (auditing, recognition, training, oversight etc.) • Feedback Process
Rescheduled Late Completed Programme Schedule Key-
9104-1 Table of Contents / Book Bosses • 9104-1 Standard Mike R • ForewordMike R • ScopeRick D, Tim L, Vince M, Gualtiero A • ReferencesTim L, Ian F, Hans L • Definitions tbd – wait until last Patrice B • General tbd – wait until last Patrice B • Requirements for Accreditation BodiesIan F, Lori S-G, Gualtiero A*, Mike G • Requirements for Certification BodiesTim L, Reg B, Ian F, Hans L • Auditors (reference to 9104-3) Gualtiero A w/ sector lead review • Requirements for Assessment and ReportingRick D, Tim L, Tamaki N, Herbert M, Ian F, Reg B • - 9101 reference Hans L • - Multisite Rick D, Vince M, Ian F, Reg B • Oversight (reference to 9104-2) Tamaki N, Tim L • OASIS DatabaseHans L, Jay M, Mike R • OPMTRick D, First name listed is Book Boss for that section.
9104-1 Table of Contents / Book Bosses • Feedback ProcessHans L • Sector Management StructureTim L, Tamaki N, Herbert M • Cross FrontierIan F, Reg B, Tim L, Tamaki N, Herbert M • RecordsTim L • Fees and FinancialsMike R • Responsibilities – (Note: 11. OPMT, tbd • 13. SMS, and 14. Cross Frontier • may be grouped into this chapter. Will • include OASIS responsibilities) • Notes tbd • Appendix A – Information for OASIS DatabaseHans L, Reg B • Appendix B – Change Procedure for OASISHans L • Appendix C – Process FlowsReg B First name listed is Book Boss for that section.
Next Steps(30 – 90 Days) Next Steps • Complete Outline / Table of Contents (Completed 12/19/07) • Assign Book Boss / Section Leads (Completed 12/19/07) • Last call of new/revised topics (Completed 1/15/2008) • Resolve wording of resolutions (OPMT action) • Resolve wording of multisite (OPMT action and SMS actions) • Establish conference calls between sectors & team members to discuss any unresolved issues. (At discretion of chapter Book Boss) Scheduled Milestones • All Drafts – complete and due March 26, 2008 (Sent to Mike R for coordination into review document for Naples 9104-1 face-to-face meeting) • Face to Face Meeting – at IAQG meeting in Naples (Team to review draft – discuss issues – assign actions – plan next activities)
Next Meetings Next Meeting Tuesday, Feb 26 – Telecon Future Meetings Tuesday, Mar 25 – Telecon Tuesday, Apr 8 – Face-face Naples, Italy 8:00am-12noon Same room as OPMT