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Winter 2009

Consensus Ballot Requirements and Procedures. Winter 2009. Objectives. Identify balloting stages and requirements Discuss the difference in how consensus is reached in HL7 and in TC 215 Identify steps to plan to remove balloting issues Discuss harmonized ballots between SDO’s.

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Winter 2009

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  1. Consensus Ballot Requirements and Procedures Winter 2009

  2. Objectives • Identify balloting stages and requirements • Discuss the difference in how consensus is reached in HL7 and in TC 215 • Identify steps to plan to remove balloting issues • Discuss harmonized ballots between SDO’s

  3. Strategic Plan of TC 215 • New business plan for ISO/TC 215 is being developed • Develop standards plus Adopt and Adapt standards • Consider all of the Agreements between ISO and other SDO’s (Standards Development Organization) • Harmonization with other Standards Development Organizations

  4. Beginning a Consensus Project • Drafting a new item • New topic that has not had standard development • Adoption of a Standard from another recognized Standards Body • Pilot Project and Partner SDO • Liaison A to TC 215 • Vienna Agreement with CEN TC 251 • Adapting work from another standards body • Harmonization of ongoing work using agreements between SDOs

  5. TC 215 Consensus Process • Comments with the NMB vote • Affirmative vote > comments are usual • Negative vote >comments are required • Negative comments > May but usually is NOT rescinded • Consensus achieved in each country prior to the NMB vote • All comments are required to be revised into the document, ISO editors will check to make sure

  6. Project Stages (default path) • TC secretariat ballot work: • Preliminary – preliminary work item • Proposal – new work item proposal • Preparatory – working draft (no vote – this is a working time for the work group) • Committee – committee draft • ISO/Central Secretariat • Enquiry – draft international standard • Approval – final draft international standard • Publication as an ISO deliverable

  7. Balloting in ISO/TC 215 • All ballots use the default path, unless an agreement has made changes in how the default path is applied to the ballot stage. • The specified agreement is used along with the default path to determine the ballot path for the specified document. • All TC ballots begin at the TC secretariat and move to the ISO/Central Secretariat

  8. Example: Vienna Agreement (VA) • New Item drafted • ISO initiated –ISO lead • CEN initiated –CEN lead • Form 4 checked to coordinate with CEN or ISO • VA initiated for the document • Balloting is Parallel (occurs together) • Implementation of the ballot stages depends on additional agreements • DIS ballot is most important for ISO TCs • FDIS ballot is most important for CEN TCs

  9. Preparation for the NWIP Ballot • Develop a draft document • Use the ISO template (Rice Model) • Outline acceptable, draft document preferred • Present the preliminary draft in the WG setting • Gain support of experts within the WG for the draft work item • Option • Send the draft for informal comments prior to the actual NWIP ballot

  10. Proposal and the NWIP Ballot • New work item proposal (NWIP) • Ready for first ballot within the Technical Committee • Scope, purpose, justification, references, liaisons have been defined (form 4) • Allowed responses (yes, no, abstain) • Comments are desired as this matures the document • Requirements to pass the NWIP ballot stage • 5 Participating (“P”) members must agree to name an expert • Majority of those “P” members voting, agreed to add the document to the TC 215 active body of work

  11. DIS Ballot Preparation • Document text must be in ISO Template OR in HTML format • Figures (for ISO format) • Each in a separate file • Each piece of the figure must be completely revisable • Completed comment table

  12. DIS Ballot Timelines • DIS ballot ISO/CS preparation time is 1 month • AFNOR and DIN have special arrangements with ISO/CS, they are allowed to choose to translate the document prior to DIS ballot preparation---Allowed time is 2 months • DIS ballot time is 5 months • Options: • ISO/TC 215 may agree to shorten the 5 month ballot time using a Executive Council resolution – All NMB’s would need to agree • Meeting announcement when results are needed may limit the additional translation time period.

  13. DIS Ballot Results • 2/3 of the “P” members voting must vote affirmative • Any negative votes must have technical comments, not just editorial • All “P” members voting, vote affirmative, document moves directly to publication (unless superseded by an agreement) • ANY negative vote means FDIS ballot is initiated

  14. FDIS/Publication • 2/3 of the “P” members voting must vote affirmative • Any negative votes must have technical comments • Comments at this stage are usually not revised into the document, but saved for the next version • ISO/CS has combined FDIS with Publication • Immediately post ballot, document is ready to go for publication • Document Proof's should be carefully checked as ISO editors have been know to make substantive changes.

  15. ISO Deliverable: TR • Technical Report • Informative only • For the Draft Technical Report (DTR) ballot a draft is required not an outline • DTR ballots are at the same level as a CD ballot • Does not require an NWIP ballot • Upon approval TR is published • Is not subject to automatic review, however all TCs are requested to set up a review process for all TRs published from the TC

  16. ISO Deliverable: TS • Technical Specification • NWIP ballot required • Revised document is then balloted as a draft technical specification • Both ballots are 3 months • Publication-upon approval TS is published • Must be reviewed after 3 years

  17. Time Frames for IS default path • Accelerated = 24 months • NWIP directly to DIS ballot • Publish in 24 months or less • Regular = 36 months (default) • CD stage up to 12 months • DIS up to 18 months • FDIS up to 30 months • Extended time frame = 48 months

  18. ISO/TC 215 Agreements • Vienna Agreement (ISO and CEN) • ISO agreements with SDOs ( ASTM and OASIS) • Liaison agreements at the TC level (Liaison A) • Special Agreements with ISO for the TC level • Partner SDO (IEEE) • Pilot Project (HL7) • Liaison Agreements at the WG level (Liaison D)

  19. References • ISO Directives 2008 • May be downloaded from the public part of the ISO web site • Information taken from: • Annex F • Target dates • Fast-track procedure • Figures • FAQ for graphics • Provision of texts and graphics in electronic form • ITSIG specification for the preparation of exchange of graphics

  20. Questions • Please contact: • Audrey E Dickerson, RN MS ISO/TC 215 Secretary adickerson@himss.org • Mike Kroll, TC secretary support mkroll@himss.org

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