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MODULE B - PROCESS

MODULE B - PROCESS. SUBMODULES B1. Organizational Structure B2. Standards Development: Roles and Responsibilities B3. Conformity Assessment: Roles and Responsibilities B4. Initiating Standards Projects B5. Consensus Process for Standards Development

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MODULE B - PROCESS

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  1. MODULE B - PROCESS SUBMODULES B1. Organizational Structure B2. Standards Development: Roles and Responsibilities B3. Conformity Assessment: Roles and Responsibilities B4. Initiating Standards Projects B5. Consensus Process for Standards Development B6. The Basics of Parliamentary Procedure B7. The Appeals Process B8. International Standards Development B9. ASME Conformity Assessment Programs B10. Performance Based Standards

  2. REVISIONS DATE SLIDE CHANGE 11/22/10 Changed “Codes and Standards Board of Directors” to “Council on Standards and Certification” throughout. ASME C&S Training Module B8

  3. B8. International Standards Development

  4. OBJECTIVES This submodule will • Describe the multiple paths to international standardization. ASME C&S Training Module B8

  5. AGENDA • ASME International Standards • Normative References • U.S. National Adoption of ISO Standards • ISO Adoption of ASME Standards • ISO Standards Development ASME C&S Training Module B8

  6. I. ASME International Standards ASME C&S Training Module B8

  7. WHAT MAKES A STANDARD “INTERNATIONAL”? • Criteria • A development process characterized by openness, transparency, international participation and due process (WTO principles) • A record of success in meeting or a potential to meet global marketplace and public safety needs • The ability to maintain technical relevance ASME C&S Training Module B8

  8. INTERNATIONAL STANDARDIZATION • ASME develops standards intended to meet needs of industries and governments on global basis • ASME standards developed under process that meets WTO principles for international standards development • To address global relevance, an ASME committee may take various approaches, including: • development of performance based and prescriptive standards as means of compliance with regulations or essential safety requirements; • normative or informative references to non-ASME international, regional, or national standards; and • national adoptions of non-ASME international standards ASME C&S Training Module B8

  9. ASME INTERNATIONAL STANDARDS • Some ASME codes and standards in international use • Boiler and Pressure Vessel Code (over 100 countries) • B31 Piping Codes • B16 Standards on Valves, Flanges, Fittings and Gaskets • Bioprocessing Equipment Standard ASME C&S Training Module B8

  10. ASME INTERNATIONAL STANDARDS • International Participation • Enhances international acceptance and use • Delegate position on ASME Committees • Represents recognized group of interested parties (e.g., individuals from a jurisdiction, professional society, trade organization, users group) • Represented group reviews/comments on work of committee or submits proposals • Group works in own country, in native language. • Delegate on standards committee has first consideration voting privilege on standards actions. ASME C&S Training Module B8

  11. ASME International Standards • International Participation – Alternative Models • B31.3 (Process Piping) International Review Group • Member of organization involved with process piping outside U.S. and Canada • Review and comment on balloted proposals • Advise committee of desirable changes to B31.3 • BPE (Bioprocessing Equipment) European Subcommittee • Review and comment on balloted proposals • Evaluates issues of concern for European industry • BPV (Boilers and Pressure Vessels) International Interest Review Group (IIRG) • Review and comment on balloted proposals • Representatives of national agencies that have accepted at least one section of ASME BPV Code as means of meeting regulatory requirements. ASME C&S Training Module B8

  12. II. Normative References ASME C&S Training Module B8

  13. NORMATIVE REFERENCES • Approach • Incorporate normative reference to ASME Standard in ISO Standard • Example • B31.3 Process Piping Code referenced in ISO 15649:2001, Petroleum and natural gas industries – Piping • Advantages • Maintain control of technical content • No need to exert the sometimes extensive effort in creating new standard • Users can continue to use familiar requirements ASME C&S Training Module B8

  14. III. U.S. National Adoption of ISO Standards ASME C&S Training Module B8

  15. U.S. NATIONAL ADOPTION • Definition • Adoption of ISO standard as American National standard • Reasons for U.S. national adoption • No ASME standard exists • ISO standard is the industry recognized standard ASME C&S Training Module B8

  16. U.S. NATIONAL ADOPTION • Procedure • Process ISO standard in accordance with ASME and ANSI procedures. • Withdraw or modify existing ASME standard. • Notes: • ANSI procedures allow for.. • Identical adoption (and expedited approval) • Modified adoption • ASME procedures require • Approval by appropriate Board and Council on Standards and Certification ASME C&S Training Module B8

  17. MODIFIED U.S. NATIONAL ADOPTION • Approaches and rationales • Process modified U.S. national adoption; add special U.S. requirements in appendix • Best when U.S. standard requires additions but no changes to ISO standard • Allows multinational companies to use same standards document both inside and outside U.S. • Process modified U.S. national adoption • When ISO standard needs technical changes for U.S. use ASME C&S Training Module B8

  18. POP QUIZ #1 A new ISO standard covering an area already covered in the U.S. by an existing ASME standard has rapidly become the standard of preference in much of the industry. The new standard does not address a couple of issues important in the U.S., but otherwise meets all U.S. needs. What action might ASME take to update its U.S. standard in a way that meets the needs of both domestic and multi-national companies? _____ ASME C&S Training Module B8

  19. IV. ISO Adoption of ASME Standards ASME C&S Training Module B8

  20. SUBMISSION OF ASME STANDARDS TO ISO • Rationale • Make the ASME standard recognized more internationally • The ISO Technical Committee has a stronger technical base • Requirements • Obtain approval of • Consensus committee • Appropriate Board • Council on Standards and Certification • Submit as New Work Item proposal • Use ISO format (ISO template) • NOTE: With this option the U.S. would lose control over the technical content in the resulting ISO standard. ASME C&S Training Module B8

  21. POP QUIZ #2 True or False. All standards recognized and used internationally are ISO Standards. _______ ASME C&S Training Module B8

  22. V. ISO STANDARDS DEVELOPMENT ASME C&S Training Module B8

  23. INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) • Purpose • To facilitate the internationalization and unification of standards and related activities • Membership • 140 countries, each represented by a national standards body, each with one vote • ANSI is the U.S. member body • Official languages • English, French, Russian • Outputs • International standards, technical reports, etc. ASME C&S Training Module B8

  24. Technical Management Board (TMB) Technical Committee (TC) Subcommittee Working Group Ad Hoc Group ISO ORGANIZATION ASME C&S Training Module B8

  25. ISO ORGANIZATION • Technical Management Board (TMB) • Manages ISO’s technical activities and sets policy • 12 member countries • 4 permanent members • 8 rotating members Technical Management Board Technical Committee Subcommittee Working Group Ad Hoc Group ASME C&S Training Module B8

  26. ISO ORGANIZATION • Technical Committee (TC) • Responsible for a particular technical area, e.g Pipe Fittings • Membership: all countries • P = Participating (must vote) • O = Observer (may vote) • L = Liaison (no vote) • TMB appoints a national body to provide Chair and Secretariat Technical Management Board Technical Committee Subcommittee Working Group Ad Hoc Group ISO has more than 180 Technical Committees ASME C&S Training Module B8

  27. THE TC SECRETARIAT • Responsibilities • Provides administrative and technical support to the committee in accordance with ISO Directives • Examples: meeting arrangements, agendas, letter ballots • Works closely with ISO Central Secretariat • Must remain strictly neutral in its dealings NOTE: ASME is Secretariat for TC 5/SC 10 on Flanges; and TC 96/SC 6 on Mobile Cranes ASME C&S Training Module B8

  28. ISO ORGANIZATION • Subcommittee • Responsible for a specific aspect of a TC’s responsibility • P and O members only* • Parent TC appoints Secretariat *NOTE: A country’s Subcommittee membership category may differ from its TC category. Technical Management Board Technical Committee Subcommittee Working Group Ad Hoc Group ISO has close to 600 Subcommittees ASME C&S Training Module B8

  29. ISO ORGANIZATION • Working Group/Ad Hoc Group • Formed for single project • Collection of individually appointed experts Technical Management Board Technical Committee Subcommittee Working Group Ad Hoc Group ASME C&S Training Module B8

  30. ISO NORMATIVE PUBLICATIONS • International Standard • Requires approval of 2/3 of P-members with less than 1/4 of voting members dissenting • Five year review cycle • Technical Specification (TS) • Requires only 2/3 of P-members • Three year review cycle • Publicly Available Specification (PAS) • Requires only a simple majority • Three year review cycle ASME C&S Training Module B8

  31. OTHER ISO PUBLICATIONS • Technical Report (TR) • Provides information only • Industry Technical Agreement (ITA) • Results from international workshop • Provides information only ASME C&S Training Module B8

  32. POP QUIZ #3 Consensus for approval of an ISO Standard is developed by a _____ • Technical Management Board • Technical Committee • Subcommittee • Working Group • Ad Hoc Group ASME C&S Training Module B8

  33. POP QUIZ #4(Extra Credit) Which of the following ISO publications define standards or norms? _____ • International Standard • Industry Technical Agreement • Publicly Available Specification • Technical Report • Technical Specification ASME C&S Training Module B8

  34. ISO STANDARDS DEVELOPMENT • Stages of Development Process • Proposal • Preparatory • Committee • Enquiry • Approval • Publication (cont’d) ASME C&S Training Module B8

  35. ISO STANDARDS DEVELOPMENT • Development process 1. Proposal New Work (NP) New Work Item Proposal (NP) Vote by TC or SC ACCEPTED (cont’d) ASME C&S Training Module B8

  36. Submitted to Parent TC/SC ISO STANDARDS DEVELOPMENT • Development process (cont’d) 2. Preparatory New Work (NP) Proposal Drafted Working Draft (WD) ACCEPTED (cont’d) ASME C&S Training Module B8

  37. Submitted to Parent TC/SC Committee Draft (CD) ISO STANDARDS DEVELOPMENT • Development process (cont’d) 3. Committee TC or SC Comments or Letter Ballot Draft International Standard (DIS) (cont’d) ASME C&S Training Module B8

  38. Draft International Standard (DIS) ISO STANDARDS DEVELOPMENT • Development process (cont’d) 4. Enquiry Letter Ballot Final Draft International Standard (FDIS) (cont’d) ASME C&S Training Module B8

  39. Final Draft International Standard (FDIS) ISO STANDARDS DEVELOPMENT • Development process (cont’d) 5. Approval International Standard (IS) Yes/No Vote (cont’d) ASME C&S Training Module B8

  40. Standard Published ISO STANDARDS DEVELOPMENT • Development process (cont’d) 5. Approval 6. Publication Final Draft International Standard (FDIS) International Standard (IS) Yes/No Vote (cont’d) ASME C&S Training Module B8

  41. POP QUIZ #5 The document used to propose a standards action to an ISO Technical Committee is called a _____. ASME C&S Training Module B8

  42. FAST TRACK DEVELOPMENT • Development process 1. Proposal New Work Item Proposal (NP) Vote by TC or SC Existing Standard (Draft International Standard) Existing Standard ACCEPTED FOR FAST TRACK (cont’d) ASME C&S Training Module B8

  43. FAST TRACK DEVELOPMENT • Development process (cont’d) 4. Enquiry 5. Approval Existing Standard (Draft International Standard) Letter Ballot Final Draft International Standard (FDIS) Yes/No Vote International Standard (IS) ACCEPTED FOR FAST TRACK ASME C&S Training Module B8

  44. TECHNICAL ADVISORY GROUP (TAG) • Role • The means by which U.S. participates in ISO Technical Committees • Responsible for a specific technical area • ANSI accredits TAG • Scope of TAG typically matches that of a specific ISO committee or subcommittee • Prepares the U.S. position on issues • Represents U.S. at committee meetings ASME C&S Training Module B8

  45. TECHNICAL ADVISORY GROUP (TAG) • Specific Responsibilities • Determines the U.S. position on • ISO drafts out for ballot • ISO Technical Committee agenda items • Designates U.S. delegations • Initiates and approves U.S. proposals to TC for new work • Recommends the TAG membership ASME C&S Training Module B8

  46. TECHNICAL ADVISORY GROUP (TAG) • Membership • Open to all U.S. national interested parties (companies, technical and trade organizations, government agencies and individuals) • Balanced (no single interest category has majority) ASME C&S Training Module B8

  47. TAG ADMINISTRATION • TAG Administrator • Organization is accredited by ANSI to administer a TAG • Provides Chairman and administrative services in accordance with ANSI and ISO procedures • TAG Secretary • TAG Administrator “staff” • Duties include meeting arrangements and minutes, agendas, letter ballots, etc. • For ASME TAG, an ASME staff person ASME C&S Training Module B8

  48. TAG PROCEDURES • Requirements • Must be based on ANSI Model Operating Procedures • May include changes and additions • Possible additions: • ASME categories of interest • Things to consider when thinking of hosting an ISO meeting • Generic Procedures for ASME-administered TAG’s ASME C&S Training Module B8

  49. TAG PROCEDURES • Basic concepts • Openness • One member, one vote • Balance • All negatives considered • Appeals process ASME C&S Training Module B8

  50. POP QUIZ #6 Which of the following apply? U.S. Technical Advisory Groups administered by ASME shall: • Be balanced • Be a Standards Committee • Have a scope the same as the ISO activity • Be accredited by ANSI ASME C&S Training Module B8

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