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. ASME C&S Training Module B8 1 REVISIONS CHANGESLIDEDATE Changed “Codes and Standards Board of Directors” to “Council on Standards and Certification” throughout. 11/22/10

3. B8. International Standards Development

4. ASME C&S Training Module B8 3 OBJECTIVES This submodule will –Describe the multiple paths to international standardization.

5. ASME C&S Training Module B8 4 AGENDA I.ASME International Standards II.Normative References III.U.S. National Adoption of ISO Standards IV.ISO Adoption of ASME Standards V.ISO Standards Development

6. ASME C&S Training Module B8 5 I. ASME International Standards

7. ASME C&S Training Module B8 6 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

8. ASME C&S Training Module B8 7 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

9. ASME C&S Training Module B8 8 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

10. ASME C&S Training Module B8 9 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.

11. ASME C&S Training Module B8 10 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.

12. ASME C&S Training Module B8 11 II. Normative References

13. ASME C&S Training Module B8 12 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

14. ASME C&S Training Module B8 13 III. U.S. National Adoption of ISO Standards

15. ASME C&S Training Module B8 14 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

16. ASME C&S Training Module B8 15 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

17. ASME C&S Training Module B8 16 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

18. ASME C&S Training Module B8 17 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? _____

19. ASME C&S Training Module B8 18 IV. ISO Adoption of ASME Standards

20. ASME C&S Training Module B8 19 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.

21. ASME C&S Training Module B8 20 POP QUIZ #2 True or False. All standards recognized and used internationally are ISO Standards. _______

22. ASME C&S Training Module B8 21 V. ISO STANDARDS DEVELOPMENT

23. ASME C&S Training Module B8 22 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.

24. ASME C&S Training Module B8 23 ISO ORGANIZATION Technical Management Board (TMB) Technical Committee (TC) Subcommittee Working GroupAd Hoc Group

25. ASME C&S Training Module B8 24 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 GroupAd Hoc Group

26. ASME C&S Training Module B8 25 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 ISO has more than 180 Technical Committees Technical Management Board Technical Committee Subcommittee Working GroupAd Hoc Group

27. ASME C&S Training Module B8 26 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

28. ASME C&S Training Module B8 27 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. ISO has close to 600 Subcommittees Technical Management Board Technical Committee Subcommittee Working GroupAd Hoc Group

29. ASME C&S Training Module B8 28 ISO ORGANIZATION Working Group/Ad Hoc Group –Formed for single project –Collection of individually appointed experts Technical Management Board Technical Committee Subcommittee Working GroupAd Hoc Group

30. ASME C&S Training Module B8 29 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

31. ASME C&S Training Module B8 30 OTHER ISO PUBLICATIONS Technical Report (TR) –Provides information only Industry Technical Agreement (ITA) –Results from international workshop –Provides information only

32. ASME C&S Training Module B8 31 POP QUIZ #3 a.Technical Management Board b.Technical Committee c.Subcommittee d.Working Group e.Ad Hoc Group Consensus for approval of an ISO Standard is developed by a _____

33. ASME C&S Training Module B8 32 POP QUIZ #4 (Extra Credit) a.International Standard b.Industry Technical Agreement c.Publicly Available Specification d.Technical Report e.Technical Specification Which of the following ISO publications define standards or norms? _____

34. ASME C&S Training Module B8 33 ISO STANDARDS DEVELOPMENT Stages of Development Process 1.Proposal 2.Preparatory 3.Committee 4.Enquiry 5.Approval 6.Publication (cont’d)

35. ASME C&S Training Module B8 34 New Work (NP) Vote by TC or SC ACCEPTED ISO STANDARDS DEVELOPMENT Development process 1. Proposal New Work Item Proposal (NP) (cont’d)

36. ASME C&S Training Module B8 35 Submitted to Parent TC/SC ISO STANDARDS DEVELOPMENT Development process (cont’d) 2. Preparatory Working Draft (WD) Proposal Drafted New Work (NP) ACCEPTED (cont’d)

37. ASME C&S Training Module B8 36 Draft International Standard (DIS) TC or SC Comments or Letter Ballot ISO STANDARDS DEVELOPMENT Development process (cont’d) 3. Committee Committee Draft (CD) Submitted to Parent TC/SC (cont’d)

38. ASME C&S Training Module B8 37 ISO STANDARDS DEVELOPMENT Development process (cont’d) 4. Enquiry Final Draft International Standard (FDIS) Letter Ballot Draft International Standard (DIS) (cont’d)

39. ASME C&S Training Module B8 38 ISO STANDARDS DEVELOPMENT Development process (cont’d) 5. Approval Final Draft International Standard (FDIS) Yes/No Vote International Standard (IS) (cont’d)

40. ASME C&S Training Module B8 39 ISO STANDARDS DEVELOPMENT Development process (cont’d) Standard Published Yes/No Vote 5. Approval6. Publication Final Draft International Standard (FDIS) International Standard (IS) (cont’d)

41. ASME C&S Training Module B8 40 POP QUIZ #5 The document used to propose a standards action to an ISO Technical Committee is called a _____.

42. ASME C&S Training Module B8 41 Vote by TC or SC Existing Standard (Draft International Standard) ACCEPTED FOR FAST TRACK FAST TRACK DEVELOPMENT Development process New Work Item Proposal (NP) 1. Proposal Existing Standard (cont’d)

43. ASME C&S Training Module B8 42 Yes/No Vote 5. Approval International Standard (IS) Letter Ballot Final Draft International Standard (FDIS) FAST TRACK DEVELOPMENT Development process (cont’d) 4. Enquiry Existing Standard (Draft International Standard) ACCEPTED FOR FAST TRACK

44. ASME C&S Training Module B8 43 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

45. ASME C&S Training Module B8 44 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

46. ASME C&S Training Module B8 45 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)

47. ASME C&S Training Module B8 46 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

48. ASME C&S Training Module B8 47 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

49. ASME C&S Training Module B8 48 TAG PROCEDURES Basic concepts –Openness –One member, one vote –Balance –All negatives considered –Appeals process

50. ASME C&S Training Module B8 49 POP QUIZ #6 a.Be balanced b.Be a Standards Committee c.Have a scope the same as the ISO activity d.Be accredited by ANSI Which of the following apply? U.S. Technical Advisory Groups administered by ASME shall:

51. ASME C&S Training Module B8 50 SUBMITTING A U.S. POSITION Step 1: Determining the consensus position –Option 1 (2 ballots needed) Draft sent to TAG for ballot Consolidated position prepared Consolidated position balloted –Option 2 (1 ballot needed) Draft sent to TAG for comment Project Team prepares proposed position Proposed position balloted

52. ASME C&S Training Module B8 51 SUBMITTING A U.S. POSITION Step 2: Submitting the position to ISO Technical Advisory Group (TAG) ISO Secretariat ANSI TAG Position U.S. Ballot

53. ASME C&S Training Module B8 52 EFFECTIVE ISO PARTICIPATION Guidelines/Considerations –Begin participation in early stages of draft development. –Consider being a Convener. –Study the ISO Directives (procedures). –Know how to use the ISO Template. –Review ANSI’s Guide for U.S. Delegates to ISO Meetings.

54. ASME C&S Training Module B8 53 SUMMARY I.ASME International Standards II.Normative References III.U.S. National Adoption of ISO Standards IV.ISO Adoption of ASME Standards V.ISO Standards Development

55. ASME C&S Training Module B8 54 REFERENCES –Codes and Standards Policy CSP-4, International Standardization http://cstools.asme.org/csconnect/CommitteePages.cfm? Committee=A01000000&Action=7609 –Operating Procedures for ASME Administered U.S. Technical Advisory Groups for ISO Activities http://cstools.asme.org/csconnect/pdf/CommitteFiles/21386.pdf –ANSI Procedures for U.S. Participation in the International Standards Activities of the ISO http://public.ansi.org/ansionline/Documents/Standards%20 Activities/International%20Standardization/ISO/intl0504.doc –ANSI Guide for U.S. Delegates to IEC and ISO Meetings* –ISO Directives* –ISO Templates* –Vienna Agreement* * Available on C&S Web site at http://www.asme.org/Codes/ About/Links/Links_Codes_Standards.cfm