MODULE B - PROCESS SUBMODULES B1.Organizational Structure B2.Standards Development: Roles and Responsibilities B3.Conformity Assessment: Roles and Responsibilities.

MODULE B - PROCESS

SUBMODULESB1. Organizational StructureB2. Standards Development: Roles and ResponsibilitiesB3. Conformity Assessment: Roles and ResponsibilitiesB4. Initiating Standards ProjectsB5. Consensus Process for Standards

DevelopmentB6. The Basics of Parliamentary ProcedureB7. The Appeals ProcessB8. International Standards DevelopmentB9. ASME Conformity Assessment ProgramsB10. Performance Based Standards

ASME C&S Training Module B8 2

REVISIONS

CHANGE SLIDEDATEChanged “Codes and Standards Board of Directors” to “Council on Standards and Certification” throughout.

11/22/10

B8. International Standards Development


OBJECTIVES

This submodule will– Describe the multiple paths to international

standardization.


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




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


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 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 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 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.




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




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


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


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


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? _____




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.


POP QUIZ #2

True or False. All standards recognized and used internationally are ISO Standards. _______


V. ISO STANDARDS DEVELOPMENT


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.


ISO ORGANIZATION

Technical Management Board (TMB)

Technical Committee (TC)

Subcommittee

Working Group Ad Hoc Group


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



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 Committee

Subcommittee



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


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 Committee

Subcommittee



ISO ORGANIZATION

• Working Group/Ad Hoc Group– Formed for single project– Collection of individually

appointed experts


Technical Committee

Subcommittee



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


OTHER ISO PUBLICATIONS

• Technical Report (TR)– Provides information only

• Industry Technical Agreement (ITA)– Results from international workshop– Provides information only


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 _____


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? _____


ISO STANDARDS DEVELOPMENT

• Stages of Development Process

1. Proposal

2. Preparatory

3. Committee

4. Enquiry

5. Approval

6. Publication

(cont’d)


New Work

(NP)

Vote by TC or SC ACCEPTED


• Development process

1. Proposal

New Work Item

Proposal (NP)

(cont’d)


Submitted to Parent

TC/SC


• Development process (cont’d)

2. Preparatory

Working Draft (WD)

Proposal Drafted

New Work

(NP)ACCEPTED

(cont’d)


Draft International

Standard(DIS)

TC or SC Comments

or Letter Ballot



3. Committee

Committee Draft (CD)

Submitted to Parent

TC/SC

(cont’d)




4. Enquiry

Final Draft International

Standard (FDIS)

Letter Ballot

Draft International

Standard (DIS)

(cont’d)




5. Approval


Standard (FDIS)

Yes/No Vote

International Standard

(IS)

(cont’d)




Standard Published

Yes/No Vote

5. Approval 6. Publication


Standard (FDIS)


(IS)

(cont’d)


POP QUIZ #5

The document used to propose a standards action to an ISO Technical Committee is called a _____.


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)


Yes/No Vote

5. Approval


(IS)Letter Ballot

Final DraftInternational

Standard (FDIS)

FAST TRACK DEVELOPMENT


4. Enquiry

Existing Standard

(Draft International

Standard)

ACCEPTED FOR FAST TRACK


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



• 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



• 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)


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


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


TAG PROCEDURES

• Basic concepts– Openness– One member, one vote– Balance– All negatives considered– Appeals process


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:


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


SUBMITTING A U.S. POSITION

• Step 2: Submitting the position to ISO

Technical Advisory

Group(TAG)

ISO Secretariat

ANSITAG

PositionU.S.

Ballot


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.


SUMMARY





V. ISO Standards Development


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%20Activities/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

MODULE B - PROCESS SUBMODULES B1.Organizational Structure B2.Standards Development: Roles and Responsibilities B3.Conformity Assessment: Roles and Responsibilities.

Documents

adoption of asme standards

standards committee

prescriptive standards

standards actions

global basis asme standards

asme codes

asme cs training module

asme committees