MODULE B - PROCESS

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
CHANGE
SLIDE
DATE
Changed Codes and Standards Board of Directors
to Council on Standards and Certification
throughout.
11/22/10
3
B8. International Standards Development
4
OBJECTIVES

• This submodule will
• Describe the multiple paths to international
  standardization.

5
AGENDA

• ASME International Standards
• Normative References
• U.S. National Adoption of ISO Standards
• ISO Adoption of ASME Standards
• ISO Standards Development

6
I. ASME International Standards
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

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

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

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.

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.

12
II. Normative References
13
NORMATIVE REFERENCES

• Approach
• Incorporate normative reference to ASME Standard
  in ISO Standard
• Example
• B31.3 Process Piping Code referenced in ISO
  156492001, 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
III. U.S. National Adoption of ISO Standards
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

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

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

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? _____
19
IV. ISO Adoption of ASME Standards
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.

21
POP QUIZ 2
True or False. All standards recognized and used
internationally are ISO Standards. _______
22
V. ISO STANDARDS DEVELOPMENT
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.

24
ISO ORGANIZATION
25
ISO ORGANIZATION

• Technical Management Board (TMB)
• Manages ISOs 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
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
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

28
ISO ORGANIZATION

• Subcommittee
• Responsible for a specific aspect of a TCs
  responsibility
• P and O members only
• Parent TC appoints Secretariat
• NOTE A countrys
• 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
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
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

31
OTHER ISO PUBLICATIONS

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

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

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

34
ISO STANDARDS DEVELOPMENT

• Stages of Development Process
• Proposal
• Preparatory
• Committee
• Enquiry
• Approval
• Publication

(contd)
35
ISO STANDARDS DEVELOPMENT

• Development process

1. Proposal
New Work (NP)
Vote by TC or SC
New Work Item Proposal (NP)
ACCEPTED
(contd)
36
ISO STANDARDS DEVELOPMENT

• Development process (contd)

2. Preparatory
Working Draft (WD)
Proposal Drafted
New Work (NP)
ACCEPTED
(contd)
37
ISO STANDARDS DEVELOPMENT

• Development process (contd)

3. Committee
Draft International Standard (DIS)
TC or SC Comments or Letter Ballot
(contd)
38
ISO STANDARDS DEVELOPMENT

• Development process (contd)

4. Enquiry
Letter Ballot
Final Draft International Standard (FDIS)
(contd)
39
ISO STANDARDS DEVELOPMENT

• Development process (contd)

5. Approval
International Standard (IS)
Yes/No Vote
(contd)
40
ISO STANDARDS DEVELOPMENT

• Development process (contd)

5. Approval
6. Publication
Final Draft International Standard (FDIS)
International Standard (IS)
Yes/No Vote
(contd)
41
POP QUIZ 5
The document used to propose a standards action
to an ISO Technical Committee is called a _____.
42
FAST TRACK DEVELOPMENT

• Development process

1. Proposal
Vote by TC or SC
Existing Standard (Draft International Standard)
New Work Item Proposal (NP)
Existing Standard
ACCEPTED FOR FAST TRACK
(contd)
43
FAST TRACK DEVELOPMENT

• Development process (contd)

5. Approval
4. Enquiry
Yes/No Vote
International Standard (IS)
Letter Ballot
Final Draft International Standard (FDIS)
Existing Standard (Draft International Standard)
ACCEPTED FOR FAST TRACK
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

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

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)

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

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 TAGs

49
TAG PROCEDURES

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

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

51
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
SUBMITTING A U.S. POSITION

• Step 2 Submitting the position to ISO

ISO Secretariat
ANSI
Technical Advisory Group (TAG)
TAG Position
U.S. Ballot
53
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 ANSIs Guide for U.S. Delegates to ISO
  Meetings.

54
SUMMARY

• ASME International Standards
• Normative References
• U.S. National Adoption of ISO Standards
• ISO Adoption of ASME Standards
• ISO Standards Development

55
REFERENCES

• Codes and Standards Policy CSP-4, International
  Standardization
• http//cstools.asme.org/csconnect/CommitteePages.c
  fm?CommitteeA01000000Action7609
• Operating Procedures for ASME Administered U.S.
  Technical Advisory Groups for ISO Activities
• http//cstools.asme.org/csconnect/pdf/CommitteFile
  s/21386.pdf
• ANSI Procedures for U.S. Participation in the
  International Standards Activities of the ISO
• http//public.ansi.org/ansionline/Documents/Standa
  rds20Activities/International20Standardization/
  ISO/intl0504.doc
• ANSI Guide for U.S. Delegates to IEC and ISO
  Meetings
• ISO Directives
• ISO Templates
• Vienna Agreement
• Available on CS Web site at
  http//www.asme.org/Codes/About/Links/Links_Codes
  _Standards.cfm