ans basic 0109

8/14/2019 ANS Basic 0109

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American National Standards Process Summary

Source: [email protected]

2009

mailto:[email protected]


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Mission

To enhance the global competitiveness of

U.S. business and the American quality of life by promoting and facilitating voluntary

consensus standards and conformity

assessment systems and ensuring their

integrity.

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ANSI is…ANSI is…

Only accreditor of U.S. Standards Developers

Only body that approves standards as American

National Standards (ANS)

Represents the US Internationally at ISO (International

Organization for Standardization)

Represents the US Internationally through its US

National Committee at the IEC (International

Electrotechnical Commission)

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ANS Governance BodiesANS Governance Bodies

Executive Standards Council (ExSC) Accredits American National Standards Developers

Accredits US Technical Advisory Groups (TAGs) to ISO

Oversees Accredited Standards Developer Audit Program

Maintains most ANSI procedures and policies

Hears appeals and considers complaints

Board of Standards Review (BSR) Approves American National Standards

Hears appeals and considers withdrawal requests

ANSI Appeals Board (AB)

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Standards Developer AccreditationStandards Developer Accreditation

Only ANSI-Accredited Standards Developers may submit their

standards through the American National Standard approval

process

ANSI-accreditation signifies that the standards developer iscommitted to an open, fair and time-tested consensus process that

benefits stakeholders and the American public

ANSI-Accredited Standards Developers are accredited to the

requirements contained in the ANSI Essential Requirements:

Due process requirements for American National Standards

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Benefits of Accreditation and ANSBenefits of Accreditation and ANS

approvalapproval

Hallmarks of the ANS Process Openness, due process, consensus by a balance of materially-

affected interests, consideration of views and objections Transparency of the process

Fundamental fairness - Ensures level playing field Minimizes some legal risks by requiring procedural

safeguards (re: antitrust, product liability/negligence, etc.) Government acceptability (e.g. National Technology

Transfer & Advancement Act of 1995) Accreditation is a prerequisite for the National Adoption of

an ISO or IEC standard as an ANS

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ANSI Accreditation RequirementsANSI Accreditation Requirements

A standards developer’s written procedures for the development and approval of proposed

American National Standards must meet ANSI due process and consensus requirements

1. Openness

2. Balance

Outreach to achieve balance is required

More than Standards Action only Discrete interest category definitions

2. Lack of Dominance

3. Public comment opportunity

4. Consideration of Views and Objections

5. Comment Resolution

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ANSI Accreditation RequirementsANSI Accreditation Requirements

7. Recirculation Opportunity:Unresolved objections and attempted resolution together with any

substantive changes since the last public review must be provided to allconsensus body members – whether each voted on the first ballot or not

7. Consensus Body Vote Tally:

If recirculation required, then final vote is a reconciliation of originalvote with recirculation vote: if a member did not vote on therecirculation, the original vote stands

7. Numerical Requirements for Consensus

8. Standards Developer Appeals Process

9. Policy for Retention of Evidence of Compliance

10. Compliance with ANSI’s Patent Policy

11. Compliance with ANSI’s Commercial Terms and Conditions Provisions

12. Interpretations and Metrics Policies

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Accreditation FeesAccreditation Fees

$3,000 Initial Application Fee

Annual National Assessment Fee – sliding scale in

2009 from $1,740 for 0-3 ANS to $30,325 for 2001+ Includes cost of periodic procedural audit (5 year

cycle)

If a developer has paid fewer than 5 NationalActivity Assessment Fees, then the cost of the initialaudit will be pro-rated

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Accreditation ProcessAccreditation Process

ProceduProcedu

resresReview of Due Process

Requirements

Apply

S t a n d

a r d s

A c t i o n

S t a n d a r d

s

A c t i o n S t a n

d a r d s

A c t i o n

Public Review

Accreditation

APPROVEDAPPROVED

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Maintenance of AccreditationMaintenance of Accreditation

Procedural audit typically once every 5 years

Submission of periodic compliance forms when ANSI’s

procedural requirements change

Typically an annual online survey issued in January Submission of procedural revisions for approval (reaccreditation

process: similar to steps in the accreditation process) Revisions must be submitted in strike-through underline format to

[email protected]

Payment of ANSI Membership/Maintenance of Accreditation

Dues

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Accredited Standards DevelopersAccredited Standards Developers

Currently there are about 220 ASDs

Developing standards in virtually all industry sectors

A few examples: medical devices, telecommunications, recordsmanagement, fire protection, welding, earth-moving machinery,information technology and interoperability, air-conditioning and refrigeration, electrical safety, sunglasses, bicycle helmets,boilers and pressure vessels, metalworking skills assessment,welding skills certification, nuclear equipment operator certification, certification of hazardous waste incinerator operators, etc.

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TheThe American National Standard American National Standard DesignationDesignation

Signifies that standards…

Are developed using fair, open process that ensures a

level playing field

Meet the needs of materially affected interests

Are voluntary – compliance is not required unlessadopted by regulation or statute

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Consensus…Consensus…

…means substantial agreement has beenreached by directly and materiallyaffected interests categories. This

signifies the concurrence of more than asimple majority, but not necessarilyunanimity. Consensus requires that allviews and objections be considered, and

that an effort be made toward theirresolution

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ANS ANS Approval ProcessApproval Process

Stage 1: PINS form to ANSI Announcement of project initiation PINS deliberation if claim of conflict or duplication is raised

Stage 2: Approval of draft Consensus body approves text of draft standard Must meet numerical requirements for consensus as described

in developer’s accredited procedures (e.g. approval by amajority of consensus body and 2/3 of those voting, etc.)

Stage 3: Public Review BSR-8 form initiates announcement in Standards Action.

Developer is also expected to announce in industry publications, etc. (multiple public reviews are possible)

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Stage 4: Comment resolution Public and consensus body member comments

Stage 5: Recirculation (if applicable) Unresolved negative comments from consensus body

members and public review commenters as well as an

attempt at resolution and any substantive changes to the

text, must be recirculated to the entire consensus body to

allow them to vote, reaffirm a vote or change a vote

Stage 6: Appeals at developer level

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Stage 7: Submittal to ANSI for approval Submittal of final standard for approval with evidence of

consensus (BSR-9 form)

Stage 8: Notification of decision by ANSI BSR Notification of final approval/disapproval issued via E-mail

and all those who appealed at the developer level have theright to file a procedural appeal with the ANSI BSR

Stage 9: Appeal at ANSI Hearing is scheduled if appeal is filed

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AppealsAppeals

Informal resolutions encouraged

Appeals to a developer: in accordance with accredited

procedures

Appeals to ANSI: Board of Standards Review (BSR) – ANS

Executive Standards Council (ExSC) – accreditation and

procedural compliance issues

Appeals Board – final level after the BSR or ExSC

appeal concludes

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Schedule Audit, AuditPreparation and

Data Collection

Conduct Audit

1) On site or Mail-In

2) Informal Post Audit Briefingfor On-site Audit

Post Audit

1) Develop Audit Report

2) Formal Post Audit Telecon

3) Transmit Audit Report

Audit Report and Audit

Response are Reviewed by

Audit Sub-Committee

Audit

Closed

Audit Discussed at

ExSC

Accreditation

Suspended or

Withdrawn or ASD

Disagrees withAudit Outcome

Audit

Closed

Appeal to ANSI

ExecutiveStandards

Council

Special

Audit

Audit Process – Summary FlowAudit Process – Summary Flow

Appeal

to ANSI AppealsBoard

Audit Remains Open

PendingReaccreditation

Developer complies

with ExSC requirements

and accreditation is

reinstated

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ANSI’s Standards Action ANSI’s Standards Action

www.ansi.org/standardsaction

Available freely to the public

Published every week

Includes national and international activity

Announces: PINS (project initiation notices); public review

periods for American National Standards: accreditations

and standards; and final approval decisions.

Announces meetings, all actions re: ANS; any proposed

revisions to ANSI procedural requirements, etc.

http://www.ansi.org/standardsaction

http://www.ansi.org/standardsaction

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Contacts:Contacts: Procedures & Standards AdministrationProcedures & Standards Administration

Ms. Anne Caldas, Senior Director, ANSI/PSA

Telephone: 212-642-4914

E-mail: [email protected]

Mr. Jim Thompson, Senior Manager, Standards Developer & U.S.

ISO/TAG Accreditation ProgramsTelephone: 212-642-4963


Mr. Jay Moskowitz, Director, ANSI Audit Program

Telephone: 212-642-8925E-mail: [email protected]









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Information SourcesInformation Sources

www.ansi.org

Public Library

Standards Action

Electronic Standards Store (ESS)www.NSSN.org


Training: www.standardslearn.org

http://www.ansi.org/

http://www.nssn.org/


http://www.standardslearn.org/

http://www.standardslearn.org/


http://www.nssn.org/

http://www.ansi.org/

ans basic 0109

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