1 overview of the u.s. standardization and conformity assessment systems overview of ansi and the...

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Overview of the U.S. Standardization and Conformity Assessment Systems

Overview of ANSI and the U.S. Standards System

2007 © ANSISlide 2

Overview of the U.S. Standardization and Conformity Assessment System

Importance of Standards

“The international language of commerce is Standards”

Source:

Donald L. Evans, Former U.S. Secretary of Commerce,

From Standards & Competitiveness: Coordinating for Results

2007 © ANSISlide 3


WTO/TBT Definitions*

Standard - Document that provides, for common and repeated use, rules, guidelines or characteristics for products or related processes and production methods, with which compliance is not mandatory. It may also include or deal exclusively with terminology, symbols, packaging, marking or labelling requirements as they apply to a product, process or production method.

Technical Regulations – Document which lays down product characteristics or their related processes and production methods, including the applicable administrative provisions, with which compliance is mandatory.

Conformity Assessment (Conformance) – Any procedure used, directly or indirectly, to determine that relevant requirements in technical regulations or standards are fulfilled. (e.g., testing, certification)

*World Trade Organization Technical Barriers to Trade Agreement, Annex 1http://www.wto.org/english/docs_e/legal_e/17-tbt_e.htm

2007 © ANSISlide 4


WTO/TBT Principles for the Development of International Standards*

Transparency Openness Impartiality and Consensus Effectiveness Coherence Development Dimension

*World Trade Organization Technical Barriers to Trade Agreement Second Triennial Review, Annex 4

http://docsonline.wto.org/DDFDocuments/t/G/TBT/9.doc

http://docsonline.wto.org/DDFDocuments/t/G/TBT/9.doc

2007 © ANSISlide 5


The ANSI Federation

2007 © ANSISlide 6


What is ANSI?

ANSI is the “Umbrella Organization” for and coordinator of the U.S. voluntary standards and conformity assessment systems.

Duties and responsibilities include: Develop and promote U.S. policies and positions Accredit SDOs and approve American National Standards (ANS) Accredit certifiers of products, personnel and management systems Provide standards and compliance solutions domestically and

internationally

2007 © ANSISlide 7


A Private- and Public-Sector Partnership Since 1918

ANSI is not a government agency or a standards developerANSI is not a government agency or a standards developer

• Academia • Individuals • Government • Manufacturing • Trade Associations

A Federation A Federation of members representing . . .of members representing . . .

• Professional Societies • Service Organizations • Standards Developers • Consumer and Labor Interests• and many more

What is ANSI?

2007 © ANSISlide 8


ANSI: A Private-Sector Organization

ANSI is an independent not-for-profit (501(c)3) organization.

ANSI does not receive government oversight or subsidization.

Advantages: Public and private sectors

are coequal partners Impartiality Market relevance

2007 © ANSISlide 9


ANSI’s Member-Driven Policy Development

Approach in the U.S.

Approach in many other countries

Standards Users

(e.g. regulators, companies, etc.)

National Standards Body (e.g. ANSI, SAC)

Standards Developers(Including Consortia)

ANSI’s strength comes through

effective representation

of member interests

Other National Standards

Bodies receive authority and

funding through legal mandate

2007 © ANSISlide 10


U.S. PRIVATESECTOR

U.S.-HeadquarteredSTANDARDS DEVELOPING

ORGANIZATIONS

FOREIGN NATIONALSTANDARDS BODIES(ANSI PEER BODIES)

Geneva-HeadquarteredSTANDARDSDEVELOPING

ORGANIZATIONS(ISO, IEC)

REGIONALSTANDARDIZATION

BODIES(COPANT, PASC, ESOs)

EUROPEANCOMMISSION

U.S. PUBLIC SECTOR

COMPANIES

TRADE ASSOCIATIONS

CONSUMER INTERESTS

OTHERS

U.S. GOVERNMENT




ANSI serves as the official U.S. member and sets policy for U.S. participation in the International Organization for Standardization (ISO) International Electrotechnical Commission (IEC) Pacific Area Standards Congress (PASC)

U.S. technical positions for ISO and IEC activities are developed by Technical Advisory Groups (US TAGs) Allows all affected parties (including U.S. government) to

participate in standardization activities

ANSI International Interaction (Standardization)

ISO / IECANSI & USTAGSU.S.



The U.S. Standards System



The U.S. System: Comparisons

Compared with many other countries, the U.S. system…

Emphasizes private-sector solutions to ensure quality and protect Environment, Health and Safety (EHS)

Places a higher degree of confidence in private-sector conformity assessment activities for regulatory and non-regulatory functions

Provides a stronger voice and greater authority to standards users and individual stakeholders

Relies on a strong judicial system, brand-name recognition, open media and corporate social responsibility

Is highly decentralized



The U.S. System: Benefits

Speed and flexibility – solutions are delivered to market and implemented quickly

Participation – able to accommodate input from a wide spectrum of stakeholders

Efficiency – prevents unnecessary or costly regulation and allows multiple approaches to ensure health, safety, and quality

The U.S. approach facilitates economic development and innovation



U.S. Regulatory Reliance on Voluntary Standards

U.S. regulators use voluntary standards to offset the need for additional regulations or to enhance existing regulations.

When regulations are necessary, U.S. regulators are required by law to use voluntary standards whenever possible.

When appropriate voluntary standards do not exist, regulators work in partnership with private-sector SDOs to develop suitable standards.



The U.S. System: A Toolbox

Rather than mandating a “one-size fits all” solution, the U.S. system allows players to find the tools and solutions that best fit their needs.

Approaches, philosophies and positions often vary across industry sectors. Such variations are seen as beneficial and are promoted in the “U.S. Standards Strategy.”



Standards Used in the U.S.: Different tools for different market needs

National Participation

• Treaty Organizations

• Non-Treaty Organizations

Direct Participation

• Nationally Accepted

• Internationally Accepted

Consortia

Examples

ISO, IEC, ITU, CODEX, etc.

Features Formality in process

One country, one vote

Examples

ASTM International, ASME, SAE, etc.

Features

Direct link between technical experts and SDOs

Examples

SNIA, W3C, IGRS, etc.

FeaturesWide range of processes and

procedures allows flexibility










Consortia

Examples


FeaturesFormality in process

One country, one vote

Examples


Features


Examples






Standards Used in the U.S.:National Participation

Treaty Organizations: U.S. government agencies serve as national bodies. For example: CODEX (U.S. Department of Agriculture) ITU (U.S. Department of State) OECD (U.S. Department of State)

Non-Treaty Organizations: ANSI Serves as national body and coordinates broad spectrum of private-sector input: International Organization for Standardization (ISO) International Electrotechnical Commission (IEC)










Consortia

Examples


Features

Formality in process through

“one country, one vote” system

Examples


Features


Examples

IGRS, SNIA, W3C, etc.

Features

Wide range of processes and




Standards Used in the U.S.:Accredited/Approved Standards

ANSI is responsible for accrediting SDOs and approving standards as “American National Standards.”

National and international SDOs voluntarily choose to receive ANSI accreditation/approval (the U.S. has no legal requirement)

Accreditation and approval do not guarantee U.S. market acceptance; individual users have complete freedom to choose which standards best suit their needs.

ANSI accreditation and approval processes do not evaluate a standard’s technical merit, but only evaluate the process by which a standard was developed.



Accredited/Approved Standards:ANSI Essential Requirements

Openness Transparency Consensus Due Process Balance

ANSI Accredited Standards Developing Organizations (SDOs)

3-A

AGMA

ASC X9 ASA ACCA

AH&LA AIHA AIAA

ASSE

BHMA

AWWA AWS AWEA

BICSI BOMA BIFMA

CSA

HPS

DISA DASMA EIMA

HFES HI IESNA

IIAR

NCMA

ISEA ISA ISANTA

NCSL NCPDP NECA

NASPO

SIA

NSF NIRMA OLA

SSFI SIA SMA

TMS SPI TCA TOY-TIA

AMCA

AISC

ARI ATIS AA

AITC AISI ALI

ATA

CCPA

ACMI ASIS AIIM

CSAA CAPA CLSI

EASA

ITSDF

EIA ESTA EIA

IEEE IEST IIE

IWCA

NEMA

IPC ISA JCSEE

NFPA NGA NGCMA

OPCC

SPRI

OEOSC OPEI PMMI

SBS SAE SCTE

TAPS TCIA TPI USDA

AAMA

ANS

AAMVA ABMA ABYC

ANLA API ASNT

AMT

CFPMI

NPES AAMI ACDE

CAP CPA CAGI

EOS/ESD

INMM

FCI FMGTEEM

C

12AMA IAF IAAMC

KCMA

NISO

LIA MSS MHI

NIMSNIST/ITL

NPPC

PSA

SMPTE

PCA PWMA PMI

SVIA SAAMI SES

USPRO UL UAMA UAMA

ABMA

ASQ

ACC ACI ADA

ASAE ASB ASCE

AHAM

CGA

ARMA ASTM AIM

CAM-I CEA CSPA

GICC

IAPMO

GEIA GEI HPVA

ICPA ICC ITI

MBC

NSC

NACENAHBR

CNAAMM

NSAA NADCA NERC

RPTIA

SDI

RSTC RVIA RESNA

SJI SSCI TIA

UCC VITA WQA WDMA

AFPA AGA

ASHRAE

ASME

AGRSS ALI

CEMA CTI

HIBCC HL7

NETA I3A

NBBPVI NBFAA

NAESB NALFA

RIA RMA

TCATA CI

WCMA WMMA










Consortia

Examples


FeaturesFormality in process through

“one country, one vote” system

Examples


Features


Examples






Standards Used in the U.S.:Consortia Standards

Consortia consist of groups of like-minded participants who place a priority on developing standards quickly enough to meet market demands or to harmonize or differentiate specifications within an industry.

Hundreds of consortia organizations operate in the global economy. Many have global membership, including both U.S. and international companies.

Consortia usually have a narrow focus, with some only developing a single specification. However, some consortia are very broad and develop a large number of standards (examples: W3C, OASIS, etc.)

Companies often rely on consortia standards in areas where the technology changes rapidly.



The U.S. Standards System

Private-Sector

Activities Carried out independent of the ANSI

Structure

Standards Developers

Trade Associations

Companies

Consumers

NGOs Academics

OthersGovernment

U.S. Policies and Positions

Government Agencies are members of ANSI and

of SDOs. Agencies participatedirectly in voluntary standards

development and policy setting and use

voluntary standards when it supports their missions

Government

Regulators

CPSC, EPA. FCC, USDA,

etc.

Procurement Agencies

DOD, NASA, USDA, etc.

NIST

NIST coordinates

Federal activities in voluntary

standards



The U.S. Conformity Assessment System

International Activities

Domestic Activities

Designating Authorities Accreditors

Testers, Inspectors & Certifiers SDOC

A2LA

FCC(Telecom)

USDA(Food)

ANSI (ANAB)

NIST (NVLAP)

EPA (ENLAP)

UL

Intertek

TUV

John Deere

HP

Includes accredited and non-accredited

bodies

IEC (IECEE, IECx, IECQ)

ISO (CASCO)

Other International Fora

U.S. Positions developed

through ANSI/USNC

IAF

ILAC

Other

ANSI

ABs

Other Generally manufacturers of

high-tech and low-volume products

No “official” U.S.

representative



Conformity Assessment (ISO/IEC 17011)

InspectionBodies

QMS/EMSCertifiers

PersonnelCertifiers

Standards Developing Organizations

and U.S. TAGs

ANSI Procedures

“EssentialRequirements”

Standards

ISO/

IEC

Guide

17025

ISO/

IEC

Guide

17020

ISO/

IEC

Guide

65

ISO/

IEC

Guide

17021

ISO/

IEC

Guide

17024

TestLabs

ProductCertifiers

Accreditation Programs

Various Programs

Various Programs



U.S. System

“The Drivers” Companies, Government

Agencies and other Standards Users

“The Vehicle” Standards

Developers & Conformity

Assessment Bodies

“The Road” ANSI



For more information:

Headquarters

1819 L Street, NW Sixth Floor Washington, DC 20036

Tel: +1 202.293.8020Fax: +1 202.293.9287

www.ansi.org | webstore.ansi.org | www.nssn.org

American National Standards Institute

Contacts Gary Kushnier

Vice President – International PolicyPhone: +1.202.331.3604E-mail: [email protected]

Steven BipesDirector – International PolicyRegional & Bilateral ProgramsPhone: +1.202.331.3607E-mail: [email protected]



Questions or Comments?



Additional slides



ANSI in Numbers

Revenue $25 million annual budget

Development of Standards 0% ($0.0m) Sale of Publications 50% ($12.5m) Membership Dues and Fees 20% ($5.0m) Accreditation Services 19% ($4.8m) Other 11% ($2.7m) Est. total public sector portion of all of the above 10% ($2.5m)

ISO/IEC Annual Dues $2.1 million Technical Committees of ANSI 0 Number of Standard Developing Organizations (SDOs) accredited by ANSI208 Technical Committees of ANSI’s SDO members 565 Number ANSI Standards Panels 5 Total number of American National Standards published 9,915 Estimated number of voluntary standards published in the U.S. 100,000 Number of voluntary standards referenced in U.S. laws & regulations over 6,000 Number of company interests represented by ANSI 125,000 Number of professionals represented by ANSI 3.5 million Year ANSI was established 1918

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ANSI accredited Personnel Certifiers

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ANSs(American National

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US Private & Government

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Trade Associations, Consumers,Educational Institutions,Individuals,

Others

NPC (Accreditation of Certifiers)

Non-ANS Standards

AIC

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A2

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AC

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Accredited Laboratories

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ITU Sector

Members

ITAC

Policy Technical (Accreditation

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* Institute policy committees& councils

SIM

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Standards Liaison

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DH

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WTO

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http://www.wto.org/

http://www.whitehouse.gov/government/cabinet.html

http://www.fao.org/

http://www.iso.org/

http://www.usda.gov/

http://www.forquality.org/


http://www.commerce.gov/

http://www.technology.gov/

http://www.ita.doc.gov/

http://www.nacla.net/

http://www.aplac.org/

http://www.ilac.org/

http://www.apec.org/apec/apec_groups/committees/committee_on_trade/sub-committee_on_standards.html

http://www.iso.org/

http://www.pri-network.org/


http://www.aplmf.org/index.shtml

http://www.bipm.org/

http://www.apmpweb.org/

http://www.oiml.org/

http://www.iasonline.org/

http://www.aiha.org/

http://iaac-accreditation.org/

http://www.iaf.nu/

http://www.jtc1.org/

http://www.iec.org/

http://www.copant.org/

http://www.apec-pac.org/

http://www.whitehouse.gov/

http://www.ustr.gov/

http://www.whitehouse.gov/omb/


http://www.asq.org/

http://www.ansi.org/conformity_assessment/accreditation_programs/accreditation_certification_programs.aspx?menuid=4

http://www.ansi.org/conformity_assessment/personnel_certification/overview.aspx?menuid=4

http://www.ansi.org/standards_activities/domestic_programs/overview.aspx?menuid=3

http://webstore.ansi.org/

http://www.anab.org/

http://www.a2la.org/

http://www.aclasscorp.com/

http://www.itu.int/cgi-bin/htsh/mm/scripts/mm.list?_search=1&_languageid=1&_search_countryid=244&_country=United%20States%20of%20America

http://www.state.gov/e/eb/adcom/c668.htm

http://www.apmpweb.org/

http://www.nist.gov/

http://www.state.gov/

http://www.export.gov/comm_svc/

http://www.mac.doc.gov/

http://www.ita.doc.gov/td/td_home/about.html

http://www.fsis.usda.gov/

http://www.ita.doc.gov/td/standards/

http://www.nist.gov/public_affairs/orgchart.htm

http://www.export.gov/comm_svc/eac.html


http://www.aphis.usda.gov/

http://www.oie.int/

http://www.doe.gov/

http://www.dod.gov/

http://www.va.gov/

http://www.treasury.gov/

http://www.dol.gov/

http://www.justice.gov/

http://www.doi.gov/

http://www.hud.gov/

http://www.hhs.gov/

http://www.ed.gov/index.jhtml


http://www.commerce.gov/

http://www.fda.gov/

http://www.osha.gov/

http://www.eh.doe.gov/techstds

http://dsp.dla.mil/

http://www.whitehouse.gov/government/cabinet.html

http://www.nsf.gov/

http://www.usps.com/

http://www.fcc.gov/

http://www.epa.gov/

http://www.nrc.gov/

http://www.nasa.gov/externalflash/Anniversary_VisMar/index_noaccess.html

http://www.usitc.gov/

http://www.gsa.gov/Portal/gsa/ep/home.do?tabId=0

http://www.ftc.gov/

http://www.cpsc.gov/

http://standards.nasa.gov/

http://www.pascnet.org/

http://www.iso.org/

http://www.fas.usda.gov/

http://www.dhs.gov/

http://www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/index.asp

https://www.ippc.int/

http://www.codexalimentarius.net/

http://www.wto.org/

http://www.wto.org/english/tratop_e/sps_e/sps_e.htm

http://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm

http://www.fao.org/

http://ts.nist.gov/ts/htdocs/210/sccg/icspdes.htm

http://www.ita.doc.gov/itac

http://www.apec.org/apec/apec_groups/working_groups/telecommunications_and_information.html

http://www.itu.int/

http://www.citel.oas.org/

http://www.aphis.usda.gov/ppq

http://www.state.gov/e/eb/adcom/c667.htm

http://www.state.gov/e/eb

http://www.state.gov/e/eb/cip



http://www.iso.org/

http://www.iso.org/

http://www.dot.gov/

http://www.nhtsa.dot.gov/cars/rules

http://www.fema.gov/

http://ts.nist.gov/

http://ts.nist.gov/ts/htdocs/210/ssd.htm

http://ts.nist.gov/ts/htdocs/210/gsig/nvcase.htm

http://ts.nist.gov/ts/htdocs/210/214/214.htm

http://ts.nist.gov/ts/htdocs/210/ncsci/about.htm



*Documentary Standards, excluding “national participation models”

Coordinates U.S. System and policy

development

Coordinates USG use & participation

Participates in U.S. policy development

Provides technical input for

standards development

Independently runs

standards development

activities*

Legal metrology

&TBT

Inquiry Point

ANSI X X

Standards Developers

(Including Consortia)

X X

Companies X X

Government Agencies(regulators and procurement)

X X

NIST X X X X

The U.S. Standards System: Who’s Who



Additional Slides on Conformity Assessment



What is Conformity Assessment?

Conformity Assessment

Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled

ISO/IEC 17000:2004Conformity Assessment –Vocabulary and general principles



Conformity Assessment

Facilitates trade globally and eliminate barriers

Builds confidence and reduces risk for customers

Offers a range of tools to assist in procurement Suppliers Declaration of Conformity (SDoC) to Third-party testing and certification



Metrology and measurement capabilities Sampling Testing Inspection Declaration of conformity Certification (products, services, personnel) Management system registration/certification Accreditation (ANSI role) Enforcement

Components of Conformity Assessment



Conformity Assessment System

Accreditation Bodies (ABs)

Testing Laboratories Certification Bodies Inspection Bodies

Products(Procedures,

Services)

QMS/EMS(ISO 9000 / ISO 14000)

Personnel Buildings, Facilities, Mines, Procedures, Services, etc.



Key Characteristics of U.S. CA System

In the United States, conformity assessment activities are not centrally organized

Activities are a mix of government (regulations) and private sector (market activities)

Approaches vary among sectors