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

1

2010

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

Overview of the U.S. Standards and Conformity Assessment SystemSlide 2

Table of Contents

Importance of Standards and Conformance

The U.S. Approach to Standards and Conformance

Overview of the ANSI Federation

Overview of Conformity Assessment


Key Terms / Concepts

StandardsMarket-driven specifications for a product, service, person, process or system, with which compliance is voluntary

Technical Regulations Mandatory specifications, which may include (or reference) particular standards or conformity assessment procedures

Conformity Assessment Processes used to verify the compliance of a product, service, person, process or system to either a standard or a regulation (e.g., testing, certification)


Statistics: Standards and Trade

According to the WTO, in 2007 global export trade in merchandise surpassed $13.5 trillion, and global export trade in commercial services surpassed $3.2 billion

The U.S. Commerce Department estimates that standards impact roughly 80% of all world commodity trade, and that number is growing every day

Those who understand how to effectively influence standardization and compliance programs will have the greatest success in the global marketplace



When developed and used responsibly, standards facilitate a company’s ability to open and access markets

When overlooked, standards can negatively impact a company’s ability to do business in the U.S. and abroad

Standards and conformance impact your bottom line

Standards and conformance impact your ability to do business internationally


For example: Coke and Pepsi in India

Full or partial bans of Coke and Pepsi in seven Indian States

Allegations that Coke and Pepsi contain excessive pesticide residue – unsafe

Loss of market share and brand integrity for U.S. soft drink giants

Avoidable with globally acceptable food safety and hygiene standards and certification


The U.S. Approach to Standards and Conformance


Guiding Principles of the United StatesStandardization System

Standards and their

related compliance

criteria should meet

societal and market

needs and should not

be developed to act

as barriers to trade


Guiding Principles of the United StatesStandardization System

The U.S. endorses

the globally accepted

standardization

principles of the

World Trade Organization

Technical Barriers to

Trade Agreement


The WTO Principles

Transparency

Openness

Impartiality and Consensus

Effectiveness and Relevance

Coherence

Development Dimension


The U.S. is supportive of

any international standard that:

is technically suitable

is used throughout a given

market sector worldwide, and

was developed

in accordance with

the WTO principles


U.S. Standards and Conformity Assessment SystemReliable - Flexible - Responsive

Market driven Flexible and sector-based Industry-led and government-supported

www.us-standards-strategy.org

As defined in the United States Standards Strategy,

this system is designed to . . . Support stakeholder engagement Address emerging priorities Allow stakeholders to find custom-fit solutions


United States Standards Strategy (USSS)

Reaffirms U.S. commitment to a sector-based approach to voluntary standardization activities, domestically and globally.

Built upon the traditional strengths of the U.S. system – such as consensus, openness, and transparency – while giving additional emphasis to speed, relevance, and meeting the needs of public interest constituencies.

www.ansi.org/usss


U.S. Standards and Conformity Assessment SystemReliable - Flexible - Responsive

The National Conformity Assessment Principles for the

United States document

helps consumers, buyers, sellers, regulators

and other interested parties understand key aspects of

compliance verification.

www.ansi.org/ncap

The NCAP is a guidance

document that can be

considered in conjunction

with the United States

Standards Strategy


U.S. Standards and Conformity Assessment System

comparison with many other economies

Emphasizes private-sector standards solutions

Relies on private-sector compliance verification for both regulatory and non-regulatory functions

Provides greater authority to standards users and stakeholders


Standards users drive standardization activities

Standards bodies drive standardization activities

U.S. Standards and Conformity Assessment System comparison with many other economies (continued)

Bottom Up

Top Down


The U.S. System: A Toolbox

Rather than mandating a “one-size fits all” solution, the U.S. system allows users 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.”


U.S. Standards System Different tools for developing globally-relevant standards

National Participation Direct Participation

Consortia

Treaty Organizations

Non-Treaty Organizations

Nationally Accepted Internationally

Accepted

Examples

Non-Treaty: ISO, IEC

Treaty: ITU, CODEX

Examples

ASTM International, ASME, SAE, etc.

Examples

IGRS, W3C, etc.


Summary of U.S. Participation in ISO and IEC

ISO

Participation in 620 TCs and SCs (roughly 79% of total)

P Memberships: 570 O Memberships: 50

U.S. – held International Secretariats: 18% of total

IEC

Participation in 153 TCs and SCs (roughly 89% of total)

P Memberships: 153 O Memberships: 0

U.S. – held International Secretariats: 14% of total


ANSI: Coordinator for U.S. Participation

U.S. Reps. to ISO Council / IEC CB ANSI staff on ISO Council -- 1 USNC President on IEC Council Board -- 1

U.S. Reps. to TMB/SMB ANSI Staff – 1 on TMB and 1 on SMB Volunteers – 1 (on SMB)

ISO and IEC International Secretariats Most U.S. – held Secretariats are administered

by volunteers ANSI staff administer U.S. – held Secretariats

only at the request of ANSI constituents. 13 U.S. – held Secretariats are administered by

ANSI staff.

Leadership of U.S. mirror committees (TAGs) Leadership positions on U.S. TAGs are held by

ANSI member volunteers.

U.S. Technical Expert Participation U.S. technical contributions to ISO and IEC are

provided by ANSI member volunteers.

U.S. Contributions to ISO and IEC

ANSI Staff

ANSI delegates most ISO and IEC work to volunteers within the

U.S. system (e.g. companies, trade

associations, SDOs, etc)




Consortia




Accepted

Examples


Treaty: ITU, CODEX

Examples


Examples

IGRS, W3C, etc.


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.


Many American National Standards (ANS)are International Standards

Criteria WTO/TBT Principles Criteria Reflected in

the ANS Process

Transparency

Openness

Impartiality & Consensus

Effectiveness & Relevance

*

Coherence

Development Dimension

**

* Although the ANS process does not directly evaluate Effectiveness & Relevance, adherence to the other ANS criteria helps to assure the effectiveness and global relevance of ANS.

** Although the ANS process does not evaluate for this criteria, it is strongly encouraged in the U.S. Standards Strategy, and many SDOs engage in extensive international outreach and development activities


Examples of ANSI-Accredited SDOs

American Dental Association

NationalElectricalManufacturersAssociation

National Fire Protection Association

International Code Council

American Society of MechanicalEngineers

ASTM International

Society of Automotive Engineers

Institute of Electrical andElectronics Engineers

Underwriters Laboratories Inc.

AmericanSocietyof CivilEngineers

American Petroleum Institute

And more than 200 additional organizations


Getting Involved in U.S.-Based SDOs


Getting Involved in U.S.-Based SDOs (2)




Consortia




Accepted

Examples


Treaty: ITU, CODEX

Examples


Examples

IGRS, W3C, etc.


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.


U.S. Standards SystemMultiple Path Approach to Standard-Setting

Traditional SDOs and consortia each have a role to play

Consortia and other forums have become more clearly recognized – and embraced – as an integral part of the global standards system


The Role of Government in the U.S. Standards and Conformance Systems


U.S. Standards and Conformity Assessment SystemThe public-private partnership

No single government agency has control over standards Each agency determines which standards meet its needs

National Technology Transfer and Advancement Act (NTTAA) (Public Law 104-113) Encourages each government agency to seek existing private sector

standards that are appropriate for its purpose and mission


The Role of Government Agencies

OMB Circular A-119

The National Technology Transfer and Advancement Act(NTTAA, Public Law 104-113)

Before regulating, each government agency is required to seek and consider using existing private sector standards that are appropriate for its needs

If so, the agency will use (i.e. reference) the private sector standard If not, the agency is expected to work with the private sector to develop the

needed standards, and to reference them in its regulations Agencies creating their own standards must report to the Administration and

Congress on an annual basis the justifications for doing so NIST has the legal responsibility of implementing the NTTAA


The Role of Government Agencies

Significant elements of OMB Circular A-119 and The NTTAA:

U.S. regulators and procurement officials can use any standard from any source in the world which help them meet their Congressional mandates

These standards do not need to first be transposed into American National Standards by ANSI

These directly referenced standards include ISO, IEC, SDOs

These standards may also be consortia standards

Regulators and procurement officials may make reference to applicable parts of standards – i.e. are not limited to referencing only whole standards


ANSI – Coordinator of the Private Sector led System Responsible for coordinating U.S. private sector participation in the U.S. private sector led

Standards and Conformance systems The National Standards Body for the United States – Represent the U.S. in intl. and regional standards fora An Accreditation Body for private sector programs – Represent the U.S. in intl. and regional accreditation fora Private sector, non-profit, membership organization Supported by membership fees, sale of publications, funded programs, accreditation programs and periodic government grants

Standards Developing Organizations (SDOs) Responsible for the development of standards for the specific technical sectors Some, but not all, accredited by ANSI When accredited, can administer U.S. mirror committees to ISO and IEC Private trade and professional organizations, often non-profit Business models vary by sector

Conformity Assessment Bodies (CABs) Testing Laboratories, Certification Bodies, Inspection Bodies Responsible for demonstrating compliance with standards (including those referenced by mandatory technical regulations) Some, but not all, accredited by ANSI Business models vary by sector (non-profit, for-profit, public sector, etc.)

NIST – National Institute of Standards & Technology – U.S. Department of Commerce Coordinates the activities of Federal agencies in the U.S. private sector led Standards & Conformance Systems National Metrology Institute for the U.S. – Represents the U.S. in international and regional metrology fora Accreditation Body for public sector programs – Represent the U.S. in international and regional accreditation fora U.S. government public sector body

Structure of the U.S. Standardization System


*Documentary Standards, excluding “national participation models”

U.S. Standards SystemExamples of roles and responsibilities


U.S. Standards System: policy development

Cabinet Departments

DOC ANSI

TA ITANACLA

APLACILAC

APEC/SCSC

ISO

PR

I-N

ad

cap

FQ

S-I

APLMF

BIPM

APMPOIML

IAS

AIH

ASSOs &

Consortia without

ANSI accreditatio

n

TPSCSC-S&TB

IAAC IAF JTC1 IEC

COPANTPAC

Executive OfficeOf the President

US

TR

OM

B

Standards and Conformity Assessment Bodies of the U.S.

International

Regional

Government

Non-Government

Program / Body

L.A

.B

ASQ

ANAB accredited QMS/EMS Certifiers

ANSI accredited

Product Certifiers

ANSI accredited Personnel Certifiers

SDOs with ANSI

accredited procedures

CAPC

USNC

IPC

Board

IECTAGsIEC

TAGs

USNCIEC

TAGsIEC

TAGsIEC

TAGs

USISO

TAGs

ISO/IEC Guides62 / 66(17021)

ISO/IEC Guide

65

ISO/IEC 17024

QMS/EMS Certified Product/Service

Providers

Certified Products

(Processes, Services)

CertifiedPersonnel

ANSs(American National

Standards)

US Private & Government

Sectors:Organizations,Government,Companies,

Trade Associations, Consumers,Educational Institutions,Individuals,

Others

NPC (Accreditation of Certifiers)

Non-ANS Standards

AIC

(Accreditation of Laboratories)

A2

LA

AC

LA

SS

Accredited Laboratories

Tested Products

(Processes, Services)

ITU Sector

Members

ITAC

Policy Technical (Accreditation

of SDOs)

* Institute policy committees& councils

SIM

NIST

S

tate

US&FCS

MAC

MAS

FSIS

Standards Liaison

Laboratories / Metrology

200+ FCS Officers

worldwide including 4 Regional

Standards Attachés

Oth

ers

USDA

APHIS

OIE

DO

E

DO

D

VA

Tre

asu

ry

DO

L

DO

J

DO

I

HU

D

HH

S

DO

Ed

US

DA

DO

C

FD

A

OS

HA

ES

&H

DS

P

Other Agencies

NS

F

US

PS

FC

C

EP

A

NR

C

NA

SA

ITC

GS

A

FTC

CP

SC

TS

P

Recognition (via ISO/IEC 17011)

PASC

Standardization

Accreditation

Other iSDOs

FAS

(Accreditation of Certifiers)

(Accreditation of Laboratories)

(Metrology)

(Standardization

)

(Standardization-Telecom)

(C

ert

ifica

tio

n)

(Test

ing

)

(S

tan

dard

izati

on

)

ANSI Essential

Requirements

ISO/IEC 17025

DH

S

USCO

IPPC

CODEX

WTO

SPS

TBT

FAOInquiry point ICSP

(Members)

ITAC16

US Private Sector

APEC-TEL

Inquiry point

(Standardization-SPS)

ITU

CITEL

LegendPPQ ACICIP

EB

CIP

NSBs

ESOs

Others

Other SDOs

DO

TN

HTS

A

FEM

A

Members

IPRPC

TS

SSD

NVCASE

NVLAP

NCSCI

Summary of the U.S. System

“The Drivers” Companies, Government

Agencies and other Standards Users

“The Road” ANSI

“The Vehicle” Standards

Developers & Conformity

Assessment Bodies


The ANSI Federation


ANSI is the “Umbrella Organization” for theU.S. standards and conformance systems.

Represents U.S. globally

Ensures integrity of the standards and conformity assessment system

Offers neutral forum

Accredits standards developers and conformity assessment organizations


Members of the ANSI Federation include . . . Academia Individuals Government Manufacturing Trade Associations

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

The ANSI Federation represents more than 125,000 companies

and organizations and 3.5 million professionals worldwide


American Dental Association

NationalElectricalManufacturersAssociation

National Fire Protection Association

Examples of ANSI-Accredited Standards Developers and U.S. TAGs

International Code Council

American Society of MechanicalEngineers

ASTM International

Society of Automotive Engineers

Institute of Electrical andElectronics Engineers

Underwriters Laboratories Inc.

AmericanSocietyof CivilEngineers

American Petroleum Institute

And more than 200 additional organizations

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 FM GTEEMC

12AMA IAF IAAMC

KCMA

NISO

LIA MSS MHI

NIMS NIST/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

NACE NAHBRC NAAMM

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

Link to full list of ANSI accredited and non-ANSI accredited SDOs: www.nssn.org/sdoinfo.aspx


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 ANSI 208 Technical Committees of ANSI’s SDO members 565 Number ANSI Standards Panels 5 Total number of American National Standards published as of 12/31/05 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


ANSI promotes alignment with Internationally

Recognized Principles for Standards Development

WTO TBT Committee Third Triennial Review – Annex

4

ANSI Essential Requirements

for the development of

American National Standards

openness

transparency

due process

consensusReferenced in the

United States Standards Strategy


ANSI Standards Panels


Coordination and Harmonization Activities

ANSI Standards Panels are cross-sector coordinating bodies established to promote the

development and compatibility of voluntary consensus standards and conformity

assessment programs necessary to support national and global priorities

Coordinate the efforts of the private and public sectors

Identify existing standards and compliance programs

Define where gaps exist

Recommend where additional work is needed

Identify organizations that can perform the needed work


Coordination and Harmonization Activities ANSI Standards Panels

2003

Homeland Security

Standards Panel

2004

Nanotechnology Standards Panel

2005

Healthcare Information Technology Standards

Panel

2006

ID Theft Prevention

and ID Management

Standards Panel

2007

Biofuels Standards

Coordination Panel


Coordination and Harmonization Activities ANSI Standards Panels (continued)

Healthcare Information Technology Standards Panel

Contract with the U.S. Department of Health and Human Services to support widespread interoperability among healthcare software applications, accelerate decision making, and eliminate barriers to standards harmonization.

Nanotechnology Standards Panel

Established at the request of the Office of Science and Technology Policy, Executive Office of the President of the United States to facilitate the development of standards supporting nomenclature/terminology; materials properties; and testing, measurement and characterization procedures.

Homeland Security Standards PanelPartnership with the U.S. Department of Homeland Security to accelerate development and adoption of consensus standards critical to homeland security. Support also provided to the 9-11 Commission for private sector preparedness.


Coordination and Harmonization Activities ANSI Standards Panels (continued)

ID Theft Prevention and ID Management Standards Panel

Partnering with the Better Business Bureau to facilitate within 18 months the timely development of voluntary consensus standards aimed at minimizing the scope and scale of identity theft and fraud.

Biofuels Standards Coordination PanelLaunched in conjunction with the U.S. Department of Energy and several other federal agencies to promote the development and compatibility of voluntary consensus standards and related conformity assessment programs necessary to support the large-scale commoditization of biofuels.


Specifics:ANSI’s Roles and Responsibilities


ANSI’s Roles and Responsibilities

help advance U.S. industries’ global competitiveness

Advance acceptance of U.S. innovation and technology in global trade

accredit SDOs and approve American National Standards (ANS)

accredit certifiers of products, personnel and management systems

develop and promote standards and conformity assessment-related policies and positions for the United States

represent U.S. standardization stakeholders in domestic, regional and international forums


ANSI’s Roles and Responsibilities (continued)

U.S. member of ISO

U.S. member of the IEC, via ANSI’s U.S. National Committee

member of regional forums in the Pacific Rim and the Americas

liaison with groups in Europe, Africa and the Middle East

bilateral agreements with other national standards bodies


U.S. PRIVATESECTOR

U.S.-HeadquarteredSTANDARDS DEVELOPING

ORGANIZATIONS

FOREIGN NATIONALSTANDARDS BODIES(ANSI PEER BODIES)

Geneva-HeadquarteredINTERNATIONAL

STANDARDIZATIONBODIES

(ISO, IEC)

REGIONALSTANDARDIZATION

BODIES(COPANT, PASC, ESOs)

EUROPEANCOMMISSION / APEC

U.S. PUBLIC SECTOR

COMPANIES

TRADE ASSOCIATIONS

CONSUMER INTERESTS

OTHERS

U.S. GOVERNMENT


ANSI serves as the official U.S. member and sets policyfor U.S. participation in the International Organization for Standardization (ISO) International Electrotechnical Commission (IEC)

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 Activities (Standardization)

ISO / IECANSI & USTAGSU.S.


ISO – Geneva, Switzerland

ANSI one of 5 permanent members to the Council of 18 4 permanent members to the Technical Management Board of 12

ANSI and its members participate in 79% of Technical Committees (570) administer 18% of TC Secretariats (118)

ANSI Participation in ISO

ISOANSIU.S.


IEC - Geneva, Switzerland

U.S. National Committee to the IEC (USNC) A board level committee of ANSI one of 5 permanent members of the council board of 15 participates in 89% of Technical Committees (153) assigned Secretariats for 16% of TC Secretariats (23)

ANSI Participation in IEC

IECUSNCANSIU.S.


ESOs

ANSI serves as the official U.S. member of two regional bodies Pan American Standards Commission (COPANT) Pacific Area Standards Congress (PASC)

The Institute has a dialogue with representatives of the European Standards Organizations (ESOs)(CEN, CENELEC and ETSI), the European Commission and EFTA

ANSI has MOUs with various countries globally to coordinate Standardization and Conformity Assessment activities

ANSI Regional Activities (Standardization)


Regional Standards Organizations


The United States is highly engaged in Asia Pacific Standards and conformance activities:

ANSI is the official U.S. member of the Pacific Area Standards Congress (PASC) and the Pacific Accreditation Cooperation (PAC)

The U.S. is also represented in other Asia Pacific Specialist Regional Bodies (SRBs) . . .

ANSI Regional Interaction (Asia Pacific)


PASC is one of five Specialist Regional Bodies (SRBs) which are recognized by APEC as having specialized expertise in the areas of:

Standardization (PASC) Accreditation (PAC, APLAC) Metrology (APMP, APLMF)

The five Asia Pacific SRBs are: Pacific Area Standards Congress (PASC) Pacific Area Cooperation (PAC) Asia Pacific Laboratory Accreditation Cooperation (APLAC) Asia-Pacific Legal Metrology Forum (APLMF) Asia-Pacific Metrology Programme (APMP)

The SRBs provide critical specialized support to the APECCommittee for Trade and Investment (CTI) –Subcommittee on Standards and Conformance (SCSC)

The SCSC is composed of the government trade representatives of the APEC region who meet to ensure that standards and conformance issues do not create technical barriers

PASC, together with the other SRBs and the SCSC, are working closely with the APEC Business Advisory Council (ABAC) to facilitate trade and provide critical infrastructure in the Asia Pacific region in the area of standards and conformance

PASC-APEC-SRB Relationships


PASC

PAC

APLAC

APLMF

APMP


Pacific Area Standards Congress (PASC)Members

Australia (SA) Brunei Darussalam (CPRU) Canada (SCC) Chile (INN) China (SAC) Colombia (ICONTEC) Fiji (FTSQCO) Hong Kong – China (ITCHSKAR) Indonesia (BSN) Japan (JISC) Republic of Korea (KATS) Malaysia (DSM)

Mexico (DGN) Mongolia (MASM) New Zealand (SNZ) Papua New Guinea (NISIT) Peru (INDECOPI) Philippines (BPS) Russia (GOST-R) Singapore (SPRING SG) South Africa (SABS) Thailand (TISI) USA (ANSI) Vietnam (STAMEQ/TCVN)

ASEAN / ACCSQ economies (in blue) (Note: Cambodia (ISC), Laos (DISM), Myanmar (MSTRD) not in APEC / PASC)


The United States is engaged in standards and conformanceactivities in the Americas:

ANSI is the official U.S. member of the Pan American Standards Commission (COPANT) and a full member of the InterAmerican Accreditation Cooperation (IAAC)

The U.S. is also represented in the InterAmerican Metrology System (SIM) by NIST

The three specialist regional bodies (srbs) of the Americas are: Pan American Standards Commission (COPANT) InterAmerican Accreditation Cooperation (IAAC) InterAmerican Metrology System (SIM)

The SRBs provide specialized support in the areas of standardization, accreditation and metrology in the Americas

Many ANSI members and accredited SDOs currently engaged in specific technical cooperation activities with partners in the region

ANSI Regional Interaction (Americas)


Pan American Standards Commission(COPANT) - Members

Argentina (IRAM) Barbados (BNSI) Bolivia (IBNORCA) Brazil (ABNT) Canada (SCC) Colombia (ICONTEC) Costa Rica (INTECO) Cuba (NC) Chile (INN) Dominican Republic

(DIGENOR) Ecuador (INEN) El Salvador (CONACYT) Guatemala (COGUANOR)

Grenada (GDBS) Guyana (GNBS) Honduras (COHCIT) Jamaica (JBS) Mexico (DGN) Nicaragua (MIFIC) Panama (COPANIT) Paraguay (INTN) Peru (INDECOPI) Saint Lucia (SLBS) Trinidad & Tobago (TTBS) USA (ANSI) Uruguay (UNIT) Venezuela (FONDONORMA)


Middle East and Africa

ANSI also interfaces with representatives of regional standards organizations from the Middle East and Africa

In 2005, ANSI participated in an ASTM International Open House for standards leaders from the Middle East and Africa. The following countries and organizations were represented:

Gulf Standardization Organization (GSO) for the GCC (Gulf Cooperation Council - an economic and political policy-coordinating forum for the six member states Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the UAE)

Arab Industrial Development and Mining Organization (AIDMO)

Bahrain (BSMD) India (BIS) Iraq (COSQC)

Israel (SII) Lebanon (LIBNOR) Jordan (JISM) Kuwait (PAI) Morocco (SNIMA) Oman (DGSM) Pakistan (PSQCA) Palestine (PSI) Qatar (QGOSM) Saudi Arabia (SASO) Tunisia (INORPI) UAE (ESMA) Yemen (YSMO)


Middle East and Africa

In 2007, ANSI participated in an ASTM International Open House for standards leaders from Sub-Saharan Africa. The following countries and organizations were represented:

Botswana (BOBS) Congo (OCC) QUAE (Ethiopia) Ghana (GSB) Lesotho (LSQAS) Malawi (MBS) Mauritius (MSB)

Nigeria (SON) Rwanda (RBS) South Africa (SABS) Swaziland (SQAS) Zambia (ZABS) Zimbabwe (SAZ)

ANSI also works with: ARSO – the African Organization for Standardization, and SADCSTAN – The Southern African Development (SADC)

Cooperation in Standardization via SABS which is the designated coordinator for African standardization from the

Pacific Area Standards Congress


European StandardsOrganizations (ESOs)

CEN, CENELEC, and ETSI are the European counterparts to the ISO, IEC, and ITU-T and are known collectively as the European Standards Organizations (ESOs)

The ESO’s are composed of the national standards bodies of Europe

CEN the European Committee for Standardization, produces European standards in all areas except for electrotechnical and telecommunications

CENELEC the European Committee for Electrotechnical Standardization, works to produce a single set of harmonized electrotechnical standards in Europe

ETSI the European Telecommunications Standards Institute, determines and produces European telecommunications standards

ANSI interacts with the ESOs in various ways, including holding 20 ANSI-ESO dialogues since 1989. In 2005, ANSI also began holding delegation meetings with the ESO’s Joint Presidents Group (JPG).


European StandardsOrganizations (ESOs)

ANSI – ESO Partnership

Ongoing interaction

20 dialogues since 1989

February 2007, EC-CEN Biofuels Conference

November 7, 2007, ANSI meeting with ESO Joint Presidents Group (JPG) and European Commission – Brussels

February 6-7, 2008, CEN/CENELEC/ETSI/ANSI Interoperability Conference – Warsaw, Poland

September 23, 2008, ANSI-ESO/JPG meeting with EC and EFTA

September 24, 2008, ANSI-ESO Workshop on U.S.-EU Standards and Conformance


ANSI meeting with ESO Joint Presidents Group (JPG) and European Commission, EFTA

The ANSI-ESO Dialogue represents the leadership of the U.S. and EU standards and conformance systems.

Format is a four-sided table:

U.S. Private Sector

U.S. Government

EU Private Sector

European Commission, EFTA


International Projects and Initiatives


Overview of Regional and Bilateral Initiatives

Pre-2006 2006 2007 2008 2009 and beyond

Maintain existing engagement while expanding international

projects

Ongoing Regional and Bilateral Policy Engagement

ANSI China Program

Increased Engagement in India

Increased Engagement in Southeast Asia


China Program Genesis

ANSI hired a Representative for China Affairs (Elise Owen) and launched China Program in 2006, responding to member focus on issues and opportunities in China

Three main priority areas for ANSI China Program: Communicate and promote U.S. positions for standardization and conformity assessment in China Work to ensure that standards facilitate trade Promote the benefits of the U.S. Standards System in China

2007 ANSI Membership Survey defined overarching areas of concern for China, including transparency, conformity assessment policies, and inconsistent U.S. message

China Program facilitates “continuous engagement” through senior and working-level communication, workshops, projects, etc. to effectively advance U.S. priorities


China Program: Recent Accomplishments

April 2008: MOU with Certification and Accreditation Administration of China (CNCA) that builds on a longstanding MOU with the Standardization Administration of China (SAC)

Supporting Initiatives to advance the safety of products exported from China to the U.S. (e.g. toys)

Increasing outreach to and visibility in Chinese industry Addressing high-level China policy concerns

(e.g. TC participation policies, revisions to CCC regulations, etc.) Launching ANSI Manufacturer Member Roundtable in China Development of StandardsPortal


Why StandardsPortal?

Problem: No central resource to help companies find the standards,

conformity assessment and technical regulations needed to enter and compete in target markets.

Solution: StandardsPortal answers key questions exporters face when

attempting to enter their target markets


ANSI Engagement in India

January 2007: ANSI President and CEO India Networking Visit March 2007: ANSI and U.S. Department of Commerce (DOC) Staff-level Fact-

finding Mission December 2007: ANSI signs tripartite MOU with Bureau of Indian Standards

(BIS) and Confederation of Indian Industry (CII) September 2008: ANSI, CII and BIS co-organize workshop on “Leveraging the

TBT Agreement” sponsored by U.S. DOC and Indian Ministry of Commerce and Industry

March 2009: U.S. – India Standards and Conformance Cooperation Program (SCCP) launched in Washington and Delhi (www.standardsportal.org/us-indiasccp)


Southeast Asia

2007/2008: ANSI Carries out U.S. Trade and Development Agency (USTDA) sponsored Vietnam Standards Training Program (VSTP)

September 2008: ANSI delivers presentation to ASEAN Consultative Committee for Standards and Quality (ACCSQ) plenary meeting

Ongoing: Working to identify additional opportunities for projects and programs in individual Southeast Asian countries


Future Areas of Focus: International Projects

ANSI will continue its commitment to policy activities while also working to increase externally funded projects that support ANSI’s

international policy objectives

Benefits to ANSI Members: Maximize international impact with limited resources Strengthen international alliances and partnerships Increase opportunities to address issues and concerns before they arise


Overview of Conformity Assessment


What is Conformity Assessment?

ISO/IEC 17000:

“ demonstration that specified requirements relating to a product, process,

system, person or body are fulfilled”

“Note: includes activities such as testing, inspection and certification as well as the

accreditation of conformity assessment bodies”


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

Conformity Assessment


U.S. Standards and Conformity Assessment Systemreliable – flexible – responsive

The National Conformity Assessment Principles (NCAP) for the United States document explains key aspects of compliance verification.

National Conformity Assessment Principles

for the United Stateswww.ansi.org/ncap

The NCAP is a guidance document that can be considered in conjunction with the United States Standards Strategy (USSS).


U.S. Conformity Assessment System

Standards are just good ideas unless products, processes, systems and personnel conform to them.

The U.S. conformity assessment system, much like the standards system, evolved in

decentralized manner.

Conformity assessment activities are not centrally organized Approaches vary among sectors


U.S. Conformity Assessment System

Activities are a mix of government (regulatory programs) and private sector (market-

based programs)

The system relies on private sector mechanisms to achieve both non-regulatory and

regulatory conformance

Designed to provide more confidence in the quality of the product, service, or system

by consumers, the public, and employers


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


3rd Party Conformity Assessment System Structure

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.


Standards Developing

Organizations

and U.S. TAGs

ANSI Procedures

“EssentialRequirements”

Standards

Examples of Accreditation Programsin the United States

Conformity Assessment (ISO/IEC 17011)

PersonnelCertifiers

Accreditation Bodies:

ANSI

ISO/

IEC

17024

QMS/EMSCertifiers

ISO/

IEC

17021


ANSI-ASQ NAB

ISO/

IECGuide

65

ProductCertifiers


A2LAANSIIAS

InspectionBodies

ISO/

IEC

17025

ISO/

IEC

17020

TestLabs


A2LAANSI-ASQ NAB

IAS

Accreditation Bodes:A2LA

ANSI-ASQ NAB

IAS, L-A-BPJLA, NVLAP

Products (Procedures,

Services)

Personnel QMS/EMS (ISO 9000/ ISO

14000)

Buildings, Facilities, Mines,

Procedures, Services, etc.

Products (Procedures,

Services)


ANSI

ISO/

IEC

14065

Greenhouse Gas Verifiers

Green-house Gas Emissions


IAF International

Accreditation Forum

IAACInter American Accreditation Cooperation

PAC

Pacific Accreditation Cooperation

APLACAsia-Pacific Laboratory

Accreditation Cooperation

EA European


ILACInternational Laboratory


International Recognitionis Essential


Internationally Accepted Standards and Conformity Assessment Principles

TransparencyTransparencyOpennessOpenness

Due ProcessDue Process

Consensus

• Agreed to by . . .Agreed to by . . .

• WTOWTO

• ISOISO

• IECIEC

• ANSIANSI

• ANSI AccreditedANSI AccreditedSDOsSDOs


The Conformity Assessment Balance

value confidence

for suppliers for acceptanceinterests


Conformity Assessment and Risk

Perceived Risk

Independence and Rigor of Conformity Assessment

Supplier’s Declaration

1st party conformity assessment

Certification

3rd party conformity assessment


Confidence/Regulation Spectrum

veryregulated

unregulated

complete trust

100% verification

paperclip

produce

pharmaceuticals


ObjectiveOne Standard : One Test : Accepted Everywhere (1:1:1)

In a global marketplace, the objective of the

standardization process must be a single,

technically valid and globally relevant

standard with a single test of conformance to

that standard.

This will allow products to be distributed for

worldwide commerce without change or

modification.

One Standard – One Test – Accepted EverywhereOne Standard – One Test – Accepted Everywhere


For more information

American National Standards Institute

Headquarters Operations

1819 L Street, NW 25 West 43rd Street

Sixth Floor Fourth Floor

Washington, DC 20036 New York, NY 10036

T: 202.293.8020 T: 212.642.4900

F: 202.293.9287 F: 212.398.0023

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

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