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

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

June 2009

International Policy DepartmentAmerican National Standards Institute

2009Slide 2Overview of the U.S. Standardization and Conformity Assessment Systems

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 (examples include: testing, certification, inspection, accreditation)


Importance of Standards

International standards harmonize cross-border requirements – opening markets for large, medium

and small enterprises.

The global market follows standards.


The U.S. Approach to Standards and Conformance


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

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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


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


Guiding Principles of the United StatesStandardization System

The U.S. endorses the globally accepted standardizationprinciples of the World Trade Organization Technical Barriers to Trade Agreement and Related Decisions


The WTO Principles

TransparencyOpennessImpartiality and ConsensusEffectiveness and RelevanceCoherenceDevelopment Dimension


is technically suitable

is used throughout a given market sector worldwide, and

was developed in accordance with the WTO principles

The U.S. is supportive of any international standard that:


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






















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

ExamplesISO, IEC, ITU, CODEX, etc.

ExamplesASTM International, ASME, SAE, etc.

ExamplesIGRS, W3C, etc.


The ANSI Federation


The American National Standards Institute facilitates voluntary

consensus standards, conformity assessment and related activities in

the United States.






















ANSI’s mission is 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.






















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

http://www.ada.org/index.asp

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

http://www.nssn.org/sdoinfo.aspx


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

U.S. private sector-led / public sector-supported standards and conformance systems

The National Standards Body for the United States – Represent the U.S. in international non-governmental standards fora

An Accreditation Body for private sector programs – Represent the U.S. in international non-governmental accreditation fora

Private-sector, non-profit, membership organization Supported by membership fees, sale of publications,

funded programs, accreditation programs, and periodic government grants

Structure of the U.S. Standardization System



Standards Developing Organizations (SDOs) Responsible for the development of standards for the specific

technical sectors Some, but not all, are ANSI-accredited standards developers Can administer U.S. mirror committees to ISO and IEC

– ANSI-accredited Technical Advisory Groups (TAGs) to ISO– U.S. National Committee (USNC)-approved TAGs to 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 and 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


Specifics:ANSI’s Roles and Responsibilities

Internationally, Regionally, and Bilaterally


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)


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 in the Middle East to coordinate Standardization and Conformity Assessment activities

ANSI Regional Activities (Standardization)


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”


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 States

www.ansi.org/ncap

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


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


Supplier Organization

Accreditation bodies

Assess competence

Conformity assessment bodies

Audit conformity

Accredited 3rd-Party Hierarchy(ISO/IEC 17011 standard for accreditation bodies)


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


IAF International

Accreditation Forum

IAACInter American Accreditation Cooperation

PAC Pacific Accreditation

Cooperation

APLACAsia-Pacific Laboratory

Accreditation Cooperation

EA European


ILACInternational Laboratory


International Recognitionis Essential


Standards Developing

Organizationsand 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/IEC

Guide 65

ProductCertifiers


A2LAANSIIAS

InspectionBodies

ISO/IEC

17025

ISO/IEC

17020

TestLabs


A2LAANSI-ASQ NAB

IAS

Accreditation Bodes:A2LA

ANSI-ASQ NABIAS, L-A-B

PJLA, 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


For more information

American National Standards Institute

Headquarters Operations1819 L Street, NW 25 West 43rd StreetSixth Floor Fourth FloorWashington, DC 20036 New York, NY 10036

T: 202.293.8020 T: 212.642.4900 F: 202.293.9287 F: 212.398.0023

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

Gary KushnierVice President, International Policy

[email protected]

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