Overview of the u s standards and conformity assessment system
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Overview of the U.S. Standards and Conformity Assessment System. International Policy Department American National Standards Institute. June 2009. Table of Contents. Importance of Standards and Conformance The U.S. Approach to Standards and Conformance Overview of the ANSI Federation

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Overview of the u s standards and conformity assessment system

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

International Policy Department

American National Standards Institute

June 2009


Table of contents

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

Key Terms / Concepts

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

Technical RegulationsMandatoryspecifications, which may include (or reference) particular standards or conformity assessment procedures

Conformity AssessmentProcesses 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

Importance of Standards

International standards harmonize cross-border requirements – opening markets for large, medium and small enterprises.

The global market follows standards.


Overview of the u s standards and conformity assessment system

The U.S. Approach to Standards and Conformance


U s standards and conformity assessment system comparison with many other economies continued

Top Down

Bottom Up

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

Standards bodies drive standardization activities

Standards users drive standardization activities


U s standards and conformity assessment system the public private partnership

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

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 agencies1

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 system reliable flexible responsive

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

  • Market driven

  • Flexible and sector-based

  • Industry-led and government-supported

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

www.us-standards-strategy.org


Overview of the u s standards and conformity assessment system

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


Overview of the u s standards and conformity assessment system

The WTO Principles

Transparency

Openness

Impartiality and Consensus

Effectiveness and Relevance

Coherence

Development Dimension


Overview of the u s standards and conformity assessment system

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 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 and Conformity Assessment System comparison with many other economies


U s standards system different tools for developing globally relevant standards

U.S. Standards SystemDifferent tools for developing globally-relevant standards

.


Overview of the u s standards and conformity assessment system

The ANSI Federation


Overview of the u s standards and conformity assessment system

The American National Standards Institute facilitates voluntary consensus standards, conformity assessment and related activities in the United States.


Overview of the u s standards and conformity assessment system

ANSI’s missionis 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

Members of the ANSI Federation include . . .

The ANSI Federation represents more than 125,000 companies and organizations and 3.5 million professionals worldwide


Overview of the u s standards and conformity assessment system

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

ASTM International

American Society of MechanicalEngineers

International Code Council

American Dental Association

NationalElectrical

Manufacturers

Association

National Fire Protection Association

Society of Automotive Engineers

Institute of Electrical andElectronics Engineers

Underwriters Laboratories Inc.

American

Society

of Civil

Engineers

American Petroleum Institute

And more than 200 additional organizations


Overview of the u s standards and conformity assessment system

ANSI Accredited Standards Developing Organizations (SDOs)

3-A

ASC X9

ASA

ACCA

AMCA

ARI

ATIS

AA

AAMA

AAMVA

ABMA

ABYC

ABMA

ACC

ACI

ADA

AFPA

AGA

AGMA

AH&LA

AIHA

AIAA

AISC

AITC

AISI

ALI

ANS

ANLA

API

ASNT

ASQ

ASAE

ASB

ASCE

ASHRAE

ASME

ASSE

AWWA

AWS

AWEA

ATA

ACMI

ASIS

AIIM

AMT

NPES

AAMI

ACDE

AHAM

ARMA

ASTM

AIM

AGRSS

ALI

BHMA

BICSI

BOMA

BIFMA

CCPA

CSAA

CAPA

CLSI

CFPMI

CAP

CPA

CAGI

CGA

CAM-I

CEA

CSPA

CEMA

CTI

CSA

DISA

DASMA

EIMA

EASA

EIA

ESTA

EIA

EOS/ESD

FCI

FM

GTEEMC

GICC

GEIA

GEI

HPVA

HIBCC

HL7

HPS

HFES

HI

IESNA

ITSDF

IEEE

IEST

IIE

INMM

12AMA

IAF

IAAMC

IAPMO

ICPA

ICC

ITI

NETA

I3A

IIAR

ISEA

ISA

ISANTA

IWCA

IPC

ISA

JCSEE

KCMA

LIA

MSS

MHI

MBC

NACE

NAHBRC

NAAMM

NBBPVI

NBFAA

NCMA

NCSL

NCPDP

NECA

NEMA

NFPA

NGA

NGCMA

NISO

NIMS

NIST/ITL

NPPC

NSC

NSAA

NADCA

NERC

NAESB

NALFA

NASPO

NSF

NIRMA

OLA

OPCC

OEOSC

OPEI

PMMI

PSA

PCA

PWMA

PMI

RPTIA

RSTC

RVIA

RESNA

RIA

RMA

SIA

SSFI

SIA

SMA

SPRI

SBS

SAE

SCTE

SMPTE

SVIA

SAAMI

SES

SDI

SJI

SSCI

TIA

TCATA

CI

TMS

SPI

TCA

TOY-TIA

TAPS

TCIA

TPI

USDA

USPRO

UL

UAMA

UAMA

UCC

VITA

WQA

WDMA

WCMA

WMMA

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


Structure of the u s standardization system

Structure of the U.S. Standardization System

  • 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 system1

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


Structure of the u s standardization system2

Structure of the U.S. Standardization System

  • 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.)


Structure of the u s standardization system3

Structure of the U.S. Standardization System

  • 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


Overview of the u s standards and conformity assessment system

Specifics:ANSI’s Roles and Responsibilities Internationally, Regionally, and Bilaterally


Overview of the u s standards and conformity assessment system

U.S. PUBLIC SECTOR

U.S. PRIVATE

SECTOR

U.S. GOVERNMENT

COMPANIES

TRADE ASSOCIATIONS

U.S.-Headquartered

STANDARDS DEVELOPING ORGANIZATIONS

EUROPEAN

COMMISSION / APEC

CONSUMER INTERESTS

OTHERS

REGIONAL

STANDARDIZATION

BODIES

(COPANT, PASC, ESOs)

Geneva-Headquartered

INTERNATIONAL

STANDARDIZATION

BODIES

(ISO, IEC)

FOREIGN NATIONAL

STANDARDS BODIES

(ANSI PEER BODIES)


Ansi international activities standardization

ANSI International Activities (Standardization)

  • 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 regional activities standardization

ANSI Regional Activities (Standardization)

  • 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

ESOs


Overview of the u s standards and conformity assessment system

Overview of Conformity Assessment


What is 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 system reliable flexible responsive1

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.

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

National Conformity Assessment Principles for the United States

www.ansi.org/ncap


Conformity assessment

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


Accredited 3 rd party hierarchy iso iec 17011 standard for accreditation bodies

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

Accreditation bodies

Assess competence

Conformity assessment bodies

Audit conformity

Supplier Organization


Components of conformity assessment

Components of Conformity Assessment

  • Metrology and measurement capabilities

  • Sampling

  • Testing

  • Inspection

  • Declaration of conformity

  • Certification (products, services, personnel)

  • Management system registration/certification

  • Accreditation (ANSI role)

  • Enforcement


Overview of the u s standards and conformity assessment system

International Recognition

is Essential

IAF

International Accreditation Forum

PAC

Pacific Accreditation Cooperation

EA

European Accreditation Cooperation

ILAC

International Laboratory Accreditation Cooperation

APLAC

Asia-Pacific Laboratory Accreditation Cooperation

IAAC

Inter American Accreditation Cooperation


Examples of accreditation programs in the united states

Examples of Accreditation Programsin the United States

Conformity Assessment (ISO/IEC 17011)

Standards

Accreditation Bodies:

ANSI

Accreditation Bodes:

A2LA

ANSI-ASQ NAB

IAS, L-A-B

PJLA, NVLAP

Accreditation Bodies:

A2LA

ANSI-ASQ NAB

IAS

Accreditation Bodies:

ANSI

Accreditation Bodies:

A2LA

ANSI

IAS

Accreditation Bodies:

ANSI-ASQ NAB

ANSI Procedures“EssentialRequirements”

ISO/IEC

17025

ISO/IEC

17024

ISO/IEC

17020

ISO/IEC

Guide 65

ISO/IEC

17021

ISO/IEC

14065

Greenhouse Gas Verifiers

InspectionBodies

PersonnelCertifiers

QMS/EMSCertifiers

ProductCertifiers

TestLabs

Standards Developing Organizations

and U.S. TAGs

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

Green-house Gas Emissions

Products (Procedures, Services)

QMS/EMS (ISO 9000/ ISO 14000)

Personnel

Products (Procedures, Services)


For more information

For more information

American National Standards Institute

HeadquartersOperations

1819 L Street, NW25 West 43rd Street

Sixth FloorFourth Floor

Washington, DC 20036New York, NY 10036

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

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

Gary Kushnier

Vice President, International Policy

202.331.3604

[email protected]


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