Mfr Nara- T8- Ansi- Ansi Briefing- 12-3-03- 00020

COMMISSION SENSITIVE

[Unclassified]

MEMORANDUM

FOR THE RECORD

Event: Meeting with American National Standards Institute (ANSI) Type of event: Briefing Date: Dec. 3, 2003 Special Access Issues: NA Prepared by: Emily Walker Team Number: 8 Location: 1819 L Street, Washington, D.C. 20036 Participants - Non-Commission: Assessment;

ANSI: Lane W. Hallenbeck, Vice President Conformity

Matthew Deane, Homeland Security Program, Fran Schrotter;

Emergency Corps Program, NY Safety Council: William G. Raisch Participants - Commission: Emily Walker

The purpose of this meeting at ANSI was to determine what procedures the organization had in place to develop standards and certify compliance officers for these standards. ANSI is the "policy forum for the U.S. voluntary consensus standards and conformity assessment communities and is recognized by both the public and private sectors in this regard'".

"A

primary goal of the American National Standards development process is to provide standards that improve the quality of life in the US, promote US Business products and practices globally, and enable a public-private sector partnership that provides more flexibility than the Government rule-making process."

2

ANSI's standards are accepted widely by industry and the Gov~rnment.

ANSI does not "review or endorse the content of an American National Standard".

3

"ANSI's

approval of a standard as such provides assurance that the standard was developed in compliance with all of ANSI's due process-based requirements.

The ANSI process ensures that there is an

opportunity for all those who are interested in and affected by a standard to participate in its development.

I 2 3

4

,,4

ANSI Position Statement Issued Nov. 8,2002 "Reference to Standards and Building Codes". IBID IBID IBID

COMMISSION SENSITIVE

COMMISSION SENSITIVE

The meeting focused on the role that ANSI could play in helping the Commission lead the development of emergency preparedness standards. ANSI does perform this role in many instances, and particularly is performing a coordinating role for standards for homeland security. They have the capability, practice and experience to perform this role. They are interested in participating with the Commission.

The final consensus of the meeting is that I would write up an action plan for the 9-11 Commission to approve which would be to set up a panelled by ANSI to develop standards for emergency preparedness for the private sector and submit recommendations to the Commission by April 15. The Commission would write a fonnalletter to ANSI requesting this action and ANSI would get Board approval. The group would be invited in January to convene. The Commission would work with ANSI to develop the participants and the discussion topics. A separate panel would be set up for recommending incentives.

Attachments: ANSI Position Statement in Reference to Standards and Building Codes ANSI Conformity Assessment Overview ANSI National Conformity Assessment Principles for the U.S.

COMMISSION SENSITIVE

ANSI

Position Statement Issued November 8,2002

American National Standards Institute

ANSI Position Statement

on Reference

to Standards

and Building Codes

The American National Standards Institute (ANSI) is the policy forum for the U.S. voluntary consensus standards and conformity assessment communities and is recognized by both the public and private sectors as such. Among other things, ANSI accredits standards developers and approves standards as American National Standards when those standards were developed in accordance with the requirements set forth in the ANSI Procedures for the Development and Coordination of American National Standards.

While ANSI

believes that the approval of a document as an American National Standard indicates that a developer has undertaken steps to ensure that the standard represents a consensus of involved and affected stakeholders and is thus beneficial to the public interest, ANSI also recognizes that no single standardization system can address all the needs of the vast diversity of sectors within the United States. ANSI is pleased that the National Fire Protection Association (NFPA), an ANSI Accredited Standards Developer, has chosen to develop and approve NFPA 5000™, Building Construction and Safety Cadet», as an . American National Standard. Approval of a document as an American National Standard (ANS) indicates that the sponsor of that document voluntarily subjected the standard to an open, transparent, consensus development process subject to ANSI's neutral third-party oversight. Participation by a developer in the ANS process establishes a connection between that developer and the larger recognized network of ANSI-accredited standards developers who consider the interests of key stakeholders in industry, consumers, government and the public in developing American National Standards. ANSI is pleased that the International Code Congress (ICC), also an ANSI-accredited developer, has chosen to develop the ICC/ANSI Al17.1-1998

standards

Accessible and Usable Buildings and Facilities

standard as an American National Standard. At the same time, ICC has chosen not to submit its International Building Codes for approval as American National Standards.

(continued)

HeadquartQrs

1819 L Street, NW, Wa~hington

D.C. 20036 • Tel: 202,293,8020

> N'.HNYork Offj(x~ 2S West 43rd Street, New York,

fa.x: 202.293.9287

NY 10036 • Tel: 212..642.4900 Fax: 212.398.0023

www.ansLorg

A primary goal of the American National Standards development process is to provide standards that improve the quality of life in this country, promote U.S. business products and practices globally, and enable a public-private partnership that provides more flexibility than the government rule-making process. The wide acceptance of American National Standards by industry and the government regardless of the standards development method used is evidence that the ANSI process is in harmony with the needs of those who use standards. ANSI-accredited

standards developing organizations - and the experts that populate the consensus

bodies of these groups as voting members - serve an important public interest function in devising American National Standards.

The public interest is both served and protected if the standards developer is accredited by

ANSI and if its development process meets the Institute's requirements for openness, balance, consensus and other due process safeguards. ANSI does not review or endorse the content of an American National Standard.

ANSI's approval of a

standard as such provides assurance that the standard was developed in compliance with all of ANSI's due process-based requirements.

The American National Standards process ensures that there is an opportunity for

all those who are interested in and affected by a standard to participate in its development.

Due process is key

to ensuring that American National Standards are developed in an environment that is equitable, accessible and responsive to the requirements of various stakeholders.

The ANS process includes a series of checks-and-

balances that provide comprehensive due process safeguards: •

Appeals provisions relating to the ANSI-accredited

status of ANS developers and the approval of a

standard as an ANS; •

Equal access to voting member status on consensus bodies;

•

Public notice requirements at various phases in the development cycle, including an opportunity for public review and comment on all substantive drafts of the proposed standard;

•

Consideration of all comments received whether from a voting member of

a consensus

body or a

public review commenter; and •

Mandatory procedural audit of all ANSI-accredited accreditation.

developers as a condition of maintaining

Overview

Page 1 of2

eStanduds About

Store

Conformity

Assessment

Espariol

Buyers in the global market demand that sellers fulfill their needs. Competing suppliers are motivated to convey assurance to their customers in the most efficient manner. Confidence that these needs can and will be met is bu il t th roug h a variety of mea ns, including the assessment of conformity to standards.

r"'lembership S tan

Overview

ANSI

dar d s Act i v i tie

Co n f o rm ity

s

Ass e ss rn ent

Overview National Conformity Assessment Principles United States Product Certification Accreditation

for

the

How to Apply Process Summary Fee Structure ANSI Accredited Product Certification Bodies and Applicants Person n el Certification Accreditation

How to Apply Process Summary Fee Structure ANSI Accredited Personnel Certification Bodies and Applicants FAQs Quality

Management

Environmental Management Systems Registration Benefits Procedures, Guides and Forms ANSI - Accredited Certification Program Marks Corn rn ittees

Conformity Committee

Consumer

Affairs

Government News

Affairs

& Publications

r"'leetings

&

Ed u cat ion Ot her

Conform ity Assessment is defined as "any activity concern ed with determ ining directly or indirectly that relevant requirements are fulfilled". There are many of these conformity assessment activities applied in today's marketplace including Accreditation, Certification, Inspection, Registra tion , Supplier's Declaration ,and Testing, but the one dimension that ANSI is directly engaged with is Accreditation.

Systems

Registration

International Assessment

Since ANSI promotes and facilitates standards that define requirements, it's logical that the Institute is concerned with and involved inactivities that assess conform ity. Governa nce of Conform ity Assessment policy at ANSI flows from the Board of Directors through the Conformity Assessment Policy Committee (CAPC) to the International Conformity Assessment Committee (ICAC) and the Accreditation Committees and Councils.

Events

ANSI provides Accreditation services, specifically personnel areas that recognize the competence product or personnel certification in accordance

in product and of bodies to carry with requirements

out

d efi ned in Intern ationa I Sta ndard s 3,7. AN S I Accred ita tion prog ra rris are themselves created in accordance with similar international guidelines4 as verified by government and peer review assessments. Fu rthermore, in part nersh ip with the Registra r Accre d itation Board (RAB), ANSI also serves the marketplace in the provision of a National Accreditation ma nagement

Program systems

(NAP) registra

for Quality1,5 rs

and

Enviro

nmental2,6

Continuing pressures in the global marketplace to preclude redundant and costly barriers to trade dri ve the need for acknowledgement of equivalency across boundaries. AccordinglY,ANSI is involved in several international and regional arra nqernents for multi-I ateral recognition. These include the International Accreditation Forum (IAF), the Inter-American Accreditation Cooperation (IAAC) and the Pacific Accreditation Cooperation (PAC). ANSI is also recognized by the U.S. Department of Commerce via the National Institute for Standards and Technology (N 1ST) and their National Voluntary Conformity Assessment System Evaluation (NVCASE) pro gra m.

& Tr a i n i n 9

S e r vic e s

l.i b r a r v Internet Car e e r

Resources 0 p port

u nit i e s

ISO

9001 :2000,

management

2 ISO 14001, guidance

http://www.ansi.org/conformity

Quality

Environmental for use

3 ISO/IEC certification

17024, General of persons

4 ISOIIEC

Guide

61,

management

requirements

General

requirements

systems

- Requirements

systems

for bodies

- Specification

operating

for assessment

assessmentloverview/overview.aspx?menuid=4

with

and

12/1/2003

Overview

Page 2 of2

accreditation 5 ISO/IEC assessment

of certification/registration Guide and

bodies

62, General requirements certification/registration

for bodies operating of quality systems

6 ISO/IEC Guide 66, General requirements assessment and certification/registration management systems (EMS)

for bodies operating of environmental

7 ISOIIEC Guide 65, General product certification systems

requirements

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

for bodies

operating

12/1/2003

Certification and Accreditation: Models in the United States and Their Possible Uses in Homeland Security Mary Saunders National Institute of Standards and Technology ANSI-Homeland

Security Standards Panel Meeting June 9-10, 2003

Conformity Assessment • Definition: Any activity concerned with determining directly or indirectly that requirements are fulfilled • Relevant to requirements for products, services, systems and organizations • May be conducted by: - a supplier (first party) - a buyer (second party) - an organization independent of both buyer and seller (third party)

1

Characteristics of the U.S. Conformity Assessment System • Conformity assessment activities are not centrally organized • Activities are a mix of government (regulatory programs) and private sector (market-based programs) • Approaches vary among sectors

Supplier's Declaration of .Conformity • Examples: consumer products, motor vehicles, IT equipment • Possible elements: - In-house testing - Third party testing - Supplier quality system

• Responsibility lies with the supplier to ensure requirements are met

2

Second Party Programs • Examples: large distributors, manufacturers buying components from a variety of sources, procurement entities • Necessary condition: significant buying power • Possible elements: - Buyer testing to own specifications - Third party testing to buyer specifications - Supplier quality system

• Responsibility shared by supplier and buyer

Third Party Programs • Examples: certification of electrical safety of equipment used in the workplace, telecommunications equipment • Required elements: -

Impartiality Competent personnel Quality system Ability to conduct follow-up assessments

• Responsibility shared among buyer, supplier and certifier

3

Role of Accreditation • Definition: procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks • Possible applications: -

Testing and calibration laboratories Inspection bodies Certification bodies (product, system and personnel) Management system registrars

• Builds confidence through independent evaluation and verification of technical competence

Conformity Assessment: Possible Homeland Security Applications • To verify/validate performance characteristics for products and systems - For product listing - For comparative evaluation - Etc.

• To establish levels of protection • To determine interoperability • To establish the competence of training course providers • To verify personnel competencies

4

Examples of Current Programs • FAA's Security Technology Deployment Office - Mission is to identify, test, select and deploy advanced technology security systems to improve domestic aviation security - Equipment may be qualified, assessed as effective, or certified - Involves in-house testing and evaluation

Examples of Current Programs • National Institute of Justice (NIJ) - Administers testing programs for commercially available law enforcement and corrections equipment to ensure that equipment utilized in the field is safe, reliable and meets the needs of the user community - Conducts: • standards-based testing to confirm compliance with N IJ standards • comparative evaluation programs where equipment is fieldtested and test data published, allowing users to select the product that best suits their needs and requirements

- Testing is conducted both in-house and in NIJapproved independent laboratories

5

Examples of Current Programs • NIJ partnership for certification of chemical/biological agent protective ensembles - NFPA 1994 adopted by reference by NIJ • Outlines performance requirements, test protocols, certification and application procedures

- Testing and certification program conducted by the Safety Equipment Institute - Certified equipment eligible for grant funding

Factors in Determining Program Characteristics • Specific approach will depend on: - Risk associated with product, system, personnel failure - Breadth/specificity of need - Stability of technology - Number and range of product and system providers

• Goal: effective, efficient progra-ms that meet user needs; assure requirements are met

6

Challenges • Existing equipment must be tested for neW applications • Primary need is for assessment of field performance, not performance in a controlled environment • Diverse threats • Potentially diverse user requirements • Different needs and capabilities

Relationship between Standards and Conformity Assessment • Use of well-written standards in a conformity assessment process adds credibility and validity to the process • Standards should specify all essential characteristics of a product • Test methods should be capable of evaluating the conformity of a product to the specified requirements in a manner that produces test results that are within an acceptable accuracy range • Results should be consistent from test to test • Results should be reproducible

7

Range of Homeland Security Standards-related Needs • Guides to instruments • Performance standards • Test methods • Testing protocols • Certification procedures ~ technical specifications and evaluation criteria • Proficiency testing programs • Measurement Assurance Programs

8

NArION.Al. CONI~~O:llNl[]~Y~ ASSI£SS}\tfl~N~r

:PRIN CIPlJl~S }?()R'rIlE

UNIrfED

SrfKfES

Conformity assessment activities form a vital link between standards and products, services, processes, systems, personnel qualifications and organizations.

American National Standards Institute

AMERICAN

NATIONAL

STANDARDS

INSTITUTE

The American National Standards Institute (ANSI) is a private non-profit organization that administers and coordinates U.S. voluntary standardization and conformity assessment activities. Its mission is to enhance U.S. global competitiveness and the American quality of life by promoting, facilitating and safeguarding the integrity of the voluntary standardization system.

2

NATIONAL

CONFORMITY

ASSESSMENT

PRINCIPLES

FOR THE UNITED

STATES

a

PURPOSE

The "National Conformity Assessment Principles for the United States" articulates the principles for U.S. conformity assessment activities that will allow consumers, buyers, sellers, regulators and other interested parties to have confidence in the processes of providing conformity assessment, while avoiding the creation of unnecessary barriers to trade. We base these principles on the conformity assessment language in the Agreement on Technical Barriers To Trade, one of the agreements within the World Trade Organization (WTO).1 These principles supplement the language of the agreement to give additional clarity and focus to conformity assessment in the United States. We intend the concise and clear presentation of these principles for the United States to promote national and intemational understanding and recognition of competently conducted U.S. conformity assessment processes resulting in increased acceptance of U.S. products- within national and intemational markets. National and intemational acceptance is vital to the continued economic health of the United States, as well as to the protection of human health, safety and the environment. Because standards underlie all conformity assessment activities, this document is intended to be a companion to the principles of the U.S. standards system as described in the "National Standards Strategy for the United States." These two sets of principles should be considered together in the evaluation of standards and conformity assessment activities and related issues.

3

1

Also referred to as the Final Act of the 1986-1994

2 For

Round of trade negotiations.

purposes of this document, the term "product" includes products, services, processes, systems,

personnel

,

Uruguay

qualifications

and organizations.

p

~

NATIONAL

CONFORMITY

ASSESSMENT

PRINCIPLES FOR THE UNITED STATES

I

m

CONFORMITY

ASSESSMENT

ISO/IEC Guide 2: 1996, Standardization and related activities - General vocabulary, defines Conformity Assessment as "any activity concerned with determining directly or indirectly that relevant requirements are fulfilled." Conformity assessment includes sampling and testing, inspection, supplier's declaration of conformity, certification and management system assessment and registration. It also includes accreditation of the competence of those activities by a third party and recognition (usually by a government agency) of an accreditation program's capability. While choice one of can be

each of these activities is a distinct operation, they are closely interrelated. The of the most appropriate assessment processes, as well as the quality with which any them is performed, can have a significant effect on the confidence and reliance that placed on the results of the entire conformity assessment.

The evolution of the global marketplace has made buyers and regulators increasingly dependent not only on standards but also on the methods used to ensure that products comply withthe requirements of those standards. Conformity assessment activities therefore form a vital link between standards (which define the necessary characteristics or requirements) and the products themselves. Conformity assessment can verify that a particular product meets a given level of quality or safety and can provide explicit or implicit information about its characteristics, the consistency of those characteristics and/or the performance of the product. Conformity assessment, can also increase a buyer's confidence in a product, furnish useful information to a buyer and help to substantiate advertising and labeling claims. Information on conformance (or nonconformance) to a particular standard can provide an efficient method of conveying information needed by regulators or buyers on the product's safety and suitability. Because conformity assessment forms a vital link between standards that define product characteristics or requirements and the products themselves, stakeholders in conformity assessment must better understand these conformity assessment principles to use and benefit from conformity assessment effectively. As the global marketplace continues to evolve, buyers, regulators and suppliers will depend increasingly on standards and conformity assessment to assure that products fulfill specified requirements. Understanding these conformity assessment principles will aid stakeholders in their decision-making regarding conformity assessment usage. In addition, such understanding will encourage stakeholders in conformity assessment to work towards harmonization of requirements and the global acceptance of all competently performed conformity assessments.

4

rm

ApPLICABILITY

OF PRINCIPLES

The principles in this document may be beneficial to either first, second or third parties or to government users of conformity assessment, as well as to any of the different types of conformity assessment activities (accreditation, certification, inspection, registration, supplier's declaration of conformity, and testing). There is no one-size-fits-all solution. Industry, government, consumers and other users rely on the results of the conformity assessment to meet the needs of supplier and acceptance authorities in a cost-effective manner. Consideration should be given to approaches that facilitate trade, provide regulatory confidence and protect public safety.

5

NATIONAL

CONFORMITY

ASSESSMENT

PRINCIPLES FOR THE UNITED STATES

DEFINITIONS The definitions in this document are based on ISO/IEC Guide 2: 1996.3 Some variances, noted in italics, occur where the term is not in Guide 2 or has another specific meaning in the United States. Definitions are included in this document to preclude confusion and to make it more understandable. In different contexts, the same tenn can mean very different types of activities. Accreditation Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. (These tasks include sampling and

testing, inspection, certification and registration.) Certification Procedure by which a third party gives written assurance that a product, process, service or person conforms to specified requirements. Conformity Assessment that relevant requirements

Any activity concerned with determining are fulfilled.

directly or indirectly

First, Second and Third Party The first party is usually the supplier. The second party is usually the customer. The third party is that person or body that is recognized as being. independent of the parties involved, as concerns the issue in question. Inspection Conformity evaluation by observation priate by measurement, testing or gauging.

and judgment

accompanied

as appro-

Procedure used to provide formal notice that an accreditation body is competent to carry out specific tasks. These tasks include accreditation of testing laboratories and inspection, certification and registration bodies. A governmental recognition system is a set of one or more procedures l!sed by a Federal agency to provide recognition.

Recngnitlon

Registration Procedure used to give written assurance that a system conforms to specified requirements. Such systems include those established for the management of product, process or service quality and environmental performance.

The selection of one or more specimens of a product, process or service for the purpose of evaluating the conformity of the product, process or service to specified requirements. Sampling

6

Supplier's Declaration Procedure by which a supplier gives written assurance product, process or service conforms to specified requirements

that a

Test Technical operation that consists of the determination of one or more characteristics of a given product, material, equipment, organism, person s qualification, physical phenomenon, process or service according to a specified technical procedure (test method). Testing

Action of carrying out one or more tests.

Test Method

Specified technical procedure for performing

a test.

General vocabulary. Conformity draft standard ISO/IEe . 17000, Conformity assessment - General vocabulary and functional approach.

3

ISO/IEC Guide 2, Standardization and related activities -

Assessment

terms in this Guide are subject to revision in the forthcoming

NATIONAL

CONFORMITY

ASSESSMENT

PRINCIPLES fOR THE UNITED STATES

CONFORMITY

ASSESSMENT

1.

Conformity Assessment requirements and procedures obstacles to national/international trade."

2.

Conformity assessment requirements and procedures applicants and provide them with equal treatment.

PRINCIPLES do not create unnecessary

are open and transparent

to all

All parties desiring to have their products, processes, services or personnel assessed for compliance with relevant requirements are allowed to make application to any conformity assessment body and have their applications accepted and processed in a reasonable time.

3.

Conformity assessments are competently conducted and based on appropriate standards requirements and procedures. Conformity assessment requirements and procedures are based on international guides and standards to the extent feasible. Organizations conducting conformity assessment are encouraged to demonstrate their competency to conduct conformity assessment activities using accepted standards and requirements for conformity assessment, either through formal recognition or accreditation activities or by maintaining adequate records and documentation that are available for public review.

4.

The characteristics of a sector and the associated risks of the product conformity assessment requirements and procedures.

5.

Information on all conformity assessment requirements and procedures for obtaining conformity assessments are publicly available. Information on costs and processing times are available at any time to all applicants.

drive the

(continued)

7

4 "Unnecessary

obstacles

to trade," as used in this Principle,

of the use and meaning of the WTO TBT Agreement. particular customers,

standard can provide an efficient method of conveying or society on the product's

market-relevant confidence facilitate Assessment favorable

is understood

Information

conformity

safety and suitability.

assessment

programs

needs with a single assessment simultaneous Bodies

introduction

(each country

to be within the context

on a product's information Efficient,

can often satisfy

competently

both regulatory

to common or multiple requirements.

of products shall accord

than that it accords to its own bodies)

globally.

National

conformance

conducted, and market

Such programs

Treatment

to the bodies of other countries is one of the most effective

to a

needed by regulators,

can

of Conformity treatment

no less

means of facilitating

these kinds of programs.

NATIONAL 1"

x

CONFORMITY

ASSESSMENT

PRINCIPLES FOR THE UNITED STATES

PRINCIPLES 6.

Conformity

assessment

and timely

procedures

information

to applicants

7.

(CONTINUED)

of ongoing

promptly

and efficiently.

conformity

assessments

Accurate

are provided

on request.>

Information

requirements

determine

are completed

on the status

fees.

information

are limited

Protective

to what

measures

is not communicated

is necessary

are taken

to any person

to assess

so that

conformity

confidential

or organization

and

or proprietary

not having

legal right

to such information.f

8.

All applicants

who apply

for conformity

to the imposition

of any fees charged.

for all applicants,

taking

arising

from differences

formity place

assessment

into account between

bodies.

competition

or creates

assessment When

are treated

communication,

location

equally

fees are imposed,

transportation

of facilities

and other costs

of the applicants

Fees are not imposed

in a manner

unnecessary

to trade."

obstacles

with respect

they are comparable and the con-

that restricts

market-

(continued) 5 Unnecessary

applicants

delays in the performance

into the marketplace. restrict marketplace

assessment

can cause significant marketplace

economic

competition adequate

lishing the transition

activities or the failure to keep

assessment

work can impede product entry

As a result, such delays can cause economic competition

and create unnecessary

Failure to provide timely information

applicants

of conformity

apprised of the status of ongoing conformity

on programmatic

Inadequate

and create barriers to trade.

period, conformity

risks to health, safety or the environment

assessment

scheme

transition periods can also restrict

Conformity

changes

assessment

barriers to trade.

changes in a conformity

injury to stakeholders.

time to make any necessary

injury to the affected companies,

and unacceptable

assessment

whenever

bodies should allow

possible.

However,

in estab-

bodies need to take into account any significant

associated

with noncompliance

of the product to the new

requirements. Where relevant, product's

any certification

mark, number or other identification

label or on the product's

manual/accompanying

be provided to the applicant at the time of application Approval

for its use on the product

fulfillment

8

of all conformity

identification prepare

is only provided

for product

for distribution

tion of packaging 6 All companies

to conformity

if the applicant

is provided

and personnel

up-front, the applicant

have the right to have any proprietary

bodies protected.

to persons or organizations

Conformity

cannot begin to If, on the other can proceed with with cancella-

(not having

assessment

is not provided

legal right to such information)

to the company.

information

can cause serious and unacceptable

Failure by conformity

economic

of the WTO TBTAgreement.

or accidentally thereby

assessment

that they provide

released to any person

decreasing

the value of the

bodies to adequately

protect such

injury to the affected companies.

obstacles to trade," as used in this Principle,

of the use and meaning

information

bodies should restrict access to

that have a legal right to such records. Protective meas-

information

7 "Unnecessary

the applicant

for the product.

is willing to assume the risks associated

ures should be taken so that such information or organization

successful

mark, number or other

in the event that the product fails the assessment.

assessment

such information

of the assessment,

should

of the assessment.

on the applicant's

If the certification

This will delay time-to-market

hand, the mark, number or other identification preparation

be dependent

requirements.

after completion

distribution.

rather than after completion

will of course

assessment

that will be required on the

documentation/packaging/carton

is understood

to be within the context

PRINCIPLES 9.

10.

(CONTINUED)

The location, timing and sample selection process for the conformity assessment work are chosen in a manner that enables competent conformity assessment and minimizes inconvenience and costs to applicants. When requirements

and procedures

change, stakeholders

are notified expeditiously.

Transition periods allow applicants adequate time to make necessary changes. However, the transition period takes into account any significant risks to health, safety or the environment associated with noncompliance of the product to the new requirements.

11.

Organizations conducting conformity assessment have effective procedures for reviewing complaints, and such procedures are open to all stakeholders. Organizations take appropriate corrective action whenever they justify a complaint.

1 2. As appropriate, procedures

conformity assessment bodies undertake reasonable surveillance to ensure continued product conformity and protection of their mark.

9

I

NATIONAL

CONFORMITY

ASSESSMENT

PRINCIPLES FOR THE UNITED STATES

! ! i

SUGGESTED

READING

The World Trade Organization

(WTO) Agreements

(also known as) Final Act of the 1986-1994 Uruguay Round of trade negotiations AGREEMENT ON TECHNICAL BARRIERS TO TRADE (Article 5: Procedures for Assessment of Conformity by Central Government Bodies; Article 6: Recognition of Conformity Assessment by Central Government Bodies; Article 7: Procedures for Assessment of Conformity by Local Government Bodies; Article 8: Procedures for Assessment of Conformity by Non-Governmental Bodies; and Article 9: International and Regional Systems) Breitenberg, Maureen A., The ABC's of the U.S. Conformity Assessment System, U.S. Department of Commerce, Technology Administration, National Institute of Standards and Technology (NIST), April 1997 ISO/lEC Guide 2, International

Organization

for Standardization,

Switzerland,

1996

ISO/lEC Compendium Conformity Assessment Guides and Standards, 4th Edition, International Organization for Standardization, Switzerland, 1999

10

This National document

Conformity

lvas approved

Assessment

by the /1NSI

Principles for the United States

BO(1i'd of Directors

on September

24, 2002.

American National Standards Institute

AMERICAN

NATIONAL

STANDARDS

Headquarters 1819 LStreet, NW Sixth Floor Washington, DC 20036

T:

202.293.8020

F:

202.293.9287

New York Office 25 West 43rd Street New York, NY 10036

T:

212.642.4900

F:

212.398.0023

E:

[email protected]

W:

web.ansi.org

An electronic version of this text is available via ANSI Online (http://www.ansi.org/ca)

INSTITUTE