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: ANSI: Lane W. Hallenbeck, Vice President Conformity
Assessment; 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. ,,4

I ANSI Position Statement Issued Nov. 8,2002 "Reference to Standards and Building Codes".
2 IBID
3 IBID
4 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
American National Standards Institute
Position Statement
Issued November 8,2002

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 standards

developer, has chosen to develop the ICC/ANSI Al17.1-1998 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 fa.x: 202.293.9287

> N'.HNYork Offj(x~ 2S West 43rd Street, New York, 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 developers as a condition of maintaining

accreditation.
Overview Page 1 of2

eStanduds Store
Conformity Assessment Overview Espariol
About ANSI

r"'lembership Buyers in the global market demand that

sellers fulfill their needs. Competing suppliers
S tan dar d s Act i v i tie s are motivated to convey assurance to their
customers in the most efficient manner.
Co n f o rm ity Ass e ss rn ent
Confidence that these needs can and will be
Overview met is bu il t th roug h a variety of mea ns,
National Conformity including the assessment of conformity to
Assessment Principles for the standards.
United States
Product Certification
Accreditation Since ANSI promotes and facilitates standards that define
How to Apply requirements, it's logical that the Institute is concerned with and
Process Summary involved inactivities that assess conform ity. Governa nce of
Fee Structure Conform ity Assessment policy at ANSI flows from the Board of
ANSI Accredited Product Directors through the Conformity Assessment Policy Committee
Certification Bodies and (CAPC) to the International Conformity Assessment Committee (ICAC)
Applicants
and the Accreditation Committees and Councils.
Person n el Certification
Accreditation
How to Apply Conform ity Assessment is defined as "any activity concern ed with
Process Summary determ ining directly or indirectly that relevant requirements are
Fee Structure fulfilled". There are many of these conformity assessment activities
ANSI Accredited Personnel applied in today's marketplace including Accreditation, Certification,
Certification Bodies and
Inspection, Registra tion , Supplier's Declaration ,and Testing, but the
Applicants
one dimension that ANSI is directly engaged with is Accreditation.
FAQs
Quality Management Systems
Registration ANSI provides Accreditation services, specifically in product and
Environmental Management
personnel areas that recognize the competence of bodies to carry out
Systems Registration
product or personnel certification in accordance with requirements
Benefits
Procedures, Guides and Forms d efi ned in Intern ationa I Sta ndard s 3,7. AN S I Accred ita tion prog ra rris
ANSI - Accredited Certification are themselves created in accordance with similar international
Program Marks guidelines4 as verified by government and peer review assessments.
Corn rn ittees Fu rthermore, in part nersh ip with the Registra r Accre d itation Board
International Conformity (RAB), ANSI also serves the marketplace in the provision of a National
Assessment Committee
Accreditation Program (NAP) for Quality1,5 and Enviro nmental2,6
ma nagement systems registra rs

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
Consumer Affairs several international and regional arra nqernents for multi-I ateral
recognition. These include the International Accreditation Forum (IAF),
Government Affairs the Inter-American Accreditation Cooperation (IAAC) and the Pacific
Accreditation Cooperation (PAC). ANSI is also recognized by the U.S.
News & Publications
Department of Commerce via the National Institute for Standards and
r"'leetings & Events Technology (N 1ST) and their National Voluntary Conformity
Assessment System Evaluation (NVCASE) pro gra m.
Ed u cat ion & Tr a i n i n 9

Ot her S e r vic e s

l.i b r a r v
ISO 9001 :2000, Quality management systems - Requirements
Internet Resources

Car e e r 0 p port u nit i e s 2 ISO 14001, Environmental management systems - Specification with
guidance for use

3 ISO/IEC 17024, General requirements for bodies operating

certification of persons

4 ISOIIEC Guide 61, General requirements for assessment and

http://www.ansi.org/conformity assessmentloverview/overview.aspx?menuid=4 12/1/2003

Overview Page 2 of2

accreditation of certification/registration bodies

5 ISO/IEC Guide 62, General requirements for bodies operating

assessment and certification/registration of quality systems

6 ISO/IEC Guide 66, General requirements for bodies operating

assessment and certification/registration of environmental
management systems (EMS)

7 ISOIIEC Guide 65, General requirements for bodies operating

product certification systems

http://www.ansi.org/conformity_assessment/overview/overview.aspx?menuid=4 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 field-
tested 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 NIJ-
approved 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 assess-
ment 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.

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 pro-
viding 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 con-
ducted U.S. conformity assessment processes resulting in increased acceptance of U.S.
products- within national and intemational markets. National and intemational accept-
ance is vital to the continued economic health of the United States, as well as to the pro-
tection of human health, safety and the environment.

Because standards underlie all conformity assessment activities, this document is intend-
ed 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.

1 Also referred to as the Final Act of the 1986-1994 Uruguay Round of trade negotiations.

2 For purposes of this document, the term "product" includes products, services, processes, systems,
personnel qualifications and organizations.

I
, p

~ NATIONAL CONFORMITY ASSESSMENT PRINCIPLES FOR THE UNITED STATES

 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 sam-
pling and testing, inspection, supplier's declaration of conformity, certification and man-
agement system assessment and registration. It also includes accreditation of the compe-
tence of those activities by a third party and recognition (usually by a government agency)
of an accreditation program's capability.

While each of these activities is a distinct operation, they are closely interrelated. The
choice of the most appropriate assessment processes, as well as the quality with which any
one of them is performed, can have a significant effect on the confidence and reliance that
can be 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 there-
fore form a vital link between standards (which define the necessary characteristics or
requirements) and the products themselves. Conformity assessment can verify that a par-
ticular product meets a given level of quality or safety and can provide explicit or implic-
it information about its characteristics, the consistency of those characteristics and/or the
performance of the product. Conformity assessment, can also increase a buyer's confi-
dence in a product, furnish useful information to a buyer and help to substantiate adver-
tising and labeling claims. Information on conformance (or nonconformance) to a partic-
ular standard can provide an efficient method of conveying information needed by regu-
lators 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 ben-
efit from conformity assessment effectively. As the global marketplace continues to
evolve, buyers, regulators and suppliers will depend increasingly on standards and con-
formity 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, sup-
plier'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 regu-
latory confidence and protect public safety.

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 differ-
ent 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 Any activity concerned with determining directly or indirectly

that relevant requirements are fulfilled.

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 and judgment accompanied as appro-

priate by measurement, testing or gauging.

Recngnitlon 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 recog-
nition system is a set of one or more procedures l!sed by a Federal agency to provide
recognition.

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.

Sampling 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.

6 Supplier's Declaration Procedure by which a supplier gives written assurance that a

product, process or service conforms to specified requirements

Test Technical operation that consists of the determination of one or more characteristics
of a given product, material, equipment, organism, person s qualification, physical phe-
nomenon, 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.

3 ISO/IEC Guide 2, Standardization and related activities -General vocabulary. Conformity

Assessment draft standard ISO/IEe .
terms in this Guide are subject to revision in the forthcoming
17000, Conformity assessment - General vocabulary and functional approach.

NATIONAL CONFORMITY ASSESSMENT PRINCIPLES fOR THE UNITED STATES

 CONFORMITY ASSESSMENT PRINCIPLES

1. Conformity Assessment requirements and procedures do not create unnecessary

obstacles to national/international trade."

2. Conformity assessment requirements and procedures are open and transparent to all
applicants and provide them with equal treatment.

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 drive the
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.

(continued)

4 "Unnecessary obstacles to trade," as used in this Principle, is understood to be within the context
of the use and meaning of the WTO TBT Agreement. Information on a product's conformance to a
particular standard can provide an efficient method of conveying information needed by regulators,
customers, or society on the product's safety and suitability. Efficient, competently conducted,
market-relevant conformity assessment programs can often satisfy both regulatory and market
confidence needs with a single assessment to common or multiple requirements. Such programs can
facilitate simultaneous introduction of products globally. National Treatment of Conformity
Assessment Bodies (each country shall accord to the bodies of other countries treatment no less
favorable than that it accords to its own bodies) is one of the most effective means of facilitating
these kinds of programs.

NATIONAL CONFORMITY ASSESSMENT PRINCIPLES FOR THE UNITED STATES

1" x
 PRINCIPLES (CONTINUED)

6. Conformity assessment procedures are completed promptly and efficiently. Accurate

and timely information on the status of ongoing conformity assessments are provided
to applicants on request.>

7. Information requirements are limited to what is necessary to assess conformity and

determine fees. Protective measures are taken so that confidential or proprietary
information is not communicated to any person or organization not having legal right
to such information.f

8. All applicants who apply for conformity assessment are treated equally with respect
to the imposition of any fees charged. When fees are imposed, they are comparable
for all applicants, taking into account communication, transportation and other costs
arising from differences between location of facilities of the applicants and the con-
formity assessment bodies. Fees are not imposed in a manner that restricts market-
place competition or creates unnecessary obstacles to trade."

(continued)

5 Unnecessary delays in the performance of conformity assessment activities or the failure to keep
applicants apprised of the status of ongoing conformity assessment work can impede product entry
into the marketplace. As a result, such delays can cause economic injury to the affected companies,
restrict marketplace competition and create unnecessary and unacceptable barriers to trade.

Failure to provide timely information on programmatic changes in a conformity assessment scheme

can cause significant economic injury to stakeholders. Inadequate transition periods can also restrict
marketplace competition and create barriers to trade. Conformity assessment bodies should allow
applicants adequate time to make any necessary changes whenever possible. However, in estab-
lishing the transition period, conformity assessment bodies need to take into account any significant
risks to health, safety or the environment associated with noncompliance of the product to the new
requirements.

Where relevant, any certification mark, number or other identification that will be required on the
product's label or on the product's manual/accompanying documentation/packaging/carton should
be provided to the applicant at the time of application rather than after completion of the assessment.
Approval for its use on the product will of course be dependent on the applicant's successful
fulfillment of all conformity assessment requirements. If the certification mark, number or other
identification is only provided after completion of the assessment, the applicant cannot begin to
8 prepare for product distribution. This will delay time-to-market for the product. If, on the other
hand, the mark, number or other identification is provided up-front, the applicant can proceed with
preparation for distribution if the applicant is willing to assume the risks associated with cancella-
tion of packaging in the event that the product fails the assessment.

6 All companies and personnel have the right to have any proprietary information that they provide
to conformity assessment bodies protected. Conformity assessment bodies should restrict access to
such information to persons or organizations that have a legal right to such records. Protective meas-
ures should be taken so that such information is not provided or accidentally released to any person
or organization (not having legal right to such information) thereby decreasing the value of the
information to the company. Failure by conformity assessment bodies to adequately protect such
information can cause serious and unacceptable economic injury to the affected companies.

7 "Unnecessary obstacles to trade," as used in this Principle, is understood to be within the context
of the use and meaning of the WTO TBTAgreement.
PRINCIPLES (CONTINUED)

9. 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.

10. 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, conformity assessment bodies undertake reasonable surveillance

procedures to ensure continued product conformity and protection of their mark.

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 Conformity Assessment Principles for the United States
document lvas approved by the /1NSI BO(1i'd of Directors on September 24, 2002.
American National Standards Institute

AMERICAN NATIONAL STANDARDS INSTITUTE

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: info@ansi.org
W: web.ansi.org

An electronic version of this text is available

via ANSI Online (http://www.ansi.org/ca)