National Conformity Assessment Principles For the U.S.
Conformity assessment activities
form a vital link between standards and products, services, processes, systems, personnel
qualifications and organizations.
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.
I. 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 international understanding and recognition
of competently conducted U.S. conformity assessment processes resulting in increased acceptance
of U.S. products² within national and international markets. National and international 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.
II. 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 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 with the 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.
III. 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.
IV. 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 term
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
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.
nspection
Conformity evaluation by observation and judgment accompanied as appropriate by measurement,
testing or gauging.
Recognition
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 used by a Federal agency to provide recognition.
Registration
Procedure used to give written assurance that a system conforms tospecified 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.
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 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.
V. CONFORMITY ASSESSMENT PRINCIPLES
- Conformity Assessment requirements and procedures do
not create unnecessary obstacles to national/international trade.4
- 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.
- 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.
- The characteristics of a sector and the associated risks
of the product drive the conformity assessment requirements and procedures.
- 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.
- 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.5
- 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.6
- 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 conformity assessment bodies. Fees are not imposed in a
manner that restricts marketplace competition or creates unnecessary obstacles to trade.7
- 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.
- 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.
- As appropriate, conformity assessment bodies undertake
reasonable surveillance procedures to ensure continued product conformity and protection of their mark.
SUGGESTED READING
The World Trade Organization (WTO) Agreements
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/IEC Guide 2, International Organization for Standardization, Switzerland, 1996
ISO/IEC Compendium Conformity Assessment Guides and
Standards, 4th Edition, International Organization for Standardization, Switzerland, 1999
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.
³ ISO/IEC Guide 2, Standardization and related activities
— General vocabulary. Conformity Assessment terms in this Guide are subject to revision in
the forthcoming draft standard ISO/IEC 17000, Conformity assessment — General vocabulary and
functional approach.
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.
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 establishing 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 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 cancellation 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 measures 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
TBT Agreement.
This National Conformity Assessment
Principles for the United States document was approved by the ANSI Board of Directors on September
24, 2002.
