•

NBSIR 87-3576

The ABC'S OF STANDARDS-RELATED

ACTIVITIES IN THE UNITED STATES

Maureen A. Breitenberg

U.S. DEPARTMENT OF COMMERCE

National Bureau of Standards

Standards Code and Information

Office of Product Standards Policy

Gaithersburg, MD 20899

May 1987

J

U.S. DEPARTMENT OF COMMERCE, Malcolm Baldrige, Secretary

NATIONAL BUREAU OF STANDARDS. Ernest Ambler, Director

REPRODUCED BY

U.S. DEPARTMENT OF COMMERCE

NATIONAL TECHNICAL

INFORMATION SERVICE

SPRINGFIELD, VA 22161

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REPORT NO.

BIBLIOGRAPHIC DATA NBSIR 87/ I PB8? - 224309 ASMay 1987

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The ABC's of Standards Related Activities in the United States

5. AUTHOR(S)

Maureen A. Breitenberg

,. PERFORMING ORGANIZATION (If jo/nl or other than N8S. lee Inurucl/on')

NATIONAL BUREAU OF SfANDARDS

U.S. DEPARTMENT OF COMMERCE

GAITHERSBURG, MD 20899

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•• Type of Report & Period eo"'ered

Final

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NBS Category No. . KB8- I~O

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11. A,BSTRACT (A 200·word or less focluol summary of mO.1 ",n'f'conl Info""ollon. If /locumenl Includ.. a ",n'(lconl

b,blio,rophy or IIlerolure sur.ey. menlion II here)

This report provides an introduction to voluntary standardization. product certification and laboratory accreditation for a reader who is not fully familiar with these topics. It highlights some of the more important aspects

of these fields; furnishes the reader with both historical and current

infonnation on these topics; describes the importance and impact of the

development and use of standards; and serves as background for using available

documents and services.

U. KEY WORDS (Si" 10 Iwe'..e enlries; olphobelicol order; c~jlolize only proper names; and uporote key _rds by semicolonS)

certification; inspection; laboratory accreditation; standardization; standards;

testing

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Foreword

The Standards Code and Information Program in the NBS Office of Product Standards

Policy from time to time develops and publishes standards-related documents as a

service to producers and users of standards and certification systems, both in

the government and in the private sector. This report has been designed as an

introdur.tion to standardization, certification, and laboratory accreditation for

those not fully familiar with these fields and their interrelationships. We hope

that this material will be informative and will also serve to stimulate wider and

more profitable applications of standardization. In addition, the interested

reader mdY wish to take further advantage of other available publications and

services provided by this office, some of which are described in the appendix.

Donald R. Mackay

Manager, Standards Code and Information

Office of Product Standards Policy

Preceding page blank iii
\v
Table of Contents

Page

Foreword 1

Acknowledqements ••••••• ••••••••••••••••••••••••••••••••••••••••••••• 111

Abstract •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• iv

Introduction 1

Background ••••••••••••••••••••••••••••••••••••••••••••••••••••·••••••••• 1

HIstorical Notes on Standardization ••• •••••••••••••••••••••••••••••••• 2

Types of Standards •••••••••••••• •••••••••••••••••••••••••••••••••••••• 3

Private Standards Organizations in the U.S ••••••••••••••••••••••••••••• 5

Standards Development Procedures ••••••••••••••••••••••••••••••••••••••• 7

Benefits and Problems of Standardization ••••••••••••••••••••••••••••••• 7

Certiflcation •••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 8

Laboratory Accreditation •••••••••••••••••••••••••••••••••••••••••••••• 10

Summary •••••••••••••••••••••••••••••••••'•••••••••••••••••••••••••••••• 11

Appendi>e •••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 12

Footnotes ..••••••••••••••••••••••••••••••••••••••••••••••••••••••••••• 15

Preceding page blank y

Acknowledgements

1 would like to thank Tom Kelsey, International Trade Administration; dipl.- Ing.

Alfonse F. Donko, Deputy Managing Director, Osterreichisches Normungsinstitut

(ON), and many others for their careful review of and comments on this document.

1 would especially like to thank Walter Leight, OPSP, who oversaw the preparation

of many of the initial drafts of this document.

Maureen A. Bre1tenberg

Standards Code and Information

Preceding page blank vii

Abstract

ThiG report provides an introduction to voluntary standardization, product.

certification and laboratory accreditation for a reader who is not fully familiar

with these topics. It highlights some of the more important aspects of these

fields; furnishes the reader with both historical and current information on

these topics; descrlbes the importance and impact of the development and use of

standards; and serves as background for using available documents and services.

K~y Words: Certification; inspection; laboratory accreditation; standardization;

standards; testing

Preceding page blank ix

Introduction

-The inch is a standard of measurement.

Honey is a standard of exchange.

Words are standards of communication.

Traffic lights are safety standards.

Octane numbers of gasoline are quality standards.

'No more than l' shrinkage' is a performance standard.- ·!I

As the above indicates, standardization has a major impact on our lives, yet .ost

people know little about the process or about the standards the••elves. They know

that camera film marked ISO 100 is likely to give good results in a ca.era with

the film speed set at 100, but few understand that the ISO 100 marking on the

package means that the film conforms to a standard established by the

International Organization for Standardization (ISO), an international

organization that writes standards. Few people question that three-holed

notebook paper will align with the three rings in .ost notebooks, yet such

confidence would not be possible without standards. While driving we are on the

lookout for hexagonal, not round or square-shaped stop signs, just as we know

that inverted triangles indicate where traffic should yield. These are just a

few of the thou~ands of standards that impact on our lives.

Because standards have such an impact, it is important to have some familiarity

with what they are and how they are developed and used. This paper is designed

to be an introduction to some of the more significant aspects of standards

development, product certification, and laboratory accreditation. It will also

discuss some of the benefits and problems associated with these processes. The

interested reader is encouraged to increase his knowledge of the field by taking

advantage of other available publications and services described in the appendix.

Background

A standard was defined by the National Standards Policy Advisory Committee as:

"A prescribed set of rules, conditions, or requirements concerning

definitions of terms; classification of components; specification of materials,

performance, or operations; delineation of procedures; or measurement of quantity

and quality in describing materials, products, systems, services, or practices.-

~/

Though often unrecognized, standards can help to assure health and safety and to

increase the quality of life. Standards are vital tools of industry and

commerce. They often provide the basis for buyer-seller transactions, hence they

have tremendous impact on companies and nations, and even on the economic fabric

of the world market.

In the United States alone, approximately 30,000 current voluntary standards have

been developed by more than 400 organizations. These do not include a much

greater number of procurement specifications (developed and used by Federal,

State, and local procurement authorities), as well as mandatory codes, rules and

regulations containing standards developed and adopted at Federal,
State, and local levels. In addition, numerous foreign national, regional and

international organizations produce standards of interest and importance to U.S.

manufacturers and eKporters.

There are numerous international organizations that produce standards. The

International Organization for Standardization (ISO) probably produces the

largest nuaber of International Standards, having issued approKimately 6,000

standard.. ISO's work is carried out through some 2,300 technical bodies in

which more than 20,000 experts from allover the world participate annually in

the development of ISO standards.

The international General Agreement on Tariffs and Trade (GATT) has as one of its

major components the Agreement on Technical Barriers to Trade (usually referred

to as the Standards Code). The framers of the Standards Code recognized that

standards and standards-related activities can seriously hinder the free flaw of

goods in international commerce. The Code established, for the first time, some

requirements for the procedures by which standards are developed, adopted, and

used and for the systems which determine conformity with such standards.

The Trade Agreements Act of 1919 implemented the Standards Code in the United

States. Federal agencies are required under the Act to:

--Not engage in standards actiVities that are prepared, adopted or applied to

create, or have the effect of creating, unnecessary obstacles to the foreign

trade of the United States;

-Ensure that imported products are treated no less favorably than domestic

products;

-Use international standards, if appropriate, as a base for developing new

standards;

-Develop standards based on performance rather than design criteria, if

appropriate; and

- Allow foreign suppliers access to their certification systems an the same basis

as access is permitted to domestic suppliers.- 1/

Hi.torical Note. on Standardization

The history of standardization is both fascinating and demonstrative of the scope

and variety of such activities. A predecessor of the American National Standards

Institute (ANSI) noted that one of the first known attempts at standardization in

the Western world occurred in 1120. King Henry I of England ordered that the

ell, the ancient yard, should be the eKact length of his forearm, and that it

should be used as the standard unit of length in hi. kingdom. !/

That history also notes that, in 1689, the Boston city fathers recognized the

need for standardization when they passed a law making it a civic crime to

manufacture bricks in any Bize ather than 9K4K4. The city had just been

destroyed by fire, and the city fatherB decided that standards would assure

rebuilding in the most economic and fastest way possible. !/

2
Eli Whitney is sometimes referred to as -the Father of Standardization- in the

area of interchangeability, having originated and implemented the concept of mass

production in the United States in 1180. He was awarded a contract to produce

10,000 muskets by then Vice-President Thomas Jefferson. Though standardized

parts had been successfully used in other parts of the world, Whitney brought the

concept to this country when he divided the manufacturing process into individual

steps and put different groups to work on each step of the process. All parts of

the same type were copied from a model .usket and were made to be

interchangeable. Subsequently, when he appeared before Congress with a

collection of assorted parts and proceeded to asseable ten working muskets by

selecting the required parts at random, Congress was convinced of the benefits of

mass production aade possible by standardization. !I

Standards are known to have existed as early as 1000 B.C. when cylindrical stones

were used as units of weight in Egypt. However, the great blaze in downtown

Baltimore in February 1904 and other, similar catastrophes provided tragic and

undeniable evidence of the importance of standards. While the fire in Baltimore

burned, fire engines from as far away as New York rushed to the scene only to

discover that their hoses would not fit Baltimore hydrants. Those -alien· fire

engines were uselessl The inferno burned tor more than thirty hours, destroying

1526 buildings covering more than seventy city blocks. All electric light,

telephone, telegraph, and power facilities were also razed. II In contrast, 23

years later, help from 20 neighboring towns saved Fall River, Massachusetts from

destruction since hydrants and hose couplings had been standardized in these

communities. ~I

As late as 1927, a color-blind motorist had as good (or as bad) a chance as

anyone else when trying to interpret traffic signals. Purple, orange, green,

blue, yellow, and red lights greeted him as he drove from state to state. In

some states, green meant -Go,· in others ·Stop.· Red, not yellow, lights meant

caution in New York City. In 1927 a national code for colors was established

through the work of the American Association of State Highway Officials, the

National Bureau of Standards and the National Safety Council. ~I Iaagine the

chaos that would occur during rush hour in any major D.S. city today if newcomers

and tourists did not know what traffic signals meantl

Probably the most significant standard ever developed in the United States,

however, was the railroads' standard track gage. This standard, now used in

Great Britain, the U.S., Canada and much of continental Europe, enables railroad

rolling stock to cross the country. ~I

It was the Second World War, however, that brought the urgency of extending

do~estic standardization to the international level. Allied supplies and

facilities were severely strained because of the incompatibility of tools,

replacement parts, and eqUipment. The War. highlighted the need for standards

aimed at reducing inventories and increasing compatibility.

Type. of Standards

Standards may be classified in numerous ways, some of which are described here.

ISO Draft Guide 2 differentiates eight types based on purpose. 111 A basic

standard has a broad ranging effect in a particular field, such-Ss a standard for

metal which affects a range of products from cars down to screws. Terminology

3
staDdards define wordl permittinq representativel of an indultry or partiel to a

traDsaction to use a comaon, clearly understood language. Testing standards

define the test aethods to be used to assess the performance or other

characteristic. of a product. Product standards establish qualities or

requireaents for a product (or related group of products) to assure that it will

serve its purpose effectively. Process standards specify requirements to be met

by a proces., such as an asseably line's operation, in order to function

effectively. Service standards, such as for servicing or repairing a car,

establish reqUirements to be aet in order to achieve the designated purpose

effectively. Interface standards, such as the point of connection between a

telephone and a computer terainal, are concerned with the compatibility of

products. The last type provides a listing of data requireaeDts for a product or

service for which values need to be obtained.

Standards aay also be classified by the intended user group. These

classificatioDs raDge froa company standards, meant for use by a single

industrial organization, to international standards. International standards are

developed and proaulgated by international governmental and non-governmental

organizations, such as the North Atlantic Treaty Organization's (NATO's) Military

Agency for Standardization (governmental) and the ISO (non-governmental).

International standards aay be voluntary or mandatory in nature. A harmonized

standard, on the other hand, can be either an atteapt by a country to make its

standard coapatible with an international, regional or other standard or it can

be an agreement by two or aore nations on the content and application of a

standard, the latter of which tends to be mandatory. Harmonized standards may

also be identical in content to other standards. There are still other

classifications such as industry standards, developed and promulgated by an

industry for aaterials and products related to that industry; and ailitary or

government standards, such as those designed to be used by the Department of

Defense or by the Federal Government. These should not be confused with Federal

and Military Specifications, used by the Federal Supply Services in the General

Services Adainistration and by the Department of Defense respectively.

Specifications are a set of conditions and requirement. that provide a detailed

description of a procedure, process, material, product, or service for use

priaarily in procurement and aanufacturing. !!/

Another distinction among standards is the aanner in which they specify

requireaents. Those standards that describe how a product is supposed to

function are called performance staDdards. ID contrast, design standards define

characteristics or how the product is to be built. For example, a perforaance

standard for water pipe might set requiremeDts for the pressure per square iDch

that a pipe must withstand, along with a test method to determiDe if a speciaen

meets the requirement. On the other hand, the specification that a pipe be made

of a given gage of copper would characterize a design standard. The distinction,

however, between these two types of standards is not always clear cut. It is

possible to includa two different requireaents within the same standard, one of

which is stated in terms of performaDce and the other in terms of desigD. For

example, in a standard for copper pipe, requirements for the pipe can be

specified in terms of its performance (being able to withstand a given amount of

pressure), but the same standard may require that the pipe's flanges or couplings

meet specific design requireaents.

4
Design standards may be appropriate~ as in testing methods where the need for

comparability may outweigh other considerations. In general, however,

performance standards, though usually more difficult to write and enforce, tend

to be less restrictive than design standards, and more likely to encourage

innovation. For that reason, signatories to the Standards Code are encouraged to

write technical regulations and standards in terms of performance, rather than

design, characteristics.

Still another classification scheme distinguishes between voluntary standards,

which by themselves impose no obligations regarding use, and mandatory

standards. A mandatory standard i8 generally publi8hed as part of a code, rule

or regulation by a regulatory government body and imposes an obligation on

specified parties to conform to it. However, the distinction between these two

categories may be lost when voluntary consensus standards are referenced in

government regulations, effectively making them -mandatory- 8tandard8. Voluntary

consensus standards may also become -quasi-mandatory· due to conditions in the

marketplace. For example, the health care industry is sensitive to the need to

have available the safest products. to ensure patient safety arid to protect

manufacturers, vendors and health care providers against' lawsuit8. Informed

buyers of health care products will frequently insist that products meet all

appropriate voluntary consensus standards. If they wish to compete effectively,

manufacturers of such products are obliged to conform to such standard~.

It is clear, then, that standards cover a broad range of types and serve a wide

variety of purposes.

Private Standards Organizations in the D.S.

The need for safe and economical structures, 8uch a8 roads and bridges, led to

the founding of the International Association for Testing and Materials in 1896.

Its mission was to develop standardized test methods. Two years later, the

American Section of this organization was formed and became the fo.rerunner of the

American Society for Testing and Haterials, now known as ASTM. Since becoming an

independent organization in 1902, ASTH has continued to grow and now produces the

largest number of non-governmental, voluntary standards in the Dnited States.

In 1918, ASTH was one of five private, technical 80ciety originators of the

American Engineering Standards Committee, later to be known as the American

Standards Association (ASA), and subsequently as the American National Standards

Institute (ANSI). ANSI today serves as the coordinator of voluntary 8tandards

activities in the United States and as the agency that approves standards as

American National Standards. ANSI is also the coordinator and manager of D.S.

participation in the work of two non-governmental, international standards

organizations, ISO and the International Electrotechnical Commission (IEC).

Another of the major private standards organizations, the American Society of

Mechanical Engineering (ASHE), was founded in 1880 and first issued the ASHE

Boiler Code in 1914. Today that Code is mandatory not only in the United States,

but in many other countries throughout the world. In 1952, a forerunner of ANSI

stated: wProbably no other single standard in America has done more for national

safety than the ASHE Boiler Code. w ~/ The ASHE Boiler Code may be the most

Widely used voluntary standard in the world.

5-
The founding of the Society of Automotive Engineers (SAK) in 1910 led to the

pioneering efforts of the American automotive industry to achieve substantial

inter-company technical standardization. Most drivers now take these efforts for

granted when choosing motor oils by SAE designations (such as 10W-40) without

being aware of the full significance and background of the detailed standards

development process.

Most consumers also take for granted the familiar U~ mark on a range of products

from electrical appliances to fire extinguishers. The Underwriters ~aboratories

(UL), founded in 1894, is not only a major standards writer, but also operates

non-profit testing laboratories whose mission is to investigate products and

materials with respect to hazards that might affect life or property and to list

those items which appear to pose no significant hazards.

The work of other major standards organizations, althou9h equally Vital, tends to

be less well known outside the standards community. For example, the National

Fire Protection Association (NFPA) has for more than three quarters of a century

produced the National Electrical Code, used in building construction, and many

other. standards affecting our safety from fires and other hazards. We accept

without conscious thought the safety of aircraft unaware of the standards

produced by the Aerospace Industries Association of America (AlA) for guidance

and control systems and many other items. The Association of American Railroads'

(AAR) standards similarly affect our railroads. Even the quality and size of

paper is standardized through the work of the Technical Association of the Pulp

and Paper Industry (TAPPI).

In all, more than 400 organizations develop voluntary standards of many different

types for a broad range of services, products, and tests. Some organizations,

such as ANSI and ASTM, are primarily concerned with standards. Others are trade

associations interested in all matters affecting their members. The Electronic

Industries Association, for example, has been a standards developer in the areas

of electrical and electronic products and components since 1926.

Many professional and technical organizations are also standards developers. The

Institute of Electrical and Electronics Engineers (IEEE), which traces back to

1884, maintains more than 500 standards with 800 more under development. IEEE is

responsible for the National Electrical Safety Code, widely used by governments

and regulatory agencies for electric supply and communications installations.

Still other standards developers are primarily research and testing bodies, such

as the National Sanitation Foundation (NSF), which develops standards for

products from a health and sanitation perspective. The Factory Mutual Research

Corporation (FH), another standards developer, is a ·product listing· type of

organization, as is UL.

In addition, building code organizations, such as the Building Officials and Code

Administrators International (BOCA), the International Conference of Building

Officials (ICBO),.and the Southern BUilding Code Congress International (SBCCI),

are involved in standards development. These organizations are composed of

building, construction, zoning, and inspection officials; they have developed

model building codes adopted by thousands of State and local governments.

6
The broad range of or9anizations participating in standards development reflects

the impact standards have on a vast spectrum of interests and di.ciplines.

Standards Development Procedur••

Two of the most widely used procedures for alsuring consensus in the development

of standards are the committee and the canvass methods.

Committee Method. Committee standards are .ubject to wide revie~ and

consideration by all interested parties. The requirementl of this process vary

among organizations. In 80me organizations, consensus may be defined a. an

agreement of at least 51' of the participants. Other organizations may also

include requirements for due process, appeals procedures, the mandatory

consideration of negative votes or comments, and for ·committee balance.· Balance

is achieved when all parties having an interest in the outcome of a standard have

an opportunity to participate and where no single interest can dominate the

outcome. Standards organizations differ widely in the emphasis placed on each of

these requirements. Organizations which emphasi~e all four factors, ,in addition

to the achievement of substantial agreement among participant8, produce 8tandards

that are more likely to be adopted and used.

Canvass method The ·canvass· method is frequently used by an organization that

has prepared a standa~d under its own internal procedures. To gairt greater

stature and acceptance of the drafted standard, the developer may then submit it

to balloting by a set of organizations representing a variety of interests, such

as manufacturers, consumers, government, and others. Any objectlons or comments

from organizations on the ·canvass list· must be addressed and satisfactorily

resolved. Changes in a proposed standard, as well as any unresolved objections

and the developing organization's rationale for its response, must be resubmitted

to the ·canvass list.· It is crucial that all inter~sted groups be included on

the list. Two problems sometimes arise: the response level may be low and

consumers and others on the ·canvass list· may have difficulty commeriting on a

standard, because they did not participate in the initial drafting and may not

understand the reasons for or implications of particular provisions.

Benefits and Problems of Standardization

On the whole, the benefits ot standardization far outweigh the difficultie~ and

potential for abuse. Standards promoteunderltandin9 between buyer and seller

and make possible mutually beneficial commercial transactions. Product

attributes cannot always be evaluated by individual purchasers by inspection or

even from prior experience. However, a product's conforaance to accepted

standards readily provides an efficient method of conveying complex information

on the product's SUitability. Architects use standards in a shorthand manner

when drafting plans for buildings; purchasing agents can also use standards as an

easy way of communicating their needs to potential suppliers. In a host of

situations standards are or may be used to replace large quantities of complex

information.

Standards underlie mass production methods and processes. They promote more

effective and organized social interaction, such al the example of the

standardized colors for traffic lights and many other Widely accepted

conventions, Standards are essential in efforts to improve 'product safety and a

to clean up the environment. Standardized and interchangeable parts can reduce

inventory requirements and facilitate product repairs. They can also promote

7
fair competition by facilitating the comparison of price. of Itandardized

commodities.

In general, standards permit society to make more effective. use of its resources

and allow more effective communication among all parties to particular

activities, transactions, or processes. Indeed, standard. are crucial to every

form of scientific and industrial process. Without standards, the quality of

life would be significantly reduced.

No system, particular1, one as comple. and diverse as the O.S. voluntary

standards system, is without problems. In a recent case of great significance,

the United States Supreme Court on May 17, 1982, rendered its decision in favor

of Hydrolevel, a manufacturer of low-water fuel cutoff deVices, in the case of

American Society of Mechanical Engineers (ASME) v. Hydrolevel. It found ASME

liable for conspiring to restrain trade since two subcommittee officers, serving

as volunteers but acting in the name of ASME, issued a misinterpretation of a

standard and produced an adverse effect on the competitiveness of the plaintiff.

Similarly, the Federal Trade Commission held hearings on standards and

certification and uncovered -substantiated complaints of individual standards and

certification actions that have, in fact, unreasonably restrained trade or

deceived or otherwise injured consumers.- !il

In part, problems result from the sometimes substantial costs of participation in

standards development, making it difficult (if not impossible) for small firms

and non-industry representativel to be active in the process. The standards

themselves may cause problems if highl, technical in nature. It is frequently

difficult, if not imposlible, to get qualified consumer representatives to

participate actively. This seriously complicates the attempts to achieve

balanced representation by all interests conce~ned.

Other problems may occur when a standard undergoes review and revision~ Unless

the original writers of the standard participate in its revision, the reviewers

may not be able to understand how the document was prepared, what was eliminated

from consideration, and the reasons or assumptions underlying decisions and the

resultant provisions. Problems can also occur in the application of specific

provisionl if the intent behind them is unclear. Rationale statements, which

sometimes accompany a standard, are specifically designed to define the purpose

and scope of the standard, to e.plain ~he criteria used in developing its

reqUirements and to provide all other relevant information at the disposal of the

developers•. However, the use of rationale statements is not yet e.tensive. ~I

Certification

-The first time a craftsman claimed that his product met a commonly accepted

standard, the most basic form of certification came into being.- 161 Today

product certification schemes range from the simple to the complei: The

hallmarking of precious metals was an early form of certification. Many early

attempts, most unsuccessful, were also .ade to certify weights and measures to

provide a uniform bali. for the e.change of good.. Now there are over 100

private organizations and over 60 Federal program. in the Onited States which

certify product. ranging from electrical cords to kitchen cabinets. In addition,

man, certification progra•• are operated at the state and local level. Consumers

see evidence of the extensiveness of certification when they note the

Underwriters' Laboratory (UL) certification mark on many products ranging from

coffee potsto fire extingUishers; the U. S. Department of Agriculture

8
(USDA) mark on meats, poultry and other agricultural products; and the

International Wool Secretariat's Wool.ark and Noolmarkblend on wool or wood blend

textile goods. These are only a few of the .any certification programs which are

conducted in the United St~tes.

Product certification is intended to confirm that a particular product confor.s

to one or more specified standards, thus providing the user with explicit or

implicit information about the characteristics and/or performance of the product.

Certification is a method for increasing a buyer's confidence in.8 product and

for furnishing product information.

In the U.S., if a manufacturer or lupplier attests to the fact that hil product

meets one or more standards, the procels is called lelf-certification. Thil

process is also known as a manufacturer's declaration in other partl of the

world. The manufacturer's capability, integrity, and reputation deter.ine the

degree of confidence that can be placed in Belf-certification.

Third-party certification is the term applied to the process by which an

organization, independent of either the .anufacturer or lupplier, allellel the

product's conformance to one or aore standards. A manufacturer'l overall quality

control program may also be examined as part of the certification procels. A

quality control program is a series of activities desi9ned to alsure that quality

is being maintained at all phases of production. There are hundreds of

third-party certification programs in the United States operated by Federal,

State, and local governments and by many private organizations. Third-party

certification programs differ greatly from one another, and the degree of

confidence in the resultant certification depends on the program's type and

comprehensiveness.

The methods used in third-party certification programs can be classified as

follows:

o Type-testing/Initial Inspection - This assures that the manufacturer's design

specifications can produce a product that conforms to a particular standard.

Products from a production run are not inspected or tested, and there is no

information on whether products from a production run also consistently meet the

specification.

o Audit-Testing - In this procedure, test samples are selected at random from the

marketplace. Extensive testing is usually required to provide adequate assurance

that products meet the desired standard.

o Surveillance of the Manufacturing Process - Assessment of a manufacturer's

production and control processes can, at relatively low cost, provide assurance

that the manufacturer's quality control procedures are adequate.

o Field Investigations - Alleged failures of products under use conditions are

investigated to determine the cause of failure and to suggest appropriate

corrective action.

9
o Batch·testing • A sample of products is selected tram a production batch and

tested tor conformance to the standard. If the saapling procedure and the sample

size are adequate, batch-testing aakes it likely that all products in that batch

conform to the standard. It does not, however, ensure that a specific untested

product in the batch will aeet the standard nor does it furnish information on

the quality of products produced in earlier or subsequent batches. Batch testing

is used in many certification prograas for bUilding products, such as those for

energy conservation.

o 100 Percent Testing· Each individual product is tested to determine if it

meets the designated standard. If the testing procedures are adequate, the

procedure provides the highest possible level of assurance that the product

conforms to a particular standard. It is also usually the most expensive method

and can be applied only where the test has no adverse effect on the product. !II

Many programs apply two or more of these methods in their certification process.

The choice of methods depends on the needs of both the buyer and the seller and

the nature of the-product. The methods chosen can greatly affect both the cost

of the prograa and the level of confidence that can be ascribed to it. ANSI and

ISO have each developed criteria to evaluate certification programs. ANSI has

also developed a program to accredit certification scheaes which meet its

criteria, but only two prograas have been accredited to date.

Laborator, lecred1tat1on

Laboratory accreditation is a process for evaluating testing facilities and

designating those laboratories judged competent to perfora specific tests using

standard test methods, where available. The National Voluntary Laboratory

Accreditation Program (NVL1P) in the National Bureau of Standards, Department of

Commerce, and the American Association for Laboratory Accreditation (AALA) are

the two largest accreditat10n agencies in the United States. There are many

other Federal, State and local government program., as veIl as many private

sector laboratory accreditation prograas. Soae of these include: the Department

of Defense's (DOD) programs for accrediting laboratories which test products

which will later be sold to DOD; the State of Massachusetts programs for

accrediting concrete testing laboratories and laboratories which test solid fuel

burning appliances; and the National Kitchen Cabinet Association's (NKCA)

accreditation program for laboratories which test kitchen cabinets as part of the

NKCA's certification program. l!1

It should be emphasized that laboratory accreditation assesses the capability of

a laboratory to conduct testing, generally using standard test methods. The

accreditation process should not be confused with certification nor with the

validation of a certification, which is -an action by a third party to assure

that the producer (or certifier) is adhering to the requirements of a given

certification program.-!!I Laboratory accreditation neither reviews nor

assesses products, nor does it check the tests conducted on specific products or

product batches. In addition, laboratories aay be accredited to conduct tests

(such as EPA's accreditation program for laboratories testing drinking water) in

fields where no certification program exists.

Laboratory accreditation, however, can affect the quality at certification

programs by requiring evidence that a certifying laboratory has competent

personnel, adequate equipment, and sufficient knowledge of the testing

10
procedures for which accreditation is sought. Also, laboratory accreditation is

assuming increased importance in trade. As countries seek acceptance of their

test data by trading partners, they must assure that the data comes from

competent laboratories. Laboratory accreditation can help to provide that

assurance.

Standardization, product certification, and laboratory accreditation are closely

linked. In many developing countries, all three activities are conducted by the

same organization. Certification programs are communication tools designed to

reduce the cost of elchanging information between buyer and seller. The quality

of the information conveyed depends on both the competence of the testing

laboratory selected and the adequacy and appropriateness of the standards against

which the product is to be evaluated. Certification can result in widespread

consumer deception if performance characteristics or test methods contained in

the standard are insufficient to assure adequate product performance or if the

testing laboratory is incompetent or has biases which affect the reporting of

test results.

Considering the number of standards in existence and the variety of fields

covered by private sector standards development and certification organizations,

the United States has one of the most developed and complex standardization and

certification systems in the world. Furthermore, the number of Federal, State,

and local government standardization and certification activities and the large

volume of standards, regulations, and procurement specifications that these

agencies have developed, result in an immense impact of standardization and

related activities on almost every aspect of life in the Dnited States. Not only

are considerable resources invested in this country in such activities every

year, but purchasers (consumers) depend on standards and certification to ensure

that products purchased are safe and perform satisfactorily. Recognition of the

impact of standards and certification on trade, as evidenced by the Standards

Code, is also increasing. Society depends on standardization and related

activities for its existence.

11
lPPINDIX

Intor.ation lvailable tro.

The Standardl Code and Intor.ation (SCI) Program

National Bureau ot Standardl

l~iniltration Building, Roo. 1629

Gaitherlbur9, ND 20899

(301) 975-.0.0

o Directory of International and Regional Organizations Conducting

Standards-Related Activities (NBS SP 649)

Directory'contains infor.ation on 272 international and regional organizations

which conduct standardization, certification, laboratory accreditation, or other

standards-related activities. Volume describes their work in these areas, as

well as the scope of each organization, national affiliations of members, U.S.

participants, restrictionl on aembership, and the availability of any standards

in English.

o Standards Activities of Organizations in the United States (NBS SP 681)

The directory summarizes the standardization activities of aore than 750

organizations in the United States, including Pederal and State agencies and

appro.iaately 420 private sector groups that develop standards. It also contains

listings of State procureaent offices, sources of standards documents and

information, a subject indea and related listings that cover acronyms and

initials, defunct bodies and organizations with name changes.

o Private Sector Product Certification Programs in the Dnited States (NBS SP 703)

This directory presents information fro. 109 private sector organizations in

the United States which engage in product certification activities. Entries

describe the type and purpose of each organization, the nature of the actiVity,

products certified, standards used, certification requirements, availability and

cost of services, and other relevant details.

o Pederal Government Certification Programs for Products and Services

(NBS SP 714)

T'his directory presents information on 61 U.S. Government certification

programs for products and services. Entries describe the scope and nature of

each certification progra., testing and inspection practices, standards used,

methods of identification and enforcement, reciprocal recognition or acceptance

of certification, and other relevant details.

o KWIC Indea (Computer Output Microform (COM) produced)

The KWIC Index contains the titles of more than 25,000 U.S. voluntary product

and engineering standards. A standard can be located by means of any significant

or key word in the title. Key words are arranged alphabetically. 1 standard with

five key words, for eaaaple, would therefore be listed in five different places.

To purchase .icrofiche copies of the 1985 revision ot the Index, contact the

National Technical Infor.ation SerVice, 5285 Port Royal Road, Springfield, VA

22161; (703) 487-4600. Use order no. PB86-154408; COlt is $13.50 for purchasers

in the D.S.

12
o tbt news

This newsletter provides information on government programs and available

services established in support of the GATT Agreement on Technical Barriers to

Trade (Standards Code). tbt news reports on the latest notifications of proposed

foreign regulations; bilateral consultations with major D.S. trade partners;

programs of interest to U.S. exporters; and availability of standards and

certification information. Subscription is free upon request.

o Technical Barriers to Trade

This booklet explains the basic rules of the international Agreement on

Technical Barriers to Trade negotiated during the Tokyo Round of the Multilateral

Trade Negotiations (HTN), and describes Title IV of the D.S. Trade Agreements lct

of 1979 which implements the United States' obligations under the Agreement. The

Agr~ement, popularly known as the Standards Code, was designed to eliminate the

use of standards and certification systems as barriers to trade. The booklet

describes the functions of the Departments of Commerce and Agriculture, the

Office of the U.S. Trade Representative, and the State Department in carrying out

the U.S.'s responsibilities.

o "GATT Standards Code Activities"

This brochure gives a brief description of NBS' activities in support of the

Standards Code. These actiVities include operating the D.S. GATT inquiry point

for information on standards and certification systems; notifying the GATT

Secretariat of proposed U.S. regulations; assisting U.S. industry with

trade-related standards problems; responding to inquiries on foreign and O.S.

proposed regulations; and preparing reports on the Standard Code.

o Report to th~ United States Congress on the Agreement on Technical Barriers to

Trade - "Standards Code"

This 2nd triennial report describes the programs and activities established to

implement the Standards Code in the United States by the four responsible D.S.

government agencies: Office of the U.S. Trade Representative; Department of

Commerce (National Bureau of Standards, International Trade Administration);

Department of Agriculture and Department of State.

o Free handout material on the Office of Product Standards Policy's (OPSP), the

National Center for Standards and Certification Information's 1NCSCI) and GATT

activities, and standards-related information such as: Government sources of

specifications and standards, use of the KWIC index, foreign and international

standards bodies, U.S. standards organizations, State purchasing offices, NCSCI

fact sheet and its certification rules activity, and OPSP publications list

(bibliography).

In addition to general inquiry services, the following assistance is also

available:

o GATT Hotline

A telephone hotline provides current information received from the GATT

Secretariat in Geneva, Switzerland, on proposed foreign regulations which may

significantly affect trade. The recorded message is updated weekly and gives the

product, country, closing date for comments (if any) and Technical Barriers to

Trade (TBT) notification number. The hotline number is (301) 975-4041 (not

~~ll-free).

13
o Assistance to D.S. and foreign exporters -- Current regulations and

certification information for the manufacture of products in the U.S. for export

are obtained from foreign countries. To aid foreign exporters, NCSCI provides

director, information on State offices prepared to respond to queries concerning

condition. to be met b, goods for sale in their state, as well as standards and

certification information for export to the D.S.

14
rOOTNO'lES

~I USA Standards Institute, -What is ••• a Standard? the USA Standards

Institute? a USA Standard?,- USA Standards Institute, New York, New York, p. 1.

21 National Policy on Standards for the United States and a Recommended

Implementation Plan, National Standards Policy Advisory Coaaittee, Washington~

D.C.,December, 1978. p. 6.

31 International Trade Administration, The Tokyo Round Agreements: Technical

Barriers to Trade - Volume 4, Dept. of Commerce, Washington, D.C., September

1981.

!I American Standards Association, -Through History with Standards- in Rowen

Glie (ed.), Speaking of Standards, Cahner Books, Boston, MA, 1972, p. 38.

51 Ibid., p. 42.

61 Ibid., p. 44.

71 Rexmond C. Cochrane, Measures for Progress: A History of the National Bureau

of Standards, National Bureau of Standards, D.S. Department of Commerce,

Washington, D.C., pp. 82-86, 1974.

~I American Standards Association, p. 60.

91 Ibid., p. 68.

191 Ibid., p. 50.

~I International Organization for Standardization, draft revision of ISO GUide

2. -General terms and their definitions concerning standardization~ certification

and testing laboratory accreditation,- July 1985.

~I W. E. Andrus, Jr., Draft NBS Glossary of Terms for Product Standardization,

~roduct Certification and Laboratory Accreditation, D.S. national Bureau of

Standards, Dept. of Commerce, 1974.

!ll American Standards Association, p. 48.

!!I Bureau of Consumer Protection, Standards and Certification: Final Staff

Report - April 1983, Federal Trade Commission, Washington, D.C., April, 1983, p.

2.

~I David A. Swankin, Rationale Statements for Voluntary Standards -- Issues,

Techniques, and Consequences, National Bureau of Standards, Dept. of Commerce,

Gaithersburg, MD. November, 1981.

~I International Organization for Standardization, Certification: Principles

and Practice, International Organization fo~ Standardization, Geneva,

Switzerland, 1980, p. 7.

15
12/ Douglas B. Thomas, NVLAP Glossary of Terms for Laboratory Accreditation,

Product Certification and Standardization, U.S. National Bureau of Standards,

Washington, D.C. 1980.

!!/ Charles W. Hyer, Principal Aspects of U.S. Laboratory Accreditation

P~ogra.B, National Bureau of Standards, Gaithersburg, HD 20899, October 1984.

~I Ibid. 21.

16