NISTIR 6014 

THE ABC's OF THE U.S. CONFORMITY ASSESSMENT

SYSTEM

Maureen A. Breitenberg 

Office of Standards Services 

National Institute of Standards and Technology 

Gaithersburg, MD 20899 

April 1997 

 
Foreword

The Office of Standards Services periodically publishes 

information related to standards and conformity assessment as a 

service to producers and users of such systems -- both in the 

government and in the private sector. This report provides those 

not fully familiar with these fields with an introduction to some 

of the complexities. We hope that this material will be 

informative and will serve to stimulate wider understanding of the 

purpose and nature of the various aspects of conformity 

assessment, as well as interrelationships among related 

activities. The interested reader may wish to take advantage of 

other available publications and services provided by the Office 

of Standards Services. 

iii

 
Acknowledgements

I would like to thank John Donaldson, ANSI; Charles Hyer, The 

Marley Organization; Walter Leight, NIST; and Krista Johnsen 

Leuteritz, NIST; and many others for their careful review of and 

comments on this document. 

 Maureen A. Breitenberg 

 Office of Standards Services 

iv

 
Abstract 

This report is designed to provide the reader with an introduction 

to conformity assessment and information on how the various 

conformity assessment activities are interlinked. It highlights 

some of the field's more important aspects and serves as 

background for using available documents and services. 

Key Words: accreditation; certificates of conformity; 

certification; certification marks; conformance testing; 

conformity; environmental management systems; inspection; 

laboratory accreditation; product listing; quality assurance; 

quality system; quality system registration; recognition; 

registration; standardization; standards; testing 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

v
Table of Contents

 

Page 

Foreword .................................................. iii 

Acknowledgements .......................................... iv 

Abstract .................................................. v 

Introduction .............................................. 1 

Standardization ........................................... 2 

Conformity Assessment ..................................... 4 

 Inspection ............................................. 4 

 Testing ................................................ 5 

 Criteria for Laboratory Evaluation .................... 6 

 Laboratory Accreditation ................................ 7 

 Laboratory Accreditation Evaluation Criteria .......... 9 

 Other Considerations .................................. 11 

 U.S. Laboratory Accreditation System .................. 12 

 Certification............................................ 13 

 Types of Certification ................................ 14 

 Third Party Certification Programs in the 

 United States ....................................... 15 

 Choice of Standards ................................... 18 

 Certification Methodology ............................. 18 

 Certificates or Marks of Conformity 

 (Certification Marks)................................ 19 

 Certification Program Evaluation Criteria ............. 19 

 Other Considerations .................................. 20 

 U.S. Certification Program Accreditation System ....... 20 

 Management System Assessment/Registration ............... 21 

 The ISO 9000 Standards ................................ 22 

 The ISO 14000 Standards ............................... 22 

 Management System Assessors ........................... 23 

 Management System Registration ........................ 23 

 Accreditation of U.S. Registrars ...................... 25 

 Accreditation Program Recognition ....................... 25 

vii
International/Regional Cooperation in Conformity Assessment 26 

Summary ................................................... 27 

Appendix -- List of Acronyms ............................... 29 

Footnotes .................................................. 36 

viii
1 

INTRODUCTION

The U.S. marketplace is becoming increasingly globalized 

as evidenced by the vast array of products made in foreign 

countries, which are available to U.S. consumers. This 

growing complexity has made buyers increasingly 

dependent on formal methods and procedures for ensuring 

that the products, services, and systems that they purchase -

- whether domestic or foreign -- consistently meet their 

needs. 

Some product characteristics are vital for safe and effective 

performance, and many of these characteristics cannot be 

evaluated simply by picking up and examining the product 

in the marketplace. Such characteristics need to be 

determined, assessed, and assurance provided to the buyer 

(or other interested party) that the product conforms to 

requirements and that conformance is consistent from 

product to product. For example, if a buyer determines that 

it is critical that an airplane part be able to withstand 

pressure of at least 5000 newtons per square centimeter, 

then the buyer needs assurance that none of the purchased 

parts will fail to withstand such pressure. The buyer cannot 

determine whether a part meets this requirement by simply 

looking at it. 

Conformity assessment is defined in ISO/IEC1

 Guide 2: 

1996 as: "any activity concerned with determining directly 

or indirectly that relevant requirements are fulfilled." 

Conformity assessment procedures provide a means of 

ensuring that the products, services, or systems produced or 

operated have the required characteristics, and that these 

characteristics are consistent from product to product, 

service to service, or system to system. Conformity 

assessment includes: sampling and testing; inspection; 

certification; and quality and environmental 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 inclusion or absence of any of 

these activities, 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 process. In addition, 

standards, which underlie each of these activities, can also 

have a major impact on the outcome of each specific 

conformity assessment activity as well as a cumulative 

effect on the outcome of the entire process. Conformity 

assessment activities form a vital link between standards 

(which define necessary characteristics or requirements for 

products) and the products themselves. Together standards 

and conformity assessment activities impact almost every 

aspect of life in the United States. 

This impact is especially evident when one considers 

specific product examples. A state-of-the-art computer is 

of no benefit without compatible software. A new and 

technologically superior appliance is useless if its plug does 

not fit the outlet; or (worse yet!) appears to fit, but actually 

increases the potential for fire or electrical shock. We do 

not want to purchase a product that appears to meet our 

needs and then discover that it has potentially dangerous 

undetected defects. If we purchase products on a regular 

basis, we also don't want to find that they are periodically 

unacceptable because of unexplained or unexpected 

variations in production or delivery processes. 

Conformity assessment can verify that a particular product 

meets a given level of quality or safety, and provide the 

user with explicit or implicit information about its 

characteristics, the consistency of those characteristics, 

and/or 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 a 

company's advertising and labeling claims regarding a 

product.2

 Conformity assessment is therefore an important 

marketplace communications device -- a means of 

exchanging information between buyer and seller. It is 

vital for buyers, sellers, and other interested parties to 

understand the conformity assessment process to 

competently judge the value of a particular assessment 

scheme and to use the information resulting from that 

scheme to make intelligent marketplace choices. 

The quality of the conformity assessment information 

conveyed depends on: the impartiality and competence of 

the assessment body; the types of assessment activities 

included in the scheme; and the adequacy and 

appropriateness of the standards against which the product 

is evaluated. Improperly conducted conformity assessment 

activities may result in widespread buyer deception. If 

properly conducted, however, conformity assessment can 

furnish valuable information to the marketplace and can 

serve as the basis for increased opportunities for national 

and international trade. 

The impact of conformity assessment on both domestic and 

international trade was prominently noted in the 1994 

Agreement of Technical Barriers to Trade (TBT 

Agreement) of the international General Agreement on 

Tariffs and Trade of the World Trade Organization (WTO). 

The TBT Agreement recognized that conformity 

assessment activities can expedite or seriously hinder the 

free flow of goods in international commerce and 

established procedural requirements for conformity 

assessment schemes to avoid the establishment of 

unnecessary obstacles to trade. The agreement requires 

that conformity assessment procedures3

 be "prepared, 

adopted and applied so as to grant access for suppliers of 

like products originating in the territories of other Members 

[signatories to the agreement] under conditions no less 

favorable that those accorded to suppliers of like product of 

national origin or originating in any other country... ." The 

Agreement also requires that such procedures not be 

"prepared, adopted or applied with a view to or with the 
2 

effect of creating unnecessary obstacles to international 

trade." Ideally, a properly conducted conformity 

assessment program benefits, not hinders, the free flow of 

goods into the marketplace. 

This report will provide the reader an overview of the topic 

of conformity assessment to better understand its impact on 

the marketplace. The report will: (1) discuss some 

concerns regarding the standards used in conformity 

assessment activities; (2) describe each type of conformity 

assessment activity and examine some of the issues 

involved in assessing the activity's competence; and (3) 

identify some of the interrelationships among conformity 

assessment activities. 

To improve readability, this report will use the term 

product to refer to a product, service, process, and/or 

system. The reader should also note that while many 

examples in this paper refer to products (because such 

examples are generally easier to understand), the 

implications are equally applicable to services, processes, 

and systems. 

STANDARDIZATION

A standard was defined by the National Standards Policy 

Advisory Committee4

 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." 

Standards5

 are known to have existed as early as 7000 B.C. 

when cylindrical stones were used as units of weight in 

Egypt. In more modern times, 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 useless! The 

inferno raged for more than thirty hours, destroying 1526 

buildings covering more than seventy city blocks. All 

electric light, telephone, telegraph, and power facilities 

were also razed. In contrast, 23 years later, help from 20 

neighboring towns saved Fall River, Massachusetts from 

destruction since hydrants and hose couplings had by then 

been standardized in those communities. 

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 (now the National Institute of 

Standards and Technology (NIST)) and the National Safety 

Council. Imagine the chaos that would occur during rush 

hour in any major U.S. city today if newcomers and tourists 

did not know what traffic signals meant! 

Probably the most significant standard ever developed in 

the United States, however, was the railroads' standard 

track gage. This standard (now also used in Great Britain, 

the United States, Canada and much of continental Europe) 

enables railroad rolling stock to cross the country. 

It was the Second World War, however, that brought the 

urgency of extending domestic standardization to the 

international level. Allied supplies and facilities were 

severely strained due to the incompatibility of tools, 

replacement parts, and equipment. The War highlighted 

the need for standards aimed at reducing inventories and 

increasing compatibility. 

Standards may be classified in numerous ways, some of 

which are described here. Standards can define words so 

that an industry or parties to a transaction may use a 

common, clearly understood language. Test method 

standards define the process/procedures to be used to assess 

the performance or other characteristics of a product. 

Product standards establish qualities or requirements for a 

product (or related group of products) to ensure that it will 

function safely and/or effectively. Process standards 

specify requirements to be met by a process (e.g., an 

assembly line operation) to function effectively. Service 

standards (e.g., standards for servicing or repairing a car), 

establish requirements to be met to achieve the designated 

purpose of this service. Interface standards (e.g., a standard 

for the point of connection between a telephone and a 

computer terminal), are concerned with the compatibility of 

products. Another type of standard lists product data 

requirements for which values must be obtained. 

Still another classification scheme distinguishes between 

voluntary standards, which by themselves impose no 

obligations regarding use, and mandatory standards. A 

mandatory standard is generally published 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" standards. 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 use the safest products available to 

ensure patient safety and to protect manufacturers, vendors 

and health care providers against lawsuits. Informed 

buyers of health care products will frequently insist that 
3 

products meet all appropriate voluntary consensus 

standards. If manufacturers wish to compete effectively, 

their products must conform to such standards. 

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

and serve a wide variety of purposes. In the United States 

alone, there are approximately 49 000 private sector 

voluntary standards developed by more than 620 

organizations.6 This number does not include 

approximately 44 000 regulatory and procurement 

standards (developed and used by approximately 80 federal 

regulatory and procurement authorities) or other codes, 

rules and regulations containing standards that have been 

developed and adopted by state and local government 

authorities. There are also company standards, developed 

for use by a company or organization for its own products 

or for the products it purchases. However, some company 

standards gain such widespread marketplace acceptance 

that they can and do become de facto industry standards, 

such as the architecture for the personal computer 

established by IBM and widely used in the personal 

computer industry. 

In addition, numerous foreign national, regional and 

international organizations produce standards of interest 

and importance to U.S. manufacturers and exporters. The 

International Organization for Standardization (ISO) and 

the International Electrotechnical Commission (IEC) 

produce the largest number of international standards. In 

its 1996 catalog, ISO had 10 189 international standards, in 

addition to other technical documents. In 1995 alone, the 

IEC issued 429 standards totaling 17 000 bilingual pages. 

Standards are vital tools of industry and commerce because 

they promote understanding between buyers and sellers and 

make possible mutually beneficial commercial 

transactions. As noted before, buyers cannot always 

evaluate product specifications or characteristics by 

inspection or even from prior experience. Information on a 

product's conformance (or nonconformance) to a particular 

standard can provide an efficient method of conveying 

information needed by a buyer on the product's safety and 

suitability. 

While physical measurement standards tend to be objects 

(e.g., a standard meter, kilogram, etc.,) rather than pieces of 

paper, these types of standards are outside the scope of this 

paper. Most standards are written documents. Such 

standards have little or no significance -- unless they are 

used. Some standards never receive widespread acceptance 

and use. Others may have been accepted by industry at one 

time, but now apply to technologies that have become 

outdated. One of the most important uses for standards is 

within a conformity assessment process. Standards provide 

the basis for conformity assessment activities that, in turn, 

are the basis for many buyer-seller transactions. Hence 

standards used in conformity assessment activities can have 

tremendous impact on companies and nations and even on 

the economic fabric of the world market. Because 

standards have such an impact on the validity of conformity 

assessment activities, it is important to have some 

familiarity with them. 

Standards can cover many aspects of the conformity 

assessment process. They can describe characteristics of 

the product for which conformity is sought; the 

methodology (e.g., test, inspection or other assessment 

methods) used to assess that conformity; or even the 

conformity assessment process itself (e.g., how a 

certification program should be operated). Standards used 

in conformity assessment should be clearly and concisely 

written, readily understood, precise, technically credible, 

and contain only unambiguous requirements - the absence 

or presence of which can be objectively verified. The use 

of well written standards in a conformity assessment 

process lends credibility and validity to the process, 

increasing its usefulness. Requirements in such standards 

should be stated in terms of "shall" or "will," rather than 

"may." In addition, standards for conformity assessment 

methods (e.g., test methods) used in the conformity 

assessment process 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. The results should also be 

consistent with results produced by the same laboratory 

when it repeats the test using the same or a similar test 

method. The results should also be reproducible, i.e., 

capable of being duplicated by other testing bodies using 

the same or similar test methods. 

Standards used in conformity assessment should not 

impede innovation. For this reason, performance standards, 

which describe how a product is supposed to function, are 

preferred over design (also called prescriptive) standards, 

which define how the product is to be designed or 

constructed.7

 For example, a performance standard for 

water pipe might set requirements for the pressure per unit 

area that a pipe must withstand, along with a test method to 

determine if a pipe sample meets the requirement.8

 

Manufacturers are free to choose any product design, 

material, and manufacturing process as long as the pipe can 

perform in the specified manner. On the other hand, a 

standard that requires that a pipe be made of a given gage 

of copper and have a given diameter is a design standard. 

Manufacturers trying to comply with such as standard are 

not free to make the pipe out of stainless steel, for example, 

or to vary the size of the diameter no matter how such 

changes impact the pipe's performance. For this reason, 

including design requirements in standards can discourage 

innovation. 

The example above is rather simplified. Few standards are 

purely design or performance in nature. Most are a mix of 

requirements of both types. Requirements in a standard, 

for example, may be mostly written in terms of 

performance; while the test method for ensuring 

conformance might be written in design terms. In fact, 

design requirements are frequently more appropriate for 
4 

test methods where the need for accuracy and 

reproducibility usually outweigh other considerations. It 

should also be noted that the determination of conformance 

to performance standards may be more difficult than for 

design standards. For example, it is usually more difficult 

to determine that a pipe can perform in the specified 

manner than it is to determine that a pipe is made of a given 

gage of copper and has a given diameter. Performance 

standards are also more difficult to write. Therefore, the 

use of performance standards, while desirable, may not be 

practical in all situations. In some cases, the disadvantages 

associated with the use of performance standards may 

outweigh other considerations. 

However, in general, when products can be defined in 

terms of required performance characteristics, the resulting 

performance standards tend to be less restrictive than 

design standards. Performance standards are also more 

likely to allow the inclusion of technological innovations in 

the product and to prevent unnecessary barriers to trade. 

This is why the United States and the other signatories to 

the WTO Agreement are encouraged to write technical 

regulations and standards in terms of performance rather 

than design.9

It should also be noted that writing a poor performance 

standard is as easy as writing a poor design standard. A 

poorly written standard of EITHER type is unlikely to lead 

to greater technological innovation, increased trade, or to 

an acceptable outcome when used in a conformity 

assessment process. 

Standards used in conformity assessment should also be 

chosen so that they specify all essential characteristics of a 

product necessary for achieving the objective of the 

conformity assessment activity. For example, if assurance 

of the electrical safety of a coffee pot is the objective, a 

standard that covers only the electrical safety of the coffee 

pot's cord and does not cover the pot's heating element 

would not meet the objective. Knowing what aspects of the 

product will be evaluated in a conformity assessment 

process and whether there are other aspects that might 

impact quality, safety, or performance allows the user of 

the conformity assessment data to evaluate the data's 

significance. 

Given the large number of national and international 

standards, it is not surprising that a number of standards are 

redundant or overlapping. In a few areas (particularly 

building and construction), there are sometimes five or six 

standards that, while not identical, define functional 

requirements for the same type of product or material. This 

redundancy makes it especially important to know not only 

which aspects of the product are covered in a conformity 

assessment process, but which standard(s) was used. 

Requirements in two different standards covering the same 

characteristics may be very different. To understand the 

results of a conformity assessment process, the user needs 

to know what standard(s) was used. 

CONFORMITY

ASSESSMENT

In addition to information on the standards used, those who 

rely on conformity assessment results also need to know 

and understand which types of conformity assessment 

activities were included in the process. The following 

sections cover a number of conformity assessment 

activities including: inspection; testing; laboratory 

accreditation; certification programs and their 

accreditation; management system assessment/registration 

and accreditation; and the recognition (usually by a 

government agency) of the competence of accreditation 

programs. 

INSPECTION

Inspection is defined in ISO/IEC Guide 2 as "conformity 

evaluation by observation and judgment accompanied as 

appropriate by measurement, testing or gauging." In the 

European Standard, EN 45004, inspection is defined as the 

"(e)xamination of a product design, product, service, 

process or plant, and determination of their conformity with 

specific requirements, or on the basis of professional 

judgment..." While a number of people regard inspection 

as an activity that is distinct from other types of conformity 

assessment activities, most other conformity assessment 

activities do involve inspection to some degree. For 

example, it would be unusual to test a product without first 

looking at it (inspecting it) to determine if it is intact or has 

undergone rough handing that might have damaged it and 

could therefore affect the outcome of the testing. Likewise, 

it would be unusual to assess a company's quality system, 

without inspecting the elements of the facility that could 

impact the system's operation. Because some type of 

inspection is included in most forms of conformity 

assessment and because the topic of conformity assessment 

is so complex, this paper will not deal with inspection as a 

separate type of conformity assessment activity. However, 

the reader should be aware that this activity exists and that 

inspection can and often does provide information that is 

used in conformity assessment. ISO has also published a 

guide on the topic, ISO Guide 39: 1988, "General 

requirements for the acceptance of inspection bodies," 

which is currently being updated. 

TESTING

Testing laboratories support billion dollar industries and 

affect the entire operation of U.S. industry and the U.S. 

regulatory system. Each day major corporate and 

regulatory decisions are made based on data produced by 
5 

testing laboratories. 

Test data are used in many tasks including: 

 o product design and research; 

 o quality control prior to acceptance of incoming 

 materials/components, during production, and 

 prior to shipment/sale; 

 o insurance underwriting; 

 o meeting contractual agreements; 

 o satisfying government regulatory requirements; 

 o certification and labeling; 

 o buyer protection and information; 

 o product comparisons; 

 o building and structure design, construction and 

 related engineering tasks; 

 o medical and health services; 

 o environmental protection; 

 o product operation, maintenance and repair; 

 o legal proceedings; and 

 o forensic work. 

Flawed test data can result in defective products capable of 

causing serious injury or harm to the user or the 

environment. Defective products (such as fire detection 

and mitigation equipment and systems, security alarms, 

aircraft, and autos) can also result in serious injury or death 

- not only to users, but also to unsuspecting bystanders. 

Testing can be performed by laboratories differing widely 

in size, legal status, purpose, range of testing services 

offered, and technical competence. They may be 

government regulatory laboratories, government research 

laboratories, or government supported laboratories -- at the 

federal, state or local levels. They can also be 

college/university laboratories, independent private sector 

laboratories, laboratories affiliated with or owned by 

industrial firms or industry associations, or manufacturers' 

in-house laboratories. Test laboratories can be for-profit or 

nonprofit. Laboratories can operate facilities in one or 

multiple locations; and may even operate in multiple 

countries. Laboratories can offer only a limited range of 

testing services or services in many fields. There are 

almost as many different types of laboratories as there are 

different types of users of the test data that the laboratories 

produce. 

A test is defined by ISO/IEC Guide 2 as a: "technical 

operation that consists of the determination of one or more 

characteristics of a given product, process or service 

according to a specified procedure." Test data result from 

the performance of a test. If the test method is well written, 

it is sufficient that the test data comply with the test 

method's requirements for accuracy and variability 

requirements. 

Accuracy (or bias) refers to the degree of departure of the 

test result from the "true value." For example, if a product 

is weighed and the result is 5.1 kg (when the actual weight 

is 5.0 kg), the test or measurement is inaccurate by .1 kg. 

The required degree of accuracy will depend on the 

characteristic being tested and the impact of test data 

accuracy on the ability of the product being tested to 

perform in an acceptable manner. 

Variability (or precision) refers to the degree of difference 

between the results from several repetitions of the same 

test. For example, if that same product (weighing 5.0 kg) 

were measured three times and the weights were recorded 

as 5.1 kg, 4.9 kg, and 5.0 kg., these results vary less than if 

measurements for that product were 4.5 kg, 5.0 kg and 5.5 

kg. 

Variability can be further defined in terms of repeatability, 

which is a measure of the variation among the test results 

when the same or similar test is repeated within ONE 

laboratory. Reproducibility (or replicability) is a measure 

of variation of test results from similar tests conducted in 

DIFFERENT laboratories. Reproducibility can be a key 

concern in conformity assessment programs that use 

multiple laboratories. 

Problems in the accuracy and variability of test results 

occur not only due to errors by the laboratory staff or 

defects in the test equipment, but also arise from other 

factors, such as flaws or variables in the test method or in 

the sample selection process. As noted elsewhere, the 

selection of good test methods is vital to the production of 

good test results. Because test results are a vital component 

of most conformity assessment programs, the use good test 

data is essential for the credibility of any certification 

program. 

Standards organizations have long recognized the 

importance of the link between testing and laboratory 

competence. For example, ISO and IEC have published 

Guide 25, "General Requirements for the Competence of 

Calibration and Testing Laboratories," which establishes 

general requirements for laboratory competence to conduct 

specific calibrations or tests. Laboratory requirements in 

this guide include: having an appropriate organizational 

structure; having adequate resources and using only 

properly trained staff; having a good quality system; using 

equipment that has been adequately maintained and 

calibrated; conducting tests under acceptable environmental 

conditions and using appropriate test methods; and 

producing accurate, clear, unambiguous, and objective test 

reports. The compliance of a laboratory with ISO/IEC 

Guide 25 or its equivalent provides some assurance of the 

competence of that laboratory. 

CRITERIA FOR LABORATORY 

EVALUATION

The following list contains general criteria that may be 

used in evaluating laboratories. 
6 

1. Laboratory Organization/Independence (No 

Conflict-of-Interest)

The laboratory should be a legal entity organized in a 

manner that permits satisfactory performance of all 

required functions. In addition, a laboratory and its staff 

should be impartial or independent (that is free from any 

outside influence), which might bias the integrity and 

objectivity of the work performed. 

2. Financial Stability

The laboratory should have sufficient resources to enable it 

to properly use and maintain the test equipment and 

facility, to satisfactorily perform all required functions, and 

to adequately indemnify itself against financial 

liabilities/penalties resulting from its operations. The 

laboratory's business should also be sufficiently diversified 

so that the loss of a single client does not seriously 

jeopardize its financial well being. 

3. Staff Qualifications Requirements

Each staff member in the laboratory should have the 

education, training, knowledge, and experience necessary 

to perform the tasks assigned and an appropriate level of 

supervision should be maintained. The training of each 

staff member should be kept current and documented. 

4. Adequate Quality System

The laboratory should have a quality system appropriate to 

the type and amount of work performed. The system 

should be reviewed periodically by management and 

revised as needed to ensure continued acceptable 

performance. The quality system should be suitably 

documented in a comprehensive, up-to-date quality manual, 

which is readily available for consultation by staff. Internal 

audits should be conducted and documented by the 

laboratory as needed to evaluate its compliance with the 

requirements in its quality documentation, as well as to 

assess the efficiency and effectiveness of the system's 

operation. The results of such audits should be reported to 

top management and appropriate action taken and 

documented. 

5. Sampling Requirements

If a laboratory receives test materials in quantities larger 

than the amount required for the test, the laboratory should 

sample the material in such a manner as to ensure that the 

sample tested is representative of the entire quantity of 

material received. Where sample selection is the 

responsibility of the test laboratory, the laboratory should 

use appropriate sampling methods and/or techniques. 

6. Sample Control/Integrity Requirements

The laboratory should have an effective system that ensures 

both the identity and integrity of the test samples. 

Maintaining the integrity of the sample involves preventing 

it from being damaged during any stage of its collection, 

shipment, storage, or handling. Such damage can include: 

physical damage; loss of part of the sample due to leakage 

or other causes; contamination by foreign materials; failure 

to maintain the sample within appropriate temperature or 

atmospheric conditions; or other deterioration, such as 

deterioration resulting from samples being held too long 

before testing. Where the sample may be used as legal 

evidence, a complete record may be required on who had 

custody of the sample from collection through testing, and 

(when needed) up until its disposal. 

7. Statistical Methods Requirements

The statistical methods used to interpret or to provide 

additional information about test data should be appropriate 

and adequate for the type and level of testing undertaken. 

Control charts, which help distinguish random errors from 

systematic (assignable cause) errors or variations, should be 

employed as needed to alert laboratory personnel to 

potential problems in test procedures or equipment. 

8. Recordkeeping Requirements

A laboratory should maintain all test records, observations, 

calculations and derived data for all tests it performs for an 

appropriate time period or as required by law. 

9. Test Report Content/Format Requirements

Test reports should include all information relevant to 

sample selection, test performance, and test results. It may 

also be useful for a laboratory that is involved in related 

conformity assessment work or research to note if any 

relationship exists between that work/research and the 

results contained on the test report. Test data should be 

displayed in a format that is easy to read and understand. 

Data included in such reports should be routinely audited 

and validated, i.e., checked for questionable values and 

accepted or rejected based on an established set of criteria. 

Audit levels (the amount of work subject to review and the 

extent of those reviews) should be appropriate for the type 

and amount of work being performed as well as the skill of 

the analyst or technician conducting the tests. 

10. Available Operational Manuals/Instructions

The laboratory should have readily available instructions 

on the operation and maintenance of all materials and 

equipment, copies of the test methods and standards 

employed with any additional instructions needed on their 

application, sample selection and handling procedures, and 

any other relevant information necessary to ensure the 

quality of the work performed. 

11. Participation in Proficiency Testing Program
7 

The laboratory should participate in proficiency testing to 

the extent appropriate to ensure the competence of its 

testing processes. Proficiency testing allows a laboratory to 

compare its test results with results obtained from other 

laboratory(s) from tests performed on the same or similar 

items. Proficiency testing can provide the laboratory with 

valuable feedback on the competence of its testing 

processes. 

12. Adequacy of Facilities and Equipment

The laboratory should own or have access to all equipment 

required to perform all test methods it conducts. In 

addition, the facility should require test methods to be 

conducted in a controlled environment to prevent any 

adverse effects on the accuracy of the test result. 

Specifically, the testing environment should be free from 

excessive temperatures, temperature fluctuations, dust, 

moisture, dryness, vibration, and electromagnetic or other 

interference. The laboratory should also have adequate 

lighting, heating and ventilation. When needed, specialized 

facilities such as clean rooms should be available. 

13. Equipment Maintenance/Repair/Calibration 

Requirements 

Equipment calibration, preventative maintenance and repair 

procedures and the choice of reference materials10 used for 

calibration should be appropriate for the nature and amount 

of work being performed. Equipment calibrations should 

be traceable11 to some ultimate or national reference 

standard.12 Complete records should be maintained on all 

calibration, maintenance and repair procedures performed. 

14. Adequate Control over Subcontractors

The laboratory should have a system to ensure that testing 

and related work performed by any of its subcontractors is 

at an acceptable level of quality. The nature of the system 

should be appropriate for the type and amount of work 

being performed by the subcontractor. 

15. Appeals Procedure

The laboratory should have a mechanism to deal with 

technical questions, appeals, complaints and challenges, 

originating either from the customer or from interested 

regulatory or other parties. 

LABORATORY 

ACCREDITATION

While a laboratory can declare its compliance with 

requirements such as those listed above, or laboratory users 

can validate a laboratory's compliance for themselves, 

another method to ensure the quality and accuracy of 

laboratory test results is through the use of an independent 

third party. A third party (independent of the laboratory 

and the purchasers or users of laboratory testing and test 

data) can accredit the competence of a laboratory to 

conduct specific tests or to operate in specific fields. 

Accreditation is defined in ISO/IEC Guide 2 as a: 

"procedure by which an authoritative body gives formal 

recognition that a body or person is competent to carry out 

specific tasks." In the case of laboratory accreditation, the 

tasks are tests or specific types of tests. Laboratory 

accreditation does not provide any guarantees about the test 

results obtained from the performance of any specific test 

procedures. Laboratory accreditation means that the 

laboratory is capable of performing specified test methods 

and procedures correctly, not that the laboratory has 

competently tested all products in each and every instance. 

In addition, accreditation provides assurance about a 

laboratory's capability SOLELY within the scope or areas 

for which accreditation was granted. If a laboratory is 

accredited to test concrete, no assurance is provided 

regarding that laboratory's ability to test any product other 

than concrete. It should also be noted that not being 

accredited does not necessarily imply that the laboratory is 

not technically competent since not all laboratories seek or 

require accreditation, and accreditation programs may not 

exist in the laboratory's field of operation. 

Users of test results must understand the laboratory 

accreditation process, the criteria used, and the scope of 

accreditation to assess the value of that accreditation. This 

knowledge is necessary to make intelligent choices 

regarding the use of test results produced by the accredited 

laboratories. While laboratory accreditation is related to 

other aspects of conformity assessment, it is nonetheless a 

distinct procedure. Unlike product or service certification 

(which is described later in this report), laboratory 

accreditation involves neither the review nor assessment of 

products or services. While accredited laboratories may be 

used in certification programs, laboratories may be 

accredited to conduct tests (such as EPA's accreditation 

program for laboratories testing drinking water) in fields 

where no certification program exists. Some certification 

programs also use laboratories that are not accredited. 

Accreditation may recognize both the technical competence 

and impartiality (lack of conflicts-of-interest) of a testing 

laboratory, or only its technical competence. The inclusion 

or exclusion of a requirement for impartiality is only one of 

many differences among the various approval criteria used 

in U.S. laboratory accreditation schemes. Such differences 

in requirements or criteria for accreditation must be 

considered in evaluating a particular scheme. 

Since most U.S. laboratory accreditation/designation 

schemes were designed to meet particular governmental or 

private sector needs, such schemes tend to take distinctive 

forms and use different sets of procedures to ensure that a 

laboratory has sufficient competence to perform the 
8 

specified testing. Some schemes involve only a simple 

review of data submitted by a laboratory with no attempt at 

verification. Others require a full scale on-site evaluation 

of the laboratory's facilities, staff and equipment, and 

include a review of the results of internal audits, quality 

system reviews, and proficiency testing. Comparable 

programs, even those which are conducted by the same 

organization or government agency, may include different 

types or number of assessment procedures and may provide 

different degrees of assurance regarding a laboratory's 

competence. 

Meeting regulatory requirements is probably the primary 

reason for a laboratory to participate in an accreditation 

program. Congress, state, and local governments can 

mandate that required testing be done by an accredited 

laboratory. Federal, state and local government agencies 

may also impose a requirement for laboratory accreditation 

through regulations issued under their own legal authority. 

Laboratories may also require accreditation to meet testing 

requirements imposed by foreign governments on products 

imported into their countries. 

However, laboratories may also wish to participate in an 

accreditation program as: (1) an outside check of their 

internal quality control program; (2) proof of competence 

to higher level management within the organization; (3) a 

competitive advantage over other unaccredited laboratories; 

(4) a means of protection in liability proceedings; or (5) a 

means of establishing credibility with the public. In 

addition, contracts or procurement requirements may 

mandate the use of an accredited laboratory to conduct any 

required testing. A laboratory desiring to compete for such 

work would have to seek accreditation. Laboratories can 

also sometimes secure reduced medical care and related 

insurance rates by providing proof of a safe working 

environment through accreditation. An accreditation 

requirement could also be imposed as a condition of sale by 

a purchaser of a laboratory. 

The reasons for and benefits of seeking accreditation are as 

diverse as the laboratories themselves. In general, 

however, laboratories participate in accreditation programs 

in expectation of some type of economic return (such as 

increased business) on the resources they invest in 

obtaining the accreditation. 

Eligibility requirements for laboratories seeking 

accreditation vary among programs. Some federal 

programs restrict eligibility to state government 

laboratories, such as NIST's program to accredit state 

weights and measures laboratories. Other programs place 

different restrictions on eligibility. For example, the U.S. 

Department of Agriculture (USDA) program for inspecting 

grain for export restricts the number of approved 

laboratories in a particular geographical area to ensure that 

each approved laboratory has an adequate market share. 

Some accreditation programs are restricted to laboratories 

operated by the body doing the accreditation, such as the 

Department of Veterans Affairs' (VA) program to accredit 

the laboratories of its medical centers. This type of 

program falls into a categorical gray area somewhere 

between laboratory accreditation and internal quality 

assurance -- since elements of both are present. In other 

programs, eligibility may be restricted to those holding 

membership in the accrediting organization. However, it is 

generally desirable that a program impose as few 

restrictions on eligibility as possible. 

The terminology used to refer to a laboratory that satisfies 

the criteria established by a laboratory evaluation program 

also varies greatly. Some programs use the term 

"accredited," while others use the term "designated." Other 

programs refer to such a laboratory as "inspected," 

"accepted," or even "nationally recognized." Even the 

same term, such as "accredited," can be used by different 

programs to mean very different types of assessments. 

Different terms may also have different legal implications 

or may reflect differences between various agencies' or 

organizations' legal authority. 

The term laboratory "designation" is increasingly being 

used rather than "accreditation" for schemes in which 

government agencies, public authorities, certification 

bodies, companies and others identify or "designate" one or 

more laboratories to perform specific types of testing for 

their own use or for the purpose of implementing 

regulations, standards, or specifications in which the 

organization or agency has an interest. Regulators, 

certifiers and others sometimes designate test laboratories 

through a contractual or similar relationship with the 

laboratory. The use of the term "designation" may be 

preferable, particularly if the depth of technical competence 

assessment is less than what is usually encompassed under 

accreditation. A designation type program is usually 

conducted by a body for its own use, rather than for use by 

others. 

One should note the distinction between the acceptance 

body (the organization responsible for accepting and using 

the data produced by an accredited laboratory) and the 

accrediting body (the body that administers the laboratory 

accreditation program and issues the accreditation). For 

example, the accreditation body for a laboratory that tests 

radiation dosimeters may be NIST's National Voluntary 

Laboratory Accreditation Program (NVLAP), but the 

acceptance body -- the body that uses the data to regulate 

dosimeters -- is the Nuclear Regulatory Commission 

(NRC). This is an important difference that the reader 

should be aware of when reviewing information on 

laboratory accreditation programs. 

Laboratories can be accredited in several ways. One way is 

for the laboratory to be accredited to test in an entire field 

of testing. The American Society for Testing and Materials 

(ASTM) Standard E 1224-94: Categorizing Fields of 

Capability for Laboratory Accreditation Purposes
9 

defines a field of testing as a "broad sphere of science, 

engineering, or technology used to describe a general area 

of testing for classification purposes." ASTM E 1224-94 

lists these fields as acoustic and vibration testing, biological 

testing, chemical testing, electrical testing, ionizing 

radiation, mechanical testing, metrology, 

non-destructive testing, optics and photometry, and thermal 

testing. 

A laboratory can also be accredited in a scientific 

discipline, such as biochemistry, or for a specific 

technology (such as gene splicing), or in relation to specific 

products, such as blood product testing or concrete sample 

testing. Accreditation can also be limited to the conduct of 

specified test methods. 

In general, the broader the scope of approval, the more 

difficult and time consuming it is for the accrediting body 

to thoroughly assess the laboratory's ability to perform all 

test methods and to test all sizes and types of products 

within that scope. However, the narrower the scope of 

accreditation, the more likely it is that a laboratory 

performing a broad range of testing will have to obtain 

multiple accreditations. 

There are a number of standards or guidelines on how to 

operate a laboratory accreditation program, such as 

ISO/IEC Guide 58: 1992 - Calibration and testing 

laboratory accreditation systems - General requirements for 

operation and recognition. In the United States, a number 

of organizations have also attempted to address the issue of 

judging technical competence of laboratory accreditation 

bodies through standards documents, such as the American 

Society for Testing and Materials (ASTM) E 994-1995, 

"Guide Calibration and Testing Laboratory Accreditation 

Systems: General Requirements for Operation and 

Recognition." 

Not all laboratory accreditation programs are equally 

thorough and not all laboratory accreditation bodies are 

equally competent. The users of accreditation, accredited 

laboratories, and the test data produced by accredited 

laboratories should be aware of the following factors when 

evaluating a laboratory's accreditation or an accreditation 

process. These factors may affect the ability of the 

accreditation process to provide assurance that an 

accredited laboratory is capable of producing accurate and 

precise test data that is well accepted by all users. 

LABORATORY ACCREDITATION 

EVALUATION CRITERIA

1. Accreditation Body/Independence (No Conflict-ofInterest)

The accreditation body should be a legal entity organized in 

a manner that permits the satisfactory performance of all 

required functions. If the process is to be credible, the 

accrediting body and its assessors should be free from any 

outside influence that might bias the results of the 

accreditation process. No relationship should exist between 

the laboratory and the accreditation body or its assessors 

that might influence the objectivity and outcome of the 

accreditation process. 

2. Accreditation Body Procedures

The laboratory accreditation body should have published 

procedures on its operations, including procedures for 

granting, maintaining, modifying, suspending and 

withdrawing accreditation; and for maintaining the 

confidentiality of proprietary information. In general, 

participation in the accreditation process should not be 

conditional upon a laboratory's membership in any 

association or organization. Unjustified fees, financial 

requirements, or other conditions for application, which 

restrict participation and are not relevant to the competence 

of the laboratory, should also be avoided. 

 

3. Financial Stability

The body should have sufficient resources to satisfactorily 

perform all required functions, and to adequately indemnify 

itself against financial liabilities/penalties resulting from its 

operations. The body should have sufficient financial 

resources to allow it to refuse accreditation should that 

prove necessary. 

4. Staff Qualifications Requirements

The accreditation body should be able to demonstrate that 

its personnel are qualified. Assessors should have the 

knowledge and experience necessary to perform all 

required assessments in the accreditation process, including 

detailed knowledge of the assessment criteria and the 

standards, test methods, and equipment involved. 

Assessors should also be able to effectively communicate 

the results of the assessment. Each staff member's training 

should be kept current and documented. Financial benefit 

accruing to the accreditation body from assessor training 

should be avoided to discourage the training of marginally 

qualified assessors. 

5. Adequate Quality System

The body should have a quality system appropriate to the 

type, range and number of accreditations performed. The 

presence of an effective quality system in the accreditation 

scheme is important for maintaining confidence in the 

process. The system should be reviewed periodically by 

management and revised as needed to ensure continued 

acceptable performance. The quality system should be 

suitably documented in a comprehensive, up-to-date quality 

manual, which is readily available for consultation by staff. 

The body should conduct and document the results of 

internal audits as necessary to evaluate compliance with the 
10 

requirements in its quality documentation and to assess the 

efficiency and effectiveness of the system's operation. 

6. The Application Process

The accreditation body's assessment process should include 

a detailed application process. The application should 

include: the scope of accreditation being sought; an 

agreement by the applicant to comply with all requirements 

and fees imposed by the accreditation body; information on 

the laboratory, its staff and facilities; as well as the 

laboratory's quality manual and other quality 

documentation as appropriate. 

7. Standards/Test Methods Used

The choice of standards and test methods used in a 

laboratory accreditation scheme has a significant impact on 

the validity of the scheme and the accuracy, 

representativeness, and reproducibility of the results. 

Accreditation programs should only accept and use test 

methods that are capable of producing accurate and precise 

test results. 

8. The Assessment Process

The accrediting body should have a means of ensuring fair 

and equitable assessor selection and assignment. The 

accreditation body should appoint only competent and 

impartial assessors to conduct the assessment and provide 

them with any instructions and/or procedures needed. The 

assessment process should include: an initial meeting 

between the assessment team and the applicant to discuss 

the assessment; an evaluation of all areas of the laboratory 

required to ensure compliance with the accreditation 

requirements; documentation of the evaluation in a written 

report; and a follow up meeting between the team and the 

applicant to discuss the report and results of the assessment. 

9. Adequate Control over Subcontractors

The accreditation body should have a system to ensure that 

any work related to the accreditation performed by a 

subcontractor is of acceptable quality. The nature of the 

system should be appropriate for the type and amount of 

work performed by the subcontractor(s). The body should 

also be able to provide interested parties with adequate 

evidence of the competence of all subcontractors. 

10. Accreditation Decision

The accreditation body should make a decision on 

accreditation based on all evidence collected during the 

accreditation process. Responsibility for accreditation 

decisions should not be delegated by the accreditation body 

to another party. 

However, in some cases, it may be useful for the 

accreditation body to accept as equivalent to its own 

accreditation, an accreditation issued by another 

accreditation body(s). This should only be done after the 

accreditation body has thoroughly reviewed the 

requirements, procedures, and process used by the other 

accreditation body(s), and the two (or more) bodies have 

established a formal agreement listing the terms and 

conditions under which such recognition will occur. 

11. Recordkeeping Requirements

The accrediting body should maintain adequate records on 

the data collected, findings and reports related to all 

assessments performed; the qualifications, training and 

experience of each assessor; the assessment procedures 

used; and the laboratories accredited. All documentation 

regarding a laboratory should be restricted to persons or 

organizations considered by the accreditation body as 

having a legal right to such records. 

12. Surveillance System

The accreditation body should have a documented system 

in place for laboratory surveillance and periodic 

reassessment (including participation by the laboratory in a 

proficiency testing program) to ensure that accredited 

laboratories continue to comply with all accreditation 

requirements. The laboratory should be required to assist 

the body as necessary in gauging continued compliance. 

The accrediting body should also have procedures that 

permit the swift withdrawal of accredited status from 

laboratories that fail to comply with the terms and 

requirements for accreditation, as well as procedures for 

notifying other interested parties of the change in 

accreditation status. The body should also require that any 

significant changes in an accredited laboratory's operations 

be promptly reported. Based on such information, the body 

should then decide in a timely manner whether 

accreditation should be continued or terminated. 

13. Control of the Accreditation Document/Logo

The accrediting body should have mechanisms in place that 

minimize the potential for fraud or deception by a 

laboratory regarding its accreditation status or the meaning 

of that status. The body should have requirements 

regarding the use of its mark and the accreditation 

document, as well as a system in place to enforce those 

requirements. The body should take appropriate action 

against an accredited laboratory that misuses or 

misrepresents its mark or its accreditation or fails to 

continue to meet the requirements for accreditation. The 

body should also take action against unaccredited 

laboratories that misrepresent their accreditation status. 

14. Appeals Procedure

Disagreements may occasionally arise among parties 

involved in an accreditation program. The program should 

include an impartial appeals mechanism to handle 

disagreements that cannot otherwise be resolved. 
11 

Procedural requirements for appeals should be documented 

with minimal limitations on their timing and on who may 

file. 

15. Accredited laboratory listing

An accreditation body should periodically publish a listing 

of the accredited laboratories, the scope of accreditation, 

and any limitations/restrictions on the availability of the 

testing laboratories' services. 

OTHER CONSIDERATIONS

There are other considerations for evaluating the 

competence and usefulness of an accreditation program, 

these include: 

1. Recognition of Laboratory Accreditation Program

Widespread recognition or acceptance of a laboratory 

accreditation program can reduce the need for extensive 

retesting of a product. Programs that are well accepted are 

usually more cost effective since the need for multiple and 

duplicative assessments is reduced. Lack of recognition 

can result in the need for a laboratory to obtain multiple 

accreditations of the same (or essentially the same) testing 

services, sometimes based on all or most of the same 

accreditation criteria. 

In some cases, lack of recognition can result from 

inadequate knowledge or information on the program, 

rather than problems in the program itself. Based on 

information collected by Mr. Charles Hyer, the author of a 

number of NIST publications in this area, laboratories 

desiring to be accredited/designated nationwide to conduct 

electrical safety-related testing of construction materials, 

for example, have to gain the acceptance of at least 43 

states, over 100 local jurisdictions, the International 

Conference of Building Officials (ICBO), the Building 

Officials and Code Administrators (BOCA), the Southern 

Building Code Congress International (SBCCI), a number 

of federal agencies, as well as of several large corporations. 

Recently Congress recognized the importance of problems 

arising from redundant requirements in laboratory 

accreditation and other conformity assessment areas in its 

passage of the Technology Transfer and Advancement Act 

of 1996. Section 12 of the Act requires that federal 

agencies coordinate their conformity assessment activities 

with each other and with those of state government 

agencies and the private sector with the goal of 

"eliminating unnecessary duplication and complexity in the 

development and promulgation of conformity assessment 

requirements and measures." As a result, an effort is 

underway in the United States to upgrade the quality of and 

to facilitate mutual recognition among accreditation 

programs, known as the National Council for Laboratory 

Accreditation (NACLA). This joint government/industry 

program is composed of those in government and industry 

who actively support development of a system for 

recognizing the competence of testing and calibration 

laboratories -- both nationally and internationally. The 

work of this Council began in early 1997. Its efforts may 

help to decrease requirements for redundant accreditations 

and facilitate mutual recognition in the U.S. laboratory 

accreditation system. 

In addition, the National Environmental Laboratory 

Accreditation Conference (NELAC), sponsored by the U.S. 

Environmental Protection Agency (EPA), concerned state 

agencies, and others involved in environmental testing, is 

working to promote mutual acceptance of environmental 

test data among states. 

 

2. Program Scope

The scope of a laboratory accreditation program can impact 

the program's usefulness. Laboratory accreditation 

programs that are very narrow in scope -- designating or 

accrediting laboratories to test only a narrowly defined 

range of products within the agency's or organization's area 

of responsibility -- are usually of interest to only a few 

organizations. A laboratory that offers a broad range of 

testing services may need multiple accreditations that can 

increase the lab's cost of doing business and may restrict 

entrance into additional testing areas. On the other hand, 

accreditation programs that accredit laboratories to conduct 

too broad a scope of testing may not be able to adequately 

assess the competence of the laboratory for all test methods 

or testing areas within the scope, reducing the value of the 

accreditation. 

3. Accreditation Costs

Accreditation costs are of concern to all laboratories, 

particularly smaller laboratories or laboratories that offer a 

broad range of testing services. Such costs must be 

balanced against the amount of new testing work likely to 

result from accreditation. 

Multiple accreditations can be required to perform testing 

for different countries, or even for more than one state 

and/or local jurisdiction. Multiple accreditations may also 

be required for different products or testing fields -- all of 

which can considerably increase total accreditation costs. 

These costs are generally passed on to the users of the 

testing services. 

THE U.S. LABORATORY 

ACCREDITATION SYSTEM

The U.S. laboratory accreditation system is different from 

that of most foreign countries. The majority of foreign 

accreditation bodies are public organizations or 
12 

organizations with some direct government involvement. 

There is also a growing tendency in foreign countries to run 

national laboratory accreditation schemes in a coordinated 

fashion. In the United States, laboratory accreditation 

schemes are operated by all levels of government and by 

the private sector. No centralized coordinating body exists, 

though some coordination does take place between specific 

programs on their own initiative or through the intervention 

of other interested bodies, such as government agencies, 

trade associations or professional societies. This lack of 

coordination may be reduced as NACLA's and NELAC's 

work progresses. 

The different types of U.S. programs are briefly described 

below. 

1. Federal Government Laboratory Accreditation 

Programs

Requirements for laboratory accreditation/designation 

programs within the federal government vary greatly by 

program. While some programs, such the National 

Voluntary Laboratory Accreditation Program (NVLAP), 

are quite comprehensive; others involve only minimal 

review of a laboratory's qualifications. The requirements 

and scope of each accreditation program have generally 

been tailored to meet specific agency needs. With the 

exception of NVLAP, which was established to provide 

laboratory accreditation services, regulation or procurement 

(rather than laboratory accreditation/designation) is usually 

the agency's primary goal. In some cases, the accredited or 

designated laboratories provide only an initial product 

screening, with federal laboratories maintaining final 

responsibility for producing the test data used in enforcing 

regulations, such as the Mine Safety and Health 

Administration's (MSHA) programs for conformity 

assessment of mining products and equipment. 

Eligibility requirements for accreditation also vary among 

programs. Some programs restrict applications to state 

laboratories only, such as NIST's program for accrediting 

state weights and measures laboratories. As noted above, 

the VA program accredits only the laboratories of its 

medical centers. Some agencies, such as DOD's Defense 

Logistics Agency (DLA), designate or accredit laboratories 

found to be capable of performing specific tests on 

products procured by that agency. Such programs are open 

only to potential government suppliers. 

Terminology also varies by program. A 1989 GAO report 

noted the use of 10 different terms for accreditation with at 

least 18 different meanings by the 20 programs it reviewed. 

The same term, such as "accredited," used by different 

programs can mean very different types of assessments and 

assessment procedures. Different terms may also have 

different legal implications or may reflect differences 

between various agencies' legal authority to conduct 

specific programs.13

2. State/Local Government Laboratory Accreditation 

Programs

States administer many laboratory accreditation programs 

for a variety of reasons. In most cases, state and local 

government agencies accredit laboratories to test regulated 

products and require that such products be inspected and/or 

tested by an approved laboratory. An example is the 

regulation of building and electrical products at the state or 

local government level by requiring that the products be 

tested/inspected and bear the mark of a recognized or 

approved testing laboratory. In other cases, the state or 

local government programs, like some federal programs, 

accredit or designate laboratories that provide a 

surveillance/screening service for testing product 

compliance. In such cases, state/local government 

laboratories usually maintain responsibility for producing 

the test data used in enforcement situations. 

States also evaluate laboratories for other purposes, such as 

to assist them in enforcing federal regulations. For 

example, states have primary enforcement responsibility 

for the national requirements for ensuring the quality of 

public water systems. In carrying out this obligation, states 

accredit local laboratories to test drinking water. State and 

local authorities also accredit or designate laboratories to 

test products prior to their procurement by a state agency. 

As with federal programs, state and local requirements for 

laboratory accreditation/designation vary greatly by 

program. Some programs are quite comprehensive, while 

others involve only minimal review of a laboratory's 

capabilities. The terminology used for accreditation also 

varies extensively. 

3. Private Sector Laboratory Accreditation Programs

Private sector accrediting bodies also administer laboratory 

accreditation programs for a variety of reasons. These 

reasons range from assisting laboratories in defending their 

competence in professional malpractice matters to assisting 

an industry to avoid government regulation by undertaking 

self-policing efforts. Many private sector laboratory 

accreditation programs are operated as an integral part of a 

private sector certification program. In addition, 

accreditation programs can be established to assist 

government agencies in enforcing regulations, such as in 

the testing of building and construction products. The 

criteria and terminology used in private sector laboratory 

accreditation/designation schemes again vary greatly. 

Private sector programs also differ in size and scope. The 

American Association of Blood Banks (AABB) operates an 

accreditation program for blood bank and transfusion 

services that is recognized by many state authorities. The 

College of American Pathologists (CAP) program accredits 

hospitals and independent medical laboratories, and their 

program is used by the Department of Veterans Affairs 

(VA) to ensure the competence of VA medical facilities. 
13 

The American Association for Laboratory Accreditation 

(A2LA) operates an accreditation program that accredits 

laboratories in a number of testing fields. 

At the international level, the IEC Quality Assessment 

System for Electronic Components (IECQ) accredits testing 

facilities capable of demonstrating compliance of electronic 

components to prevailing requirements and standards, 

which are based on IEC standards. This accreditation 

program is part of a reciprocal worldwide certification 

system, in which certificates of conformity issued by an 

approved laboratory in one participating country are 

accepted by all other participating countries. 

The IEC also operates the IEC System for Conformity 

Testing for Safety of Electrical Equipment (IECEE). The 

IECEE's objective is the reciprocal recognition of test 

results (not certification marks or certificates of 

conformity) among the participating countries. Equipment 

is tested by approved laboratories against prevailing 

specifications and requirements, including safety, based on 

IEC standards. Any electrical products for which there are 

appropriate IEC standards can be included within the 

program. 

CERTIFICATION14

While a close interrelationship exists among 

standardization, testing, laboratory accreditation and 

certification, these areas are distinct. Certification is the 

process of providing assurance that a product conforms to a 

standard or specification or that a person is competent to 

perform a certain task. The use of certification in the 

marketplace dates back to the earliest times. An inscribed 

stone of the 4th Century BC, found in Eleusis, Greece in 

1893, cited a decree regarding the manufacture of bronze 

fittings for the erection of the columns of a new stoa 

(portico) that became the Philonion Stoa. The bronze 

specified was copper/tin in a ratio of 11 parts copper to 1 

part tin. Professor Varoufakis in his book, Materials 

Testing in Classical Greece, Technical Specifications of the 

4th Century BC, argued that the discovery of such a 

specification implies the existence of some type of check or 

verification. Professor Varoufakis tested the possibility 

that this check could have been conducted based on color 

differences between polished specimens of bronze differing 

in tin content. He noted a distinct color difference between 

two specimens when the tin content differed by only 2%. 

A similar process for identifying and differentiating gold 

alloys was already in use in ancient Greece. These may 

have been two of the earliest forms of certification -- metals 

of unknown content certified as to their composition on the 

basis of inspections for color.15

From 1890 to 1900, when the use of gas for domestic 

cooking and heating began to gain widespread popularity, 

many new gas appliances were developed and sold. Early 

records indicate that some thought was given to 

establishing a gas appliance testing laboratory as early as 

1903. The Baltimore investigation, conducted by the 

National Bureau of Standards in 1923, analyzed accidents 

resulting from the use of domestic gas appliances and 

flexible gas tubing. The City of Los Angeles started a 

similar laboratory and field study in 1924. Both 

investigations pointed to the need for a certification 

program for gas appliances. In 1925, the American Gas 

Association established a laboratory to test and certify gas 

appliances. The first certified gas heaters and ranges 

appeared on the market in 1926. 

Just 60 years ago, U.S. drug manufacturers could produce 

and sell drugs without testing them on either animals or 

humans and without any kind of governmental approval. 

Governmental action could only be taken against drugs that 

were misbranded or adulterated. In 1937, physicians in 

Tulsa, Oklahoma reported to the American Medical 

Association (AMA) the deaths of six patients from a 

liquefied version of the then wonder drug sulfa. Ultimately 

this drug killed 107 people, mostly children, before doctors 

realized what was happening and the drug was recalled. 

This tragedy led to the enactment of the 1938 Food, Drug 

and Cosmetic Act, which requires that drugs be tested and 

approved by the Food and Drug Administration before 

marketing. From such early beginnings, government and 

private sector certification programs have grown both in 

size and complexity. 

Some (but not all) certification programs mandate that 

accredited laboratories conduct any required testing, but (as 

noted above) there are laboratory accreditation schemes 

that are not associated with a certification program. 

Certification and laboratory accreditation programs both 

use standards, but not all standards are intended for these 

uses. Because standards, testing, laboratory accreditation, 

and certification are linked; strengths as well as 

deficiencies in any one area can have significant 

consequences for the other areas. For example, 

improvements in test method standards can significantly 

increase the capability of a laboratory to produce valid test 

data, which may then be used in a certification program. 

Product certification schemes range from the simple to the 

complex. Many private organizations, as well as federal 

and state agencies in the United States, certify products 

ranging from electrical cords to meat products. In addition, 

many certification programs are operated at local 

government (city, township, county, etc.) levels. 

Consumers see evidence of the extensiveness of 

certification-related activities when they note the 

Underwriters Laboratories (UL) mark on such products as 

electric coffee pots and fire extinguishers, the U.S. 

Department of Agriculture (USDA) mark on poultry and 

other agricultural products, and the International Wool 

Secretariat's Woolmark or Woolmarkblend on wool and 

wool blend textile goods - only a few of the many 

certification marks that may appear on consumer products. 
14 

TYPES OF CERTIFICATION

1. First Party Certification is the process by which a 

manufacturer or supplier declares that the product meets 

one or more standards based on: (1) the manufacturer's 

confidence in the quality control system, or (2) the results 

of testing or inspection the manufacturer undertakes or 

authorizes others to undertake on his/her behalf. This 

process is known as a manufacturer's or supplier's 

declaration of conformity. The manufacturer's capability, 

integrity, and reputation determine the degree of confidence 

that can be placed in this type of certification. 

In the United States, the criteria and procedures 

recommended for a supplier’s declaration program are 

established in American National Standards Institute 

(ANSI)16 Standard Z-34.2-1987, "American National 

Standard for Certification - Self-Certification by Producer 

or Supplier." At the international level, ISO/IEC Guide 22: 

1996 - "General Criteria for Supplier's Declaration of 

Conformity," also contains a list of such criteria and 

recommended procedures. Such procedures frequently 

include the requirement that the manufacturer's declaration 

be based on conformance with all requirements of a 

standard unless full disclosure is made of any limitations of 

the certification. Usually there are additional requirements 

for the adequate use and maintenance of test equipment, an 

effective quality control system, fully-trained staff, written 

certification procedures, and adequate record keeping. 

One of the most familiar certification programs in the 

United States involves the identification of the weight of 

motor oils by the manufacturer of conformance to the 

Society of Automotive Engineers (SAE) standards. 

Consumers will recognize such weight designations as SAE 

10W-40W or 10W-30W on the motor oils that they buy. 

These SAE designations are placed on the motor oils by the 

manufacturer based on his/her own testing and quality 

control mechanisms. This is primarily a supplier’s 

declaration program, though SAE does audit manufacturers' 

declarations to ensure that SAE standards are not being 

misused. 

2. Second Party Certification is also common in the 

United States. In this case, it is usually the buyer who 

requires and certifies that the products he/she wishes to 

purchase from suppliers meet one or more standards. The 

nature of these programs varies greatly depending on the 

type of product being purchased and the needs of the buyer. 

These certifications are generally only available to and 

mandatory for those companies wishing to become 

suppliers to that buyer. 

3. Third party certification is a type of certification in 

which the producer's claim of conformity is validated by a 

technically and otherwise competent third party (a body not 

controlled by or under the influence of the producer or 

buyer. The sponsor of the third party program (the 

certifier) may be responsible for collecting the required 

data, generating test results or conducting inspections, in 

addition to reviewing the results of such activities and 

making a final determination on the product's conformance 

or lack of conformance. The certifier may also delegate all 

or part of the data collection and review activities to 

another party or parties. The degree of confidence that can 

be placed in third party certification programs varies 

greatly depending on (1) the number and types of 

testing/inspection methods used within the program to 

ensure product conformance, (2) the adequacy of the 

manufacturer's quality control system, and (3) the 

competence of the body that conducts the testing and/or 

inspection and evaluates the test results. 

Recommended criteria and procedures for third party 

certification programs in the United States are established 

in ANSI Standard Z-34.1-1993, "American National 

Standards for Certification - Third-Party Certification 

Programs for Products, Processes, and Services." 

However, the recently issued ISO/IEC Guide 65: 1996 

"General requirements for bodies operating product 

certification systems," developed by the ISO CASCO 

Committee17 is likely to gain considerable acceptance 

nationally and internationally in the future. 

THIRD PARTY CERTIFICATION 

PROGRAMS IN THE UNITED STATES

1. Private Sector Certification Programs

U.S. private sector third party certification programs, 

described below, are operated by many different types of 

organizations including: 

 o Professional or technical societies, such as the 

American Dental Association (ADA) or the 

American Society of Sanitary Engineering 

(ASSE); 

 o Trade associations, such as the Association of 

Home Appliance Manufacturers (AHAM) or the 

International Safe Transit Association (ISTA); 

 o Independent testing/inspection organizations, 

such as Underwriters Laboratories (UL), Factory 

Mutual Research Corp. (FMRC), ETL Testing 

Laboratories, and the MET Electrical Testing 

Company; 

 o Organizations oriented toward consumers, 

industrial buyers, or users of the product, such as 

Good Housekeeping magazine, which offers a 

consumer protection program for products it 

approves; 
15 

 o Organizations composed of producers, testing 

laboratories, and others concerned with the wellbeing of an industrial group and/or its customers, 

such as the Solar Rating and Certification Corp. 

(SRCC), a nonprofit organization founded in 

1980 to test and certify solar thermal panels and 

systems; 

 o Organizations comprised of government 

officials involved in the regulation of an industry, 

such as the Building Officials and Code 

Administrators International (BOCA), the 

International Conference of Building Officials 

(ICBO), the Southern Building Code Congress 

International (SBCCI), and the International 

Association of Plumbing and Mechanical 

Officials (IAPMO); and 

 

 o Other miscellaneous organizations, such as a 

ship classification society or nonprofit 

organizations representing the kosher food 

consumer. 

One of the oldest certification programs has been operated 

since 1870 by the American Bureau of Shipping (ABS), a 

ship classification society. It is concerned with the design, 

construction and periodic survey of merchant ships and 

other marine structures. ABS certifications cover over 

12,400 vessels. Other certified products include: cargo 

containers, mobile offshore drilling and production units, 

fixed offshore structures, work boats, cranes, yachts, cargo 

handling engines, and related machinery and materials. 

Another well established industry trade association 

certification program is that of the American Gas 

Association (AGA), operated since 1925, and which has 

joined with its Canadian counterpart to form International 

Approval Services (IAS). Over 700 U.S. and Canadian 

manufacturers participate in IAS's program for gas 

appliances and accessories. IAS currently certifies a wide 

range of products including gas appliances and related 

accessories and electric and oil appliances. Products are 

tested in IAS facilities and requirements for certification 

include: a review of the construction and performance 

information for the product, factory and quality control 

inspections and annual product testing/inspections. 

Additional documentation may also be required. IAS 

publishes an annual directory of certified appliances and 

accessories. 

More recently established appliance certification programs 

for room air conditioners, refrigerator-freezers, 

dehumidifiers, and humidifiers are operated by the 

Association of Home Appliance Manufacturers (AHAM). 

The Air-Conditioning and Refrigeration Institute (ARI) 

certifies appliances ranging from air conditioning 

equipment to water coolers and solar collectors. 

A program familiar to many consumers is that of the 

American Dental Association (ADA), a professional 

society that operates a program for certifying dental 

materials, instruments, and equipment, including toothpaste 

and tooth brushes. The ADA certification program uses 

ADA standards and requires the submittal of a detailed 

application describing the product's specifications. ADA 

also requires a declaration by the manufacturer that the 

product meets the standard. Product samples obtained on 

the open market are tested by ADA. Upon approval, ADA 

authorizes the use of the ADA Seal of Certification and 

publishes approved product lists. 

Most consumers take for granted the familiar "UL" mark 

on a variety of products from electrical appliances to fire 

extinguishers. The Underwriters Laboratories (UL), an 

independent testing laboratory founded in 1894, is not only 

a major standards writer, but also tests products and 

materials with respect to potential hazards to life or 

property, listing18 those items that appear to pose no 

significant hazards. The Factory Mutual Research 

Corporation (FM), is another "product listing" organization, 

similar to UL. It is a non-profit testing and research 

organization whose purpose is to minimize industrial 

property damage through a number of activities, including 

product approval. FM issues lists of approved products that 

can vary from industrial trucks to building materials. 

Gardeners might recognize the AARS (All-America Rose 

Selections) mark on the rose bushes they purchase. Over 

40% of the roses sold in the United States bear the AARS 

symbol indicating that the rose bush meets certain quality 

requirements. The AAS (All-America Selections) mark is 

used in connection with seed for flowers and vegetables 

that meet similar requirements. 

The work of other major certification organizations, 

although equally vital, may be less well known outside the 

testing/inspection community. The Maple Flooring 

Manufacturers Association certifies floor finishes and 

sealants. The National Cotton Council of America, a trade 

association, certifies wrapping and banding materials for 

cotton bales. MEA Certifications certifies carpet under the 

Department of Housing and Urban Development (HUD) 

carpet certification program developed by the Carpet and 

Rug Institute. 

The American Society of Mechanical Engineers (ASME) 

accredits manufacturers of boilers, water heaters, pressure 

vessels and nuclear components, which, in turn, certify that 

their products meet ASME Code requirements through the 

completion of a Code data report. The National Board of 

Boiler and Pressure Vessel Inspectors (NBBI), an 

organization composed of chief boiler inspectors in the 

United States and Canada, registers manufacturers Code 

data reports and commissions the inspectors who provide 

independent third party inspection of products 

manufactured under the Code. The value of certifying 

these products to ASME Codes is recognized 
16 

internationally. 

Several 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), engage in certification-related activities. 

Composed of building, construction, zoning, and inspection 

officials, these organizations have developed model 

building codes that have been adopted by hundreds of state 

and local governments. The organizations evaluate 

products and materials and approve them for conformance 

with the requirements established in their building codes. 

Over one hundred seventy eight private sector 

organizations in the United States certify or list different 

types of products.19 Many others certify services. The 

broad range of organizations involved in certification 

reflects the impact of certification on a vast spectrum of 

interests and disciplines. 

2. Federal Government Certification Programs20 

Federal government certification programs can be classified 

into several general categories: 

 o Programs to certify products directly affecting 

the health or safety of the user or the general 

public. 

 o Programs that test products to avoid the 

necessity for retesting at local levels or prior to 

each procurement. 

 o Programs to provide a uniform basis for trade 

by assessing the quality and condition of 

products offered for sale. 

Examples of the first type of certification program include 

the evaluation and approval by the Food and Drug 

Administration (FDA), U.S. Department of Health and 

Human Services, of new animal and human drugs, medical 

devices, biologicals, and other products; the certification by 

the Federal Aviation Administration (FAA), U.S. 

Department of Transportation, of airplanes, major airplane 

components, and related services; and the certification by 

the Mine Safety and Health Administration (MSHA), 

Department of Labor, of electrical equipment used in 

mines. 

An example of the second type of program is the 

Department of Defense's (DoD) Qualified Products Listing 

(QPL) Program for parts, materials and components used in 

military systems. This program reduces retesting prior to 

each government purchase by testing products and placing 

those approved on appropriate QPL's. An extension of this 

concept also underlies the DoD Qualified Manufacturing 

Lists (QML's) Program, in which a manufacturer's process 

controls and manufacturing capabilities are evaluated and 

approved for an entire range of products. 

An example of the third type of program is the U.S. 

Department of Agriculture's (USDA) voluntary program to 

grade and certify meat and meat products (on a voluntary 

basis) using uniform quality grading standards for the 

buying and selling of such products. The USDA also 

certifies dairy products, fresh and processed fruits, 

vegetables, nuts and related products. The National 

Oceanic and Atmospheric Administration (NOAA), U.S. 

Department of Commerce, likewise inspects and grades 

processed fish and shellfish at a seafood processor's 

request. 

3. State Certification Programs

States administer many certification programs that cover a 

diversity of products for a variety of reasons. In some 

cases, states inspect or test products under authority 

delegated by the federal government. For example, many 

states inspect meat and meat products, certifying those that 

meet standards established by the USDA. These states then 

authorize the use of the appropriate USDA marks. Many 

states also inspect and issue certificates of conformity for 

manufactured homes under authority delegated by the U.S. 

Department of Housing and Urban Development (HUD). 

States may also impose additional state requirements and 

simultaneously check for conformity to these and federal 

requirements. 

States also regulate products under their own authority for 

health and safety reasons, including amusement rides and 

insulation, depending on each state's perception of the 

health and safety impact of such products on its population. 

Products may be inspected and/or tested directly by the 

states themselves, or indirectly through a requirement that 

such products be inspected and/or tested and certified by an 

approved body, such as a nationally recognized laboratory. 

An example of the latter is the regulation of electrical 

building products by imposing a state requirement that they 

be tested/inspected and bear the mark of a "nationally 

recognized testing laboratory." The term "nationally 

recognized laboratory" is currently defined by each state 

and/or municipality. 

States regulate products of direct or indirect economic 

importance. Florida and California, for example, inspect 

products important to their citrus fruit industry. Nebraska, 

with a considerable agricultural industry, regulates tractors 

through a testing program at the University of Nebraska 

and issues certificates of conformity for approved models. 

California, with its air pollution problem, stringently 

regulates auto emissions equipment. 

States also inspect/test/certify materials, products, systems 

and services they procure, such as materials for the 

construction of state roads and bridges. In yet other cases, 

the states establish standards and leave enforcement 

(testing, inspection, etc.) to local authorities. This is 
17 

sometimes true for building and construction materials. 

States operate certification (also called licensing programs) 

to regulate the services offered by professionals in fields 

ranging from medicine to insurance. 

CHOICE OF STANDARDS

As noted before, the standards chosen for use in 

certification (or other types of conformity assessment) 

programs should specify accurate and reproducible 

methods of testing for the specified characteristics if the 

certification program is to have any validity. The standards 

should also be clearly written and be capable of being 

uniformly interpreted. ISO/IEC Guide 7: 1994 has stated 

that standards suitable for product certification "....should 

be written in such a way that they facilitate and do not 

retard the development of technology." However, there are 

many other elements to consider when choosing standards 

for a certification program. 

One of the most obvious considerations in selecting 

standards is the determination of what characteristics need 

to be assessed to achieve the objectives of the program. 

The standards should specify all those and only those 

characteristics and requirements that are necessary to 

define the properties of the product or its performance; if 

this is not possible, then reference should be made to other 

relevant standards. Unless the chosen standards do, in fact, 

adequately specify all product characteristics that need to 

be assessed, it will not be possible to fully achieve the 

program's objectives and the program's value may be 

questionable. 

Certification schemes are normally established to indicate 

that a product meets one or more sets of acceptable or 

minimum requirements. But what is acceptable? What 

may be acceptable to one buyer may not be acceptable to 

another. Certification programs may choose standards that 

result in certified products that satisfy a particular group or 

organization, such as the government, or the program may 

choose standards expected to satisfy a larger group of 

buyers or users. The choice of standards, therefore, may 

depend on the needs of the parties likely to use the 

certification. 

Standards containing only one set of requirements and that 

define only one level of safety or quality are known as 

"pass-fail" standards. Either the product meets the 

minimum requirements (it passes and is certified) or it does 

not (it fails). Little or no attempt is made to convey 

information about the relative safety or quality of one 

certified product compared to other certified products (such 

as is conveyed through a grading system). Unless other 

methods are used to convey such information to 

buyers/users, a supplier may be less motivated to produce 

or supply products that exceed the minimum requirements 

specified in the standard. 

Certifiers may therefore wish to provide information on the 

quality or safety of one certified product relative to other 

certified products. This may be accomplished by selecting 

standards that define several levels of safety or quality and 

by including a grading scheme in the certification program. 

Information can be conveyed by stating the expected life of 

the product, such as the expected number of miles that tires 

are supposed to travel, or the versatility of the product, such 

as portable fire extinguishers rated for several specified 

types of fires, or the efficiency of the product, such as the 

energy efficiency rating for appliances. Buyers, assured of 

at least a minimum level of safety and/or quality, can then 

choose among certified products based on any additional 

level of quality or safety that they desire, other 

characteristics or features, and/or price. 

A choice must also be made as to whether the 

establishment of conformity should be based on an 

assessment of a product's performance or its design. As 

noted above, performance standards, tend to be difficult to 

develop and difficult to use in assessing compliance. 

Problems may also arise in establishing reliable test 

methods for assessing conformity, thus potentially 

increasing certification costs. 

The choice of standards for a certification program has a 

significant impact on the validity of the program, the value 

of the information conveyed by the certification, and the 

program's cost. 

CERTIFICATION METHODOLOGY

Third party certification programs differ greatly from one 

another, and the degree of confidence in the resultant 

certification depends on the type of program and its 

comprehensiveness (the number and types of 

test/inspection methods used within the program to assess 

conformity). 

The methods used in third party certification programs can 

be classified as follows: 

1. Type testing/Initial Inspection - This method attempts 

to determine if the supplier's design for the product can 

produce a product that conforms to a particular standard. 

Products from a preproduction run are inspected and/or 

tested or services or service providers are inspected/tested 

before being allowed to offer services to the public, but this 

method provides no information on whether the products or 

services supplied subsequent to the initial testing and 

inspection also consistently meet the specification. 

2. Surveillance of the Supplier's Process - Assessment of 

a supplier's materials, production and control processes can, 

at relatively low cost, provide assurance that the supplier's 
18 

quality control procedures are adequate. In some cases, a 

supplier's quality system must have been assessed and 

approved (registered) by a third party as a pre-requirement 

for application. 

3. Audit Testing - In this procedure, samples of products, 

services or individuals are selected at random from the 

marketplace or population and tested. Extensive testing is 

usually required to provide adequate assurance that group 

of objects/populations from which the samples are taken 

meet the referenced standard.

4. Field Investigations - Alleged failures of products 

during actual use are investigated to determine the cause of 

failure and to suggest appropriate corrective action. 

5. Batch testing - A sample is selected from a population 

or batch and tested for conformance to the standard. If the 

sampling procedure and the sample size are adequate, batch 

testing may be used to estimate, with a specified degree of 

confidence, that all objects in that batch or population 

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

an untested product or individual in the batch/population 

will meet the standard, nor does it furnish information on 

the quality of products produced in earlier or subsequent 

batches, or of individual in other populations. Batch testing 

is used in many certification programs for building 

products. 

6. 100 Percent Testing - In this method, each 

product/individual is tested to determine compliance with 

the designated standard. If the testing procedures are 

adequate, the procedure provides the highest possible level 

of assurance that the product/individual 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/individual. 

Many certification programs rely on two or more of these 

methods for their approval process. The choice of methods 

depends on the needs of both the buyer and the seller and 

on the nature of the product or service provided. The 

chosen methods can greatly affect both the cost of the 

program and the level of confidence that can be ascribed to 

it. 

CERTIFICATES OR MARKS OF 

CONFORMITY (CERTIFICATION 

MARKS)

ISO/IEC Guide 2 defines a certification mark (a mark of 

conformity for certification) as a: "protected mark, applied 

or issued under the rules of a certification system, 

indicating that confidence is provided that the relevant 

product, process or service is in conformity with a specific 

standard or other normative document." The marks used 

in U.S. certification programs are usually (but not always) 

registered with the U.S. Patent and Trademark Office 

(PTO) under the Trade Marks Act of 1946 (Lanham Act) as 

amended (1994). Some of these marks are registered with 

PTO as certification marks. However, others may be 

registered as trade or collective marks.21 The requirements 

established and enforced by PTO for obtaining and using 

these different types of marks vary by type of mark. 

ISO/IEC Guide 2 defines a certificate of conformity, as a: 

"document issued under the rules of a certification system, 

providing confidence that a duly identified product, 

process, or service is in conformity with a specific standard 

or other normative document." 

The marks or accompanying information should indicate 

the identity of the certification body (and any other testing 

body if applicable) and any relationship that the body(s) 

may have to the manufacturer. In addition, the certificate 

of conformity should contain information on: (1) the lot, 

batch or other production information to allow traceability 

to the production source and time of production; (2) the 

date when the certificate was issued; and (3) the officer of 

the company responsible for its issuance. Labeling 

included with the product should identify the supplier, and 

contain information on the name, type or model number 

and all instructions necessary for the correct and safe use 

and maintenance. 

Certification marks and certificates of conformity should be 

used to indicate that all essential characteristics of the 

product have been assessed. In cases where only one of 

several aspects of the product have been evaluated, such as 

flammability or electrical safety, this information should be 

conveyed in some manner to the buyer lest the mark 

mislead the buyer into placing more reliance on the 

certification than is justified. To the extent possible, the 

symbols used in connection with the certification mark 

should be capable of being interpreted without further 

definition. 

CERTIFICATION PROGRAM 

EVALUATION CRITERIA

While certification programs benefit both the seller and 

buyer of a certified product, certification programs also 

have the potential for misleading users and for other 

abuses. Some of the more significant elements to consider 

when evaluating certification programs are the similar to 

those for evaluating laboratory accreditation programs 

including: 

 

 (No Conflict-of-Interest) 

1. Certification Body/Independence 

 2. Adequate Quality System

 3. Adequate/Open Application 

Process

 4. Use of Documented Procedures
19 

 5. Use of Appropriate/Available 

 Standards

 6. Use of Valid Reproducible Test/ 

 Inspection Methods

 7. Technical and Financial 

Competence 

 on the Part of the Certifier, 

 Testing or Inspection 

Organization

 8. Adequate Control over 

 Subcontractors

 

 for the Certification Decision

9. No Delegation of Responsibility 

 10. Adequate Recordkeeping 

 Requirements

 11. Surveillance and Enforcement 

 Regarding Failure to Maintain 

 Compliance with Certification 

 Requirements. 

 12. Operation of an Impartial and 

 Documented Appeals System.

 13. Control of the Certification 

 Mark/Certificate of Conformity

OTHER CONSIDERATIONS

There are also other considerations for evaluating the 

usefulness of a certification program, including: 

1. Public Perception

Despite public perception and assumptions that certification 

implies legal responsibility for the quality and/or safety of 

the product certified by a third party, most certifiers are not 

willing to accept such responsibility. Responsibility for 

this liability generally rests with the supplier. Buyers and 

users of certification should understand these limitations. 

Buyers and users of a certification scheme should be 

adequately informed as to the purpose, scope, and technical 

limitations of the resultant certification so as not to be 

misled as to the value and degree of confidence that can be 

placed on the mark or certificate of conformity. 

2. Compatibility with and Recognition by Other 

Certification Schemes.

When U.S. certification schemes for the same product 

differ significantly, this may result in the need for extensive 

retesting at considerable expense in terms of both time and 

money, such as having to have a product certified by 

multiple certifiers to meet various state requirements. The 

potential barriers to trade that can result from differences 

among U.S. and foreign national certification programs can 

also be considerable. Preference should be given to the use 

of certification programs that are compatible with other 

national or foreign national certification schemes while still 

meeting the objectives of the scheme. 

In some cases, lack of recognition results from 

inadequacies in specific programs that need to be addressed 

by the responsible certifiers. However, lack of recognition 

can also result from inadequate knowledge or information 

on the program by certification users. It may also result 

from the vested interests of competing certifiers or others, 

rather than problems in the program itself. Widespread 

recognition or acceptance of competent certification 

programs should be encouraged to reduce the need for 

extensive retesting/inspection/certification of a product. 

 

3. Appropriate Use of Certification in Conjunction with 

Quality System Requirements 

As W. Edwards Deming22 often pointed out, quality must 

be designed into the product and ensured through an 

effective and efficient manufacturing process. Inspection, 

testing, and certification will provide information on 

whether the desired end result has been achieved, but 

usually that information comes too late in the supplier's 

process to improve the quality of the inspected/tested 

products. Certification should not be used as a substitute 

for a supplier having an effective quality system. 

4. Certification Costs

The costs involved in the certification process should be 

reasonable and in balance with the benefits likely to accrue 

to the supplier from having the product certified. Excessive 

costs in a certification process can be cause for serious 

concern for all suppliers (particularly for smaller suppliers), 

and can serve to restrict trade and competition. In most 

cases, certification costs are ultimately passed on to the 

buyers of the product. 

U.S. CERTIFICATION PROGRAM 

ACCREDITATION SYSTEM

One of the criticisms of manufacturer's declaration, namely 

that the manufacturer does not have a third party checking 

the competence and integrity of the results, fails to 

recognize that many third party certification programs also 

do not have anyone looking over their shoulder to ensure 

the quality of their programs. Like a laboratory, a certifier 

can declare its compliance with the requirements, such as 

those listed in ISO Guide 65: 1996 "General requirements 

for bodies operating product certification systems." Users 

of certification results can also validate a certifier's 

compliance for themselves. Yet another method for 

ensuring the competence of certifiers is through an 

accreditation program conducted by an independent third 

party. 

A third party (independent of the certifier and the 

purchasers or users of the certification) can accredit the 

competence of a certifier to conduct specific certification 

tasks for specific types of products. Like laboratory 
20 

accreditation, certification program accreditation does not 

necessarily give any guarantees about the certification 

results obtained from the performance of specific 

certification procedures. Certification program 

accreditation means that the certifier is capable of 

performing specified certification procedures correctly, not 

that the certifier has competently certified all products in 

each and every instance. Again, like laboratory 

accreditation, certification program accreditation only 

provides assurance about a certifier's capability within the 

scope or areas for which accreditation was granted. It 

should also be noted that lack of accreditation does not 

necessarily imply that the certifier is not technically 

competent since not all certifiers want or require 

accreditation. In some cases, accreditation programs may 

not exist in the certifier's field of operation. 

Meeting regulatory requirements is again probably the 

primary reason for a certifier to participate in an 

accreditation program. Congress, state and local 

governments can mandate that certifications be done by 

accredited certifiers. OSHA, for example, is responsible 

for the regulation of all electrical products used in the work 

place. Electrical products under OSHA's jurisdiction 

require approval and marking/listing by certifiers 

accredited by OSHA, known as Nationally Recognized 

Testing Laboratories (NRTL). 

State and local government agencies may also impose such 

a requirement through regulations issued under their own 

legal authority. Certifiers may also have to be accredited to 

meet mandatory requirements imposed by foreign 

governments on products imported into their countries. 

Like laboratories, certifiers may also participate in an 

accreditation program as an outside check of their internal 

quality control program, as proof of competence to higher 

level management within the organization, as a competitive 

advantage over other unaccredited programs, as a means of 

protection in liability proceedings, or as a means of 

establishing credibility with the public. 

The reasons for and benefits of seeking accreditation are 

many. In general, however, certifiers (and laboratories) 

participate in accreditation programs in expectation of 

some type of economic return on the resources they invest 

in obtaining the accreditation, such as new or expanded 

business opportunities. 

Again like laboratory accreditation programs, not all 

certifier accreditation programs are equally thorough and 

not all accrediting bodies are equally competent. Some 

factors that can be used to evaluate a certification program 

accreditation process were previously discussed under 

laboratory accreditation. These factors affect the ability of 

the certification program accreditation process to provide 

assurance that an accredited certifier is capable of 

competently conducting certain certification procedures for 

one or more products as defined in the scope of the 

accreditation.

The U.S. certification program accreditation system is less 

complex than that for laboratory accreditation, primarily 

because the U.S. has significantly fewer programs for 

accrediting certifiers than for accrediting laboratories. The 

two most prominent programs are the ones run by OSHA 

(which was mentioned above) and by ANSI. 

OSHA's program covers electrical equipment/materials 

used in the work place. All electrical products used in the 

work place must be tested and listed or labeled by a 

certifier (known as a Nationally Recognized Testing 

Laboratory or NRTL) that is recognized/approved by 

OSHA. Participation in the OSHA program is voluntary 

for certifiers; however, if they wish to test such products, 

they must be recognized/approved by OSHA.23 

ANSI also conducts an accreditation program for certifiers, 

which was established in the 1970s. ANSI's policies and 

procedures were revised in 1992 to be consistent with both 

relevant international standards and guides and with 

anticipated obligations under the WTO Agreement. ANSI 

accredits certifiers in a number of areas ranging from 

construction materials to drinking water additives to gas 

and electrical appliances and accessories. 

MANAGEMENT SYSTEM 

ASSESSMENT/REGISTRATION

At the national and international level, interest has 

mushroomed in quality and environmental management 

systems. Having a quality management system helps a 

supplier ensure that he/she is able to produce products that 

consistently conform to a given set of standards or 

expectations. Product quality depends on many variables, 

such as the caliber of the components or materials used; 

type of equipment used in design, production, handling, 

installation, testing and shipping; the equipment calibration 

and maintenance procedures employed; the training and 

experience of production and supervisory personnel; the 

level of "workmanship;" and sometimes the environmental 

conditions (temperature, humidity, level of dust particles) 

in the area where the product is produced. The process, 

organizational structure, procedures, and resources that 

suppliers use to control these variables to produce a product 

of consistent quality that meets defined specifications is 

called a quality system.24 The standards for quality 

systems that are best known and that are being adopted 

globally are the ISO 9000 standards. 

Environmental management systems (EMS) are designed to 

provide a comprehensive approach that can be used by 

businesses and other organizations to manage the impact of 

their activities on the environment. Environmental 

management system standards generally do not establish 

requirements for environmental compliance nor for specific 
21 

levels of pollution prevention or performance (this being 

essentially the responsibility of the appropriate regulatory 

agency(s) and/or the organization's management). 

However, management system standards do establish a 

framework that an organization can use to evaluate its 

performance against such levels. EMS standards, such as 

ISO 14001, generally stress identifying key environmental 

impacts (aspects) associated with the operations of an 

organization, setting targets and objectives for these 

aspects, and implementing the system via training and 

documentation of procedures. EMS standards, like ISO 

14001, also require that the company implement a program 

to conduct internal audits of its EMS, to conduct periodic 

management reviews of the system's effectiveness, and to 

have a commitment to continual improvement of the EMS. 

Recent publication of the first two international 

environmental management system standards (ISO 14001 

and ISO 14004) is likely to increase awareness in the 

United States of the usefulness of management systems in 

overseeing and improving environmental performance. 

THE ISO 9000 STANDARDS 

The original ISO 9000 standards were a series of three 

international standards (ISO 9000, 9001, and 9004) 

developed by ISO Technical Committee (TC) 176 and 

published in 1987 to provide guidance on selection of an 

appropriate quality management program (system) for a 

supplier's operations. The Series is generic in scope 

covering both service and manufacturing industries. The 

1994 edition of ISO 9001 contains requirements in twenty 

areas covering: management responsibility; quality system 

requirements; contract review; design control; document 

and data control; purchasing; requirements for customersupplied product; product identification and traceability; 

process control; inspection and testing; control of 

inspection, measuring and test equipment; inspection and 

test status; control of nonconforming product; corrective 

and preventative action; handling, storage, packaging, 

preservation and delivery; control of quality records; 

internal quality audits; training; servicing; and the use of 

statistical techniques. 

The United States has been an active participant in ISO TC 

176 since 1987, and the 1994 edition of the ISO 9000 

Standard Series has been adopted in the United States as 

the ANSI/ASQC Q 9000 Standard Series. The ISO 9000 

standards, which were initially intended to be advisory in 

nature and which were developed primarily for use in twoparty contractual situations or for internal auditing, are 

currently being applied under a much broader range of 

conditions and circumstances. 

The reader should also note that some national and regional 

standards bodies are developing supplemental guidance for 

the application of the ISO 9000 series to specific industries. 

For example, CEN and CENELEC are developing more 

specific requirements for the application of the ISO 9001 to 

the medical device industry;25 and the U.S. Food and Drug 

Administration (FDA) is revising its Good Manufacturing 

Practice (GMP) regulations for medical devices to follow 

ISO 9001 with appropriate additional requirements. 

THE ISO 14000 STANDARDS

In June 1992, the United Nations' Conference on 

Environmental Development was held in Brazil. At that 

Conference, ISO made a commitment to continue the work 

it had begun the prior year in the area of environmental 

management. The previous year, ISO had formed the 

Strategic Advisory Group on the Environment (SAGE) to 

develop an international consensus of what needed to be 

done in this area. The work of SAGE ultimately resulted in 

the formation of TC 207 in 1993 to develop standards in 

the field of environmental management tools and systems. 

The United States has been an active participant in ISO TC 

207 since 1993. U.S. participation in TC 207 and its 

subcommittees is jointly managed by the American Society 

of Testing and Materials (ASTM) and ASQC under the 

aegis of ANSI. The work of ISO TC 207 is divided into 

seven areas: (1) management systems; (2) audits; (3) 

labeling; (4) environmental performance evaluation; (5) life 

cycle assessment; (6) terms and definitions, and (7) 

environmental aspects in product standards. 

Work is ongoing in all of these areas. In the management 

system area, ISO 14001 and 14004 were released in the fall 

of 1996, and have been the subject of much review and 

analysis in the United States. Some U.S. companies have 

already begun to seek conformance with the standards, with 

a smaller number seeking third party registration of that 

conformance. While it is still unclear as to the extent that 

these standards will ultimately gain acceptance with U.S. 

industry, there appears to be growing acceptance of these 

standards in Europe and elsewhere. 

MANAGEMENT SYSTEM ASSESSORS

1. First party assessment or self-assessment is the 

process by which a manufacturer or supplier declares that 

the quality or environmental management system conforms 

to the requirements of ISO 9001, 9002 or 9003; ISO 14001; 

or some comparable standard. Such self-audits are usually 

major components of the system itself. Such self-audits 

can increase the confidence of management in its system 

and demonstrate to its personnel that the firm is committed 

to quality or environmental management. This process is 

also known as a manufacturer's declaration of 

conformance. 
22 

2. Second Party Assessment is also common in the 

United States. In this case, it is usually the buyer who 

requires and assesses the quality or environmental 

management systems of the suppliers from which the buyer 

wishes to purchase products. The nature of these programs 

varies greatly depending on the type of product being 

purchased and the needs and concerns of the buyer. These 

assessments are generally only available to and mandatory 

for those companies wishing to become suppliers to that 

buyer. 

3. Third party Assessment (better known as 

management system registration), is a form of 

assessment in which the supplier's claim of conformity is 

validated by a technically competent body. "Third party" 

quality or environmental management system evaluations 

and registrations may be voluntary or mandatory and are 

conducted by persons or organizations independent of both 

the supplier and the buyer. 

4. A new type of assessment has also been proposed within 

the United States and internationally -- the Supplier's 

Audit Confirmation (SAC) route -- which involved 

elements of both first party and third party evaluations. 

The SAC route would include a supplier's declaration of 

conformity to the appropriate ISO 9000 or ISO 14000 

standard combined with a third party assessment of the 

maturity of the manufacturer's quality or environmental 

management system and the effectiveness of the internal 

audit program. The details of how this new type of 

assessment would operate are still under development. 

MANAGEMENT SYSTEM 

REGISTRATION

Management system registration or approval

(sometimes misnamed "management system 

certification"26) involves the assessment and periodic audit 

of the adequacy of a supplier's management system by a 

third party, known as a registrar. When a supplier's system 

conforms to the registrar's interpretation of an ISO 9000 or 

14000 standard, the registrar issues the supplier a 

"certificate of registration." 

The reader should note that it is the supplier's system that is 

registered, not an individual product or a company's 

compliance with an established level of environmental 

performance. Consequently, management system 

registration does not imply product conformity to any 

given set of requirements or compliance with any 

established level of environmental performance. 

Management system registration is not a replacement 

for an assessment of the product to determine its quality 

or suitability nor is it a replacement for assessment of 

the organization's compliance with established 

environmental requirements. 

For example, when a product certification program is 

conducted in conjunction with a registration program, the 

buyer is provided with information on the characteristics of 

the product and on the likelihood that the product is being 

produced consistently. When an environmental 

management system assessment is conducted in 

conjunction with a compliance audit, information is 

provided not only about the organization's compliance with 

legal environmental requirements at the time of the 

compliance audit but also about the organization's ability to 

sustain or improve upon that compliance level over time. 

Currently, approximately fifty U.S. based organizations 

conduct quality system registration. In addition, according 

to Quality System Update (QSU),27 as of December 1996, 

11,738 company sites had obtained registration; and the 

number of registered U.S. companies continues to grow at a 

rapid pace. 

Some of the impetus for U.S. companies to seek quality 

system registration results from European Union (EU) 

requirements. Having an approved quality system will not 

be a blanket requirement for all products. Nevertheless, for 

suppliers of some products, having an approved quality 

system will be a key component of the EU's legal 

requirements. For most of these regulated products, 

however, ISO 9000 registration is but one alternative for 

proving compliance to the essential requirements contained 

in the so-called "new approach" directives, not an absolute 

requirement. 

However, most of the demand U.S firms are experiencing 

for ISO 9000 registration in Europe and elsewhere seems to 

be coming less from regulatory bodies than from the 

marketplace. As the importance of ISO 9000 registration 

becomes recognized and required by foreign and domestic 

buyers and as registration is seen and used by 

manufacturers as a competitive marketing tool, the demand 

for ISO 9000 compliance is expected to increase in nonregulated areas. 

The degree of interest and pressure felt by U.S. 

manufacturers to seek registration currently varies 

significantly by industry. In many of the "high tech" or 

"high safety and health risk" areas where product reliability 

is crucial, the market pressure on U.S. manufacturers to 

seek registration is likely to be considerable. In addition, 

international companies are becoming increasingly 

compliant with, and requiring their suppliers to become 

compliant with, the ISO 9000 standards and/or to have their 

quality systems registered. 

For example, the so-called "Big Three" U.S. automakers -- 

Ford, Chrysler, and General Motors (GM) -- have adopted 

a uniform set of quality system requirements (referred to as 

the Chrysler, Ford and General Motors Quality System 

Requirements QS-9000 Standard), which incorporates ISO 

9001 in its entirety. Previously each company had its own 

expectations for supplier quality systems and corresponding 
23 

assessment documents. In addition to the Big Three, the 

QS-9000 standard has been adopted by Mack Trucks, 

Volvo GM Heavy Truck, and others. 

The QS-9000 will be applied to all internal and external 

suppliers of production and service parts and materials. 

GM and Chrysler have already indicated that they will 

require third party registration by their primary suppliers 

and have provided them with a time table for completing 

that registration. Ford is still considering the issue of third 

party registration and has indicated that -- while it will 

accept third party registration -- it will not require it at this 

time. 

Another ISO 9000 based standard, TE-9000, has also been 

developed by the "Big Three" and applies to suppliers of 

both capital equipment and perishable tools for the 

following processes: assembly; balancing; casting; 

deburring; forging; forming; gaging; heat treating; 

machining; material handling; measuring; molding; 

packaging; painting; plating; robotics; stamping; tooling; 

washing; and welding. Registration is not currently 

required, but that may change. 

Other large U.S. firms also require or encourage suppliers 

to become compliant with the ISO 9000 standards or their 

equivalent, such as the aerospace industry's ARD-9000 

standards. 

In the environmental management system area, five U.S. 

registrars were approved in early 1997 by the U.S. 

accreditation system to conduct ISO 14001 registrations. 

Additional registrars are involved the approval process. 

This is still a new program in the United States, but it is 

expected to grow in coming years. While some companies 

have or are beginning to seek conformance to these 

standards, and even third party registration, it is still too 

early to speculate on the extent to which U.S. industry and 

U.S. government agencies will endorse the use of these 

standards or the effect that international marketplace 

considerations will have on the ISO 14000 standards 

acceptance and use. 

U.S. Federal Agencies Activities Related to ISO 9000

While currently there are no mandatory requirements in the 

United States for quality system approval or registration, 

some federal agencies are considering how they might use 

them within their regulatory programs. For example, in 

October 1996, FDA issued a final rule to revise its medical 

device good manufacturing practice (GMP) regulations to 

ensure compatibility with quality system specifications 

contained in ISO 9001. FDA has also begun to look at how 

the ISO 9000 Standard Series can make a useful 

contribution in the other product areas it regulates. Other 

federal agencies are also studying this issue. 

Federal agencies are also looking at the usefulness of the 

ISO 9000 standards in the procurement area. On June 29, 

1994, Secretary of Defense William Perry issued a memo 

that mandated greater use of performance and commercial 

specifications and standards and encouraged greater 

partnership between DoD and industry associations in the 

development of non-government standards. It directed the 

reduction of government oversight by substituting process 

controls and non-government standards in place of 

development and/or production testing and inspection, and 

military unique quality assurance standards. This memo 

reinforced the earlier DoD memo dated February 14, 1994 

in which DOD issued a policy statement designed to 

remove barriers within DOD to the use of the ISO 9000. 

DoD has taken a leadership role along with National 

Aeronautics and Space Administration (NASA) in the 

Government Industry Quality Liaison Panel (GIQLP), 

which is exploring the use of a government-wide single set 

of basic quality system requirements based on the twenty 

elements of ISO 9001, the use of "advanced quality 

concepts" in government procurement, and mutual 

recognition of agency audits of the basic quality system by 

other agencies. They have been joined in this effort by 

other federal agencies, including the General Services 

Administration (GSA), The Federal Aviation 

Administration (FAA), the U.S. Coast Guard, the National 

Maritime Administration (MARAD), the National Oceanic 

and Atmospheric Administration (NOAA), and the 

National Institute of Standards and Technology (NIST). 

U.S. Federal Agencies Activities Related to ISO 14000

Because the issuance of ISO 14001 and 14004 is so recent, 

no federal endorsement of these standards had been issued 

as of early 1997. However, many federal agencies have 

begun to review the potential usefulness of these standards 

within their regulatory and programs activities. The 

Interagency Committee on Standards Policy (ICSP), 

chaired by NIST, has established an ISO 14000/EMS 

Workgroup to provide information and recommendations to 

the ICSP regarding development and implementation of the 

ISO 14000 standards in the federal sector. The working 

group has been: sharing information; identifying current 

uses of ISO 14000 by agencies; as well as identifying 

agency capabilities and initiatives and ways to link agency 

efforts. In addition, the Environmental Protection Agency 

(EPA) has begun using management system standards in 

several pilot programs designed to collect data on such 

issues as how having an EMS affects or does not affect 

compliance with regulatory requirements and overall 

environmental performance. Such data is expected to be 

used by EPA in formulating its policy on the use of such 

standards.

ACCREDITATION OF U.S. 

MANAGEMENT SYSTEM REGISTRARS
24 

In 1989, the Registrar Accreditation Board (RAB) was 

established as an affiliate of the American Society of 

Quality Control (ASQC) to develop a program to evaluate 

the quality of services offered by registrars. RAB issued its 

first approval in March 1991, and several more firms have 

been approved since then. In December 1991, RAB and 

ANSI agreed to form a joint U.S. quality system 

registration program called the American National 

Accreditation Program for registrars of Quality Systems 

(ANAPRQS). This system was recently been expanded to 

include the accreditation of environmental management 

system registrars and is now referred to as the National 

Accreditation Program (NAP). 

In February 1992, RAB established an ISO 9000 auditor 

certification program. RAB recently expanded this 

program to include the certification of EMS auditors. In 

1992, RAB also established requirements for the 

accreditation of auditor training course providers. The 

course provider accreditation program is currently operated 

under the ANSI/RAB NAP and was expanded in 1996 to 

include the approval of EMS auditor training course 

providers. 

At least two European accreditation bodies also accredit 

registrars outside their geographical borders. The Dutch 

Council for Accreditation (RvA), in particular, has 

accredited a number of registrars in the United States. 

RAB is currently working towards an agreement with RvA 

regarding mutual recognition of each other's accreditations. 

In addition, the Standards Council of Canada (SCC) has 

established an accreditation program for registrars, which is 

open to U.S. registrars. Programs similar to those of the 

RAB, RvA, and SCC have been established in a number of 

other European countries and elsewhere in the world, 

though many are currently not open to U.S. registrars.28 

However, some U.S. registrars with parent bodies in 

Europe have had their parent bodies accredited by their 

national accreditation bodies. For example, TUV 

America's parent body is accredited to conduct quality 

system registrations by German Accreditation Board 

(DAR) in Germany. 

ACCREDITATION PROGRAM 

RECOGNITION

The recognition of laboratory, certifier, and registrar 

accreditation programs within the United States is a 

relatively new field. Congress mandated the use of such a 

program in conjunction with fastener testing under the 

Fastener Quality Act of 1990. Section 6 of the Act requires 

the Secretary of Commerce, acting through the Director of 

NIST, to issue regulations under which private laboratory 

accreditation entities may apply to NIST for approval to 

accredit laboratories in accordance with the requirements of 

the Act, which are to be consistent to the extent practical 

with requirements of national or international consensus 

documents. 

NIST also offers to recognize accreditation programs under 

its National Voluntary Conformity Assessment System 

Evaluation Program (NVCASE). This program will enable 

the Department of Commerce, acting through NIST, to 

evaluate and recognize accreditation bodies (as well as 

other conformity assessment bodies as appropriate) that 

meet established requirements. The program is designed to 

provide the EU and other countries with any assurances 

they might require regarding the competence of U.S. based 

testing, certification and quality system registration bodies 

to conduct conformity assessment activities mandated by 

the EU or other country under one or more MRAs. The 

final rule on the NVCASE program was published in the 

Federal Register on April 22, 1994, and a number of 

applications are now pending. 

Both the Fastener Quality Act recognition program and the 

NVCASE program will conduct assessments against 

general requirements established in appropriate 

international standards and guides. The programs will also 

use specific technical requirements that are established for 

fastener testing or within the scope of the applicable MRA. 

While other studies have also called for increasing the use 

of government recognition programs29, it is still too early 

to determine the extent to which recognition programs will 

be used as part of the U.S. conformity assessment system. 

INTERNATIONAL/REGIONAL

COOPERATION IN

CONFORMITY ASSESSMENT

A number of mechanisms are used to facilitate the 

acceptance of conformity assessment data in more than one 

country. In some cases, a conformity assessment body in 

one country will buy or establish a subsidiary within the 

geographical boundaries of a foreign country. Conformity 

assessment data can then be exchanged and accepted 

between the parent body and its subsidiary. 

In other cases, an agreement can be established between 

two or more organizations located in different countries to 

accept each other's conformity assessment data or the 

agreement may be based on the acceptance of conformity 

assessment marks or certificates of conformity. An 

example of the former type of mutual recognition 

arrangement is the IEC's System for Conformity Testing to 

Standards for Safety of Electrical Products (the IECEE 

scheme), which is designed to promote the reciprocal 

recognition of test results among the participating countries 

and to simplify the certification of electrical products at the 

national level. An example of the latter is ISO's/IEC's 

Quality System Assessment Recognition Program (QSAR) 
25 

that is currently being developed in cooperation with and 

will be operated by the International Accreditation Forum 

(IAF)30. That program is designed to encourage mutual 

recognition of ISO 9000 registration certificates by 

participating national accreditation bodies based on audits 

of each other's operations. The IAF peer reviews are 

expected to begin in March 1997 with the assessment of the 

ANSI-RAB NAP Program. 

In most mutual recognition schemes, such as the IECEE 

Scheme, parties to the agreement agree to accept each 

other's test results or reports rather than each other's 

certification marks. Test results or reports prepared in one 

participating country are accepted in other participating 

countries for the purpose of obtaining certification or 

government marketing approval by the importing country. 

Mutual acceptance of data may also result from the 

establishment of bilateral or multilateral agreements 

between governmental authorities or between a 

governmental authority and a private sector body.31 These 

agreements require each party to accept conformity 

assessment results from entities that are recognized or 

accredited by the other party or parties. However, these 

agreements are usually very difficult to reach for many 

reasons -- especially legal restrictions imposed on the 

extent to which agencies can transfer their authority for 

approving products to foreign governments or other 

entities. For that reason, most mutual recognition 

agreements between governments involve the mutual 

acceptance of test data, not certifications or approvals; each 

government retains the authority for final approval under 

such agreements. 

However, one example of a governmental multilateral 

agreement for the acceptance of certifications is the 

European Union's (EU) regional mutual recognition 

scheme for regulated products. Under the so-called "new 

approach to technical harmonization of standards," each 

EU country provides the EU Commission with a list of 

certifiers (as well as other conformity assessment bodies) 

that the country considers to be competent to perform 

certain conformity assessment tasks listed under specified 

directives. These certifiers (as well as other conformity 

assessment bodies) are referred to as "notified bodies." 

Notified bodies can declare (certify) that a regulated 

product conforms to the "essential requirements" spelled 

out in the applicable directive. Acceptable methods for 

conformity assessment, including certification, are listed in 

each directive. The certifications and subsequent product 

approval marking of any notified body must be accepted by 

all other EU countries unless there is cause to believe that 

the product was improperly certified. Each EU country is 

responsible for ensuring that the certification bodies it 

notifies comply with the criteria for competence spelled out 

in the EN 45000 series. 

Another example of such an agreement is the Agreement 

on the International Carriage of Perishable Foodstuffs and 

on the Special Equipment to be Used for Such Carriage 

(ATP). The ATP is an international agreement that sets 

standards for the testing and uses of equipment that carry 

perishable foodstuffs. USDA certifies test stations and 

laboratories in accordance with requirements of the ATP. 

These bodies can then issue U.S. ATP certificates that are 

recognized by other ATP signatories (countries). 

An example of an agreement between a governmental 

entity and a private sector body is NIST's National 

Voluntary Laboratory Accreditation Program (NVLAP) 

bilateral agreement with the Standards Council of Canada 

(SCC) -- a governmentally recognized, though private 

sector, body. Under this agreement, laboratories accredited 

by one party are recognized by the other party to the 

agreement as being competent within the scope of 

accreditation. 

While such efforts have done much to reduce the need for 

multiple assessments of products sold internationally, there 

can be many problems with mutual recognition agreements, 

including lack of clarity or the inclusion of poorly defined 

terms and responsibilities in the written agreement. The 

reader should also be cognizant of who signed the 

agreement when reviewing information on mutual 

recognition agreements (MRAs) between conformity 

assessment programs. 

An acceptance body is an organization responsible for 

accepting and using the conformity assessment data 

produced by a conformity assessment body. This body 

may be the same as or different from the conformity 

assessment body -- the body that administers the 

conformity assessment program. As previously cited, the 

accreditation body for a laboratory that tests radiation 

dosimeters might be NIST's National Voluntary Laboratory 

Accreditation Program (NVLAP), while the acceptance 

body -- the body that uses the data to regulate dosimeters -- 

is the Nuclear Regulatory Commission (NRC). This is an 

important distinction that readers should be aware of when 

reviewing information on mutual recognition arrangements 

between conformity assessment programs. If acceptance 

bodies are not parties to the agreement, they are not 

obligated and may not be willing to accept data generated 

from all signatories to the agreement. The value of the 

agreement is then questionable. 

This problem may be overcome if each conformity 

assessment body is willing to extend the use of its own 

conformity assessment mark or certificate to a conformity 

assessment body that has been accredited by the other 

party(ies). For example, as noted above, if laboratories 

(registrars or certification bodies) accredited by 

Accreditation Body A are also provided with an 

accreditation certificate from Accreditation Body B and are 

able to use Body B's accreditation mark, and vice versa, 

this problem can be overcome. 

However, under this arrangement, each party may be 
26 

assuming responsibility for (and the liability and risks 

associated with) the other party's work. Another alternative 

is to allow parties to label a conforming product with a 

mark common to all parties to the agreement. An example 

of this type of scheme is the IEC's Quality Assessment 

System for Electronic Components (the IECQ scheme). 

This scheme is designed to facilitate trade in electronic 

components by requiring participating countries to 

recognize without discrimination all IECQ approvals of 

manufacturers, distributors and test laboratories and the 

IECQ certification of components. 

Yet another alternative is to have all acceptance bodies also 

sign the agreement. This can be difficult to accomplish if 

regulatory agencies are involved and issues of statutory 

authority required to enter into such agreements are raised. 

Such problems can make the establishment of an effective 

MRA a very complex undertaking. 

Nonetheless, mutual recognition schemes are vital to trade 

because they can help to: (1) ensure an objective 

assessment of a product; (2) increase the efficiency of 

international or regional economic cooperation through the 

removal of technical barriers to trade; (3) quicken the 

circulation of products entering international or regional 

markets; (4) eliminate the need for recertification and thus 

reduce the costs incurred; and (5) ensure safety, health and 

environmental protection. 

It is likely that ISO Guides 65, 61, and 62 (which cover the 

operation of certification and quality system registration 

programs and the accreditation schemes for those activities) 

together with ISO/IEC Guides 25 and 5832 (which cover 

the operation of testing and calibration laboratories and 

laboratory accreditation schemes) will help facilitate the 

process of establishing mutual recognition agreements by 

serving as the basis for many if not most of such mutual 

recognition schemes in the future. 

SUMMARY

The U.S. system for conformity assessment is complex, 

multifaceted and comprised of many diverse activities 

including: testing, certification, management system 

registration, accreditation and accreditation program 

recognition. While each of these activities is a distinct 

operation, they are closely interrelated. The inclusion or 

absence of any of these activities, 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 

process. In addition, standards, which underlie each of 

these activities, can also have a major impact on the 

outcome of a specific conformity assessment activity as 

well as a cumulative effect on the entire process. 

Standards and conformity assessment activities together 

impact almost every aspect of life in the United States. 

Conformity assessment is an important marketplace 

communications device -- a means of exchanging 

information between buyer and seller. It is therefore 

important for buyers, sellers, and other interested parties to 

understand the conformity assessment process to 

competently judge the value of a particular assessment 

scheme and to use the information resulting from that 

scheme to make intelligent choices. The quality of the 

information conveyed depends on: the impartiality and 

competence of the assessment body; the types of 

assessment activities included in the scheme; 

and the adequacy and appropriateness of the standards 

against which the product is evaluated. 

Conformity assessment may result in widespread buyer 

deception if the performance characteristics or test methods 

contained in a standard are insufficient to ensure adequate 

product performance or if the buyer is misinformed as to 

the competence of the conformity assessment body or the 

extent to which the product characteristics have been 

evaluated. If properly conducted, however, conformity 

assessment can furnish valuable information to the 

marketplace and can serve as the basis for increased or 

diminished opportunities for national and international 

trade. 
27 

 
28 

APPENDIX - LIST OF ACRONYMS

The following is a list of initials/acronyms that may be of interest/use in reviewing 

literature in the conformity assessment field. 

A

A2LA ------- AMERICAN ASSOCIATION FOR LABORATORY ACCREDITATION 

AABB ------- AMERICAN ASSOCIATION OF BLOOD BANKS 

AARS ------- ALL-AMERICA ROSE SELECTIONS 

AAS ------- ALL-AMERICA SELECTIONS 

ABBS ------- ANTIGUA AND BARBUDA BUREAU OF STANDARDS 

ABNT ------- ASSOCIACAO BRASILEIRA DE NORMAS TECNICAS (BRAZILIAN 

 ASSOCIATION FOR TECHNICAL STANDARDS) 

ABS ------- AMERICAN BUREAU OF SHIPPING 

ACCSQ ------ ASEAN CONSULTATIVE COMMITTEE FOR STANDARDIZATION AND QUALITY 

ADA ------- AMERICAN DENTAL ASSOCIATION 

AENOR ------ ASOCIACION ESPANOLA DE NORMALIZACION Y CERTIFICACION (SPANISH ASSOCIATION 

 FOR STANDARDIZATION AND CERTIFICATION) 

AFAQ ------- ASSOCIATION FRANCAISE POUR L'ASSURANCE DE LA QUALITE (FRENCH ASSOCIATION 

 FOR QUALITY ASSURANCE) 

AFNOR ------ ASSOCIATION FRANCAISE DE NORMALISATION (FRENCH STDS. ASS'N.) 

AGA ------- AMERICAN GAS ASSOCIATION 

AHAM ------- ASSOCIATION OF HOME APPLIANCE MANUFACTURERS 

AMA -------- AMERICAN MEDICAL ASSOCIATION 

ANSI ------- AMERICAN NATIONAL STANDARDS INSTITUTE 

ANSI/ASQC Q 9000 SERIES -- U.S. EQUIVALENT OF THE ISO 9000 SERIES 

APEC ------- ASIA-PACIFIC ECONOMIC COOPERATION 

APLAC ------ ASIA-PACIFIC LABORATORY ACCREDITATION COOPERATION/APEC AGREEMENT SIGNED 

 BY THE U.S. AND 15 OTHER SIGNATORIES TO COOPERATE IN THE DEVELOPMENT OF 

 INFRASTRUCTURES FOR CALIBRATION, TESTING, AND QUALITY SYSTEMS AND 

 ACCEPTANCE OF LABORATORY ACCREDITATION 

APMP ------- ASIA-PACIFIC METROLOGY PROGRAM 

AQAP ------- ALLIED QUALITY ASSURANCE PUBLICATION, NATO 

ARI ------- AIR-CONDITIONING AND REFRIGERATION INSTITUTE 

ASEAN ------ ASSOCIATION OF SOUTHEAST ASIAN NATIONAL-FOUNDED IN 1967 AND COMPOSED OF 

 BRUNEI, INDONESIA, MALAYSIA, PHILIPPINES, SINGAPORE, THAILAND & VIETNAM 

ASME ------- AMERICAN SOCIETY OF MECHANICAL ENGINEERS 

ASMO ------- ARAB ORGANIZATION FOR STANDARDIZATION AND METROLOGY 

ASQC ------- AMERICAN SOCIETY FOR QUALITY CONTROL 

ASTM ------- AMERICAN SOCIETY FOR TESTING AND MATERIALS 

ATP ------- AGREEMENT ON THE INTERNATIONAL CARRIAGE OF PERISHABLE FOODSTUFFS AND ON 

 THE SPECIAL EQUIPMENT 

B

BBN -------- BUREAU BURUNDAIS DE NORMALISATION ET CONTROLE DE LA QUALITE (BURUNDI 

 BUREAU OF STANDARDIZATION AND QUALITY CONTROL) 

BCIQ ------- BUREAU OF COMMODITY INSPECTION AND QUARANTINE (TAIWAN) 

BDS -------- COMMITTEE FOR STANDARDIZATION AND METROLOGY AT THE COUNCIL OF MINISTERS 

 (BULGARIA) 

BELST ------ BELARUS COMMITTEE FOR STANDARDIZATION METROLOGY AND CERTIFICATION 

BENELUX ---- ECONOMIC UNION COMPRISED OF BELGIUM, THE NETHERLANDS, AND LUXEMBOURG 

BIPM ------- INTERNATIONAL BUREAU OF WEIGHTS AND MEASURES (CONVENTION DU METRE 1875) 

BIS -------- BUREAU OF INDIAN STANDARDS 

BNSI ------- BARBADOS NATIONAL STANDARDS INSTITUTION 

BOCA ------- BUILDING OFFICIALS AND CODE ADMINISTRATORS INTERNATIONAL 

BPS -------- BUREAU OF PRODUCT STANDARDS (PHILIPPINES) 

BS 5750 ---- BRITISH EQUIVALENT OF THE ISO 9000 SERIES 
29 

BSI -------- BRITISH STANDARDS INSTITUTION 

BSTI ------- BANGLADESH STANDARDS AND TESTING INSTITUTION 

C

CAC -------- CODEX ALIMENTARIUS COMMISSION 

CANACINTRA - CAMARA NACIONAL DE TRANSFORMATION, MEXICO 

CAP -------- COLLEGE OF AMERICAN PATHOLOGISTS 

CASCO ------ ISO COUNCIL COMMITTEE ON CONFORMITY ASSESSMENT 

CB FCS 

SCHEME ----- CB FULL CERTIFICATION SCHEME, A PROPOSED EXTENSION OF THE CURRENT CB 

 SCHEME 

CB SCHEME -- ALSO KNOWN AS THE IECEE SCHEME FOR RECOGNITION OF THE RESULTS OF TESTING 

 TO STANDARDS OF ELECTRICAL EQUIPMENT 

CCIR ------- INTERNATIONAL RADIO CONSULTATIVE COMMITTEE, ITU 

CCITT ------ INTERNATIONAL TELEGRAPH AND TELEPHONE CONSULTATIVE COMMITTEE, ITU 

CD --------- COMMITTEE DRAFT 

CE MARK ---- EUROPEAN UNION MARK INDICATING CONFORMANCE TO THE ESSENTIAL REQUIREMENTS 

 CONTAINED IN AN EU DIRECTIVE. 

CEN -------- EUROPEAN COMMITTEE FOR STANDARDIZATION 

CENELEC ---- EUROPEAN COMMITTEE FOR ELECTROTECHNICAL STANDARDIZATION 

CEPT ------- CONFERENCE EUROPEENE DES ADMINISTRATIONS DES POSTES ET DES 

 TELECOMMUNICATION 

CGSB ------- CANADIAN GENERAL STANDARDS BOARD 

CISPR ------ INTERNATIONAL SPECIAL COMMITTEE ON RADIO INTERFERENCE 

CNACR ------ CHINA NATIONAL ACCREDITATION COMMITTEE FOR QUALITY SYSTEM REGISTRATION 

 BODIES 

COFRAC ----- COMITE FRANCAIS D'ACCREDITATION (FRENCH COMMITTEE FOR ACCREDITATION) 

COPANT ----- PAN AMERICAN STANDARDS COMMISSION 

COSMT ------ CZECH OFFICE FOR STANDARDS, METROLOGY AND TESTING 

COVENIN ---- COMISION VENEZOLANA DE NORMAS INDUSTRIALES (VENEZUELAN INDUSTRIAL 

 STANDARDS COMMISSION) 

CSA -------- CANADIAN STANDARDS ASSOCIATION 

CSBTS ------ CHINA STATE BUREAU OF TECHNICAL SUPERVISION 

CSK -------- COMMITTEE FOR STANDARDIZATION OF THE DEMOCRATIC PEOPLE'S REPUBLIC OF 

 KOREA 

CYS -------- CYPRUS ORGANIZATION FOR STANDARDS AND CONTROL OF QUALITY 

D

DANAK ------ DANISH AGENCY FOR DEVELOPMENT OF TRADE AND INDUSTRY (ACCREDITATION BODY) 

DAR -------- DEUTSCHER AKKREDITIERUNGS RAT (THE GERMAN ACCREDITATION BOARD) 

DESC ------- DEFENSE ELECTRONICS SUPPLY CENTER, DOD 

DFARS ------ DOD FEDERAL ACQUISITION REGULATION SUPPLEMENT 

DGN -------- DIRECCION GENERAL DE NORMAS (MEXICAN STANDARDS/ACCREDITATION BODY) 

DHHS ------- U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

DIN -------- DEUTSCHES INSTITUT FUR NORMUNG (GERMAN STANDARDS INSTITUTE) 

DIS -------- DRAFT INTERNATIONAL STANDARD 

DITI ------- U.K.'S DEPARTMENT OF TRADE AND INDUSTRY 

DLA ------- DEFENSE LOGISTICS AGENCY, U.S. DEPT. OF DEFENSE 

DOC -------- U.S. DEPARTMENT OF COMMERCE 

DOD -------- DEPARTMENT OF DEFENSE 

DOE -------- U.S. DEPARTMENT OF ENERGY 

DOT -------- U.S. DEPARTMENT OF TRANSPORTATION 

DS --------- DANSK STANDARD (DANISH STANDARDS ORGANIZATION) 

DSC -------- DREJTORIA E STANDARDIZIMIT DHE CILESISE KESHILLI I MINISTRAVE (ALBANIAN 

 STANDARDS BODY) 

DSN -------- DEWAN STANDARDISASI NASIONAL (INDONESIAN STANDARDS BODY) 

DSTU ------- STATE COMMITTEE OF UKRAINE FOR STANDARDIZATION, METROLOGY AND 

 CERTIFICATION 

DTR -------- DRAFT TECHNICAL REPORT 

DZNM ------- CROATIAN STATE OFFICE FOR STANDARDIZATION AND METROLOGY 
30 

E

EAC -------- EUROPEAN ACCREDITATION OF CERTIFICATION, A MEMORANDUM OF UNDERSTANDING 

 SIGNED BY EUROPEAN NATIONAL ACCREDITATION BODIES AT UTRECHT ON MAY 22, 

 1991 TO ESTABLISH A MULTILATERAL AGREEMENT BETWEEN MEMBERS BASED ON 

 MUTUAL CONFIDENCE. COUNTRIES REPRESENTED IN EAC INCLUDE: DENMARK, 

 FINLAND, FRANCE, GERMANY, ITALY, NETHERLANDS, NORWAY, SWEDEN, 

 SWITZERLAND, AND THE UK. 

EAL -------- EUROPEAN COOPERATION FOR ACCREDITATION OF LABORATORIES (FORMED BY THE 

 MERGER OF WECC AND WELAC) 

EC --------- EUROPEAN COMMUNITY, NOW THE EUROPEAN UNION (EU) 

ECE -------- UNITED NATIONS ECONOMIC COMMISSION FOR EUROPE 

EDA -------- ECONOMIC DEVELOPMENT ADMINISTRATION, DOC 

EEA -------- EUROPEAN ECONOMIC AREA (A TREATY DESIGNED TO ESTABLISH A NINETEEN 

 (EC/EFTA) NATION FREE TRADE AREA) 

EFTA ------- EUROPEAN FREE TRADE ASSOCIATION (AUSTRIA, FINLAND, ICELAND, 

 LIECHTENSTEIN, NORWAY, SWEDEN AND SWITZERLAND) 

ELOT ------- PREDECESSOR OF EOS 

EN --------- EUROPEAN NORM OR STANDARD 

EN 29000 

SERIES ----- EUROPEAN EQUIVALENT OF THE ISO 9000 SERIES 

ENV -------- EUROPEAN PRE-STANDARDS 

EOQ -------- EUROPEAN ORGANIZATION FOR QUALITY 

EOS -------- EGYPTIAN ORGANIZATION FOR STANDARDIZATION AND QUALITY CONTROL 

EOTA ------- EUROPEAN ORGANIZATION FOR TECHNICAL APPROVALS 

EOTC ------- EUROPEAN ORGANIZATION FOR TESTING AND CERTIFICATION CREATED BY THE EU IN 

 APRIL 1990 UNDER A MEMORANDUM OF UNDERSTANDING WITH CEN AND CENELEC TO 

 PROMOTE THE MUTUAL RECOGNITION OF CONFORMITY ASSESSMENTS THROUGHOUT THE 

 EU AND EFTA COUNTRIES 

E-Q-NET ---- EUROPEAN NETWORK FOR QUALITY SYSTEM ASSESSMENT AND CERTIFICATION, A 

 BUSINESS AGREEMENT ESTABLISHED IN EARLY 1990 AMONG EUROPEAN NONPROFIT 

 REGISTRARS UNDER WHICH MEMBERS AGREE TO RECOGNIZE EACH OTHER AS BEING 

 COMPETENT BODIES IN CONFORMITY WITH EN 45012 AND THE RECOMMENDATIONS OF 

 THE EAC 

EQS -------- EUROPEAN COMMITTEE FOR QUALITY SYSTEMS ASSESSMENT ESTABLISHED IN 1989 

 WITH MEMBERSHIP FROM BOTH EU AND EFTA COUNTRIES TO HARMONIZE 

 RULES/PROCEDURES USED FOR QUALITY SYSTEM ASSESSMENT AND REGISTRATION 

 AMONG MEMBERS 

ESA -------- ETHIOPIAN AUTHORITY FOR STANDARDIZATION 

ETA -------- EUROPEAN TECHNICAL APPROVAL (APPROVAL BY AN EU AUTHORIZED BODY WHICH 

 APPLIES TO CONSTRUCTION PRODUCTS FOR WHICH THERE ARE NO EXISTING OR 

 PLANNED STANDARDS) 

ETSI ------- EUROPEAN TELECOMMUNICATIONS STANDARDS INSTITUTE 

EU --------- EUROPEAN UNION, FORMERLY THE EUROPEAN COMMUNITY (EC) 

EVS -------- NATIONAL STANDARDS BOARD OF ETHIOPIA 

F & G

FAA -------- FEDERAL AVIATION ADMINISTRATION, DOT 

FAO/WHO----- FOOD AND AGRICULTURAL ORGANIZATION/WORLD HEALTH ORGANIZATION CODEX 

 ALIMENTARIUS COMMISSION 

FAR -------- FEDERAL ACQUISITION REGULATION 

FDA -------- FOOD AND DRUG ADMINISTRATION, DHHS 

FDIS ------- FINAL DRAFT INTERNATIONAL STANDARD 

FINAS ------ CENTRE FOR METROLOGY AND ACCREDITATION (FINLAND) 

FM -------- FACTORY MUTUAL RESEARCH CORP. 

FTAA ------- FREE TRADE AREA OF THE AMERICAS, A PROPOSAL TO EXPAND NAFTA TO INCLUDE 

 OTHER COUNTRIES IN THE AMERICAS 

GDBS ------- GRENADA BUREAU OF STANDARDS 

GMP -------- GOOD MANUFACTURING PRACTICE GUIDELINES (FDA) 
31 

GOST R ----- GOSSTANDART OF RUSSIA (COMMITTEE OF RUSSIAN FEDERATION FOR 

 STANDARDIZATION, METROLOGY AND CERTIFICATION) 

GSA -------- GENERAL SERVICES ADMINISTRATION 

H, I

HD --------- HARMONIZED DOCUMENT 

HKQAA ------ HONG KONG QUALITY ASSURANCE AGENCY (ACCREDITATION BODY) 

HUD -------- DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 

IAA -------- BUREAU OF ACCREDITATION AND INTERNATIONAL COOPERATION OF THE INDUSTRIAL 

 ADVANCEMENT ADMINISTRATION (KOREAN ACCREDITATION BODY) 

IAF -------- INTERNATIONAL ACCREDITATION FORUM, AN INTERNATIONAL AGREEMENT SIGNED 

 JANUARY 28, 1993 AMONG NATIONAL ACCREDITATION BODIES TO DISCUSS ACHIEVING 

 EQUIVALENCE OF ACCREDITATION PROGRAMS/SYSTEMS AND MUTUAL RECOGNITION OF 

 EACH OTHER'S ACCREDITATION SYSTEMS IN FURTHERANCE OF INTERNATIONAL TRADE. 

MEMBERSHIP INCLUDES: 21 ACCREDITATION BODIES AND SIX ASSOCIATE MEMBERS 

IAPMO ------ INTERNATIONAL ASSOCIATION OF PLUMBING AND MECHANICAL OFFICIALS 

IATCA ------ INTERNATIONAL AUDITOR AND TRAINING CERTIFICATION ASSOCIATION, COMPOSED OF 

 21 MEMBER BODIES, WHICH AIMS INCLUDE WORLDWIDE ACCEPTANCE OF AUDITOR 

 CERTIFICATIONS AND AUDITOR TRAINING COURSE ACCREDITATIONS 

IBN -------- INSTITUT BELGE DE NORMALISATION (BELGIAN STANDARDS BODY) 

ICAO ------- INTERNATIONAL CIVIL AVIATION ORGANIZATION 

ICBO ------- INTERNATIONAL CONFERENCE OF BUILDING OFFICIALS 

ICLAB ------ IRISH CERTIFICATION AND LABORATORY ACCREDITATION BOARD 

ICONTEC ---- INSTITUTO COLOMBIANO DE NORMAS TECNICAS (CHILE) 

ICSP ------- INTERAGENCY COMMITTEE ON STANDARDS POLICY (CHAIRED BY NIST) 

IEC -------- INTERNATIONAL ELECTROTECHNICAL COMMISSION 

IECEE ------ IEC SYSTEM FOR RECOGNITION OF RESULTS OF TESTING TO STANDARDS OF 

 ELECTRICAL EQUIPMENT 

IECEx ------ IEC SCHEME FOR ELECTRICAL EQUIPMENT INTENDED FOR USE IN EXPLOSIVE 

 ATMOSPHERES DESIGNED TO PROMOTE WORLDWIDE ACCEPTANCE OF A SINGLE 

 STANDARD, A SINGLE CERTIFICATE, AND A SINGLE MARK 

IECQ ------- IEC QUALITY ASSESSMENT SYSTEM FOR ELECTRONIC COMPONENTS 

IIOC ------- INDEPENDENT INTERNATIONAL ORGANIZATION FOR CERTIFICATION, COMPOSED OF 7 

 CERTIFICATION BODIES WHICH HAVE SIGNED AN MOU TO WORK TOWARDS ELIMINATION 

 OF THE NEED FOR MULTIPLE ASSESSMENTS AND RAISE THE REPUTATION OF ISO 9000 

ILAC ------- INTERNATIONAL LABORATORY ACCREDITATION CONFERENCE 

INAPI ------ INSTITUT ALGERIEN DE NORMALIZATION ET DE PROPRIETE INDUSTRIELLE (ALGERIAN 

 STANDARDS BODY) 

INCONTEC --- INSTITUTO COLOMBIANO DE NORMAS TECNICAS (COLOMBIAN INSTITUTE FOR 

 TECHNICAL STANDARDS) 

INDECOPI --- INSTITUTO NACIONAL DE DEFENSA DE LA COMPETENCIA Y DE LA PROTECCION DE LA 

 PROPIEDAD INTELECTUAL (PERUVIAN STANDARDS BODY) 

INMETRO ---- INSTITUTO NACIONAL DER METROLOGIA, NORMALIZACAO E QUALIDADE INDUSTRIAL 

 (BRAZILIAN NATIONAL INSTITUTE FOR METROLOGY, STANDARDIZATION AND 

 INDUSTRIAL QUALITY) 

INN -------- INSTITUTO NACIONAL DE NORMALIZACION (CHILEAN NATIONAL INSTITUTE FOR 

 STANDARDIZATION) 

INNORPI ---- INSTITUT NATIONAL DE LA NORMALISATION ET DE LA PROPRIETE INDUSTRIELLE 

 (TUNISIAN NATIONAL INSTITUTE FOR STANDARDIZATION AND INDUSTRIAL PROPERTY) 

IMO -------- INTERNATIONAL MARITIME ORGANIZATION 

INSTA ------ INTERNORDIC STANDARD CERTIFICATION SYSTEM 

IPQ -------- INSTITUTO PORTUGUES DA QUALIDADE (PORTUGUESE INSTITUTE FOR QUALITY - 

 STANDARDS/ACCREDITATION BODY) 

IQA -------- INSTITUTE FOR QUALITY ASSURANCE 

IRAM ------- INSTITUTO ARGENTINO DE RACIONALIZACION DE MATERIALES (ARGENTINEAN 

 INSTITUTE FOR STANDARDIZATION OF MATERIALS) 

IRS -------- INSTITUTUL ROMAN DE STANDARDIZARE (ROMANIAN STANDARDS/ACCREDITATION BODY) 

ISAC ------- ICELANDIC BOARD FOR TECHNICAL ACCREDITATION 

ISO -------- INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 

ISIRI ------ INSTITUTE OF STANDARDS AND INDUSTRIAL RESEARCH OF IRAN 
32 

ISSUAE ----- DIRECTORATE OF STANDARDIZATION AND METROLOGY (UNITED ARAB EMIRATES) 

ITA -------- INTERNATIONAL TRADE ADMINISTRATION, DOC 

ITC -------- INTERNATIONAL TRADE CENTRE, UNCTAD-GATT 

ITQS ------- RECOGNITION ARRANGEMENT FOR ASSESSMENT AND CERTIFICATION OF QUALITY 

 SYSTEMS IN THE INFORMATION TECHNOLOGY SECTOR 

ITU -------- INTERNATIONAL TELECOMMUNICATIONS UNION, UNITED NATIONS 

J, K

JAB -------- JAPANESE ACCREDITATION BOARD FOR QUALITY SYSTEM REGISTRATION 

JAS-ANZ ---- JOINT ACCREDITATION SYSTEM OF AUSTRALIA AND NEW ZEALAND 

JBS -------- JAMAICAN BUREAU OF STANDARDS 

JDS -------- DIRECTORATE OF STANDARDS AND MEASURES (JORDAN) 

JISC ------- JAPANESE INDUSTRIAL STANDARDS COMMITTEE 

KAN -------- DEWAN STANDARDISASI NASIONAL KOMITE AKREDITASI NASIONAL (INDONESIAN 

 STANDARDS/ACCREDITATION BODY) 

KBS -------- BUREAU OF STANDARDS/INDUSTRIAL ADVANCEMENT ADMINISTRATION (REPUBLIC OF 

 KOREA) 

KEBS ------- KENYA BUREAU OF STANDARDS 

L, M

LNCSM ------ LIBYAN NATIONAL CENTER FOR STANDARDIZATION AND METROLOGY INDUSTRIAL 

 RESEARCH 

LST -------- LITHUANIAN STANDARDIZATION OFFICE 

MBS-MALAWI - MALAWI BUREAU OF STANDARDS 

MBS-MALTA -- MALTA BUREAU OF STANDARDS 

MEA -------- METALLURGICAL ENGINEERS OF ATLANTA 

MISM ------- MONGOLIAN NATIONAL INSTITUTE FOR STANDARDIZATION AND METROLOGY 

MOU -------- MEMORANDUM OF UNDERSTANDING 

MRA -------- MUTUAL RECOGNITION AGREEMENT 

MSB -------- MAURITIUS STANDARDS BUREAU 

MSHA ------- MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR 

MSIT ------- MAJOR STATE INSPECTION OF TURKMENISTAN 

MSZH ------- MAGYAR SZABVANYUGYI HIVATAL (HUNGARY STANDARDS BODY) 

MTC -------- MANUFACTURING TECHNOLOGY CENTERS 

N

NA --------- NORWAY ACCREDITATION 

NAC-QS ----- COMITE NATIONAL POUR L'ACCREDITATION DES ORGANISMES DE CERTIFICATION, 

 BELGIUM ORGANIZATION RESPONSIBLE FOR THE ACCREDITATION OF QUALITY SYSTEM 

 REGISTRARS 

NACCB ------ NATIONAL ACCREDITATION COUNCIL FOR CERTIFICATION BODIES, NOW UKAS 

NAC-QS ----- COMITE NATIONAL POUR L'ACCREDITATION DES ORGANISMES DE CERTIFICATION 

 (BELGIUM ACCREDITATION BODY) 

NAFTA ------ NORTH AMERICAN FREE TRADE AGREEMENT 

NATA ------- ASSOCIATION OF TESTING AUTHORITIES IN AUSTRALIA 

NATO ------- NORTH ATLANTIC TREATY ORGANIZATION 

NATSF ------ NORTH AMERICAN TRILATERAL STANDARDIZATION FORUM, A TRILATERAL EFFORT 

 SPONSORED BY ANSI, CAMARA NACIONAL DE TRANSFORMATION (CANACINTRA) 

 (MEXICO), AND THE STANDARDS COUNCIL OF CANADA (SCC), TO DISCUSS 

 STANDARDS AND CONFORMITY ASSESSMENT ACTIVITIES AND ISSUES AMONG THE THREE 

 COUNTRIES AND TO PROMOTE THEIR HARMONIZATION AS APPROPRIATE 

NBBI ------- NATIONAL BOARD OF BOILER AND PRESSURE VESSEL INSPECTORS 

NC --------- COMITE ESTATAL DE NORMALIZACION (CUBA) 

NCB -------- NATIONAL CERTIFICATION BODY 

NCSCI ------ NATIONAL CENTER FOR STANDARDS AND CERTIFICATION INFORMATION, NIST 

NCTL ------- NATIONAL CERTIFIED TESTING LABORATORIES 

NCWM ------- NATIONAL CONFERENCE ON WEIGHTS AND MEASURES (ADMINISTERED BY NIST) 

NELAC ------ NATIONAL ENVIRONMENTAL LABORATORY ACCREDITATION CONFERENCE (SPONSORED BY 

 THE U.S. ENVIRONMENTAL PROTECTION AGENCY-EPA) 

NIST ------- NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DOC 
33 

NNI -------- NEDERLANDS NORMALISATIE-INSTITUUT (NETHERLANDS STANDARDS BODY) 

NOAA ------- NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION, DOC NORAMET ---- NORTH 

 AMERICAN METROLOGY PROGRAM 

NRC -------- NUCLEAR REGULATORY COMMISSION 

NRTL ------- NATIONALLY RECOGNIZED TESTING LABORATORIES PROGRAM, OSHA 

NSAI ------- NATIONAL STANDARDS AUTHORITY OF IRELAND 

NSF -------- NORGES STANDARDISERINGSFORBUND (NORWAY STANDARDS BODY) 

NVCASE ----- NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEMS EVALUATION PROGRAM 

NVLAP ------ NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM, NIST 

O, P & Q

OECD ------- ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT 

OIML ------- INTERNATIONAL ORGANIZATION FOR LEGAL METROLOGY 

ON --------- OSTERRREICHISCHES NORMUNGSINSTITUT (AUSTRIAN STANDARDS BODY) 

OSHA ------- OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DOL 

PAC -------- PACIFIC ACCREDITATION COOPERATION 

PASC ------- PACIFIC AREA STANDARDS CONGRESS 

PKN -------- POLISH COMMITTEE FOR STANDARDIZATION 

PNGS ------- NATIONAL STANDARDS COUNCIL (PAPUA NEW GUINEA) 

PSI -------- PAKISTAN STANDARDS INSTITUTION 

QML -------- DOD QUALIFIED MANUFACTURING LISTS PROGRAM 

QPL -------- DOD QUALIFIED PRODUCTS LISTING PROGRAM 

QSAR ------- QUALITY SYSTEM ASSESSMENT RECOGNITION (QSAR) SCHEME/ISO 

QSR -------- QUALITY SYSTEM REGISTRAR 

R & S

RAB -------- REGISTRAR ACCREDITATION BOARD, U.S. ACCREDITATION BODY FOR QUALITY SYSTEM 

 REGISTRARS/CERTIFIER OF QUALITY SYSTEM AUDITORS, A SUBSIDIARY OF ASQC 

RELE ------- SPANISH ACCREDITATION BODY 

RILEM ------ INTERNATIONAL UNION OF TESTING AND RESEARCH LABORATORIES FOR MATERIALS 

 AND STRUCTURES 

RvA -------- DUTCH COUNCIL FOR ACCREDITATION 

RvC -------- PREDECESSOR OF RvA 

SAA -------- STANDARDS AUSTRALIA 

SABS ------- SOUTH AFRICAN BUREAU OF STANDARDS 

SAE -------- SOCIETY OF AUTOMOTIVE ENGINEERS 

SAS -------- SWISS ACCREDITATION SERVICE 

SASMO ------ SYRIAN ARAB ORGANIZATION FOR STANDARDIZATION AND METROLOGY 

SASO ------- SAUDI ARABIAN STANDARDS ORGANIZATION 

SAZ -------- STANDARDS ASSOCIATION OF ZIMBABWE 

SBCCI ------ SOUTHERN BUILDING CODE CONGRESS INTERNATIONAL 

SC --------- SUBCOMMITTEE 

SCC -------- STANDARDS COUNCIL OF CANADA 

SENORCA ---- PART OF COVENIN RESPONSIBLE FOR ACCREDITATION (VENEZUELA) 

SFS -------- FINISH STANDARDS ASSOCIATION 

SISIR ------ SINGAPORE INSTITUTE OF STANDARDS AND INDUSTRIAL RESEARCH 

 (STANDARDS/CONFORMITY ASSESSMENT BODY) 

SII -------- STANDARDS INSTITUTION OF ISRAEL 

SINCERT ---- SISTEMA NAZIONALE PER L'ACCREDIAMENTO DEGLI ORGANISMI DE CERTIFICAZIONE 

 (ITALIAN ACCREDITATION BODY) 

SIRIM ------ STANDARDS AND INDUSTRIAL RESEARCH INSTITUTE OF MALAYSIA 

SIS -------- STANDARDISERINGS-KOMMISSIONEN I SVERIGE (SWEDISH STANDARDS BODY) 

SISIR ------ SINGAPORE INSTITUTE OF STANDARDS AND INDUSTRIAL RESEARCH 

SLSI ------- SRI LANKA STANDARDS INSTITUTION 

SMIS ------- STANDARDS AND METROLOGY INSTITUTE OF REPUBLIC OF SLOVENIA 

 (STANDARDS/ACCREDITATION BODY) 

SNIMA ------ SERVICE DE NORMALISATION INDUSTRIELLE MAROCAINE (MOROCCAN STANDARDS BODY) 

SNV -------- SWISS ASSOCIATION FOR STANDARDIZATION 

SNZ -------- STANDARDS NEW ZEALAND 

SRCC ------- SOLAR RATING AND CERTIFICATION CORPORATION 
34 

STRI ------- ICELANDIC COUNCIL FOR STANDARDIZATION 

SWEDAC ----- SWEDISH ACCREDITATION BODY 

SZS -------- SAVEZNI ZAVOD ZA STANDARDIZACIJU (DEPARTMENT FOR QUALITY AND 

 CERTIFICATION - YUGOSLAVIA) 

T

TAAC ------- TRADE ADJUSTMENT ASSISTANCE CENTERS 

TBS -------- TANZANIA BUREAU OF STANDARDS 

TBT 

AGREEMENT -- 1994 AGREEMENT OF TECHNICAL BARRIERS TO TRADE OF THE INTERNATIONAL 

 GENERAL AGREEMENT ON TARIFFS AND TRADE (GATT) OF THE WTO 

TC --------- TECHNICAL COMMITTEE 

TC 176 ----- THE ISO TECHNICAL COMMITTEE RESPONSIBLE FOR THE DEVELOPMENT OF THE ISO 

 9000 AND 10000 SERIES 

TCVN ------- GENERAL DEPARTMENT FOR STANDARDIZATION, METROLOGY AND QUALITY (VIET NAM) 

TELARC ----- TESTING LABORATORY REGISTRATION COUNCIL IN NEW ZEALAND 

TGA -------- TRAEGERGEMEINSCHAFT FUER AKKREDITIERUNG GmbH (GERMAN ACCREDITATION BODY) 

TickIT ----- U.K. QUALITY SYSTEM REGISTRATION SCHEME FOR SOFTWARE COMPANIES STANDARDS 

TISI ------- THAI INDUSTRIAL STANDARDS INSTITUTE 

TR --------- TECHNICAL REPORT 

TSE -------- TURK STANDARDLARI ENSTITUSU (TURKISH STANDARDS INSTITUTE) 

TTBS ------- TRINIDAD AND TOBAGO BUREAU OF STANDARDS 

U & V

UEAtc ------ EUROPEAN UNION OF AGREMENT 

UILI ------- UNION INTERNATIONALE DES LABORATOIRES INDEPENDANTS 

UKAS ------- UNITED KINGDOM ACCREDITATION SERVICE, FORMERLY THE NACCB 

UL --------- UNDERWRITERS LABORATORIES, INC. 

UN --------- UNITED NATIONS 

UNI -------- ENTE NAZIONALE ITALIANO DI UNIFICAZIONE (ITALIAN STANDARDS BODY) 

UNIT ------- INSTITU URUGUAYO DE NORMAS TECNICAS (URUGUAYAN INSTITUTE FOR TECHNICAL 

 STANDARDS) 

UNMS ------- SLOVAK OFFICE OF STANDARDS, METROLOGY AND TESTING (STANDARDS/ 

 ACCREDITATION BODY) 

USDA ------- U.S. DEPARTMENT OF AGRICULTURE 

UZGOST ----- UZBEK STATE CENTRE FOR STANDARDIZATION, METROLOGY AND CERTIFICATION 

 (UZBEKISTAN) 

VA --------- DEPARTMENT OF VETERANS AFFAIRS 

W

WD --------- WORKING DRAFT 

WHO -------- WORLD HEALTH ORGANIZATION 

WTO -------- WORLD TRADE ORGANIZATION 

 
35 

ENDNOTES

1. ISO is the acronym for the International Organization for 

Standardization, while IEC stands for the International 

Electrotechnical Commission. The International Organization for 

Standardization (ISO) is a worldwide federation of over 90 

national standards bodies. ISO covers standardization in all 

fields, except the electrical and electronics fields that are 

covered by the International Electrotechnical Commission (IEC). 

IEC has members from over 40 countries that represent some 80% of 

the world's population. Together ISO and IEC form the world's 

largest nongovernmental system for voluntary industrial and 

technical collaboration in the field of standardization. 

2. Under 16 CFR Part 13, misrepresentations of product quality 

are regarded by the Federal Trade Commission as prohibited trade 

practices. Conformity assessment programs provide some assurance 

that claims made regarding a product's conformance to a particular 

standard are in fact valid. 

3. The Agreement covers conformity assessment procedures for 

products, processes and services including: "procedures for 

sampling, testing and inspection; evaluation, verification and 

assurance of conformity; registration, accreditation and approval 

as well as their combinations." 

4. This definition is from the National Policy on Standards for 

the United States and Recommended Implementation Plan, National 

Standards Policy Advisory Committee, Washington, DC, December, 

1978, p. 6. There is also a definition of "standard" in ISO/IEC 

Guide 2, but that definition is somewhat more complicated. The 

WTO Agreement defines standard as a "document approved by a 

recognized body, that provides, for common and repeated use, 

rules, guidelines or characteristics for products or related 

process and production methods, with which compliance is not 

mandatory. It may also include or deal exclusively with 

terminology, symbols, packaging, marking, or labeling requirements 

as they apply to a product, process or production method." It is 

less encompassing than the ISO definition of standard. It is 

important to know what definition is being used to clearly 

understand the implications of any conformity assessment 

discussions. 

5. For further information on the history of standards, see the 

American Standards Association's, "Through History with 

Standards," in Rowen Glie, (ed.), Speaking of Standards, Cahner 

Books, Boston, MA, 1972. 

6. A list of these organizations is contained in the 1996 edition 

 
36 

 

of NIST SP 806, "Standards Activities of Organizations in the 

United States." 

7. Dr. David Hemenway, NBS/GCR 80-287, "Performance vs Design 

Standards," NBS, Gaithersburg, MD, October 1980. 

8. Note that the usefulness of a performance requirement depends 

on the existence of an accurate and reliable method of assessing 

the conformity of a product or service to that requirement. 

9. The TBT Agreement requires that: "(w)herever appropriate, 

members shall specify technical regulations based on product 

requirements in terms of performance rather than design or 

descriptive characteristics." 

10. Reference materials are defined by ISO Guide 30 as a 

"material or substance one or more properties of which are 

sufficiently well established to be used for the calibration of an 

apparatus, the assessment of a measurement method, or for 

assigning values to materials." 

11. "Traceability means the ability to relate individual 

measurement results to national standards or nationally accepted 

measurement systems through an unbroken chain of comparisons." 

Examples of traceability include: equipment calibrated by NIST; 

equipment calibrated using NIST transfer standards (materials 

previously measured by NIST); or equipment calibrated using other 

NIST calibrated equipment. For further information on 

traceability, see Brian Belanger's "Traceability: an Evolving 

Concept," published in ASTM Standardization News, October 1980, 

pp. 22-28. Also see Ernest Garner and Stanley D. Rasberry's 

"What's New in Traceability," published in ASTM's Journal of 

Testing and Evaluation, Nov. 1993. 

12. Reference standards include those involving dimension and 

mass (i.e., length, weight, diameter, angle, or volume and 

density); mechanical properties (i.e. flow rate or airspeed); 

chemical/physical properties; time and frequency; etc. 

13. Information on each agency's legal authority is contained in 

NIST SP 808 - Directory of Federal Government Laboratory 

Accreditation/Designation Programs. 

14. Some organizations use other terms to refer to the process, 

such as product listing, product evaluation, product regulation, 

product approval, or the publication of research reports, but in 

this discussion, we will use the term "certification." The reader 

should be aware of the existence and use of other terms, however, 
37 

 

to describe this activity. 

15. G. J. Varoufakis, Materials Testing in Classical Greece, 

Technical Specifications of the 4th Century BC, Hellenic 

Organization for Standardization, Athens, Greece, 1983. 

16. ANSI serves as the U.S. standards coordinator and the U.S. 

member body of ISO, IEC, and several other international private 

sector standards organizations. 

17. CASCO is acronym for the ISO Council Committee on Conformity 

Assessment. This committee works to promote mutual recognition 

and acceptance of national and regional conformity assessment 

systems, and the appropriate use of international standards for 

testing, inspection, certification, and quality system 

registration. 

18. The use of the term "listed" is sometimes preferred by some 

certifiers to the term "certified" for products that have been 

evaluated and shown to be in conformance with applicable 

standards. 

19. See NIST SP 903, Directory of U.S. Private Sector Product

Certification Programs, for more information. 

20. See NIST SP 739 "Directory of Federal Government 

Certification Programs" for additional information on this topic. 

21. For more information on this topic, see NIST SP 903, 

"Directory of U.S. Private Sector Product Certification Programs," 

pp. A-3 to A-5. See also the U.S. Patent and Trademark Office 

web site at http://www.uspto.gov. 

22. W. Edwards Deming, Out of Crises, Massachusetts Institute of 

Technology, Cambridge, MA 1986. 

23. OSHA is responsible for the regulation of all electrical 

products used in the work place. For a list of the products under 

OSHA's jurisdiction that require certification by a Nationally 

Recognized Testing Laboratory (NRTL), see 29 CFR 1910. 

24. Note this definition is somewhat different from the ISO 

definitions. ISO Standard 9000-1987 defines quality system as: 

"the organization, structure, responsibilities, procedures, 

processes and resources for implementing quality management." The 

standard defines quality management as: "that aspect of the 

overall management function that determines and implements quality 

policy." The standard defines quality policy as: "the overall 

intentions and directions of an organization as regards quality, 

 
38 

 

as formally expressed by top management." These ISO definitions 

also include several additional footnotes. 

25. CEN and CENELEC have issued a draft European standard, EN 

46001 - Specific Requirements for the Application of EN 29001 to 

Medical Devices. Medical device manufacturers doing business in 

the EU will have to comply with the quality system requirements of 

EN 46001. 

26. "Quality system registration" and "quality system 

certification" are frequently used interchangeably; however, 

confusion arises when "quality system" is not placed in front of 

the term "certification." If these two words are missing, it is 

easy to confuse the assessment and approval of a manufacturer's 

quality system with product certification -- two entirely 

different activities! For that reason, the preferred term in the 

United States is "quality system registration." 

27. Quality System Update (QSU) and other related documents are 

published by Irwin Professional Publishing, a division of Richard 

D. Irwin, Inc. and a subsidiary of the Times Mirror Company. 

28. ISO has published a "Directory of Quality System Registration 

Bodies" that includes information on national accreditation 

bodies. Copies of this directory are available from ANSI. 

29. For other examples of how recognition might be used within 

the United States, see the National Research Council report, 

Standards, Conformity Assessment, and Trade: Into the 21st 

Century, National Academy of Sciences, 1995. 

30. The International Accreditation Forum (IAF) is an organization 

of national and regional groupings of accreditation bodies that 

aims to achieve and maintain confidence in the accreditation 

programs operated by accreditation body members through the: 

exchange of information; participation in joint activities; 

harmonization of operating procedures; participation in regional 

grouping that maintain regional multilateral recognition 

agreements; and participation in evaluation programs based on peer 

review of accreditation body members leading to a worldwide 

multilateral recognition agreement. IAF will begin peer 

evaluations of accreditation bodies beginning in March 1997. The 

first peer review conducted will be of the ANSI-RAB NAP Program, 

which is expected to be followed by peer reviews of the 

accreditation programs of Australia-New Zealand, Canada, China, 

Japan, and Malaysia, and the European Accreditation of 

Certification (EAC) regional mutual recognition program. Among 

other responsibilities, members agree to operate accreditation 
39 

 

programs in conformance with relevant ISO/IEC Guides and publicly 

available IAF application guides. 

31. In such cases, the private sector body is usually recognized 

in some way by its national government as the authoritative body 

in that area.