CONFORMITY ASSESSMENT
What is it, Why do we need it?

(From ASTM Standardization News, August 1996, pp. 30-33)
--Robert L. Gladhill1


Placing a product in today's marketplace can be a complex and 
expensive process.  Increasing demands are being placed on 
suppliers to assure that their products are safe, reliable, 
and do not have adverse effects on the health and the safety 
of users or on the environment.  These demands may come in 
the form of contract requirements imposed by customers, or as 
mandatory government regulations.  The supplier is faced with 
the task of ensuring that the product conforms to all imposed 
requirements.  This article describes some of the methods 
that are utilized by suppliers to provide assurance that 
their products conform to requirements; these methods are 
referred to collectively as "conformity assessment."  

What is Conformity Assessment?  

According to ISO/IEC Guide 2, "General terms and their 
definitions concerning standardization and related 
activities":  

-    Conformity assessment, any activity concerned with 
determining directly or indirectly that relevant requirements 
are fulfilled.  

-    Typical examples of conformity assessment activities are 
sampling, testing and inspection, evaluation, verification 
and assurance of conformity (suppliers declaration), 
certification, registration, accreditation and approval as 
well as their combinations.  

In the broad sense, conformity assessment can apply in 
various situations.  For example, a manufacturer who wants 
his quality system registered may be assessed for conformance 
to a standard such as the ISO 9000 series on quality 
management and quality assurance; a third party certification 
body may be assessed for conformance to a standard such as 
ISO Guide 40, "General requirements for the acceptance of 
certification bodies"; a testing laboratory may be assessed 
for conformance with a standard such as ASTM E548, Guide for 
General Criteria Used for Evaluating Laboratory Competence.  

The term "conformity assessment" is more commonly used in 
relation to determining whether a product meets a given 
specification or standard.  

Conformity Assessment Systems

For purposes of this discussion, conformity assessment 
activities may be divided into three hierarchical levels as 
listed below.  Dependent upon the specific requirements 
imposed on a product, some or all of these activities may be 
combined into a system to implement the conformity assessment 
process desired.  Specification development, promulgation of 
consensus technical standards or guidelines such as ASTM 
documents and/or development of government regulations as 
well as the process of product design and development must 
also be considered in the comprehensive framework of 
conformity assessment.  

Conformity Level.  The "conformity level" is defined here as 
the level at which the activity is conducted in performing 
the actual assessment of the product or service that is the 
subject of the specification or requirement.  Examples are 
the efforts of testing laboratories, product certifiers or 
quality system registrars.  

Accreditation Level.  The "accreditation level" applies to 
the evaluation for accreditation of bodies that perform at 
the conformity level conducted by a third party, such as a 
laboratory accreditation body, a certification system 
accreditation body, or a registrar accreditation body.  
Accreditation provides a measure of confidence to the user of 
bodies operating at the conformity level and serves as a 
credential for the conformity assessment body.  

Recognition Level.  The "recognition level" refers to the 
assessment of accreditation bodies to determine their 
conformity with specified criteria, leading to recognition of 
those that conform.  Recognition is typically a function of 
government or some entity delegated by government.  Examples 
are the U.S. Occupational Safety and Health Administration's 
(OSHA's) designation of nationally Recognized Testing 
Laboratories to certify products for safety, and the European 
Union member states' designation of "notified bodies" to 
perform specified conformity assessment actions.  

Not all conformity assessment systems necessarily contain all 
of the above levels.  The complexity of a system is dictated 
by the severity of the risk posed by the product as discussed 
below.  Naturally, the more complex the system, the higher 
the cost to perform the required conformity assessment, 
leading to a higher cost of the product.  

Role of Standards

Standards play a major role in conformity assessment.  In 
many cases, requirements or specifications incorporate 
consensus standards for one or more of the following reasons: 
to use widely agreed-upon procedures, to avoid re-inventing 
the wheel, or to promote the use of common standards and 
reduce the differences between standards, thereby easing the 
manufacturer's burden of having to make similar products to 
different standards for different markets (harmonization).  

Two types of standards are generally utilized in a conformity 
assessment system: 1) standards describing the activities of 
bodies involved in the conformity assessment process, e.g., 
laboratories, accreditation bodies or certification bodies, 
and 2) technical standards describing essential parameters of 
products or materials, test methods and other technical 
specifications.  

ASTM Committee E-36 on Conformity Assessment is active in the 
development of both domestic and international standards for 
the operation of conformity assessment bodies.  Many ASTM 
technical standards are referenced or required for conformity 
assessment processes.  

Product Development and Marketing

In addition to determining the marketability of a product, 
several things usually occur before it is introduced int he 
marketplace.  Specification s to which the product will be 
produced and expected to function must be developed.  These 
may be developed in-house or be imposed by the customer.  
Specifications sometimes require the use of consensus 
standards, such as ASTM technical or guideline documents.  
Then, a determination must be made as to how the product will 
affect the health and safety of the user or other segments of 
the population, as well as what The impact will be on the 
environment.  Depending on the severity of the anticipated 
risk, this determination may be made voluntarily by a 
manufacturer, imposed by the purchase/user of the product, or 
mandated by a government regulatory body.  

Once the risk has been assessed and requirements established, 
the conformance of the product to the requirements must be 
determined.  Depending on the specified requirements, 
different ways for verifying that the product meets the 
specifications, or "conformity assessment," may be utilized.  

In low-risk cases, verification that a product meets 
specifications can be accomplished with little difficulty, 
possibly through a supplier's declaration.  A supplier may 
simply provide a document or declaration that the product 
conforms to specifications.  An in-house laboratory or an 
independent laboratory may perform the conformance testing of 
the product, or evidence may be presented that the supplier 
has an effective quality management system in place.  

In moderate-risk cases, more elaborate procedures may be 
required to verity that the product meets specifications.  
This may include third party registration of the supplier's 
quality management system, and/or product testing in an 
independent laboratory accredited by a third party.  
Government oversight of the process may in some cases be 
required.  

In high-risk cases, a government regulatory body usually sets 
forth and mandates requirements for the product.  In order 
for the supplier to demonstrate that the product complies 
with the requirements, a more elaborate system may be 
necessary.  This may entail the same activities as those 
described for medium risk products, including formal product 
certification.  A product certification system calls for an 
administrator and conformity testing in an acceptable 
laboratory, possibly one that has been accredited.  It may 
also invoke periodic inspection of the manufacturing process 
and records, and may require that the manufacturer have a 
quality management system with formal registration to a 
standard such as ISO 9000.  For very high risk cases, 
government recognition of the accreditation or certification 
functions or some other form of government oversight may be 
mandated.  

Global Ramifications

In the global arena, mandatory requirements often differ 
considerably from one country to another due to different 
environmental factors, cultural differences, etc.  In some 
cases, artificial trade barriers may be established using 
conformity assessment practices as the barrier mechanism.  
When these issues arise and pose an impediment to trade, 
agreements between countries are often implemented in order 
to establish conditions for acceptance of each other's 
conformity assessment results, such as test reports, 
certifications, product approvals, etc.  

Many economic issues are involved.  U.S. Suppliers tend to 
prefer to have conformity assessment functions performed here 
in the United States, which normally costs significantly less 
than having them performed abroad.  It is also very expensive 
and time-consuming when conformity assessment bodies must 
undergo multiple assessments to satisfy the needs of 
different countries.  Many efforts are being put forth to 
minimize the number of assessments by having teams of peers 
from different countries perform assessments and have results 
accepted by all participating countries.  

Government-to-government agreements are currently being 
negotiated to achieve mutual acceptance of one another's test 
data, certifications and/or approvals for the purpose of 
satisfying any conformity assessment requirements.  Most 
notable are the current negotiations between the U.S. 
government and the EU and negotiation among the North 
American Free Trade Agreement (NAFTA) countries.  These 
negotiations are conducted by the Office of the United States 
Trade Representative with participation from the Department 
of Commerce and with input and advice from cognizant U.S. 
regulatory agencies and industry representatives.  The 
systems required to support mutual recognition agreements may 
range from accepting a supplier's declaration to full 
government recognition of the key players int he 
certification process.  

NIST Role

NIST has a number of conformity assessment programs and 
related activities.  The recently enacted Public Law 104-113, 
known as the "National Technology Transfer and Advancement 
Act of 1995," requires NIST "to coordinate federal, state, 
and local technical standards activities and conformity 
assessment activities, with private sector technical 
standards activities and conformity assessment activities 
with the goal of eliminating unnecessary duplication and 
complexity in the development and promulgation of conformity 
assessment requirements and measures."  

NIST also continues its traditional roles in conformity 
assessment by: (1) providing a means of government 
recognition for conformity assessment systems through the 
National Voluntary Conformity Assessment Systems Evaluation 
Program (NVCASE), (2) serving as a laboratory accreditation 
body through the National Voluntary Laboratory Accreditation 
Program (NVLAP) and (3) participating extensively in the 
consensus standards development process.  

NVCASE offers qualified bodies that operate at the 
accreditation level (laboratory accreditation bodies, 
accreditors of certifiers, or accreditors of registrars) the 
opportunity to obtain NIST recognition.  NVCASE may in some 
cases evaluate and accredit qualifying bodies that function 
at the conformity level, e.g., a product certifier.  Recently 
implemented, NVCASE is now reviewing several applications 
prior to beginning the evaluation process.  

NVLAP is a well established program that offers qualified 
testing and calibration laboratories the opportunity to 
obtain NIST accreditation for conducting specified types of 
testing or calibration.  NVLAP currently lists 700 
laboratories that have been accredited in one or more of 22 
different technical areas.  

NIST is itself a multidisciplinary scientific institution 
that encourages staff participation in many consensus 
standards organizations, both domestic and international, in 
topical areas consonant with ongoing research areas.  NIST 
sponsor 366 staff members who now hold 1193 committee 
memberships in 98 standards organizations.  In ASTM alone, 
219 NIST staff members hold 589 committee memberships.  

Conclusion  

A major factor in the concept of standards development has 
always been viable buyer-seller relationships, and conformity 
assessment underlies the building of confidence for these 
relationships.  Conformity assessment becomes a key element 
in determining whether or not given products will enter 
particular markets.  On the domestic scene, suppliers must 
satisfy client demands for product quality and/or 
performance, and especially governmental regulation that are 
directed at protecting health, safety, and the environment.  
The impact of conformity assessment on manufacturers' ability 
to sell their wares is immense.  

In the global arena, trading is even more complex.  Not only 
must a supplier satisfy mandated technical characteristics, 
but multiple government recognitions or approvals are all too 
often required.  If a supplier's customers are located in 
many countries, it may be necessary to satisfy many different 
regulations; a product may have to be manufactured with 
variations tailored for each separate market.  Sometimes 
conformity assessment practices serve as artificial trade 
barriers whether or not deliberately imposed.  Problems then 
must be overcome by legal action through the Technical 
Barriers to Trade agreement of the World Trade Organization.  

Many agencies of the U.S. government are working actively to 
eliminate or ease barriers to trade.  The free access of U.S. 
products to global markets can be best achieved by 
negotiating with other governments so that they will accept 
conformity assessment results from recognized U.S. entities 
on an equal basis with results produced in their own 
countries.  

     1  Robert L. Gladhill is program manager of both the 
National Voluntary conformity Assessment Systems Evaluation 
Program and the Accreditation Body Evaluation Program at the 
National Institute of Standards and Technology.  He is 
chairman of E36.50 on Support Operations, part of Committee 
E-36 on Conformity Assessment.