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National Trade Data Bank - The Export Connection (R)
ITEM ID : NI ISO TOCPART1
DATE : Nov 30, 1993
AGENCY : USDOC, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
PROGRAM : THE ISO 9000 STANDARD SERIES: QUALITY AND RELATED ISSUES
TITLE : Table of Contents - "Questions and Answers...", NISTIR 4721
Update sched: Occasionally
Data type : TEXT
End year : 1993
TABLE OF CONTENTS
Foreword
Acknowledgements
Abstract
Introduction
What is Quality?
What is a Quality System?
What is ISO?
What Are the ISO 9000, ANSI/ASQC Q 90, and CEN/CENELEC EN 29000
Standards?
What Sort of Information Is Contained in Each ISO 9000 Standard?
Where Can Copies of these Standards be Obtained?
Are the ISO 9000 Standards Subject to Change?
Does TC 176 Have a Plan for Revising and Supplementing the ISO 9000
Standards?
What Is the ISO 9000 Forum?
How Do the ISO 9000 Criteria Compare with Criteria Used in the
Malcolm Baldrige National Quality Award Process?
What is Quality System Registration?
Who Evaluates Quality Systems?
What is the "New Approach" for Conformity Assessment of Regulated
Products?
Will Quality System Approvals be Mandatory in the EC?
Who Will Be Able to Conduct Mandatory EC Quality System Approvals?
Will Quality System Registration Be Required for Nonregulated
Products in the EC and Elsewhere?
What is the EOTC and How Does it Fit into the Picture?
Does the U.S. Have a Scheme for Quality System Registration?
Who Evaluates the Competence of Registrars?
Where Can U.S. Industry Go to Get Additional Help?
Appendix
National Trade Data Bank - The Export Connection (R)
ITEM ID : NI ISO ABSTRCT1
DATE : Nov 30, 1993
AGENCY : USDOC, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
PROGRAM : THE ISO 9000 STANDARD SERIES: QUALITY AND RELATED ISSUES
TITLE : Abstract - "Questions and Answers...", NISTIR 4721
Update sched: Occasionally
Data type : TEXT
End year : 1993
ABSTRACT
This report provides information on the development, content and
application of the ISO 9000 standards to readers who are
unfamiliar with these aspects of the standards. It attempts to
answer some of the most commonly asked questions on quality;
quality systems; the content, application and revision of the ISO
9000 standards; quality system approval/registration; European
Community requirements for quality system approval/registration;
and sources for additional help.
Key Words: conformity assessment; EN 29000; ISO 9000; quality
assurance; quality control; quality system; quality system
registration
National Trade Data Bank - The Export Connection (R)
ITEM ID : NI ISO NIST4721
DATE : Nov 30, 1993
AGENCY : USDOC, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
PROGRAM : THE ISO 9000 STANDARD SERIES: QUALITY AND RELATED ISSUES
TITLE : Questions and Answers on Quality and Related Issues
Update sched: Occasionally
Data type : TEXT
End year : 1993
FOREWARD
The Standards Code and Information Program periodically publishes
information on various aspects of conformity assessment for use
by those who operate or benefit from such systems. Recently
there has been considerable interest in the content and
application of international standards related to quality
management, i.e., the so-called ISO 9000 series. This report
provides answers to some of the most often asked questions on
this topic. This material is intended for those who are
concerned about the ISO 9000 standards and should help foster a
wider interest in the use of quality systems in general. This
document also references other publications and services provided
by this office which readers may find useful.
The reader is also invited to share any comments on the material
presented in this document. The attainment of quality is a
dynamic and evolving process, and its continued maturation
depends on feedback from those involved in the process.
ACKNOWLEDGEMENTS
I would like to thank Mary Saunders, International Trade
Administration's Office of European Community Affairs; Mr.
Charles Hyer, the Marley Organization; Mr. Donald Mackay, Air-
Conditioning and Refrigeration Institute; Dr. Curt Reimann and
Dr. Robert Chapman, NIST's Office of Quality Programs; Patricia
Kopp, American Society for Quality Control; and NIST's Standards
Code and Information staff for their careful review of and
comments on this document.
Maureen A. Breitenberg
Standards Code and Information
ABSTRACT
This report provides information on the development, content and
application of the ISO 9000 standards to readers who are
unfamiliar with these aspects of the standards. It attempts to
answer some of the most commonly asked questions on quality;
quality systems; the content, application and revision of the ISO
9000 standards; quality system approval/registration; European
Community requirements for quality system approval/registration;
and sources for additional help.
Key Words: conformity assessment; EN 29000; ISO 9000; quality
assurance; quality control; quality system; quality system
registration
INTRODUCTION
This report was designed to answer the most commonly asked questions
on quality; quality systems; the content, application and revision of
the ISO 9000 standards; quality system approval/registration; European
Community requirements for quality system approval/registration; and
related topics. The Standards Code and Information Program at the
National Institute of Standards and Technology (NIST) has received an
increasing number of inquiries on these topics, which is indicative of
the expanding interest in quality by many sectors of the economy.
This report has been prepared to provide basic information in this
area.
WHAT IS QUALITY?
Quality improvement has now become both the corporate and
international business strategy of the 1990's. Cadillac and Milliken
and Company each advertise winning the Malcolm Baldrige Award for
quality. Ford Motor Company publicizes a "Quality is Job 1" slogan,
and many other companies are following suit. At the international
level, interest has mushroomed in quality systems as a means of
assuring the consistent conformity of products or services to a given
set of standards or expectations.
There has, however, been little agreement among either corporate
management or professionals in the field regarding the meaning of
"quality." The International Organization for Standardization (ISO)
Standard 8402 defines quality as: "the totality of features and
characteristics of a product or service that bear on its ability to
satisfy stated or implied needs." However, there are problems with
this definition. Whose needs does the service or product address?
Who are its customers? In the testing services field, for example,
totally erroneous test results may satisfy a client's needs quite well
if the faulty test report can be used to allow him to sell his
product, especially if an accurate test report would not.
Nevertheless, such results are unlikely to satisfy the needs of the
potential buyers of the product or of the agency responsible for
regulating the product.
Customers for a product or service produced by a company can be
located within or outside the company or both, depending on the
product or service. A product or service may be provided by one
company unit to another solely for the latter's use, or for subsequent
delivery to a customer outside the organization. It has been said
that most product or service defects (no matter where they occur in
the service or manufacturing process) usually find their way to the
point of interface between a company and its outside customers.
In an attempt to address this problem, ISO has added seven footnotes
to its definition, including that: "in a contractual environment,
needs are specified, whereas in other environments, implied needs
should be identified and defined" and that "needs can change with
time." Needs can be defined in terms of safety; usability;
availability; versatility; compatibility with other products;
reliability; maintainability; overall cost (including purchase price,
maintenance costs, and product life); environmental impact; or other
desired characteristics.
Even if all "needs" can be identified and adequately defined (often no
easy task), what about the issue of an "acceptable quality level
(AQL)" -- the maximum percentage of nonconforming products or service
units that should be considered satisfactory as a process average?
Stated in other words, how many (if any) mistakes can you make and
still produce a "quality" product or service? A manufacturer's
production system may be considered by his customers to produce a
"quality" product if the AQL is 0.1%, that is only one in 1,000
products contains defects. Yet a 1 in 1,000 error rate for nurses
whose job it is to hold babies (they only drop one out of a thousand)
or for containers which hold highly toxic or hazardous materials (only
one serious leak gets by for every 1,000 containers produced) are
obviously not acceptable. There is a belief among many quality
experts and their disciples that the only acceptable quality level for
any manufactured product or service is 100% ("zero defects"), and that
any failure to "do it right" the first time is not tolerable. This is
not a universally held opinion.
WHAT IS A QUALITY SYSTEM?
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 manufacturers and suppliers use to
control these variables to produce a product of consistent quality
which meets defined specifications is called a quality system. [1] The
standards that are being adopted globally for quality systems are the
ISO 9000 standards.
WHAT IS ISO?
ISO is the International Organization for Standardization, founded in
1946 to promote the development of international standards and related
activities, including conformity assessment, [2] to facilitate the
exchange of goods and services worldwide. ISO is composed of member
bodies from over 90 countries, the U.S. member body being the American
National Standards Institute (ANSI). ISO's work covers all areas
except those related to electrical and electronic engineering, which
are covered by the International Electrotechnical Commission (IEC).
The results of ISO's technical work are published as International
Standards or Guides.
WHAT ARE THE ISO 9000, ANSI/ASQC Q 90, AND CEN/CENELEC EN 29000
STANDARDS?
In 1987, the ISO published a series of five international standards
(ISO 9000, 9001, 9002, 9003, and 9004), developed by ISO Technical
Committee (TC) 176 on quality systems. This series, together with the
terminology and definitions contained in ISO Standard 8402, provides
guidance on the selection of an appropriate quality management program
(system) for a supplier's operations.
The ISO 9000 standards were intended to be advisory in nature and were
developed primarily for use in two-party contractual situations or for
internal auditing. However, the standards are currently being applied
under a much broader range of conditions and circumstances. In some
cases, compliance with one of the ISO 9000 standards (or their
equivalent) has been or will be mandated by a U.S., foreign national,
or regional government body. Conformance to ISO 9000 standards is
also being required in purchasing specifications with increasing
frequency.
The ISO 9000 Standard Series has been adopted in the United States as
the ANSI/American Society for Quality Control (ASQC) Q 90 Series (soon
to be changed to the ANSI/ASQC Q 9000 series). In Europe, it has been
adopted by the European Committee for Standardization (CEN) and the
European Committee for Electrotechnical Standardization (CENELEC) as
the European Norm (EN) 29000 Series. According to a recent survey by
ISO, forty-eight (48) countries have national standards that are
identical or equivalent to the ISO 9000 Standard Series. Additional
countries are considering their adoption.
WHAT SORT OF INFORMATION IS CONTAINED IN EACH ISO 9000 STANDARD?
The ISO 9000 Standard Series is generic in scope. Each standard
addresses a different aspect of quality assurance, depending on the
needs of the user.
ISO 9001, 9002 and 9003 describe three distinct quality system models
of varying stringency for use in different applications. Common
elements in ISO 9001, 9002, and 9003 include the need for: an
effective quality system; ensuring that measurements are valid, that
measuring and testing equipment is calibrated regularly; the use of
appropriate statistical techniques; having a product identification
and traceability system; maintaining an adequate record keeping
system; having an adequate product handling, storage, packaging and
delivery system; having an adequate inspection and testing system as
well as a process for dealing with nonconforming items; and ensuring
adequate personnel training and experience.
ISO 9000 (ANSI/ASQC Q 90), Quality Management and Quality Assurance
Standards - Guidelines for Selection and Use, explains fundamental
quality concepts; defines key terms; and provides guidance on
selecting, using, and tailoring ISO 9001, 9002, and 9003.
ISO 9001 (ANSI/ASQC Q 91), Quality Systems - Model for Quality
Assurance in Design/Development, Production, Installation and
Servicing, is the most comprehensive standard in the series. ISO 9001
covers all elements listed in ISO 9002 and 9003. In addition, it
addresses design, development, and servicing capabilities.
ISO 9002 (ANSI/ASQC Q 92), Quality Systems - Model for Quality
Assurance in Production and Installation, addresses the prevention,
detection, and correction of problems during production and
installation. It is more extensive and more sophisticated than ISO
9003.
ISO 9003 (ANSI/ASQC Q 93), Quality Systems - Model for Quality
Assurance in Final Inspection and Test, is the least comprehensive
standard. It addresses requirements for the detection and control of
problems during final inspection and testing.
ISO 9004 (ANSI/ASQC Q 94), Quality Management and Quality System
Elements - Guidelines, provides guidance for a supplier to use in
developing and implementing a quality system and in determining the
extent to which each quality system element is applicable. ISO 9004
examines each of the quality system elements (cross-referenced in the
other ISO 9000 standards) in greater detail and can be used for
internal and external auditing purposes.
WHERE CAN COPIES OF THESE STANDARDS BE OBTAINED?
Copies of ISO draft/final standards and European standards (ENs) can
be purchased from: The American National Standards Institute,
11 West 42nd Street, 13th Floor, New York, NY 10036, Phone: (212) 642-
4900, Fax: (212) 302-1286.
ARE THE ISO 9000 STANDARDS SUBJECT TO CHANGE?
According to ISO procedures, all ISO standards, including those in the
ISO 9000 series, must be reviewed and revised or reaffirmed at least
once every five years. ISO has already begun to revise and supplement
the ISO 9000 series. Some of these standards/guidelines will
supplement ISO 9000 and ISO 9004, while others will be included in the
new ISO 10000 series. Both series have been reserved for use by ISO
TC 176.
Recently released ISO standards and guidelines in the quality area
include: ISO 9000-3, Guidelines for the Application of ISO 9001 to the
Development, Supply and Maintenance of Software; ISO 9004-2, Quality
Management and Quality System Elements - Part 2: Guidelines for
Services; ISO 10011 Part 1, Guidelines for Auditing Quality Systems -
Auditing; ISO 10011 Part 2, Guidelines for Auditing Quality Systems -
Qualification Criteria for Auditors; ISO 10011 Part 3, Guidelines for
Auditing Quality Systems - Managing Audit Programs; and ISO 10012-1,
Quality Assurance Requirements for Measuring Equipment - Part 1:
Management of Measuring Equipment.
In addition, ISO/DIS (Draft International Standard) 8402-1 Quality
Systems Terminology; and DIS 9000-2 Addendum to 9000 on Guidelines for
Implementing 9001-2-3; DIS 9004-3 Addendum to 9004 on Processed
Materials are under review by ISO TC 176. ISO TC 176 is also
considering committee draft (CD) 9004-4 Addendum to 90004 on Quality
Improvement; guidance documents on project management, quality plans,
quality manuals, the economics of quality, and configuration
management; documents covering revisions to ISO 9000, 9001-2-3; and
9004; and a working draft (WD) 10012-2: Quality Assurance Requirements
for Measuring Equipment - Part 2: Measuring Equipment. [3]
Some national and regional standards bodies are developing
supplemental guidance for the application of the ISO 9000 series to
specific industries. CEN and CENELEC, for example, are developing
more specific requirements for the application of the ISO 9001 to the
medical device industry. [4] The U.S. Food and Drug Administration
(FDA) is planning to revise its Good Manufacturing Practice (GMP)
regulations for medical devices to follow ISO 9001 with appropriate
additional requirements. Draft GMP regulations are expected to be
issued by the end of 1992. The International Organization for Legal
Metrology (OIML) is developing a document entitled: "Quality Assurance
as Applied for Initial Verification of Measuring Instruments," which
provides guidance on the applicability and use of the ISO 9000
Standard Series in the manufacture of measuring instruments.
DOES TC 176 HAVE A PLAN FOR REVISING AND SUPPLEMENTING THE ISO 9000
STANDARDS?
Vision 2000 - A Strategy for International Standards' Implementation
in the Quality Arena During the 1990s is a long range plan through the
year 2000 developed by an Ad Hoc Task Force of ISO TC 176. The plan
includes providing additional guidance on how to apply the ISO 9000
series standards to four generic product categories (hardware,
software, processed materials, and services), as well as providing
guidance on related issues, such as quality system auditing. As noted
above, these documents are in various stages of development. Minor
modifications in the original ISO 9000 series are expected in 1993,
with major revisions in 1997. The long range goal, according to
Vision 2000, is to have a single Total Quality Management Standard by
the year 2000.
WHAT IS THE ISO 9000 FORUM?
ISO has established a forum to serve the needs of ISO 9000 users by:
providing information (including a newsletter); facilitating
international discussions on new developments and issues affecting the
application of the ISO 9000 standards; promoting the exchange of
experience in such areas as training, promotion and operation of
relevant schemes; harmonizing practices in the application and
interpretation of the ISO 9000 standards; providing advice to ISO TC
176 or the relevant ISO decision making body.
HOW DO THE ISO 9000 CRITERIA COMPARE WITH CRITERIA USED IN THE MALCOLM
BALDRIGE NATIONAL QUALITY AWARD PROCESS?
The Malcolm Baldrige National Quality Award process is designed to
recognize and award those firms with outstanding records of quality
performance. The purpose of the program is therefore very different
from the purpose behind the development of the ISO 9000 criteria.
While the use of the ISO 9000 standards may be a good starting point
in establishing a quality system, the criteria used in evaluating
candidates for the Baldrige Award are much more detailed and extend
beyond those areas covered by the ISO 9000 series. The Baldrige Award
criteria are results oriented and cover all operations, processes, and
work units of a company. The evaluation procedures emphasize the
dynamics involved in the integration of all aspects of a firm's
quality system and the firm's continuous improvements in quality.
WHAT IS QUALITY SYSTEM REGISTRATION?
Quality system registration or approval (sometimes misnamed "quality
system certification" [5]) involves the assessment and periodic audit of
the adequacy of a supplier's quality system by a third party, known as
a quality system registrar. When a supplier's system conforms to the
registrar's interpretation of an ISO 9000 standard, the registrar
issues the supplier a "certificate of registration." Interpretations
of an ISO 9000 standard may not be consistent from one registrar to
another.
Note that the supplier's quality system is registered, not an
individual product. Consequently, quality system registration does
not imply product conformity to any given set of requirements.
Registration programs can be conducted in conjunction with or
independently from a certification [6] program. Registrars may or may
not concurrently operate a product certification program.
WHO EVALUATES QUALITY SYSTEMS?
A manufacturer may choose to evaluate his own quality system. Such
self-audits are usually major components of the quality system itself.
Such self-audits can increase the confidence of management in its
production system and demonstrate to its personnel that the firm is
committed to quality management.
"Second party" evaluations are also common. In these cases, it is
usually the buyer who requires and conducts quality system evaluations
of his suppliers. These evaluations are mandatory only for companies
wishing to become suppliers to that buyer.
"Third party" quality system evaluations and registrations may be
voluntary or mandatory and are conducted by persons or organizations
independent of both the supplier and the buyer. According to a recent
ISO survey, 31 countries reported the existence of one or more third
party registration schemes in their countries.
WHAT IS THE "NEW APPROACH" FOR CONFORMITY ASSESSMENT OF REGULATED
PRODUCTS?
The Government of the European Community (EC) has established a
conformity assessment scheme for EC-regulated [7] products. The EC has
specified conformity assessment methods in terms of eight "modules,"
such as self-certification (also called "manufacturer's declaration"),
type testing, quality system approval, or final product verification
by a third party. Each "new approach" directive specifies the
alternative means (set of modules) which suppliers must use to certify
their products as being in conformance with the "essential
requirements" spelled out in each directive.
When EC directives require the use of a third party in the conformity
assessment process, each member country government must provide the EC
government with a list of such bodies. Each member country government
must determine that the bodies it notifies, referred to as a "notified
bodies," are competent to declare that a regulated product is in
conformity to the "essential requirements" spelled out in a particular
directive. Member states notify bodies by both conformity assessment
method (module) and by directive to the EC, which is then responsible
for compiling a list of all such bodies.
Each EC country must accept the results of conformity assessments by
notified bodies in all other EC countries unless there is cause to
believe that the product was improperly tested. Each EC country is
responsible for assuring that the bodies it designates as notified
bodies comply with the criteria for competence of testing
laboratories, certification and laboratory accreditation bodies, and
quality system registrars spelled out in the European EN 45000 series
of standards.
WILL QUALITY SYSTEM APPROVALS BE MANDATORY IN THE EC?
Having an approved quality system will not be a blanket requirement
for all products. However, for suppliers of construction products,
certain classes of medical devices and personal protective equipment,
telecommunications terminal equipment, gas appliances, commercial
scales, and possibly other products (such as pressure equipment,
recreational craft, cable ways, and lifting equipment for people),
approval of a supplier's quality system will be a key component of the
EC's legal requirements for certification. For most of these
regulated products, ISO 9000 registration is one alternative to
proving compliance, not an absolute requirement.
In other directives, such as the Council Directive dated June 14, 1989
on machinery (89/392/EEC), manufacturers of some products will be
permitted to self declare that their product conforms to the
requirements of the directive and to place the European Community (CE)
mark on the product. However, such machinery manufacturers must
maintain a file on the manufacture of those products, including
information on "the internal measures that will be implemented to
ensure that the machinery remains in conformity with the provisions of
the Directive" -- in other words, on the manufacturer's quality
system. It is possible that the ISO 9000 (EN 29000) Series Standards
could be used within the European Community to evaluate the adequacy
of such quality systems.
Manufacturers need to review all relevant EC directives for specific
requirements applicable to their products.
WHO WILL BE ABLE TO CONDUCT MANDATORY EC QUALITY SYSTEM APPROVALS?
At the present time, notified bodies must be physically located within
the geographical boundaries of the European Community. In November
1991, the EC developed a document entitled, Working Document on
Negotiations with Third Countries Concerning the Mutual Recognition of
Conformity Assessment, which provides guidance for the establishment
of mutual recognition agreements with third countries. A less
detailed directive on this topic is expected sometime in June 1992.
Until the directive is issued and one or more mutual recognition
agreements are subsequently established between the United States and
the European Community, there can be no notified bodies in the United
States. A mutual recognition agreement would allow U.S. entities to
perform all required conformity assessment procedures included within
the scope of the agreement.
There remains the possibility that some conformity assessment tasks
may be subcontracted by notified bodies to bodies outside the EC,
including organizations in the United States. Such subcontracting
would be done at the discretion of the notified body, which would
continue to be responsible for the final assessment of product
conformity. Subcontractors must comply with all requirements of the
EN 45000 series. Guidance on subcontracting can be found in Guiding
Principles for Subcontracting by "Notified Bodies" pursuant to the
Council Resolution of 13 December 1990 Concerning the Modules for the
Various Phases of the Conformity Assessment Procedures.
WILL QUALITY SYSTEM REGISTRATION BE REQUIRED FOR NONREGULATED PRODUCTS
IN THE EC AND ELSEWHERE?
In the nonregulated product area, producers desiring to do business in
the European Community (EC) and elsewhere may be required by
procurement authorities or buyers to be audited and registered as
being in compliance with an ISO 9000 standard. This is especially
likely in industries such as aerospace, autos, electronic components,
measuring and testing equipment, or in industries where safety and
liability are concerns. Such requirements will result from
marketplace demands, as opposed to regulatory requirements.
It should be noted that in the United States, the U.S. Department of
Defense is considering adopting the ISO 9000 standards in place of
some of its military quality standards (MIL-Q-9858A and MIL-I-45208A).
Other foreign government procurement authorities have already or are
likely to follow suit.
WHAT IS THE EOTC AND HOW DOES IT FIT INTO THE PICTURE?
The European Organization for Testing and Certification (EOTC) was
created by the EC in April 1990 under a memorandum of understanding
with the European Committee for Standardization (CEN), the European
Committee for Electrotechnical Standardization (CENELEC), and the
European Free Trade Association (EFTA) countries. The EOTC was formed
to promote the mutual recognition of test results, certification
procedures, and quality system assessments and registrations in
nonregulated product areas throughout the EC and EFTA. The EOTC will
also be responsible for providing technical assistance to the EC
Commission in the implementation of some EC legislation, especially in
the preparation of mutual recognition agreements with non-EC
countries. It is anticipated that there will be a Specialized
Committee of the EOTC in the area of Quality Assurance. However, this
committee will not be established until after December 31, 1992.
Nevertheless the need for expert advice in this area was recognized by
the EOTC in July 1991. The European Organization for Quality (EOQ)
and the European Committee for Quality System Assessment and
Certification (EQS) have been offered observership status in EOTC to
fill this need. The EOTC is expected to be fully operational by the
end of 1992. For further information on the EOTC, contact: EOTC, Rue
Stassart 33, 2nd Floor, B-1050 Brussels, Belgium, Phone: 32 2 519
6969, Fax: 32 2 519 69 17/19.
DOES THE U.S. HAVE A SCHEME FOR QUALITY SYSTEM REGISTRATION?
Until recently, U.S. companies relied on quality system registration
firms in Europe and Canada to register their quality systems, but this
is no longer the case. Today, the number of U.S.-based organizations
offering consulting services, assessment and/or quality system
registration is growing rapidly.
WHO EVALUATES THE COMPETENCE OF REGISTRARS?
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. The RAB and ANSI agreed to form a
joint U.S. program in December 1991. In February 1992, RAB announced
the establishment of an ISO 9000 auditor certification program.
Information on the RAB program is available from: the RAB, 611 East
Wisconsin Ave., Milwaukee, WI 53202, Phone 414-272-8575.
Programs similar to that of the RAB have been underway in Canada, in a
number of European countries, and elsewhere in the world for some
time.
WHERE CAN U.S. INDUSTRY GO TO GET ADDITIONAL HELP?
Additional information is available from:
National Center for Standards and Certification
Information (NCSCI)
National Institute of Standards and Technology (NIST)
TRF Bldg. Room A163
Gaithersburg, MD 20899
Phone: (301) 975-4040 Fax: (301) 926-1559
and from
Office of EC Affairs
International Trade Administration, Room 3036
14th and Constitution Ave., SW
Washington, DC 20230
Phone: (202) 377-5276 Fax: (202) 377-2155
Both agencies are located in the Department of Commerce and can refer
interested parties to other sources of information within and outside
the federal government.
INFORMATION AND PUBLICATIONS
AVAILABLE FROM
Standards Code and Information Program (SCI)
National Institute of Standards and Technology
[SEE LAST PAGE FOR CONTACTS/ADDRESSES]
* The ABC's of Standards-Related Activities in the United States
(NBSIR 87-3576)
This report is an introduction to voluntary standardization, product
certification and laboratory accreditation for readers not fully
familiar with these topics. It stresses some of the more important
aspects of these fields; furnishes the reader with both historical and
current information on these topics; describes the importance and
impact of the development and use of standards; and serves as
background for using available documents and services.
Order as PB 87-224309 from NTIS.
* The ABC'S of Certification Activities in the United States
(NBSIR 88-3821)
This report, a sequel to NBSIR 87-3576, The ABC'S of Standards-
Related Activities in the United States, provides an introduction to
certification for readers not entirely familiar with this topic. It
highlights some of the more important aspects of this field, furnishes
the reader with information necessary to make informed purchases, and
serves as background for using available documents and services.
Order as PB 88-239793 from NTIS.
* Laboratory Accreditation in the United States (NISTIR 4576)
This report, a sequel to NBSIR 87-3576 The ABC'S of Standards-
Related Activities in the United States and NBSIR 88-3821 The ABC'S of
Certification Activities in the United States, is designed to provide
information on laboratory accreditation to readers who are new to this
field. It discusses some of the more significant facets of this topic,
provides information necessary to make informed decisions on the
selection and use of laboratories, and serves as background for using
other available documents and services.
Order as PB 91-194495 from NTIS.
* Questions and Answers on Quality, the ISO 9000 Standard Series,
Quality System Registration, and Related Issues (NISTIR 4721)
This report provides information on the development, content and
application of the ISO 9000 standards to readers who are unfamiliar
with these aspects of the standards. It attempts to answer some of
the most commonly asked questions on quality; quality systems; the
content, application and revision of the ISO 9000 standards; quality
system approval/registration; European Community requirements for
quality system approval/registration; and sources for additional help.
Order as PB 92-126465 from NTIS.
* Directory of International and Regional Organizations Conducting
Standards-Related Activities (NIST SP 767)
This directory contains information on 338 international and
regional organizations which conduct standardization, certification,
laboratory accreditation, or other standards-related activities. It
describes their work in these areas, as well as the scope of each
organization, national affiliations of members, U.S. participants,
restrictions on membership, and the availability of any standards in
English.
Copies not available from SCI. Order as PB 89-221147 from NTIS or
order as Cat. #SP767 from Global Engineering Documents.
* Directory of European Regional Standards-Related Organizations (NIST
SP 795)
This directory identifies more than 150 European regional
organizations - both governmental and private - that engage in
standards development, certification, laboratory accreditation and
other standards-related activities, such as quality assurance. Entries
describe the type and purpose of each organization; acronyms; national
affiliations of members; the nature of the standards-related activity;
and other related information.
Copies not available from SCI. Order as PB 91-107599 from NTIS or
order as Cat. #0258-3 from Global Engineering Documents.
* Standards Activities of Organizations in the United States
(NIST SP 806)
The directory identifies and describes activities of over 750 U.S.
public and private sector organizations which develop, publish, and
revise standards; participate in this process; or identify standards
and make them available through information centers or distribution
channels. NIST SP 806, a revision of NBS SP 681, covers activities
related to both mandatory and voluntary U.S. standards. SP 806 also
contains a subject index and related listings that cover acronyms and
initials, defunct bodies and organizations with name changes.
Copies not available from SCI. Order as PB 91-177774 from NTIS or
order as Cat. #SP806 from Global Engineering Documents.
* Directory of Private Sector Product Certification Programs
(NIST SP 774)
This directory presents information from 132 private sector
organizations in the United States which engage in product
certification activities. Entries describe the type and purpose of
each organization, the nature of the activity, product certified,
standards used, certification requirements, availability and cost of
services, and other relevant details. Copies not available from SCI.
Order as PB 90-161712 from NTIS.
* Directory of Federal Government Certification Programs
(NBS SP 739)
This directory presents information on U.S. Government certification
programs for products and services. Entries describe the scope and
nature of each certification program, testing and inspection
practices, standards used, methods of identification and enforcement,
reciprocal recognition or
acceptance of certification, and other relevant details.
Copies not available from SCI. Order as PB 88-201512 from NTIS.
* Directory of Federal Government Laboratory Accreditation/
Designation Programs (NIST SP 808)
This directory provides updated information on 31 federal
government laboratory accreditation and similar type programs
conducted by the federal government. These programs, which include
some type of assessment regarding laboratory capability, designate
sets of laboratories or other entities to conduct testing to assist
federal agencies in carrying out their responsibilities. The
directory also lists 13 other federal agency programs of possible
interest, including programs involving very limited laboratory
assessment and programs still under development.
Copies not available from SCI. Order as PB 91-167379 from NTIS.
* Directory of State and Local Government Laboratory Accreditation/
Designation Programs (NIST SP 815)
This directory provides updated information on 21 state and 11
local government laboratory accreditation and similar type programs.
These programs, which include some type of assessment regarding
laboratory capability, designate private sector laboratories or other
entities to conduct testing to assist state and local government
agencies in carrying out their responsibilities. Entries describe the
scope and nature of each program, laboratory assessment criteria and
procedures used in the program, products and fields of testing
covered, program authority, and other relevant details.
Copies not available from SCI. Order as PB 92-108968 from NTIS.
* Directory of Professional/Trade Organization Laboratory Organization
Laboratory Accreditation/Designation Programs (NIST SP 831)
This directory is a guide to laboratory accreditation and similar
types of programs conducted by professional and trade organizations.
These programs accredit or designate laboratories or other entities to
assist private sector professional societies, trade associations,
related certification bodies, their membership, as well as government
agencies, in carrying out their responsibilities. This accreditation
or designation is based on an assessment of the capability of the
laboratory to conduct the testing. However, the nature of the
assessment varies considerably by organization and program.
Order as SN 003-003-03144-5 from GPO.
* Barriers Encountered by U.S. Exporters of Telecommunications
Equipment (NBSIR 87-3641)
This report addresses the perceived institution of unreasonable
technical trade barriers by major European trading partners to the
export of telecom products and systems by U.S. companies. The GATT
technical office, which has responsibilities to assist U.S. exporters
to take advantage of trade opportunities, informally contacted over a
period of six months, telecom companies and agencies to assess the
extent of unreasonableness in foreign national standards, regulations,
testing and certification requirements, and accreditation procedures.
Copies not available from SCI. Order as PB 88-153630 from NTIS.
* A Review of U.S. Participation in International Standards Activities
(NBSIR 88-3698)
This report describes the role of international standards, their
increasingly significant importance in world trade, and the extent of
past and current U.S. participation in the two major
international standardization bodies - ISO and IEC. The degree of U.S.
participation covers the 20 year period 1966-1986. A coarse analysis
of data indicates some correlation between U.S. participation and
recent export performance for several major product categories.
Copies not available from SCI. Order as PB 88-164165 from NTIS.
* An Update of U.S. Participation in International Standards
Activities (NISTIR 89-4124)
This report presents updated information on the current level
of U.S. participation in ISO and IEC (reference: NBSIR 88-
3698).
Copies not available from SCI. Order as PB 89-228282/AS from NTIS.
* A Summary of the New European Community Approach to Standards
Development (NBSIR 88-3793-1)
This paper summarizes European Community (EC) plans to aggressively
pursue its goal of achieving an "internal market" by 1992 and the
standards-related implications of such a program on U.S. exporters.
Order as PB 88-229489/AS from NTIS.
* Trade Implications of Processes and Production Methods (PPMs)
(NISTIR 90-4265)
This report discusses processes and production methods (or PPM's)
and their relationship to trade, the GATT Agreement on Technical
Barriers to Trade, and traditional product standards used in
international commerce. The report provides background information on
PPM's, a suggested definition, and the possible extension of their
application from the agricultural sector to industrial products.
Order as PB 90-205485 from NTIS.
The following documents are available upon request from SCI.
* tbt news
This newsletter provides information on government programs and
available services established in support of the GATT Agreement on
Technical Barriers to Trade (Standards Code). tbt news reports on the
latest notifications of proposed foreign regulations; bilateral
consultations with major U.S. trade partners; programs of interest to
U.S. exporters; and availability of standards and certification
information. Subscription is free upon request.
* Technical Barriers to Trade
This booklet explains the basic rules of the international Agreement
on Technical Barriers to Trade negotiated during the Tokyo Round of
the Multilateral Trade Negotiations (MTN), and
describes Title IV of the U.S. Trade Agreements Act of 1979 which
implements the United States' obligations under the Agreement.
The Agreement, popularly known as the Standards Code, was designed to
eliminate the use of standards and certification
systems as barriers to trade. The booklet describes the functions of
the Departments of Commerce and Agriculture, the Office of the U.S.
Trade Representative, and the State Department in carrying out the
U.S.'s responsibilities.
* "GATT Standards Code Activities"
This brochure gives a brief description of NIST's activities in
support of the Standards Code. These activities include operating the
U.S. GATT inquiry point for information on standards and certification
systems; notifying the GATT Secretariat of proposed U.S. regulations;
assisting U.S. industry with trade-related standards problems;
responding to inquiries on foreign and U.S. proposed regulations; and
preparing reports on the Standard Code.
* GATT Standards Code Activities of the National Institute of
Standards and Technology
This annual report describes the GATT Standards Code activities
conducted by the Standards Code and Information Program for each
calendar year. NIST responsibilities include operating the GATT
inquiry point, notifying the GATT Secretariat of proposed U.S.
Federal government regulations which may affect trade, assisting U.S.
industry with standards-related trade problems, and responding to
inquiries about proposed foreign and U.S. regulations.
* Free handout material on office activities and standards-related
information such as: government sources of specifications and
standards; foreign standards bodies; U.S. standards organizations; and
a brochure on the National Center for Standards and Certification
Information (NCSCI).
In addition to general inquiry services, the following assistance is
also available:
* EC Hotline
This hotline reports on draft standards of the European Committee on
Standardization (CEN), the European Committee for Electrotechnical
Standardization (CENELEC) and the European Telecommunications
Standards Institute (ETSI). It also provides information on selected
EC directives. The recorded message is updated weekly and gives the
product, document number and closing date for comments. The hotline
number is (301) 921-4164 (not toll-free).
* GATT Hotline
A telephone hotline provides current information received from the
GATT Secretariat in Geneva, Switzerland, on proposed foreign
regulations which may significantly affect trade. The recorded message
is updated weekly and gives the product, country, closing date for
comments (if any) and Technical Barriers to Trade (TBT) notification
number. The hotline number is (301) 975-4041 (not toll-free).
* NCSCI provides assistance to U.S. and foreign exporters in obtaining
current standards, regulations and certification information for the
manufacture of products. To aid foreign exporters, NCSCI also provides
directory information of state offices prepared to respond to queries
concerning conditions to be met by goods for sale in their state.
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STANDARDS, REGULATIONS AND CERTIFICATION INFORMATION, CONTACT:
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Phone: (301) 975-4040
SOURCES FOR ORDERING STANDARDS
(Note - copies can be obtained from the respective standards-issuing
organization and/or these sources.)
ORGANIZATION INFORMATION PROVIDED
American National Standards Institute (ANSI) ANSI and ANSI approved
11 West 42nd Street, 13th Floor industry standards
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Telex: 44 6194 NATSTA GAIT
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Suite 8100
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Telephone: (202) 755-0325 or 755-0326
Fax: (202) 205-3720
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Attn: NPODS adopted documents
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Fax: (303) 799-4097 Select European
Telex: 4322083 IHS UI Standards (CEN/CENELEC)
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Northridge, California 91324, USA Publications and Other
Information and Quotes: Reference Materials
Telephone: (818) 368-2786 Translations Service
Orders Only: (800) 755-2780 U.S./Foreign General
Fax: (818) 360-3804 Regulatory Compliance
Information
WHERE CAN COPIES OF THESE STANDARDS BE OBTAINED?
Copies of ISO draft/final standards can be purchased from: The
American National Standards Institute, 11 West 42nd Street, 13th
Floor, New York, NY 10036, Phone: (212) 642-4900, Fax: (212) 302-1286.
WHERE CAN INFORMATION ON THE WORK OF ISO TC 176 BE OBTAINED?
Information on ISO Technical Committee 176 (the committee responsible
for the development of the ISO 9000 and 10000 series standards) can be
obtained from Patricia Kopp, Standards Administrator, the American
Society for Quality Control (ASQC), 611 East Wisconsin Ave.,
Milwaukee, WI 53202, Phone: 414-272-8575.
FOOTNOTES
1./ 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, as formally expressed by top management." These ISO
definitions also include several additional footnotes.
2./ Conformity assessment includes testing, inspection,
laboratory accreditation, certification, quality system
assessment, and other activities intended to assure the
conformity of products to a set of standards and/or technical
specifications.
3./ Information on drafts or proposed standards work was
provided by Patricia Kopp, Standards Administrator at the
American Society for Quality Control (ASQC) in Milwaukee, WI,
Phone: 414-272-8575.
4./ 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 EC will have to comply with the quality system
requirements of EN 46001.
5./ ISO/IEC Guide 48 uses the term "register," though many
Europeans continue to use the term "certify."
6./ Certification is defined in ISO Guide 2-1991 as the:
"procedure by which a third party gives written assurance that a
product, process or service conforms to specified requirements."
7./ Regulated products are those for which the EC Commission
has developed or is developing an EC-wide technical harmonization
directive which provides manufacturers with a single set of
requirements that must be met to place their products on the EC
market.
|
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National Trade Data Bank - The Export Connection (R)
ITEM ID : NI ISO TOCPART2
DATE : Nov 30, 1993
AGENCY : USDOC, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
PROGRAM : THE ISO 9000 STANDARD SERIES: QUALITY AND RELATED ISSUES
TITLE : Table of Contents - "More Questions and Answers...", NISTIR 5122
Update sched: Occasionally
Data type : TEXT
End year : 1993
TABLE OF CONTENTS
Foreword
Acknowledgements
Abstract
Introduction
Why and by Whom Were the ISO 9000 Standards Developed?
How Was BS 5750 Developed?
What Is the U.S. Role in ISO TC 176?
Does the ANSI/ASQC Q90 Standard Series Differ from the ISO 9000
Standard Series?
Have Any ISO 9000 or Related Standards Been Published Since 1987?
What Is ISO TC 176 Working On?
Where Can Additional Information on the Work of ISO TC 176 Be
Obtained?
Where Can Copies of these Standards be Obtained?
What Countries Have Adopted the ISO 9000 Standard Series?
What Are the Numbering Systems Used by Countries to Designate the
ISO Standard Series?
What Is New with the ISO 9000 Forum?
What are "New Approach" Directives?
What is Quality System Registration/Approval and How Does It Relate
to Conformity Assessment?
What is the Difference Between Quality System Certification and
Quality System Registration?
Will Quality System Approvals be Mandatory in the EC?
How does the EC Product Safety Directive Relate to ISO 9000?
How Does the EC Product Liability Directive Relate to ISO 9000?
How Does the ISO 9000 Standard Series Apply to the EC Services
Sector?
Who Will Be Able to Conduct Mandatory EC Quality System
Approvals?
How Can I Find More Information on Notified Bodies and What Will I
Learn?
Where Can I Find Out More About the EC's Subcontracting
Guidelines?
Will the U.S. Be Establishing MRAs with the EC?
What is CASE or NVCASE?
Is Quality System Registration Likely to be Required for
Non-regulated Products in the EC and Elsewhere?
What is EAC?
What is the EOTC and How Does It Fit into the Picture?
What Is EQS?
What Is EQNET?
What Else Is New in This Area in the EC?
What's Happening with Non-EC European Countries?
Is the U.S. Government Planning to Use the ISO 9000 Standards?
Are Many Companies Seeking Registration in the United States?
How Do You Select a Quality System Registrar?
Who Evaluates the Competence of Registrars?
What is the Relationship Between ISO/IEC Guide 25 and ISO 9000?
What Can NIST'S Manufacturing Technology Centers Do to Help?
What Can EDA's Trade Adjustment Assistance Program Do to Help?
Is There Any Other Help Available?
Where Can U.S. Industry Go to Get Additional Information?
Appendix A - Information and Publications Available from NIST
Appendix B - Sources for Ordering Standards
Appendix C - List of Some Relevant Standards
Appendix D - Sources for Additional Information on NIST-Related
Activities and Organizations/Documents Referenced in the Text
Appendix E - Manufacturing Technology Centers (MTCs)
Appendix F - Trade Adjustment Assistance Centers (TAACs)
Appendix G - List of Acronyms
National Trade Data Bank - The Export Connection (R)
ITEM ID : NI ISO ABSTRCT2
DATE : Nov 30, 1993
AGENCY : USDOC, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
PROGRAM : THE ISO 9000 STANDARD SERIES: QUALITY AND RELATED ISSUES
TITLE : Abstract - "More Questions and Answers...", NISTIR 5122
Update sched: Occasionally
Data type : TEXT
End year : 1993
ABSTRACT
This report, a sequel to NISTIR 4721, provides additional
information on the ISO 9000 standards and related issues to
readers unfamiliar with some of the new developments in this
area. It attempts to answer additional questions on ISO 9000
standards related issues which NIST has received since the
publication of NISTIR 4721. It also identifies sources for
further help in this area.
Key Words: conformity assessment; EN 29000; EOTC; ISO Forum; ISO
9000; quality assurance; quality control; quality system; quality
system registration
National Trade Data Bank - The Export Connection (R)
ITEM ID : NI ISO NIST5122
DATE : Nov 30, 1993
AGENCY : USDOC, NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
PROGRAM : THE ISO 9000 STANDARD SERIES: QUALITY AND RELATED ISSUES
TITLE : More Questions and Answers on the ISO 9000 Series and Related Issues
Update sched: Occasionally
Data type : TEXT
End year : 1993
FOREWORD
The National Institute of Standards and Technology's (NIST)
Standards Code and Information Program periodically publishes
information on various aspects of conformity assessment systems
for use by those who operate or benefit from such systems. There
has been considerable interest in the content and application of
international standards related to quality management,
particularly ISO 9000 Standard Series. This report, a sequel to
NISTIR 4721, "Questions and Answers on Quality, the ISO 9000
Standard Series, Quality System Registration, and Related
Issues," provides updated information and answers additional
questions on this topic. This material is intended for persons
concerned about the ISO 9000 standards and should help foster a
wider interest in the use of quality systems in general.
Appendix A of this document also references other publications
and services provided by the Standards Code and Information
Program which readers may find useful.
The reader is invited to share any comments on the material
presented in this document.
ACKNOWLEDGEMENTS
I would like to thank Charles Hyer, The Marley Organization;
Patricia Kopp, American Society for Quality Control; George
Lofgren, Registrar Accreditation Board; William Breitenberg,
Citicorp Card Products; James Hollister, American Technical
Resources, Inc.; Mary Saunders, Office of European Community
Affairs, International Trade Administration; Lee Best, Office of
Measurement Services, NIST; Barbara Meigs and Otto Warnloff,
Standards Management Program, NIST; and NIST's Standards Code and
Information staff for their careful review of this document.
Maureen A. Breitenberg
Standards Code and Information
ABSTRACT
This report, a sequel to NISTIR 4721, provides additional
information on the ISO 9000 standards and related issues to
readers unfamiliar with some of the new developments in this
area. It attempts to answer additional questions on ISO 9000
standards related issues which NIST has received since the
publication of NISTIR 4721. It also identifies sources for
further help in this area.
Key Words: conformity assessment; EN 29000; EOTC; ISO Forum; ISO
9000; quality assurance; quality control; quality system; quality
system registration
INTRODUCTION
Quality improvement has now become a key U.S. domestic and
international business strategy, and worldwide interest in
quality systems as one method of assuring the consistent
conformity of products or services to a defined set of standards
or expectations has mushroomed. Nowhere is this more apparent
than in the ever increasing international adoption and use of the
ISO 9000 Standard Series. Growing demand by both buyers and
regulators within and outside the European Community for
conformity to ISO 9000 requirements has made these standards and
their usage a matter of considerable importance and concern to
U.S. companies.
This report, a sequel to NISTIR 4721 - Questions and Answers on
Quality, the ISO 9000 Standard Series, Quality System
Registration, and Related Issues, attempts to answer additional
questions on ISO 9000 standards related issues which the National
Institute of Standards and Technology (NIST) has received since
the publication of NISTIR 4721. It also identifies sources for
further help in this area.
This report is intended for persons involved with or concerned
about the ISO 9000 standards and quality system registration.
Special attention is given to ISO 9000 related events within the
European Community (EC) that might affect U.S. trade.
WHY AND BY WHOM WERE THE ISO 9000 STANDARDS DEVELOPED?
The International Organization for Standardization (ISO) is a
worldwide federation founded in 1946 to promote the development
of international standards and related activities (including
conformity assessment) to facilitate the exchange of goods and
services worldwide. ISO is composed of member bodies from over
90 countries, the U.S. member body being the American National
Standards Institute (ANSI).
In 1979, ISO formed Technical Committee (TC) 176 on Quality
Management and Quality Assurance to address the worldwide trend
towards increasingly stringent customer demands with regard to
quality combined with growing confusion in international trade
resulting from differing national and subnational quality system
requirements.
In 1987, based on the work of TC 176, ISO published the ISO 9000
Standard Series on quality management and assurance. These
standards were based on considerable input from a number of
countries, especially the United States (U.S.), Canada, and the
United Kingdom (U.K.). In particular, the ISO 9000 standards
were based in large part on the British Standards Institution's
BS 5750 Series, Quality Systems.
HOW WAS BS 5750 DEVELOPED?
In 1959, the U.S. Department of Defense (DOD) established a
Quality Management Program with the designation of MIL-Q-9858.
Four years later, it was revised to MIL-Q-9858A - its only
revision to date. In 1968, the North Atlantic Treaty
Organization (NATO) essentially adopted the provisions of MIL-Q-
9858A, Quality Program Requirements, in the form of Allied
Quality Assurance Publication 1 (AQAP-l). In 1970, the U.K.'s
Ministry of Defence adopted the provisions of AQAP-1 as its
Management Program Defence Standard DEF/STAN 05-8.[1] In 1979, the
British Standards Institution (BSI) developed the first
commercial quality management system standard, known as BS 5750.
From these predecessors, ISO created the ISO 9000 Standard Series
in 1987 - essentially adopting most of the elements of BS 5750.[2]
That same year, the ISO 9000 standards were adopted in the United
States as the ANSI/ASQC (American Society for Quality Control)
Q90 Standard Series; and BS 5750 was revised to be identical to
the ISO 9000 standards. NATO is currently revising its quality
system standards to incorporate the ISO 9000 standards.[3]
WHAT IS THE U.S. ROLE IN ISO TC 176?
The United States has been an active participant in ISO TC 176
since 1987. The ASQC, through ANSI which serves as the U.S.
member body in ISO, has been responsible for managing U.S.
representation in TC 176. ASQC also has assumed responsibility
for managing the adoption of the ISO 9000 and 10000 standards as
American National Standards.
According to ISO procedures, all ISO standards, including those
in the ISO 9000 Standard Series, must be reviewed and revised or
reaffirmed at least once every five years. The initial ISO 9000
standards (ISO 9000, 9001, 9002, 9003, and 9004 without subparts)
published in 1987 were scheduled for review in 1992/1993, as was
ISO Standard 8402 - Quality - Vocabulary, which contains relevant
terminology and definitions. Minor modifications in the original
ISO 9000 Series are expected in 1993/1994, with major revisions
in 1997/1998.[4]
The United States, which adopted the original five ISO 9000
standards in 1987 as the ANSI/ASQC Q90 Series, is actively
involved in their review. ASQC is coordinating the development
of U.S. comments and positions on the 1992/1993 revisions.
DOES THE ANSI/ASQC Q90 STANDARD SERIES DIFFER FROM THE ISO 9000
STANDARD SERIES?
ISO 9000-9004 and ANSI/ASQC Q90-94 are technically equivalent.
However, the ANSI/ASQC Q90 Series has been modified to
incorporate customary American language usage and spelling. Some
supplementary guidance on sampling and other statistical methods
and product liability and user safety has also been included in
the appendices to ANSI/ASQC Q94. ASQC is planning to renumber
the ANSI/ASQC Q90 Series as the ANSI/ASQC Q9000 series to clearly
indicate their equivalency to the ISO 9000 Series.
HAVE ANY ISO 9000 OR RELATED STANDARDS BEEN PUBLISHED SINCE 1987?
ISO has continued to supplement the ISO 9000 Series. Some of
these standards have been included as parts under ISO 9000 and
ISO 9004, while others have been included in the new ISO 10000
Series. Both the ISO 9000 and 10000 Standards Series have been
reserved for use by ISO TC 176.
Recently released ISO standards and guidelines in the quality
area include:
ISO 9000-3, GUIDELINES FOR THE APPLICATION OF ISO 9001 TO THE
DEVELOPMENT, SUPPLY AND MAINTENANCE OF SOFTWARE (1991).
ISO 9004-2, QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS - PART
2: GUIDELINES FOR SERVICES (1991).
ISO 10011 PART 1, GUIDELINES FOR AUDITING QUALITY SYSTEMS -
AUDITING (1990).
ISO 10011 PART 2, GUIDELINES FOR AUDITING QUALITY SYSTEMS -
QUALIFICATION CRITERIA FOR AUDITORS (1991).
ISO 10011 PART 3, GUIDELINES FOR AUDITING QUALITY SYSTEMS -
MANAGING AUDIT PROGRAMS (1991).
ISO 10012-1, QUALITY ASSURANCE REQUIREMENTS FOR MEASURING
EQUIPMENT - PART 1: MANAGEMENT OF MEASURING EQUIPMENT (1992).
WHAT IS ISO TC 176 WORKING ON?
The following standards are under development in TC 176's
subcommittees (SC):[5]
SC 1 - TERMINOLOGY
* DRAFT INTERNATIONAL STANDARD (DIS) 8402-1 QUALITY SYSTEMS
TERMINOLOGY
SC 2 -QUALITY SYSTEMS
* DRAFT INTERNATIONAL STANDARD (DIS) 9004-3, QUALITY MANAGEMENT
AND QUALITY SYSTEM ELEMENTS - PART 3: GUIDELINES FOR PROCESSED
MATERIALS (Will be published mid to late 1993.)
* DRAFT INTERNATIONAL STANDARD (DIS) 9000-2, QUALITY MANAGEMENT
AND QUALITY SYSTEM STANDARDS - PART 2: GENERIC GUIDELINES FOR
THE APPLICATION OF ISO 9001, ISO 9002, AND ISO 9003 (Will be
published mid to late 1993.)
* DRAFT INTERNATIONAL STANDARD (DIS) 9004-4, QUALITY MANAGEMENT
AND QUALITY SYSTEM ELEMENTS - PART 4: GUIDELINES FOR QUALITY
IMPROVEMENT (Will be published mid to late 1993.)
* COMMITTEE DRAFTS (CD) 9000-1, 9002, 9003, AND 9004-1, REVISIONS
TO ISO 9000, 9001, 9002, 9003, AND 9004 (Expected to be out for
DIS ballot shortly.)
* COMMITTEE DRAFT (CD) 9004-6, QUALITY MANAGEMENT AND QUALITY
SYSTEM ELEMENTS - PART 6: GUIDELINES QUALITY PLANS
* WORKING DRAFT (WD) 9004-5, QUALITY MANAGEMENT AND QUALITY
SYSTEM ELEMENTS - PART 5: GUIDE TO QUALITY ASSURANCE FOR
PROJECT MANAGEMENT
* COMMITTEE DRAFT (CD) 9004-7, QUALITY MANAGEMENT AND QUALITY
SYSTEM ELEMENTS - PART 7: GUIDELINES FOR CONFIGURATION
MANAGEMENT
SC 3 - QUALITY TECHNOLOGIES
* WORKING DRAFT (WD) 10012-2: QUALITY ASSURANCE REQUIREMENTS FOR
MEASURING EQUIPMENT - PART 2: MEASURING ASSURANCE
* COMMITTEE DRAFT (CD) 10013: GUIDELINES FOR DEVELOPING QUALITY
MANUALS (Expected to be out for DIS ballot shortly.)
* WORKING DRAFT (WD) 10014: GUIDE TO THE ECONOMIC EFFECTS OF
QUALITY
* WORKING DRAFT (WD) 10015: CONTINUING EDUCATION AND TRAINING
GUIDELINES
WHERE CAN ADDITIONAL INFORMATION ON THE WORK OF ISO TC 176 BE
OBTAINED?
Information on ISO Technical Committee 176 (the committee
responsible for the development of the ISO 9000 and 10000
Standard Series) can be obtained from:
The American Society for Quality Control (ASQC)
611 East Wisconsin Ave.
Milwaukee, WI 53202
Phone: 414-272-8575 or 1-800-248-1946 (U.S. and Canada)
Fax: 414-272-1734
WHERE CAN COPIES OF THESE NEW STANDARDS BE OBTAINED?
Copies of ISO draft/final standards and European standards (ENs)
can be purchased from:[6]
The American National Standards Institute
11 West 42nd Street, 13th Floor
New York, NY 10036
Phone: (212) 642-4900, Fax: (212) 302-1286
Other standards sources are listed in Appendix B.
WHAT COUNTRIES HAVE ADOPTED THE ISO 9000 STANDARD SERIES?[7]
According to information collected by ISO (as of October 20,
1991) and updated as of September, 1992,[8] the EC and fifty-six
countries have or are expected to soon adopt the ISO 9000
Standard Series as voluntary national standards. The list
includes:
Algeria European Malaysia Spain
*Argentina Community *Mexico Sweden
Australia Finland Netherlands Switzerland
Austria France New Zealand Tanzania
*Barbados Germany Norway Thailand
Belgium Greece Pakistan Trinidad/Tobago
*Brazil Hungary Philippines Tunisia
Canada Iceland Poland Turkey
Chile India Portugal United Kingdom
*China Ireland Romania United States
Columbia Israel Russia Venezuela
Cuba Italy **Saudi Arabia Yugoslavia
Cyprus Jamaica Singapore Zimbabwe
Czechoslovakia Japan South Africa
Denmark Luxembourg *South Korea
**ISO 9000 standards are in the process of being adopted by the
Saudi Arabian Standards Organization (SASO).
WHAT ARE THE NUMBERING SYSTEMS USED BY COUNTRIES TO DESIGNATE THE
ISO STANDARD SERIES?
Countries adopting the ISO 9000 standards assign numbers to the
standards based on their own national standards numbering
systems. As noted in the following examples, these numbers may
be very different from those numbers assigned by ISO to the
Series, even though the standards are identical.
In the United States, the ISO 9000 Standard Series has been
adopted as the ANSI/ASQC Q90 Series (soon to be changed to the
ANSI/ASQC Q9000 Series). In Europe, it has been adopted by the
European Committee for Standardization (CEN) and the European
Committee for Electrotechnical Standardization (CENELEC) as the
European Norm (EN) 29000 Series. In the U.K., it is BS 5750
Parts 0 to 3. In Pakistan, it is the PS 3000-3004 Series. In
Tanzania, they are TZS 500-504; while in China, they are GB/T
10300.1 - 10300.5.
WHAT IS NEW WITH THE ISO 9000 FORUM?
ISO 9000 Forum symposia have recently been held in a number of
countries on issues related to quality assurance and quality
management. In addition, the Forum has begun issuing a
newsletter, the ISO 9000 News. Subscriptions are available from
ANSI. The ISO Forum was established to serve the needs of ISO
9000 users by: providing information; facilitating international
discussions on new developments and issues affecting the
application of the ISO 9000 standards; promoting the exchange of
experience in such areas as training, promotion and operation of
relevant schemes; harmonizing practices in the application and
interpretation of the ISO 9000 standards; and providing advice to
ISO TC 176 or the relevant ISO decision making body.
WHAT ARE "NEW APPROACH" DIRECTIVES?
The Commission of the European Community (EC) has established a
conformity assessment scheme for EC-regulated products.[9] The EC
has specified conformity assessment methods in terms of eight
"modules," such as the supplier's declaration of conformity
(formerly known as self-certification), type testing, quality
system approval, or final product verification by a third party.
Each "new approach" directive specifies the alternative means
(set of modules) that suppliers may use to certify their products
as being in conformance with the "essential requirements" spelled
out in each directive.
The distinction between "old approach" and "new approach"
directives is that "old approach" directives defined all the
required technical characteristics of a product within the
directive, while the "new approach" directives specify only the
more generalized "essential requirements" necessary to protect
consumer health and safety and the environment. The task of
actually writing the specific technical requirements is left to
the three European standards-setting organizations - CEN, the
European Committee for Standardization; CENELEC, the European
Organization for Electrotechnical Standardization, and ETSI, the
European Telecommunications Standards Institute.
WHAT IS QUALITY SYSTEM REGISTRATION/APPROVAL AND HOW DOES IT
RELATE TO CONFORMITY ASSESSMENT?
Quality system registration or approval involves the assessment
and periodic audit of the adequacy of a supplier's quality system
by a third party, known as a quality system registrar. When a
supplier's system conforms to the registrar's interpretation of
an ISO 9000 or other appropriate standard, the registrar issues
the supplier a "certificate of registration." Note that the
supplier's quality system is registered, not an individual
product. Consequently, quality system registration does not
imply product conformity to any given set of requirements.
Conformity assessment, a more comprehensive term, is the
systematic evaluation of a product, process, or service to
determine the extent to which it complies with specified
requirements. Conformity assessment activities include: quality
system registration; product or service testing and/or
certification; and laboratory, certification body or quality
system registrar accreditation.[10]
WHAT IS THE DIFFERENCE BETWEEN QUALITY SYSTEM CERTIFICATION AND
QUALITY SYSTEM REGISTRATION?
These terms 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[11] -- two entirely
different activities! For that reason, ISO/IEC Guide 48 (see
Appendix C), the international document which governs the third-
party assessment and registration process for quality systems,
refers throughout to "registration," not to "certification. The
Directory of Quality System Registration Bodies, published by
ISO, confirms the Guide 48 terminology.
WILL QUALITY SYSTEM APPROVALS BE MANDATORY IN THE EC?
Having an approved quality system will not be a blanket
requirement for all products. However, approval of a supplier's
quality system will be a key component of the EC's legal
requirements for product certification in these areas:
construction products (9002 or 9003); active implantable medical
devices (9001 or 9002); personal protective equipment (9002 or
9003); telecommunications terminal equipment (9001 or 9002); gas
appliances (9002); non-automatic weighing instruments (9002);
medical devices (9001 or 9002); elevators (9001 or 9002);
pressure equipment (9001 or 9002); recreational craft (9001 or
9002); cable ways equipment (9001); measuring and testing
instruments (9001, 9002, or 9003); equipment for use in
potentially explosive atmospheres (9001 or 9002); and furniture
flammability (9002). For most of these regulated products,
quality system approval is one approach to proving compliance,
not an absolute requirement. Other methods, not involving
quality system approval, may also be allowed under these
directives.
For example, under the telecommunications terminal equipment
directive, a manufacturer has three options for proving
conformity to the essential requirement contained in the
directive: (1) EC type examination/approval of the product by a
notified body plus manufacturer's declaration of conformity to
type (whereby a notified body carries out product checks at
random intervals); (2) EC type examination of product by a
notified body plus approval by a notified body of a
manufacturer's quality system according to ISO 9002 (EN 29002);
and (3) approval by a notified body of a manufacturer's quality
system according to ISO 9001 (EN 29001) with no type approval
required.[12] Method 1 does not require any type of quality system
approval, while methods 2 and 3 do.
It should be noted that manufacturer compliance with ISO 9002 or
ISO 9003 is usually combined with some type of product testing
for full product certification to EC requirements. The full
quality assurance (ISO 9001) option includes an assessment of the
product's design to assure that it conforms to the applicable
"essential requirements."
In other directives, such as the Council Directive dated June 14,
1989 on machinery (89/392/EEC), manufacturers of some products
are permitted to self-declare that their product conforms to the
requirements of the directive and to place the European Community
(CE) mark on the product. However, such machinery manufacturers
must maintain a file on the manufacture of those products,
including information on "the internal measures that will be
implemented to ensure that the machinery remains in conformity
with the provisions of the Directive" -- in other words, on the
manufacturer's quality system. It is possible that the ISO 9000
(EN 29000) Standard Series could be used within the European
Community to evaluate the adequacy of such quality systems.
However, at the present time, no requirement is included in the
manufacturer self-declaration for third party review/approval of
the manufacturer's quality system.
Manufacturers need to review all relevant EC directives for
specific requirements applicable to their products. Each
directive requires the use of different methods for proving
conformity. It may be that some conformity assessment options,
while meeting the requirements of one directive, will not meet
the requirements of other relevant directives covering a product.
A product must meet the conformity assessment requirements of all
applicable directives for suppliers to be able to apply the CE
mark to that product. For some products, specific conformity
assessment methods, such as product type testing combined with
having an approved quality system, could end up being the only
method that will comply with all requirements contained in all
applicable directives.
HOW DOES THE EC PRODUCT SAFETY DIRECTIVE RELATE TO ISO 9000?
The EC Directive on General Product Safety 92/59 (commonly known
as the Product Safety Directive) was approved by the EC Council
on June 29, 1992. This directive covers all products placed on
the EC market -- whether regulated by the EC or not. The
directive becomes fully operational in June 1994 and applies to
the safety of products from the time that they are first placed
on the EC market and extends throughout the product's foreseeable
life. This requires that the safety of a marketed product be
monitored by member states over the product's entire life. The
directive covers both new and reconditioned products, though not
secondhand products clearly identified as antiques or in need of
repair or reconditioning.
The objective of the directive is to impose a general requirement
on producers to introduce only safe products into the EC market.
A "safe product" is defined as "a product that does not present,
in particular in respect of its design, composition, execution,
functioning, wrapping, conditions of assembly, maintenance or
disposal, instructions for handling and use, or any other of its
properties, an unacceptable risk for the safety and health of
persons, either directly or indirectly, in particular through its
effect upon other products or its combinations therewith."
The Directive requires that products intended for consumers not
present any unacceptable risks and that potential users of such
products are adequately warned of any remaining risks. Some
guidance on what is a safe product is contained in the directive.
For that reason, it is probably advisable to read this directive
in conjunction with the EC Product Liability Directive discussed
below. In general, the Product Safety Directive will not apply
to those safety aspects of a product or category of products
already covered under an EC directive.
When read in conjunction with the Product Liability Directive,
this directive may have some implications for suppliers regarding
their quality systems. In the event of legal claims, some legal
opinion has suggested that ISO 9000 registration combined with
other appropriate technical documentation related to product
safety and adequate product labeling/user instructions could
prove useful in a legal defense.[13]
HOW DOES THE EC PRODUCT LIABILITY DIRECTIVE RELATE TO ISO 9000?
On July 25, 1985, the EC Council ratified a Directive Concerning
Liability for Defective Products 85/374 (generally known as the
Product Liability Directive).[14] Under this directive, products
are considered to be defective when they do not provide the level
of safety that the public has a right to expect. That level of
safety is more clearly defined for some products in other EC
directives, such as the Medical Device Directive and the Machine
Safety Directive.
Under the Product Liability Directive, an injured consumer must
show the damage experienced, the product defect responsible for
the problem, and the relationship between them, although
negligence does not have to be proved if the manufacturer could
have reasonably foreseen the problem. It is not necessary to
prove that a product is unreasonably defective. The directive
creates a strict liability and introduces a uniform concept of
product liability in some EC nations where such a view did not
previously exist. As a result, this directive will affect almost
every company doing business in the EC to some degree.
Again, some legal opinion has indicated that while ISO 9000
registration will not protect a company from being sued for a
defective product, quality system documentation creates a
technical record that could be useful in such prospective product
liability suits.[15]
HOW DOES THE ISO 9000 STANDARD SERIES APPLY TO THE EC SERVICES
SECTOR?
There is no reference to ISO 9000, or to "quality management
systems," in EC legislation related to private sector procurement
of services, such as accounting, engineering or legal services.
The proposed EC directive on procedures for the award of public
service contracts does note that some government-owned, operated
or controlled contracting entities in the public works and
supplies sectors do impose quality management system requirements
in their qualified supplier programs. However, ISO 9000
registration is not mandatory under this directive. The EC
Commission noted that "quality control certification... exists at
the national level in particular service sectors such as the
field of engineering. It has been observed that contracting
authorities tend to require such certificates whenever a quality
assurance body exists in their country. This may have the effect
of discriminating against foreign suppliers... The directive
should therefore recognize the existence of quality assurance
schemes, and reconcile the way in which they are used with the
need to grant a fair chance to suppliers from other countries."
WHO WILL BE ABLE TO CONDUCT MANDATORY EC QUALITY SYSTEM
APPROVALS?
When EC directives require the use of a third party in the
conformity assessment process, each member country government
must provide the EC government with a list of third parties
(referred to as "notified bodies") which the member country has
determined to be competent to declare that a regulated product
conforms to the "essential requirements" spelled out in a
particular directive. Member states notify bodies by both
conformity assessment method or module (listed in the directive)
and by directive to the EC Commission, which then compiles and
publishes a list of all such bodies. For example, a quality
system registrar could be notified by an EC member country as
being competent to conduct quality system approvals in accordance
with ISO 9002 (EN 29002) under a specific directive. However,
such a body may not be a "notified body" for purposes of other
conformity assessment modules or methods listed in the directive
or for other directives.
Mandatory quality system approvals or registrations must be
conducted by notified bodies. At the present time, notified
bodies must be physically located within the geographical
boundaries of the European Community. EC member countries can
only notify bodies located within their geographical borders.
On September 21, 1992, the EC Council approved a guidance
document, "Communication to the Council on the Negotiation of the
Agreements between the European Economic Community and Certain
Third Countries on Mutual Recognition in Relation to Conformity
Assessment," which provides guidelines for the establishment of
mutual recognition agreements with third countries. Notified
bodies can only exist in the United States under the provisions
of a mutual recognition agreement between the U.S. government and
the EC. A mutual recognition agreement (MRA) would allow U.S.
entities to perform all required conformity assessment procedures
included within the scope of the agreement. Formal discussions
between representatives of the U.S. government and the EC on
establishing MRAs began on October 20, 1992 in Brussels.
There remains the possibility that some conformity assessment
tasks, including quality system audits, may be subcontracted by
notified bodies to bodies outside the EC, including organizations
in the United States. Such subcontracting would be done at the
discretion of the notified body, which would continue to be
responsible for audit assessment. Subcontractors must comply
with all applicable requirements of the EN 45000 Standard Series.
In the case of subcontractors involved in quality system audits,
the appropriate European standard is EN 45012.
HOW CAN I FIND MORE INFORMATION ON NOTIFIED BODIES AND WHAT WILL
I LEARN?
A document entitled, "Notified Bodies", which accompanied the EC
Mandate, "Communication to the Council on the Negotiation of the
Agreements between the European Economic Community and Certain
Third Countries on Mutual Recognition in Relation to Conformity
Assessment" provides further details on the responsibilities of
notified bodies. These requirements will most likely be placed
on any U.S. notified bodies. There are several points to note in
these documents:
"The notified bodies are, almost by definition, taking on the
responsibilities of their national notifying authorities and
therefore should remain answerable to them." It is therefore
unlikely that the U.S. government will be permitted to notify a
body located outside of its territory. Likewise, gaining
accreditation from an EC country's accreditation system does not
mean that a U.S. or other non-EC conformity assessment body can
become a notified body. EC member governments may also choose to
notify only some of the bodies they have accredited.
Notified bodies must be notified for specific directives and for
at least one complete module and any supplementary requirements,
though they may be notified for a subset of the products covered
by a directive.
Since market surveillance activities are aimed at ensuring the
compliance of all involved in placing a product on the market
(including the notified bodies), market surveillance activities
will probably not be carried out by notified bodies, or at least
not by those involved in the original assessment.
Notified bodies must be independent of their clients or other
interested parties. However, a manufacturer's laboratory, for
example, might be notified if it is completely independent from
the production and commercial department of the firm and if it
services production other than just that of the firm.
Notified bodies may also be called on to provide technical
guidance on how to apply the provisions of the directives, such
as how often quality audits should be conducted. However, such
technical clarifications should be discussed between member
governments to achieve consensus. Under certain conditions, the
notified bodies can also assist the surveillance authorities.
WHERE CAN I FIND OUT MORE ABOUT THE EC'S SUBCONTRACTING
GUIDELINES?
As an interim step pending the establishment of U.S.-EC MRAs or
as an alternative to MRAs, some U.S. based registrars are taking
advantage of the EC's subcontracting provisions. These
provisions allow some conformity assessment tasks, including
those in the quality system registration area, to be
subcontracted by notified bodies to bodies outside the EC,
including organizations in the United States. Subcontracting
with EC notified bodies represents an attractive option for a
number of U.S. based registrars. However, such subcontracting is
done at the discretion of the notified body, which continues to
be responsible for the final assessment of product conformity.
U.S. and other subcontractors must comply with all applicable
requirements contained in the EN 45000 Standard Series. The EC
document, Guiding Principles for Subcontracting by "Notified
Bodies" pursuant to the Council Resolution of 13 December 1990
Concerning the Modules for the Various Phases of the Conformity
Assessment Procedures provides information on the types of tasks
that can be subcontracted and the conditions under which
subcontracts may be established.
WILL THE U.S. BE ESTABLISHING MRAS WITH THE EC?
On September 21, 1992, the EC Council approved a guidance
document, "The Negotiation of the Agreements Between the European
Economic Community and Certain Third Countries on Mutual
Recognition in Relation to Conformity Assessment," on seeking
mutual recognition agreements with third countries, including the
United States. Negotiations for such agreements between the
United States and the European Community are being planned in a
number of areas based on requests from U.S. industry.
Preliminary negotiations began on October 20, 1992. Additional
product/industry specific negotiations are planned for 1993.
WHAT IS CASE or NVCASE?
At a June 21, 1991 meeting between then Secretary of Commerce
Robert Mosbacher and EC Commission Vice-President Martin
Bangemann, the Secretary proposed that the National Institute of
Standards and Technology (NIST) provide the EC with any
assurances it might require regarding the competence of U.S.
based testing, certification and quality system registration
bodies to conduct conformity assessment activities mandated by
the EC under one or more U.S.-EC MRAs. NIST has proposed a
program to deal with this responsibility, originally identified
as the Conformity Assessment System Evaluation (CASE) program,
but now entitled the National Voluntary Conformity Assessment
System Evaluation (NVCASE) program. The proposal was published
in the Federal Register on March 27, 1992, with a closing date
for comments of September 30, 1992. NIST is preparing to publish
a proposed rule in the Federal Register on the NVCASE program for
public comment in the near future.
The original proposal included the following key concepts:
- The intent of the program would be to recognize qualified
conformity assessment bodies (using international criteria to the
extent possible) to gain greater acceptance of U.S. products in
world markets.
- The program would be voluntary -- no organization would be
required to apply.
- The program would be offered on a fee-for-service basis and
would be self-supporting.
- The program would operate only in "areas related to conformity
assessment where industry would like to have NIST concentrate its
efforts" -- in other words, where industry feels there is a need
and requests such a program.
- The program would provide assurance of the competency of U.S.
conformity assessment bodies to engage in activities in product
areas regulated in foreign countries. The program would not
operate in areas that are not regulated by a foreign government.
- The program would operate either at the recognition or
accreditation levels for certification, laboratory accreditation,
and quality system registration.
- The program would not operate at the conformity assessment
level. NIST would not act as a certifier, testing laboratory or
registrar.
- The program would not operate in product areas covered by other
federal regulatory agencies unless such assistance is requested
by the agency.
IS QUALITY SYSTEM REGISTRATION LIKELY TO BE REQUIRED FOR NON-
REGULATED PRODUCTS IN THE EC AND ELSEWHERE?
The demand for ISO 9000 registration in Europe and elsewhere
seems to be coming primarily from the marketplace as a
contractual rather than a regulatory requirement. As conformity
to the ISO 9000 standards becomes recognized and required by
foreign and domestic buyers and used by manufacturers as a
competitive marketing tool, the demand for ISO 9000 compliance is
expected to increase in non-regulated areas. It is therefore
critical for manufacturers to determine what are their buyers'
requirements regarding ISO 9000 compliance.
The degree of interest and pressure specific manufacturers are
experiencing from their buyers to seek registration currently
varies significantly by industry. In many of the "high tech" or
"high safety and health risk" product areas where product
reliability is crucial (such as electronic components, aerospace,
autos, test equipment and health care products), the market
pressure on manufacturers to seek registration is likely to
increase.
The U.S. Aerospace Industries Association in its April 1992
Study, Impact of International Standardization and Certification
on the U.S. Aerospace Industry, noted that in its industry
"...(s)ome RFPs for European and other foreign customers are now
including a requirement that potential bidders be ISO 9000-
compliant." This growing demand from buyers for registration is
being noted by many other industries as well. Procurement
authorities and buyers are increasingly including ISO 9000
registration requirements in their purchase contracts. Suppliers
desiring to sell to such entities will have to be audited and
registered as being in compliance with an ISO 9000 standard under
terms acceptable to those buyers.
WHAT IS EAC?
EAC stands for European Accreditation of Certification, an
association of the European national accreditation bodies. The
overall objective of the EAC is to create a single European
system for recognizing certification/quality system registration
bodies that will provide the marketplace with adequate assurance
that certification/registration is equivalent in all European
countries. A Memorandum of Understanding (MOU) was signed by
Belgium, Denmark, Ireland, the Netherlands, U.K., Germany,
Greece, Italy, Portugal, Iceland, Norway, Sweden, and Switzerland
on May 22, 1991.
Specific objectives of the EAC, as defined in the MOU, are to:
(1) maintain and strengthen market confidence in certificates
issued by accredited bodies; (2) establish mutual confidence
between participating bodies and promote collaboration and
agreements as a means towards a European system of assessment and
accreditation; (3) provide the means for a continuous flow of
knowledge relevant to assessment and accreditation between
participating bodies and other relevant bodies; (4) work towards
a multilateral agreement on the equivalence of the operations of
the participating bodies and a declaration of their commitment to
foster general acceptance of the equivalence of certificates
issued by the certification bodies they accredit; and (5) promote
the harmonization of the operations of participating bodies.
WHAT IS THE EOTC AND HOW DOES IT FIT INTO THE PICTURE?
The European Organization for Testing and Certification (EOTC)
was created by the EC in April 1990 under a memorandum of
understanding with the European Committee for Standardization
(CEN), the European Committee for Electrotechnical
Standardization (CENELEC), and the European Free Trade Agreement
(EFTA)[16] countries. The EOTC was formed to promote the mutual
recognition of test results, certification procedures, and
quality system assessments and registrations in non-regulated
product areas throughout the EC and EFTA countries. The EOTC is
also responsible for providing technical assistance to the EC
Commission in the implementation of some EC legislation,
especially in the preparation of mutual recognition agreements
with non-EC countries. It is anticipated that there will be a
Specialized Committee of the EOTC in the area of Quality
Assurance. However, this committee will not be established until
after 1992. Nevertheless, the need for expert advice in this
area was recognized by the EOTC in July 1991. The European
Organization for Quality (EOQ)[17] and the EQS (see below) have
been offered observership status in EOTC to fill this need. The
EOTC is expected to be fully operational in 1993.[18]
WHAT IS EQS?
EQS, the European Committee for Quality Systems Assessment and
Certification, was established in 1989 with membership from both
the EC and EFTA countries. The purpose of the EQS is to avoid
multiple quality system assessments and registrations of
companies or suppliers by harmonizing the rules and procedures
used for quality system assessment and registration among
members, particularly through the effective implementation of the
European Standard, EN 45012 - General Criteria for Certification
Bodies Operating Quality System Certification. EQS promotes
methods to develop confidence in quality system assessments and
registrations carried out by competent quality system registrars.
EQS is also responsible for harmonizing the rules for quality
system assessment and registration. EQS is currently an advisor
to the European Organization for Testing and Certification (EOTC)
and is a candidate for serving as a specialized (functional)
committee of the EOTC in the quality assurance area.
WHAT IS EQNET?
EQNET, the European Network for Quality System Assessment and
Certification, is a business agreement established in early 1990
by eight quality system registration bodies - AFAQ (France), AIB-
Vincotte (Belgium), BSI Quality Assurance (U.K.), DQS (Germany),
DS (Denmark), N.V. KEMA (the Netherlands), SIS (Sweden), and SQS
(Switzerland).
The purpose of EQNET is to establish close cooperation among
members leading to mutual recognition of each other's quality
system registration certificates. Each signatory agrees to: (1)
promote the recognition of quality system certificates issued by
EQNET members; (2) coordinate the work to be performed for
quality systems registration of an organization having
subsidiaries in several EC/EFTA countries to help such an
organization to obtain appropriate quality system (QS)
certificates; (3) issue several QS certificates simultaneously
after performance of a joint audit; (4) promote bilateral
agreements between EQNET members; (5) contribute to the
development of operating procedures and promotional materials;
and (6) to present information on EQNET. A number of mutual
recognition agreements have been established between EQNET
members.
Because EQNET's membership is limited to one not-for-profit
quality system registration body per country, it is not a likely
candidate for an EOTC agreement group.
WHAT ELSE IS NEW IN THIS AREA IN THE EC?
Manufacturers should note that some countries have developed
additional guidelines for the application of the ISO 9000
standards to specific product sectors, such as medical devices
(EN 46000) and aerospace products (EN 2000 and EN 3042).
Some quality system registration programs have also based
registration requirements on documents other than ISO 9001, 9002
and 9003. For example, The U.K.'s Department of Trade and
Industry (DITI) has developed a scheme, called TickIT,
specifically for software companies which incorporates many of
the recommendations in ISO 9000-3: Guidelines for the Application
of ISO 9001 to the Development, Supply and Maintenance of
Software (the guidance document developed by ISO for software
suppliers) into its requirements for registration. The U.K.'s
National Accreditation Council for Certification Bodies (NACCB)
is offering accreditation to U.K. registrars in the software area
under the TickIT scheme.
The U.S. Registrar Accreditation Board (RAB) has set up a
committee on the use of ISO 9000-3 in registration and intends to
look at issues such as whether there is a need for a similar type
of program for software companies in the United States.
WHAT'S HAPPENING WITH NON-EC EUROPEAN COUNTRIES?
On May 2, 1992, the ministers from the twelve EC and seven EFTA
countries signed a treaty designed to establish a nineteen nation
free trade area, referred to as the European Economic Area (EEA).
While the EC/EFTA countries must still ratify the EEA Treaty,
most EFTA countries[19] can be expected to follow the EC's example
in encouraging or requiring compliance to the ISO 9000 standards.
Former Eastern Bloc countries may also follow the EC lead as they
seek and form closer ties with the European Community. The EC
has entered into bilateral Association Agreements with Poland,
Hungary, and Czechoslovakia and is negotiating similar agreements
with Bulgaria and Romania. These agreements will gradually
establish bilateral free trade areas between the EC and each of
the associated countries, with the understanding that the
ultimate goal is eventual EC membership for these countries. The
EC has also signed Trade Cooperation Agreements with Albania and
with the Baltic States. While not as far-reaching as the
Association Agreements, these agreements are expected to
contribute to the objective of eventually concluding Association
Agreements with these countries in the future.
IS THE U.S. GOVERNMENT PLANNING TO USE THE ISO 9000 STANDARDS?
The U.S. government is beginning to recognize the potential
applicability of the ISO 9000 standards to some of its regulatory
and procurement activities. U.S. federal government agencies are
in the early stages of reviewing the applicability and usefulness
of the ISO 9000 standards to their programs. Farthest along is
the U.S. Food and Drug Administration's Center for Medical
Devices and Radiological Health. The Center plans to replace its
Good Manufacturing Practices Guidelines (GMPs) with a version of
ISO 9001 by mid-1993.
DOD has adopted the ANSI/ASQC Q90 Standard Series (technically
equivalent to the ISO 9000 Standard Series), which means that the
standards are listed in the DOD Index of Specifications and
Standards (DODISS) and are available to DOD personnel through
their publications distribution center. However, the use of the
standards has not been included within the Federal Acquisition
Regulation (FAR) or the DOD Federal Acquisition Regulation
Supplement (DFARS). DOD is currently studying the use of the
ANSI Q90 Standard Series and related issues. The Defense
Electronics Supply Center (DESC) is considering obtaining ISO
9000 registrar status, depending on the outcome of the study.
The Department of Energy (DOE) is also considering use of the ISO
9000 Series in the planned 1993 publication of its safety guide
series which provides supplemental information for contractors on
DOE's orders and rules. Other agencies, such as the Federal
Aviation Administration (FAA), General Services Administration
(GSA), the National Aeronautics and Space Administration (NASA),
and the Nuclear Regulatory Commission (NRC) are looking into the
usefulness of the ISO 9000 standards within the context of their
regulatory and procurement programs.
ARE MANY COMPANIES SEEKING REGISTRATION IN THE UNITED STATES?
An increasing number of U.S. companies are seeking quality system
registration to one of the ISO 9000 or ANSI/ASQC Q90 standards.
In the Summer 1992 Registered Company Directory published by CEEM
(See Appendix D), over 400 U.S. company sites were listed as
being registered to an ISO 9000 standard. This represented an
80% increase from the total listed in the February 1992 issue of
directory, and the number of registered U.S. companies continues
to grow. CEEM's unofficial records indicate that 621 companies
sites had obtained registration as of December 21, 1992.
Some of the motivation for U.S. companies to seek quality system
registration results from EC requirements. As noted previously,
however, 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 EC's legal requirements. As already discussed,
for most of these regulated products, 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, much 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
non-regulated 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" product
areas where product reliability is crucial, the market pressure
on U.S. manufacturers to seek registration is likely to be
considerable.
HOW DO YOU SELECT A QUALITY SYSTEM REGISTRAR?
There are currently well over thirty U.S. based organizations
offering quality system registration and that number is growing.
The credentials of U.S. based registrars vary greatly. Some U.S.
registrars have sought accreditation from one or more recognized
accreditation bodies. Other U.S. registrars have established
mutual recognition agreements with foreign based registrars.
Some registrars have followed both courses, seeking mutual
recognition agreements while also pursuing accreditation. A
number of U.S. based registrars are subsidiaries of parent
companies, which are accredited in their home country. In some
cases, the registrar's parent company and the U.S. based company
have both pursued accreditation by different organizations. A
few U.S. based registrars have sought neither accreditation nor
mutual recognition agreements with foreign counterparts. These
various approaches and the resulting differences in credentials
have caused considerable confusion among U.S. companies seeking
to select a registrar.
In selecting a registrar, companies must first determine if there
are regulatory or marketplace requirements for registration. If
there are regulatory requirements, which registrars are approved
by the regulatory body to conduct the required registrations? If
there are marketplace requirements, is the manufacturer's own
declaration of the conformity of his quality system to ISO 9000
acceptable? If not, what registrars' certificates are recognized
or accepted in markets where the company wishes to sell?
It also is important for a company to not only ask if a registrar
has been accredited, but also to inquire about the product or
industry areas in which accreditation has been obtained -- the
scope of the accreditation. Registrars are not necessarily
accredited to perform work in all product or industry areas.
Companies should determine if a registrar's scope of
accreditation includes those product or service areas for which
the company is seeking registration and if the registrar has
conducted assessments of similar types of firms.
Companies should ask the registrar for references. Other
questions include: what sort of training, skills and experience
do the auditors possess? Are the auditors certified or
registered by a nationally recognized scheme? How does a
registrar protect confidential information? What sort of appeals
process or complaint resolution procedures does the registrar
have? What are the registrar's policies and procedures regarding
suspension or withdrawal of the registration? Does the registrar
adequately respond to complaints or questions in a timely manner?
Does the registrar have a good system for providing information
to an applicant on deficiencies in the quality system? How soon
can the registration be performed? Does the registrar have a
backlog? Does the registrar publish and regularly update a list
of registered companies, including the scope of registration? In
general, how well does the registrar comply with the requirements
of ISO/IEC Guide 48?
Cost is, of course, an important consideration. However, a
company should look at the total costs involved in obtaining and
maintaining a registration. Such costs include: application
fees; fees associated with document preparation; fees for quality
manual review, as well as for the subsequent review of any needed
revisions; cost of the initial visit, including travel and living
costs; cost of any follow-up visits, if needed; cost of modifying
the scope of registration, if desired; costs associated with
surveillance visits and how often such visits will be conducted;
and the cost of reassessment upon expiration of the original
registration.
WHO EVALUATES THE COMPETENCE OF REGISTRARS?
In 1989, the Registrar Accreditation Board (RAB) was established
as an affiliate of ASQC to develop a program to evaluate the
quality of services offered by registrars. RAB issued its first
approval in March 1991, and additional firms have been approved
since then. RAB and ANSI agreed to form a joint U.S. program in
December 1991. Information on the RAB program is available from:
RAB
611 East Wisconsin Ave.
P.O. Box 3005, Milwaukee, WI 53202
Phone: 414-272-8575; Fax: 414-765-8661
In February 1992, RAB announced the establishment of an ISO 9000
auditor certification program. RAB has also established
requirements for the recognition of an auditor training course.
For further information on the program, contact RAB at the above
address.[20]
The only European body which accredits registrars outside its
geographical borders is the Dutch Council for Accreditation
(RvC). It has also accredited registrars in the United States.
RAB is currently working towards an agreement with RvC regarding
mutual recognition of each other's accreditations.[21]
The Standards Council of Canada (SCC) also has established an
accreditation program for quality system registrars, which is
open to U.S. registrars.[22]
Programs similar to those of the RAB, RvC, and SCC have been
established in a number of other European countries and elsewhere
in the world, though they are currently not open to U.S.
registrars.[23] However, some U.S. registrars with parent bodies
in Europe have had their parent bodies accredited by other
European accreditation bodies, such as the National Accreditation
Council for Certification Bodies (NACCB) in the United Kingdom.
WHAT IS THE RELATIONSHIP BETWEEN ISO/IEC GUIDE 25 AND ISO 9000?
Both ISO/IEC Guide 25, General Requirements for the Competence of
Calibration and Testing Laboratories, and the ISO 9000 Standard
Series are official documents of the International Organization
for Standardization. ISO/IEC Guide 25 has also been approved by
the International Electrotechnical Commission (IEC).
Developments in the field of quality systems were considered
during ISO/IEC Guide 25 revision in 1990. For laboratories which
serve as suppliers of calibration and test results to industry
and others, ISO/IEC Guide 25 notes in its introduction:
"Laboratories meeting the requirements of this Guide
comply, for calibration and testing activities, with
the relevant requirements of the ISO 9000 series of
standards, including those of the model described in
ISO 9002 when they are acting as suppliers producing
calibration and test results."
In addition, ISO/IEC Guide 25 includes technical requirements for
the operation of a testing laboratory (i.e., participation in
proficiency testing; adherence to specified test methodologies;
and technical competence of laboratory personnel) which are not
addressed in the ISO 9002.
WHAT CAN NIST'S MANUFACTURING TECHNOLOGY CENTERS DO TO HELP?
NIST operates seven regional manufacturing technology centers
that serve as resource facilities to help manufacturers improve
their competitive position through the application of
manufacturing technology. Several of these centers have
sponsored workshops on ISO 9000. Manufacturers can contact these
centers for specific information about the types of assistance
they offer in the pre-assessment process for ISO qualification.
A list of these centers is included in Appendix E.
WHAT CAN EDA's TRADE ADJUSTMENT ASSISTANCE PROGRAM DO TO HELP?
The Department of Commerce's Economic Development Administration
(EDA) funds a Trade Adjustment Assistance Program to help ailing
companies. The program operates 12 regional centers. Companies
that have experienced declines in sales and employment, due at
least in part to increasing imports of competitive products, may
apply to the program. The centers can provide financial
assistance to companies, including assisting companies with costs
associated with ISO 9000 registration. A list of these centers
is included in Appendix F.
IS THERE ANY OTHER HELP AVAILABLE?
Some state trade assistance/development authorities, alone or in
conjunction with local colleges and universities, also have begun
to provide training or offer other assistance. Interested
parties should check with their appropriate state agencies.
WHERE CAN U.S. INDUSTRY GO TO GET ADDITIONAL INFORMATION?
Additional information on U.S., foreign, and international
voluntary standards; government regulations; and rules of
certification for nonagricultural products is available from:
National Center for Standards and Certification
Information (NCSCI)
National Institute of Standards and Technology (NIST)
TRF Bldg. Room A163
Gaithersburg, MD 20899
Phone: (301) 975-4040 Fax: (301) 926-1559
For information on the EC 1992 Single Market program, copies of
Single Market regulations, background information on the EC, or
assistance regarding specific EC trade opportunities or potential
problems, contact:
The Office of EC Affairs
International Trade Administration, Room 3036
14th and Constitution Ave., NW
Washington, DC 20230
Phone: (202) 482-5823 Fax: (202) 482-2155
Both agencies are located in the Department of Commerce and can
refer interested parties to other sources of information within
and outside the federal government.
APPENDIX A
INFORMATION AND PUBLICATIONS
AVAILABLE FROM
Standards Code and Information Program (SCI)
National Institute of Standards and Technology
[SEE LAST PAGE FOR CONTACTS/ADDRESSES]
* The ABC's of Standards-Related Activities in the United States
(NBSIR 87-3576)
This report is an introduction to voluntary standardization,
product certification and laboratory accreditation for readers
not fully familiar with these topics. It stresses some of the
more important aspects of these fields; furnishes the reader with
both historical and current information on these topics;
describes the importance and impact of the development and use of
standards; and serves as background for using available documents
and services.
Order as PB 87-224309 from NTIS.
* The ABC'S of Certification Activities in the United States
(NBSIR 88-3821)
This report, a sequel to NBSIR 87-3576, The ABC'S of Standards-
Related Activities in the United States, provides an introduction
to certification for readers not entirely familiar with this
topic. It highlights some of the more important aspects of this
field, furnishes the reader with information necessary to make
informed purchases, and serves as background for using available
documents and services.
Order as PB 88-239793 from NTIS.
* Laboratory Accreditation in the United States (NISTIR 4576)
This report, a sequel to NBSIR 87-3576 The ABC'S of Standards-
Related Activities in the United States and NBSIR 88-3821 The
ABC'S of Certification Activities in the United States, is
designed to provide information on laboratory accreditation to
readers who are new to this field. It discusses some of the more
significant facets of this topic, provides information necessary
to make informed decisions on the selection and use of
laboratories, and serves as background for using other available
documents and services.
Order as PB 91-194495 from NTIS.
* Questions and Answers on Quality, the ISO 9000 Standard Series,
Quality System Registration, and Related Issues (NISTIR 4721)
This report provides information on the development, content
and application of the ISO 9000 standards to readers who are
unfamiliar with these aspects of the standards. It attempts to
answer some of the most commonly asked questions on quality;
quality systems; the content, application and revision of the ISO
9000 standards; quality system approval/registration; European
Community requirements for quality system approval/registration;
and sources for additional help.
Copies not available from SCI. Order as PB 92-126465 from NTIS.
* Directory of International and Regional Organizations
Conducting Standards-Related Activities (NIST SP 767)
This directory contains information on 338 international and
regional organizations which conduct standardization,
certification, laboratory accreditation, or other
standards-related activities. It describes their work in these
areas, as well as the scope of each organization, national
affiliations of members, U.S. participants, restrictions on
membership, and the availability of any standards in English.
Copies not available from SCI. Order as PB 89-221147 from NTIS
or order as Cat. #SP767 from Global Engineering Documents.
* Directory of European Regional Standards-Related Organizations
(NIST SP 795)
This directory identifies more than 150 European regional
organizations - both governmental and private - that engage in
standards development, certification, laboratory accreditation
and other standards-related activities, such as quality
assurance. Entries describe the type and purpose of each
organization; acronyms; national affiliations of members; the
nature of the standards-related activity; and other related
information.
Copies not available from SCI. Order as PB 91-107599 from NTIS
or order as Cat. #0258-3 from Global Engineering Documents.
* Standards Activities of Organizations in the United States
(NIST SP 806)
The directory identifies and describes activities of over 750
U.S. public and private sector organizations which develop,
publish, and revise standards; participate in this process; or
identify standards and make them available through information
centers or distribution channels. NIST SP 806, a revision of NBS
SP 681, covers activities related to both mandatory and voluntary
U.S. standards. SP 806 also contains a subject index and related
listings that cover acronyms and initials, defunct bodies and
organizations with name changes.
Copies not available from SCI. Order as PB 91-177774 from NTIS
or order as Cat. #SP806 from Global Engineering Documents.
* Directory of Private Sector Product Certification Programs
(NIST SP 774)
This directory presents information from 132 private sector
organizations in the United States which engage in product
certification activities. Entries describe the type and purpose
of each organization, the nature of the activity, product
certified, standards used, certification requirements,
availability and cost of services, and other relevant details.
Copies not available from SCI. Order as PB 90-161712 from NTIS.
* Directory of Federal Government Certification Programs
(NBS SP 739)
This directory presents information on U.S. Government
certification programs for products and services. Entries
describe the scope and nature of each certification program,
testing and inspection practices, standards used, methods of
identification and enforcement, reciprocal recognition or
acceptance of certification, and other relevant details.
Copies not available from SCI. Order as PB 88-201512 from NTIS.
* Directory of Federal Government Laboratory Accreditation/
Designation Programs (NIST SP 808)
This directory provides updated information on 31 federal
government laboratory accreditation and similar type programs
conducted by the federal government. These programs, which
include some type of assessment regarding laboratory capability,
designate sets of laboratories or other entities to conduct
testing to assist federal agencies in carrying out their
responsibilities. The directory also lists 13 other federal
agency programs of possible interest, including programs
involving very limited laboratory assessment and programs still
under development.
Copies not available from SCI. Order as PB 91-167379 from NTIS.
* Directory of State and Local Government Laboratory
Accreditation/ Designation Programs (NIST SP 815)
This directory provides updated information on 21 state and 11
local government laboratory accreditation and similar type
programs. These programs, which include some type of assessment
regarding laboratory capability, designate private sector
laboratories or other entities to conduct testing to assist state
and local government agencies in carrying out their
responsibilities. Entries describe the scope and nature of each
program, laboratory assessment criteria and procedures used in
the program, products and fields of testing covered, program
authority, and other relevant details.
Copies not available from SCI. Order as PB 92-108968 from NTIS.
* Directory of Professional/Trade Organization Laboratory
Organization Laboratory Accreditation/Designation Programs (NIST
SP 831)
This directory is a guide to laboratory accreditation and
similar types of programs conducted by professional and trade
organizations. These programs accredit or designate laboratories
or other entities to assist private sector professional
societies, trade associations, related certification bodies,
their membership, as well as government agencies, in carrying out
their responsibilities. This accreditation or designation is
based on an assessment of the capability of the laboratory to
conduct the testing. However, the nature of the assessment
varies considerably by organization and program.
Order as SN 003-003-03144-5 from GPO.
* Barriers Encountered by U.S. Exporters of Telecommunications
Equipment (NBSIR 87-3641)
This report addresses the perceived institution of unreasonable
technical trade barriers by major European trading partners to
the export of telecom products and systems by U.S. companies. The
GATT technical office, which has responsibilities to assist U.S.
exporters to take advantage of trade opportunities, informally
contacted over a period of six months, telecom companies and
agencies to assess the extent of unreasonableness in foreign
national standards, regulations, testing and certification
requirements, and accreditation procedures.
Copies not available from SCI. Order as PB 88-153630 from NTIS.
* A Review of U.S. Participation in International Standards
Activities (NBSIR 88-3698)
This report describes the role of international standards,
their increasingly significant importance in world trade, and the
extent of past and current U.S. participation in the two major
international standardization bodies - ISO and IEC. The degree of
U.S. participation covers the 20 year period 1966-1986. A coarse
analysis of data indicates some correlation between U.S.
participation and recent export performance for several major
product categories.
Copies not available from SCI. Order as PB 88-164165 from NTIS.
* An Update of U.S. Participation in International Standards
Activities (NISTIR 89-4124)
This report presents updated information on the current level
of U.S. participation in ISO and IEC (reference: NBSIR 88-
3698).
Copies not available from SCI. Order as PB 89-228282/AS from
NTIS.
* A Summary of the New European Community Approach to Standards
Development (NBSIR 88-3793-1)
This paper summarizes European Community (EC) plans to
aggressively pursue its goal of achieving an "internal market" by
1992 and the standards-related implications of such a program on
U.S. exporters.
Order as PB 88-229489/AS from NTIS.
* Trade Implications of Processes and Production Methods (PPMs)
(NISTIR 90-4265)
This report discusses processes and production methods (or
PPM's) and their relationship to trade, the GATT Agreement on
Technical Barriers to Trade, and traditional product standards
used in international commerce. The report provides background
information on PPM's, a suggested definition, and the possible
extension of their application from the agricultural sector to
industrial products.
Order as PB 90-205485 from NTIS.
The following documents are available upon request from SCI.
* tbt news
This newsletter provides information on government programs and
available services established in support of the GATT Agreement
on Technical Barriers to Trade (Standards Code). tbt news reports
on the latest notifications of proposed foreign regulations;
bilateral consultations with major U.S. trade partners; programs
of interest to U.S. exporters; and availability of standards and
certification information. Subscription is free upon request.
* Technical Barriers to Trade
This booklet explains the basic rules of the international
Agreement on Technical Barriers to Trade negotiated during the
Tokyo Round of the Multilateral Trade Negotiations (MTN), and
describes Title IV of the U.S. Trade Agreements Act of 1979 which
implements the United States' obligations under the Agreement.
The Agreement, popularly known as the Standards Code, was
designed to eliminate the use of standards and certification
systems as barriers to trade. The booklet describes the functions
of the Departments of Commerce and Agriculture, the Office of the
U.S. Trade Representative, and the State Department in carrying
out the U.S.'s responsibilities.
* "GATT Standards Code Activities"
This brochure gives a brief description of NIST's activities in
support of the Standards Code. These activities include operating
the U.S. GATT inquiry point for information on standards and
certification systems; notifying the GATT Secretariat of proposed
U.S. regulations; assisting U.S. industry with trade-related
standards problems; responding to inquiries on foreign and U.S.
proposed regulations; and preparing reports on the Standard Code.
* GATT Standards Code Activities of the National Institute of
Standards and Technology
This annual report describes the GATT Standards Code activities
conducted by the Standards Code and Information Program for each
calendar year. NIST responsibilities include operating the GATT
inquiry point, notifying the GATT Secretariat of proposed U.S.
Federal government regulations which may affect trade, assisting
U.S. industry with standards-related trade problems, and
responding to inquiries about proposed foreign and U.S.
regulations.
* Free handout material on office activities and standards-
related information such as: government sources of
specifications and standards; foreign standards bodies; U.S.
standards organizations; and a brochure on the National Center
for Standards and Certification Information (NCSCI).
In addition to general inquiry services, the following assistance
is also available:
* EC Hotline
This hotline reports on draft standards of the European
Committee on Standardization (CEN), the European Committee for
Electrotechnical Standardization (CENELEC) and the European
Telecommunications Standards Institute (ETSI). It also provides
information on selected EC directives. The recorded message is
updated weekly and gives the product, document number and closing
date for comments. The hotline number is (301) 921-4164 (not
toll-free).
* GATT Hotline
A telephone hotline provides current information received from
the GATT Secretariat in Geneva, Switzerland, on proposed foreign
regulations which may significantly affect trade. The recorded
message is updated weekly and gives the product, country, closing
date for comments (if any) and Technical Barriers to Trade (TBT)
notification number. The hotline number is (301) 975-4041 (not
toll-free).
* NCSCI provides assistance to U.S. and foreign exporters in
obtaining current standards, regulations and certification
information for the manufacture of products. To aid foreign
exporters, NCSCI also provides directory information of state
offices prepared to respond to queries concerning conditions to
be met by goods for sale in their state.
TO OBTAIN COPIES OF THESE PUBLICATIONS, CONTACT:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, Virginia 22161, USA
Telephone: (703) 487-4650
Orders Only: (800) 553-6847
Fax: (703) 321-8547
Superintendent of Documents
U.S. Government Printing Office (GPO)
Washington, DC 20402, USA
Telephone: (202) 783-3238
Fax: (202) 512-2250
Global Professional Publications
15 Inverness Way East, P.O. Box 1154
Englewood, CO 80150-1154 USA
Telephone: (800) 854-7179
Local Phone: (303) 792-2181
Fax: (303) 792-2192
WHEN REQUESTING PUBLICATION INFORMATION FROM SCI, PLEASE SEND A
SELF-ADDRESSED MAILING LABEL TO:
Standards Code and Information Program (SCI)
National Institute of Standards and Technology
Administration Building, Room A629
Gaithersburg, Maryland 20899, USA
FOR ASSISTANCE IN OBTAINING INFORMATION ON CURRENT U.S. AND
FOREIGN STANDARDS, REGULATIONS AND CERTIFICATION INFORMATION,
CONTACT:
The National Center for Standards and Certification Information
(NCSCI)
National Institute of Standards and Technology
TRF Building, Room A163
Gaithersburg, Maryland 20899, USA
Phone: (301) 975-4040
APPENDIX B
SOURCES FOR ORDERING STANDARDS
(Note - copies can be obtained from the respective standards-
issuing
organization and/or these sources.)
ORGANIZATION INFORMATION PROVIDED
American National Standards Institute (ANSI) ANSI and ANSI approved
11 West 42nd Street, 13th Floor industry standards
New York, New York 10036, USA International and
Telephone: (212) 642-4900 Foreign Standards
Fax: (212) 398-0023 Select draft CEN/CENELEC
(212) 302-1286 (Orders Only) standards; draft ISO
Telex: 42 42 96 ANSI UI standards
Global Professional Publications Industry Standards
15 Inverness Way East, P.O. Box 1154 Federal Standards
Englewood, CO 80150-1154 USA and Specifications
Telephone: (800) 854-7179 Military Standards
Local Phone: (303) 792-2181 and Specifications
Fax: (303) 792-2192 International and
Foreign Standards
National Standards Association (NSA) Industry Standards
1200 Quince Orchard Boulevard Federal and Military
Gaithersburg, MD 20878, USA Standards, Specifications
Telephone: (800) 638-8094 and Related Documents
(301) 590-2300 NATO Standards
Fax: (301) 990-8378 Aerospace Standards
Telex: 44 6194 NATSTA GAIT
General Services Administration (GSA) Federal Standards
Federal Supply Service Bureau and Specifications
Specifications Branch
490 East L'Enfant Plaza, SW
Suite 8100
Washington, DC 20407, USA
Telephone: (202) 755-0325 or 755-0326
Fax: (202) 205-3720
ORGANIZATION INFORMATION PROVIDED
Naval Publications and Forms Center Dept. of Defense (DOD)
Attn: NPODS adopted documents
5801 Tabor Avenue Naval Publications
Philadelphia, Pennsylvania 19120-5099, USA Military Manuals and
Inquiries (not for placing orders) Other Related Forms
Telephone: (215) 697-2667
Fax: (215) 697-5914
Standardization Document Order Desk Military Standards,
Naval Publications Printing Service Specifications and
700 Robbins Avenue, Building 4, Section D Handbooks
Philadelphia, Pennsylvania 19111-5094, USA Federal Standards and
Telephone: (215) 697-2179 Specifications
Fax: (215) 697-2978
Document Center Industry Standards
1504 Industrial Way, Unit 9 Federal Standards
Belmont, California 94002, USA and Specifications
Telephone: (415) 591-7600 Military Standards
Fax: (415) 591-7617 and Specifications
International and
Foreign Standards
Information Handling Services (IHS) International and
(for IHS subscribers only) Foreign Standards
P.O. Box 1154 Industry Standards
Iverness Way East Federal Standards
Englewood, Colorado 80150, USA and Specifications
Telephone: (800) 241-7824 Military Standards
(303) 790-0600 and Specifications
Fax: (303) 799-4097 Select European
Telex: 4322083 IHS UI Standards (CEN/CENELEC)
Standards Sales Group (SSG) International and
9420 Reseda Boulevard, Suite 800 Foreign Standards,
Northridge, California 91324, USA Publications and Other
Information and Quotes: Reference Materials
Telephone: (818) 368-2786 Translations Service
Orders Only: (800) 755-2780 U.S./Foreign General
Fax: (818) 360-3804 Regulatory Compliance
Information
APPENDIX C
LIST OF SOME RELEVANT
STANDARDS
DOD Standards
MIL-Q-9858A, Quality Program Requirements
MIL-I-45208A, Inspection System Requirements
ISO Standards/Guides
ISO/IEC Guide 2, General Terms and their Definitions Concerning
Standardization and Related Activities
ISO/IEC Guide 7, Requirements for Standards Suitable for Product
Certification
ISO/IEC Guide 16, Code of Principles on Third-Party Certification
and Related Standards
ISO/IEC Guide 22, Information on Manufacturer's Declaration of
Conformity with Standards or Other Technical Specifications
ISO/IEC Guide 23 - Methods for Indicating Conformity with
Standards for Third-Party Certification Systems
ISO/IEC Guide 25, General Requirements for the Competence of
Calibration and Testing Laboratories
ISO/IEC Guide 27, Guidelines for Corrective Action to be Taken by
a Certification Body in the Event of Misuse of its Mark of
Conformity
ISO/IEC Guide 28, General Rules for a Model Third-Party
Certification System for Products
ISO/IEC Guide 39, General Requirements for the Acceptance of
Inspection Bodies
ISO/IEC Guide 40, General Requirements for the Acceptance of
Certification Bodies
ISO/IEC Guide 43, Development and Operation of Laboratory
Proficiency Testing
ISO/IEC Guide 44, General Rules for ISO or IEC International
Third-Party Certification Schemes for Products
ISO/IEC Guide 45, Guidelines for the Presentation of Test Results
ISO/IEC Guide 46, An Approach to the Review by a Certification
Body of its Own Internal Quality System
ISO/IEC Guide 48, Guidelines for Third-Party Assessment and
Registration of a Supplier's Quality System
ISO/IEC Guide 53, An Approach to the Utilization of a Supplier's
Quality System in Third-Party Product Certification
Draft ISO/IEC Guide 58, Calibration and Testing Laboratory
Accreditation Systems - General Requirements for Operation and
Recognition (Revision of ISO/IEC Guides 25, 54, and 55)
ISO 8402, Quality - Terminology
ISO 9000 (ANSI/ASQC Q90/EN 29000), Quality Management and Quality
Assurance Standards - Guidelines for Selection and Use
ISO 9000-3, Quality Management and Quality Assurance Standards
Part 3: Guidelines for the Application of ISO 9001 to the
Development, Supply and Maintenance of Software
ISO 9001 (ANSI/ASQC Q 91/EN 29001), Quality Systems - Model for
Quality Assurance in Design/Development, Production, Installation
and Servicing
ISO 9002 (ANSI/ASQC Q 92/EN 29002), Quality Systems - Model for
Quality Assurance in Production and Installation
ISO 9003 (ANSI/ASQC Q 93/EN 29003), Quality Systems - Model for
Quality Assurance in Final Inspection and Test
ISO 9004 (ANSI/ASQC Q 94/EN 29004), Quality Management and
Quality System Elements - Guidelines
ISO 9004-2, Quality Management and Quality System Elements - Part
2: Guidelines for Services
ISO 10011 Part l, Guidelines for Auditing Quality Systems -
Auditing
ISO 10011 Part 2, Guidelines for Auditing Quality Systems -
Qualification Criteria for Auditors
ISO 10011 Part 3, Guidelines for Auditing Quality Systems -
Management of Audit Programmes
ISO 10012-1, Quality Assurance Requirements for Measuring
Equipment - Part 1: Metrological Confirmation System for
Measuring Equipment
CEN/CENELEC - EN 45000 and 46000 Standards
EN 45001 General Criteria for the Operation of Testing
Laboratories
EN 45002 General Criteria for the Assessment of Testing
Laboratories
EN 45003 General Criteria for Laboratory Accreditation Bodies
EN 45011 General Criteria for Certification Bodies Operating
Product Certification
EN 45012 General Criteria for Certification Bodies Operating
Quality System Certification
EN 45012 General Criteria for Certification Bodies Operating
Certification of personnel
EN 45014 General Criteria for Supplier's Declaration of
Conformity
EN 45020 (ISO/IEC Guide 2), General Terms and their Definitions
Concerning Standardization and Related Activities
prEN 46001, Specific Requirements for the Application of EN 29001
for Medical Devices
APPENDIX D
SOURCES FOR ADDITIONAL INFORMATION ON NIST-RELATED
ACTIVITIES AND ORGANIZATIONS/DOCUMENTS REFERENCED IN THE TEXT
* NIST's National Voluntary Laboratory Accreditation Program
(NVLAP), contact:
NVLAP/NIST
Building 411, Room A162
Gaithersburg, MD 20899
Phone: (301) 975-4042
Fax: (301) 926-2884
* The Malcolm Baldrige National Quality Award Program, contact:
Office of Quality Programs/NIST
Building 101, Room A537
Gaithersburg, MD 20899
Phone: (301) 975-3771
* NIST's Calibration Program, contact:
Calibration Program/NIST
Building 411, Room A104
Gaithersburg, MD 20899-0001
Phone: (301) 975-2002
Fax: (301) 926-2884
* NIST's Standard Reference Materials Program, contact:
Standard Reference Materials Program/NIST
Building 202, Room 204
Gaithersburg, MD 20899-0001
Phone: (301) 975-6776
Fax: (301) 948-3730
* NIST's Standard Reference Data Program, contact:
Standard Reference Data Program/NIST
Building 221, Room A320
Gaithersburg, MD 20899-0001
Phone: (301) 975-2208
Fax: (301) 926-0416
* The American Society for Quality Control's (ASQC) standards,
publications, activities and services; ISO TC 176's activities,
contact:
American Society for Quality Control (ASQC)
611 East Wisconsin Ave.
P.O. Box 3005, Milwaukee, WI 53202
Phone 414-272-8575; Fax: 414-765-8661.
* The Registrar Accreditation Board's (RAB) program, contact:
Registrar Accreditation Board (RAB)
611 East Wisconsin Ave.
P.O. Box 3005, Milwaukee, WI 53202
Phone 414-272-8575; Fax: 414-765-8661.
* ANSI's activities or to purchase copies of ISO draft/final
standards, other documents, magazines, and newsletters, and/or
copies of European standards (ENs), contact:
The American National Standards Institute (ANSI)
11 West 42nd Street, 13th Floor New York, NY 10036
Phone: (212) 642-4900
Fax: (212) 302-1286.
* CEEM's Registered Company Directory, Quality Systems Update
newsletter, and other publications, contact:
CEEM
10521 Braddock Road
Fairfax, VA 22032
Phone: (800) 745-5565 or (703) 250-5900
Fax: (703) 250-5313
* The Aerospace Industries Association's (AIA) activities,
contact:
Aerospace Industries Association
1250 Eye Street, NW
Washington, DC 20005
Phone: (202) 371-8400
* The Netherlands' RvC program, contact:
Raad voor de Certificatie
Stationseg 13F
3972 KA Driebergn
Phone: +31 34 381 26 04
Fax: +31 34 381 85 54
* The British Institute of Quality Assurance's (IQA) quality
system assessor registration program, contact:
The Secretary to the Board
National Registration Scheme for Assessors of Quality
Systems
The Institute of Quality Assurance
10 Grosvenor Gardens
London, U.K. SWIW ODQ
Phone: 44-71-730-7154
* The Standards Council of Canada (SCC) Program, contact:
Standards Council of Canada (SCC)
45 O'Connor Street, Suite 1200
Ottawa, Ontario K1P 6N7
Canada
Phone: (613) 238-3222
Fax: (613) 995-4564
* The European Organization for Testing and Certification,
contact:
The EOTC
Rue Stassart 33, 2nd Floor
B-1050 Brussels
Belgium
Phone: +32 2 519 6969
Fax: +32 2 519 69 17/19.
* The International Electrotechnical Commission's (IEC) Quality
Assessment System for Electronic Components (the IECQ System),
contact:
Electronic Components Certification Board (ECCB)
Electronic Industries Association (EIA)
2001 Pennsylvania Ave., NW
Washington, DC 20006
Phone: (202) 457-4967
APPENDIX E
MANUFACTURING TECHNOLOGY CENTERS (MTCs)[24]
NORTHEAST MTC
Mr. Mark S. Tebbano, Director
Northeast MTC
NY State Science & Technology
Foundation
99 Washington Ave.
Albany, NY 12210
Phone: (518) 473-9746
SOUTHEAST MTC
Mr. James Bishop, Director
Southeast MTC
P. O. Box 1149
Columbia, SC 29202
Phone: (803) 737-0410
GREAT LAKES MTC
Dr. George Sutherland,
Director
Great Lakes MTC
2415 Woodland Ave.
Cleveland, OH 44115
Phone: (216) 987-3201
CENTERS ESTABLISHED 7/21/92
Dr. John Chernesky, Director
California MTC
California Community College
1107 Ninth Street
Sacramento, CA 95814
Phone: (310) 355-3060
Ms. Jane Pounds, Director
MTC
Minnesota Technology, Inc.
111 Third Ave.
Minneapolis, MN 55401
Phone: (612) 338-7722
MIDWEST MTC
Dr. George H. Kuper
Acting Director, Industrial
Technology Institute
P. O. Box 1485
2901 Hubbard Road
Ann Arbor, MI 48109
Phone: (313) 769-4710
MID-AMERICA MTC
Mr. Paul Clay, President
Mid-America MTC
10561 Barkley, Suite 602
Overland Park, KS 66212
Phone: (913) 649-4333
APPENDIX F
TRADE ADJUSTMENT ASSISTANCE CENTERS (TAACs)[25]
NEW ENGLAND TAAC
Richard McLaughlin, Director
New England TAAC
120 Boylston Street
Boston, MA 02116
Phone: (617) 542-2395
Fax: (617) 542-8457
(CT, RI, VT, NH, MA, ME)
NEW JERSEY TAAC
John Walsh, Acting Director
NJ Econ. Dev. Authority
Capital Place One-CN 990
200 South Warren Street
Trenton, NJ 08625
Phone: (609) 292-0360
Fax: (609) 292-0368
(NJ)
NEW YORK TAAC
John Lacey, Director
New York TAAC
117 Hawley Street, Suite 102
Binghamton, NJ 13901
Phone: (607) 771-0875
Fax: (607) 724-2404
(NY)
MID-ATLANTIC TAAC
William Gates, Director
Mid-Atlantic TAAC
486 Norristown Road
Suite 130
Blue Bell, PA 19422
Phone: (215) 825-7819
Fax: (215) 825-7834
(PA, DE, MD, VA, WV, DC)
SOUTHEASTERN TAAC
Charles Estes, Acting Director
Southeastern TAAC
GA Institute of Technology
Research Institute
151 6th St.
O'Keefe Bldg., Rm. 224
Atlanta, GA 30332
Phone: (404) 894-3858, 6789,
6106
Fax: (404) 853-9172
(AL, TN, KY, MS, GA, NC, SC, FL)
SOUTHWEST TAAC
Robert Velasquez, Director
Southwest TAAC
301 South Frio St., Suite 225
San Antonio, TX 78207
Phone: (210) 220-1240
Fax: (210) 220-1241
(TX, LA, OK)
MID-AMERICA TAAC
Paul Schmid, Director
Mid-America TAAC
Univ. of Missouri at Columbia
University Place, Suite 1700
Columbia, MO 65211
Phone: (314) 882-6162
Fax: (314) 882-6156
(MO, KS, AR)
GREAT LAKES TAAC
Margaret Creger, Director
Great Lakes TAAC
University of Michigan
School of Business
Administration
506 East Liberty Street
Ann Arbor, MI 48104-2210
Phone: (313) 998-6213
Fax: (313) 998-6224
(MI, OH, IN)
MIDWEST TAAC
Howard Yefsky, Director
Applied Strategies Int'l.
150 N. Wacker Dr, Suite 2240
Chicago, IL 60606
Phone: (312) 368-4600
Fax: (312) 368-9043
(IL, MN, IA, WI)
ROCKY MOUNTAIN TAAC
Robert Stansbury, Director
Rocky Mountain TAAC
5353 Manhattan Cir., Suite 200
Boulder, CO 80303
Phone: (303) 499-8222
Fax: (303) 499-8298
(CO, UT, NE, SD, WY, NM)
NORTHWEST TAAC
Ronald Horst, Director
Northwest TAAC
Bank of California Center
900 4th Avenue, Suite 2430
Seattle, WA 98164
Phone: (206) 622-2730
Fax: (206) 622-1105
(AK, ID, MT, OR, WA)
WESTERN TAAC
Daniel Jimenez, Director
USC - WTAAC
3716 S. Hope Street, Suite 200
Los Angeles, CA 90007
Phone: (213) 743-8427
Fax: (213) 746-9043
(AZ, CA, NV, HI)
APPENDIX G
LIST OF ACRONYMS
A
AFAQ ------- ASSOCIATION FRANCAISE POUR L'ASSURANCE DE LA
QUALITE, FRENCH ACCREDITATION BODY AND QUALITY
SYSTEM REGISTRAR
ANSI ------- AMERICAN NATIONAL STANDARDS INSTITUTE, U.S. MEMBER
BODY TO ISO
ANSI/ASQC Q
90 SERIES -- U.S. EQUIVALENT OF THE ISO 9000 SERIES
AQAP-1 ----- ALLIED QUALITY ASSURANCE PUBLICATION 1
ASQC ------- AMERICAN SOCIETY FOR QUALITY CONTROL
B
BS 5750 ---- BRITISH EQUIVALENT OF THE ISO 9000 SERIES
BSI -------- BRITISH STANDARDS INSTITUTION
C
NIST ------- NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
CASE ------- CONFORMITY ASSESSMENT SYSTEM EVALUATION PROGRAM -
NOW CALLED NVCASE
CD --------- COMMITTEE DRAFT
CE MARK ---- EUROPEAN COMMUNITY MARK
CEN -------- EUROPEAN COMMITTEE FOR STANDARDIZATION
CENELEC ---- EUROPEAN COMMITTEE FOR ELECTROTECHNICAL
STANDARDIZATION
D
DESC ------- DEFENSE ELECTRONICS SUPPLY CENTER, DOD
DFARS ------ DOD FEDERAL ACQUISITION REGULATION SUPPLEMENT
DHHS ------- U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
DIS -------- DRAFT INTERNATIONAL STANDARD
DITI ------- U.K.'S DEPARTMENT OF TRADE AND INDUSTRY
DOC -------- U.S. DEPARTMENT OF COMMERCE
DOD -------- DEPARTMENT OF DEFENSE
DOE -------- U.S. DEPARTMENT OF ENERGY
DOT -------- U.S. DEPARTMENT OF TRANSPORTATION
E
EAC -------- EUROPEAN ACCREDITATION OF CERTIFICATION, A
MEMORANDUM OF UNDERSTANDING SIGNED BY EUROPEAN
NATIONAL ACCREDITATION BODIES AT UTRECHT ON MAY 22,
1991
EC --------- EUROPEAN COMMUNITY
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)
EN --------- EUROPEAN NORM OR STANDARD
EN 29000
SERIES ----- EUROPEAN EQUIVALENT OF THE ISO 9000 SERIES
ENV -------- EUROPEAN PRE-STANDARDS
EOQ -------- EUROPEAN ORGANIZATION FOR QUALITY
EOTA ------- EUROPEAN ORGANIZATION FOR TECHNICAL APPROVALS
EOTC ------- EUROPEAN ORGANIZATION FOR TESTING AND CERTIFICATION
EQNET ------ EUROPEAN NETWORK FOR QUALITY SYSTEM ASSESSMENT AND
CERTIFICATION, A BUSINESS AGREEMENT ESTABLISHED IN
EARLY 1990 BY EIGHT QUALITY SYSTEM REGISTRATION
BODIES
EQS -------- EUROPEAN COMMITTEE FOR QUALITY SYSTEMS ASSESSMENT
AND CERTIFICATION
ETA -------- EUROPEAN TECHNICAL APPROVAL (APPROVAL BY AN EC
AUTHORIZED BODY WHICH APPLIES TO CONSTRUCTION
PRODUCTS FOR WHICH THERE ARE NO EXISTING OR PLANNED
STANDARDS)
ETSI ------- EUROPEAN TELECOMMUNICATIONS STANDARDS INSTITUTE
F & G
FAA -------- FEDERAL AVIATION ADMINISTRATION, DOT
FAR -------- FEDERAL ACQUISITION REGULATION
FDA -------- FOOD AND DRUG ADMINISTRATION, DHHS
GMP -------- GOOD MANUFACTURING PRACTICE GUIDELINES (FDA)
GSA -------- GENERAL SERVICES ADMINISTRATION
H, I & J
HD --------- HARMONIZED DOCUMENT
IEC -------- INTERNATIONAL ELECTROTECHNICAL COMMISSION
IQA -------- INSTITUTE FOR QUALITY ASSURANCE
ISO -------- INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ITQS ------- RECOGNITION ARRANGEMENT FOR ASSESSMENT AND
CERTIFICATION OF QUALITY SYSTEMS IN THE INFORMATION
TECHNOLOGY SECTOR
JAS-ANZ ---- AUSTRALIA/NEW ZEALAND ACCREDITATION BODY FOR QUALITY
SYSTEM REGISTRARS
M & N
MOU -------- MEMORANDUM OF UNDERSTANDING
MRA -------- MUTUAL RECOGNITION AGREEMENT
MTC -------- MANUFACTURING TECHNOLOGY CENTERS
NAC-QS ----- COMITE NATIONAL POUR L'ACCREDITATION DES ORGANISMES
DE CERTIFICATION, BELGIUM ORGANIZATION RESPONSIBLE
FOR THE ACCREDITATION OF QUALITY SYSTEM REGISTRARS
NACCB ------ U.K. NATIONAL ACCREDITATION COUNCIL FOR
CERTIFICATION BODIES
NATO ------- NORTH ATLANTIC TREATY ORGANIZATION
NIST ------- NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY
NCSCI ------ NATIONAL CENTER FOR STANDARDS AND CERTIFICATION
INFORMATION
NRC -------- NUCLEAR REGULATORY COMMISSION
NVCASE ----- NATIONAL VOLUNTARY CONFORMITY ASSESSMENT SYSTEM
EVALUATION, FORMERLY THE CASE PROGRAM
NVLAP ------ NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM,
NIST
O, P & Q
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
RVC -------- RAAD VOOR DE CERTIFICATIE, DUTCH COUNCIL FOR
CERTIFICATION
SC --------- SUBCOMMITTEE
SCC -------- STANDARDS COUNCIL OF CANADA, THE CANADIAN BODY
RESPONSIBLE FOR THE ACCREDITATION OF QUALITY SYSTEM
REGISTRARS
T
TAAC ------- TRADE ADJUSTMENT ASSISTANCE CENTERS
TC --------- TECHNICAL COMMITTEE
TC 176 ----- THE ISO TECHNICAL COMMITTEE RESPONSIBLE FOR THE
DEVELOPMENT OF THE ISO 9000 AND 10000 SERIES
TickIT ----- U.K. QUALITY SYSTEM REGISTRATION SCHEME FOR SOFTWARE
COMPANIES
STANDARDS
W
WD --------- WORKING DRAFT
1./ DEF STAN 05-08 has recently been revised to reflect the
provisions of ISO 9001-9004 and has been renumbered DEF/STAN 05-
21, 22, 23, and 24.
2./ Stephen D. Sawin and Spencer Hutchens, Jr., "ISO-9000 In
Operation," 1991 ASQC Quality Congress Transactions, Milwaukee,
WI, pp. 915-916.
3./ Aerospace Industries Association, Impact of International
Standardization and Certification on the U.S. Aerospace Industry,
AIA, Washington, DC, April 1992, pg. 7.
4./ These latter revisions are also referred to as the
Phase 2 revisions.
5./ Information on draft or proposed standards work was
provided by Patricia Kopp, Standards Administrator, American
Society for Quality Control (ASQC), Milwaukee, WI.
Development of Draft International Standard (DIS) 9000-4, Quality
Management and Quality System Standards - Part 4: Application for
Dependability Management, is being handled by the International
Electrotechnical Commission (IEC).
6./ NOTE: Identify draft international standards (DIS) as
such when requesting copies from ANSI.
7./ The International Electrotechnical Commission's (IEC)
Quality Assessment System for Electronic Components (also known
as the IECQ System) also requires that component manufacturers
(who wish to add products to the IECQ's Qualified Product List)
comply with the requirements of ISO 9000. To contact the IEQC
Program, see Appendix D.
8./ Robert W. Peach, The ISO 9000 Handbook, CEEM, Virginia,
1992, p. 4. These six additional countries are identified by a
single asterisk.
9./ Regulated products are those for which the EC Commission
has developed or is developing an EC-wide technical harmonization
directive which provides manufacturers with a single set of
requirements for products offered for sale in the EC.
10./ Accreditation is the procedure by which an authoritative
body gives formal recognition that a laboratory, certification
body, or quality system registrar is competent to conduct
specified conformity assessment tasks.
11./ Product certification is the procedure by which a third
party gives written assurance that a PRODUCT conforms to
specified requirements.
12./ Mary Saunders, "EC-Wide Certification of Telecom
Terminal Equipment Scheduled to Start in November," Europe Now,
ITA/DoC, July/August 1992 issue, pg. 4.
13./ Gregory G. Scott and Dr. James W. Kolka, European
Community Product Liability and Product Safety Directives, CEEM,
Virginia, 1992.
14./ In November 1990, the EC Commission also proposed a
Directive on the Liability of Suppliers of Services (90)482,
known as the Services Liability Directive. This directive, which
is intended to complement the Product Liability Directive, has
not yet been passed.
15./ Gregory G. Scott and Dr. James W. Kolka, European
Community Product Liability and Product Safety Directives, CEEM,
Virginia, 1992.
16./ The EFTA countries are Austria, Finland, Iceland,
Liechtenstein, Norway, Sweden and Switzerland.
17./ A European organization whose mission is to improve
quality and reliability of goods and services principally through
publications and training. ASQC is an affiliate member.
18./ For information on how to contact the EOTC, see
Appendix D.
19./ In a national referendum held on December 6, 1992, Swiss
voters rejected the proposal to join the EEA.
20./ The British Institute for Quality Assurance (IQA) also
operates a widely recognized system for the certification of
quality system auditors. See Appendix D.
21./ For information on how to contact the RvC, see
Appendix D.
22./ For information on how to contact the SCC program, see
Appendix D.
23./ ISO has published a "Directory of Quality System
Registration Bodies" which includes information on national
accreditation bodies. Copies of this directory are available
from ANSI. See Appendix D for information on contacting ANSI.
24./ These seven regional centers were established by NIST
to serve as resource facilities to help manufacturers improve
their competitive position through the application of
manufacturing technology.
25./ The Department of Commerce's Economic Development
Administration (EDA) funds twelve regional Trade Adjustment
Assistance Centers to help ailing companies.
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