StandardsAlliance Handbook 2022 INTRO

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STANDARDS,

METROLOGY, &
CONFORMITY
ASSESSMENT:
TOOLS TO FACILITATE TRADE
AND MARKET ACCESS

An Interactive Reference Handbook 2022 Edition

INTRODUCTION

PREPARED BY THE STANDARDS ALLIANCE, A PARTNERSHIP BETWEEN THE U.S. AGENCY FOR
INTERNATIONAL DEVELOPMENT (USAID) & THE AMERICAN NATIONAL STANDARDS INSTITUTE (ANSI)
THE STANDARDS
ALLIANCE ORGANIZATIONAL
BACKGROUND

The Standards Alliance is a public-private partnership between the


American National Standards Institute (ANSI) and the U.S. Agency
for International Development (USAID). The Alliance was announced
in November 2012 as a funding facility designed to provide capacity-
building assistance to developing countries, specifically related to
implementation of the international best practices related to National
Quality Infrastructure (NQI).

The Standards Alliance has generated lasting outcomes by uniting U.S. public and private sector
partners with developing nations to enhance standards-related policy worldwide. Since its inception,
the program has expanded to support a growing array of countries, sectors, and initiatives. Standards
Alliance technical assistance focuses on building partner countries’ NQI and supporting international
best practices for standards and regulatory development. These efforts promote economic
development and international market access.

The Standards Alliance seeks to increase the development and understanding of international
best practices to improve NQI. This includes strengthening stakeholder engagement, enhancing
intergovernmental coordination, encouraging transparency, and supporting international
harmonization of best practices for regulatory development and standards preparation, adoption,
and application.

A key goal of the Standards Alliance is to increase developing countries’ capacity to implement accepted
international best practices, thereby reducing the amount of unsafe or low-quality products, services,
and infrastructure. Ultimately, better adoption and implementation of international standards will
improve the quality and safety of goods on a global scale. The expansion of the program also seeks
to forge new avenues for bilateral partnership and pursues inclusive approaches to support gender
balance and responsiveness, especially in fields related to science, technology, and innovation.

This handbook is made possible by the generous support of the American people through the United States Agency for
International Development (USAID). The contents are the responsibility of the American National Standards Institute
(ANSI) and EN Industries LLC and do not necessarily reflect the views of USAID or the United States Government.
ACKNOWLEDGEMENTS
Since participating as an invited speaker at the first WTO Technical Barriers
to Trade committee meeting in 1995, and then moving on to work on USAID,
World Bank, and the Asian Development Bank projects in 34 countries, I learned
many things working in developing countries. It became apparent that there
was a fundamental lack of awareness of who the international and regional
metrology, standards, and conformity assessment organizations are, and what
is their contribution and assistance in supporting developing countries trade
activities. In addition, there were questions like, what’s the difference between
certification and accreditation? How are international standards developed?
What’s the WTO? Where can we get basic information? In 2008, working on a USAID project in Vietnam
with their National Standards and Metrology Institute, we conducted a series of workshops and seminars
and the same questions were asked. This led to the creation of the first version of this handbook. Over
the years that followed, I created various versions that have been published in cooperation with USAID
and the National Standards and Metrology Institutes of Afghanistan, Laos, Myanmar, and Mozambique.
Versions have been published in English, Dari, Vietnamese, and Portuguese.

TECHNICAL DEVELOPMENT
This handbook reflects the basic concepts developed by regional and international organizations
including the International Organization for Standardization (ISO), the International Electrotechnical
Commission (IEC), ASTM International, the World Trade Organization (WTO), the World Bank, Codex,
the International Bureau of Weights and Measures (Bureau international des poids et mesures;
BIPM), the International Laboratory Accreditation Cooperation (ILAC), the International Accreditation
Forum (IAF), the U.S. International Trade Commission (USITC), the National Institute of Standards and
Technology (NIST), the American National Standards Institute (ANSI), the Inter-American Metrology
System (El Sistema Interamericano de Metrología; SIM), and many others.

TECHNICAL REVIEW
Standards Alliance thanks the following individuals who provided direction, guidance, and technical
support in the development of the original and current version of the handbook; their contribution is
noted with thanks and appreciation: Dr. Seton Bennett, Deputy Director, National Physical
Laboratory – UK; Dr. B. Stephen Carpenter, Director Office of International and Academic Affairs,
NIST – USA; Dr. Charles Ehrlich, Weights and Measures Division, NIST – USA; Dr. Mauricio Frota,
Past President, Brazilian Metrology Society – Brazil; Paul Hanssen, Senior Trainer, A2LA WorkPlace
Training (AWPT) –USA; Carol Hockert, President, NCSL International – USA; Dr. Charles Motzko,
President, C. A. Motzko & Associates – USA; James Olshefsky, Director, External Relations, ASTM
International – USA; John Owen, Secretary, IAF – Australia; Dr. R. Pettit, Editor, NCSLI Measure;
Sandia National Laboratories (retired) – USA; Dianna Rodrigues, Director, Antigua & Barbuda Bureau
of Standards; Past President SIM – Antigua; Peter Unger, President, A2LA; Past Chair, ILAC – USA;
Dr. Svetlana Zhanaidarova, 1st Secretary, Central Asian Cooperation for NQI – Kazakhstan.

– Edward Nemeroff, EN Industries LLC, [email protected]

Standards, Metrology, & Conformity Assessment: Introduction https://standardsalliance.ansi.org/ 3


INTRODUCTION
The objective of this handbook is to provide the reader with a basic overview of the elements that
comprise a National Quality Infrastructure (NQI) system, including standardization, metrology,
conformity assessment procedures, and accreditation, as tools to enhance trade facilitation,
market access, and export competitiveness.
The handbook is divided into an introduction, five major sections, and an annex. The sections
on Standards, Metrology, and Conformity Assessment contain an introduction to the major
regional and international technical organizations that support a National Quality Infrastructure.
Hyperlinks are available to take the reader directly to the organization’s website. Each section is
followed by a list of reference documents and web pages for additional reading.
We hope this handbook becomes the reader’s go-to reference for NQI concepts.

INTRODUCTION

Introduction and list of acronyms and abbreviations, followed by a brief glossary of technical terms
and definitions in plain language.

SECTION 1: An Overview of NQI }

NQI and its relationship to trade facilitation.

SECTION 2: Technical Barriers to Trade }

The background and structure of the WTO TBT and SPS Agreements, including member obligations.

SECTION 3: Standards and Technical Regulations }

The role of standards and technical regulations in international trade, international and regional
standards organizations, and the standards development process.

SECTION 4: Metrology }

An overview of the science of measurement and the international system of metrological units,
the different categories of metrology, the vocabulary of metrology, and regional and international
metrology organizations.

SECTION 5: Conformity Assessment }

An introduction to the principles of conformity assessment activities that determine compliance to


standards and technical regulations.

ANNEX }

Additional resource links.

Standards, Metrology, & Conformity Assessment: Introduction https://standardsalliance.ansi.org/ 4


GLOSSARY OF
ACRONYMS
AB Accreditation Body
ANSI American National Standards Institute
APEC Asia-Pacific Economic Cooperation
APLAC Asia Pacific Laboratory Accreditation Cooperation
APLMF Asia Pacific Legal Metrology Forum
APMP Asia Pacific Metrology Programme
ARSO African Regional Organisation for Standardisation
ASTM ASTM International (formerly American Society for Testing Materials)
ASEAN Association of Southeast Asian Nations
BIPM Bureau International des Poids et Mesures (International Bureau of Weights and
Measures)
CA Conformity Assessment
CAB Conformity Assessment Body
CAC-MASQ Central Asian Cooperation on Metrology, Accreditation, Standardization, and
Quality
CASCO ISO’s Committee on Conformity Assessment
CE Marking European mark of conformity
CEN European Committee for Standardization
CENELEC European Committee for Electrotechnical Standardization
CEOC International Confederation of Inspection and Certification Organisations
CGPM Conference Generale des et Poids (General Conference on Weights and
Measures)
CODEX Codex Alimentarius Commission
COOMET Euro-Asian Cooperation of National Metrological Institutions
CRM Certified Reference Material
DEVCO ISO’s Committee on Developing Country Matters
EA European Co-operation for Accreditation
EASC Euro-Asian Interstate Council for Standardization, Metrology and Certification
EC European Commission
EMS Environmental Management System
EOQ European Organization for Quality
EOTC European Organization for Conformity Assessment
ETSI European Telecommunications Standards Institute
EU European Union
EURAMET European Association of National Metrology Institutes
EUROLAB European Federation of National Associations of Measurement, Testing and
Analytical Laboratories

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FAO Food and Agriculture Organization
GATT General Agreement on Tariffs and Trade
GUM Guide to the Expression of Uncertainty in Measurement
HACCP Hazard Analysis Critical Control Point
IAAC Inter-American Accreditation Cooperation
IAF International Accreditation Forum
IEC International Electrotechnical Commission
ILAC International Laboratory Accreditation Cooperation
IMEKO International Measurement Confederation
IRCA International Register of Certificated Auditors
ISO International Organization for Standardization
ITC International Trade Centre
ITU International Telecommunication Union
JCDCMAS Joint Committee on Coordination of Assistance to Developing Countries in
Metrology, Accreditation and Standardization
JCRB Joint Committee of the Regional Metrology Organizations and the BIPM
MAS-Q Metrology, Accreditation, Standards and Quality
MLA Multilateral Arrangement
MRA Mutual Recognition Arrangement
MSTQ Metrology, Standards, Testing and Quality
NACLA National Cooperation for Laboratory Accreditation
NAFTA North American Free Trade Agreement
NATA National Association of Testing Authorities
NCSLI NCSL International (formerly National Conference of Standards Laboratories
International)
NIST National Institute of Standards and Technology
NMI National Metrology Institute
NORAMET North American Metrology Cooperation
NSB National Standards Body
NQI National Quality Infrastructure
NVLAP National Voluntary Laboratory Accreditation Program
OIML Organisation Internationale de Métrologie Légale (International Organization of
Legal Metrology)
PAC Pacific Accreditation Cooperation
QMS Quality Management System
RMO Regional Metrology Organization
SADCA Southern African Development Community Cooperation in Accreditation
SADCMEL Southern African Development Community Cooperation in Legal Metrology
SADCMET Southern African Development Community Cooperation in Measurement
Traceability

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SANAS South African National Accreditation System
SI Système International (d’unités) – the International System of Units
SIM El Sistema Interamericano de Metrología (Inter-American Metrology System)
SoA Scope of Accreditation
SPS Agreement on the Application of Sanitary and Phytosanitary Measures
SQAM Standards, Quality Assurance, Accreditation and Metrology
TBT Technical Barriers to Trade Agreement
UILI Union Internationale des Laboratories Indépendants (International Union of
Independent Laboratories)
UNIDO United Nations Industrial Development Organization
USAID United States Agency for International Development
USMCA United States, Mexico, and Canada Free Trade Agreement
VIM International Vocabulary of Metrology
VIML International Vocabulary of Terms in Legal Metrology
WECC Western European Calibration Cooperation
WELAC Western European Laboratory Accreditation Cooperation
WELMEC Western European Cooperation in Legal Metrology
WEMC Western European Metrology Club
WSSN World Standards Services Network
WTO World Trade Organization

GLOSSARY OF TECHNICAL TERMS IN SIMPLE LANGUAGE


Accreditation Refers to both a status of conformity to a specific standard and a process
denoting commitment to continual improvement. Accreditation recognizes
the competence of testing and calibration laboratories, product certification
bodies, system certification bodies, inspection bodies, and other activities.
Calibration A written process of verification that an instrument is within its designated
accuracy. This is most often achieved by formal comparison with a
measurement standard that is traceable to national or international
measurement standards.
Certification Assures the conformity of products, services, and processes by means of
technical evaluation with the proper combinations of defined operations.

Conformity Demonstrates that specific product or service requirements are met. This
Assessment includes technical procedures such as testing, verification, inspection,
certification, and accreditation to confirm products or processes fulfill the
requirements as defined in standards or technical regulations.

Inspection A verification of the quantity and/or weight of traded goods. If it occurs at a border,
verification can consist of examining import/export documents with a visual check
of cargo on the basis on professional judgment.

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Legal Metrology The practice and process of applying regulatory structure and enforcement
to metrology to support a credible measurement system. All measurements
related to trade and consumer protection come under legal metrology.

Metrology The science of measurement.

Mutual Formal non-government agreements to recognize the results of one another's


Recognition testing, inspection, certification, or accreditation.
Arrangement
& Multilateral
Arrangements
National The national body designated to develop and maintain national measurement
Metrology standards for one or more quantities.
Institute
Product May consist of initial testing of a product combined with assessment of a quality
Certification management system. This may be followed by surveillance that takes into
account the supplier's quality management system and testing of samples
from the factory or the market. Other product certification schemes comprise
of initial testing and surveillance, while still others rely on the testing of a
sample product (type testing).

Quality Assures that a quality management system, or a formalized system that


Management documents processes, procedures, and responsibilities for achieving quality
System policies and objectives, fulfills a defined set of requirements (such as the
Certification requirements of ISO 9001, Quality Management Systems).

Standard A technical document detailing the performance or important features of a


(document) product, service, or system. Compliance is voluntary.1

Standard An instrument, reference material, or measuring system intended to define or


(measuring) reproduce one or more values of a quantity to serve as a reference.

TBT Agreement The World Trade Organization (WTO) Agreement on Technical Barriers to Trade
(TBT) is an international treaty administered by the WTO that “aims to ensure
that technical regulations, standards, and conformity assessment procedures
are non-discriminatory and do not create unnecessary obstacles to trade.”2

Technical Barrier A type of non-tariff barrier to trade resulting from divergent standards,
to Trade (TBT) conformity assessment practices, or technical regulations.

Technical A mandatory document issued by a government authority detailing product


Regulation characteristics, production methods, and administrative provisions.

1
Standards as defined by ISO/IEC Guide 2 may be mandatory or voluntary. For the purpose of the TBT Agreement, standards are
defined as voluntary and technical regulations are defined as mandatory.
2
World Trade Organization. Technical Barriers to Trade. Retrieved from https://www.wto.org/english/tratop_e/tbt_e/tbt_e.htm

Standards, Metrology, & Conformity Assessment: Introduction https://standardsalliance.ansi.org/ 8

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