LEGAL METROLOGY

Rocío M. Marbán

Julio A. Pellecer C.

2003

i
Legal metrology

To contact the authors:

2001 Producción y Servicios Incorporados S.A.

Calzada Mateo Flores 5-55, Zona 3 de Mixco
Guatemala, Centro América
Tel.: (502)431-0662
Fax: (502)434-0692
email: psi2001@itelgua.com

ISBN: 99922-770-3-3
© OEA, 2003

ii
This document is published under the joint sponsorship of SIM
and PTB.

The Inter American Metrology System, SIM (Sistema

Interamericano de Metrología, Normalización, Acreditación y
Calidad) is the regional organisation for metrology in America,
comprising national metrology institutes from the 34 member
nations represented at the Organisation of the American States,
OAS, which acts as its Executive Secretariat.

The Physikalisch-Technische Bundesanstalt, PTB, is the

federal highest authority for metrology in the Federal Republic of
Germany.

The opinions stated in this document are not necessarily opinions

of the OAS or the PTB, their bodies or staff.

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Legal metrology

CONTENTS

Acknowledgements vii

Presentation ix

Synopsis xi

1. General aspects 1

1.1. Is legal metrology necessary? 4

1.2. For whom is it necessary? 7
1.3. Why is it necessary? 10
1.4. What is its scope? 14
1.5. Study of the situation of legal metrology in
a country 17
1.5.1. Study of the legal framework of
metrology 18
1.5.2. Identification of elements subject to
quantity measurements 19

2. Basic concepts 21

2.1. Metrology 22
2.2. Legal metrology 22
2.3. Type approval 24
2.4. Verification 25
2.5. Certification 26
2.6. Accreditation 26
2.7. SI Units 27
2.8. Calibration 28

iv
 2.9. Traceability 28
2.10. Intercomparisons 29
2.11. Penalties 30
2.12. Metrological evaluation 31
2.13. Maintenance 31
2.14. Conformity assessment 32
2.15. Control of pre-packaged goods 32
2.16. Metrological control 33
2.17. Market surveillance 34

3. Scope and impact of legal metrology 35

3.1. Official rulings 39

3.1.1. Maintenance of measurement standards
and transfer of units 42
3.1.2. Type or model approval 43
3.1.3. Controls (verifications, certifications,
conformity assessment, etc.) 45
3.1.4. Supervision of organisations in charge of
particular control activities 47
3.1.5. Accreditations 48
3.1.6. Market surveillance 49
3.1.7. Control of pre-packaged products 51

3.2. Commerce 53
3.3. Health 54
3.4. Safety 55
3.5. Environment 56
3.6. Development of enterprises 58

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Legal metrology

4. Legal metrology in the juridical system of a country 61

4.1. The law on metrology, other related laws and

resolutions 64
4.2. The OIML model for a Law of Metrology 66

5. Administrative aspects 77

5.1. Public authorities involved in legal metrology

– some models 78
5.2. Assignments 88
5.3. Administrative procedures 93
5.4. Fees, fines, financial aspects 94

6. Technical aspects 97

7. Regional and international legal metrology 101

7.1. The International Organisation of Legal

Metrology, OIML 101
7.2. Europe 105
7.2.1. Regional organisations in Europe 105
7.2.2. The New Approach and the Global
Approach in Europe 106
7.3. America 110

8. The future of legal metrology 113

9. Bibliography 117

vi
ACKNOWLEDGEMENTS

This book does not pretend to reinvent Legal Metrology, on the

contrary. Thus, although we state some personal convictions, what
we strive to do is to make clear some of the concepts related to legal
metrology which are used over the world. We have studied many
documents and carried out many personal interviews with the result
that a large amount of what is here included is not original. It did not
seem to us practical or necessary to state the specific reference in
each and every case; we refer the reader to the general bibliography
and plead the known adage that “to copy from a single author is
plagiarism but to take from many is bibliographical research”.

We trust we will be forgiven this liberty and that the authors referred
to will accept this recognition on our part of the merits of their point
of view.

There are individuals and organisations that have helped us in such

a way we feel bound to give them explicit recognition. Particularly,
Oscar Harasic of the Office of Science and Technology of the OAS,
Dieter Schwohnke, Wilfried Schulz, Eberhard Seiler, and Ms. Stefanie
Reichertz of PTB in Germany, Dieter Ullrich from Mess- und
Eichwesen Niedersachsen, Michael Bosse-Arbogast from Metegra,
Kai-Uwe Thase and his professional staff from Kellogs, Dieter Buer
and Klaus Helmboldt from Eichamt Bremen, Jean-François Magana
of the BIML/OIML, Pierre Canavaggio of the Sous-Direction de
Métrologie du Ministère d’Économie, Finances et Industrie in France,
Ángel García San Román and Mrs. Carmen Sevilla Antón both from
the Centro Español de Metrología, Mrs. Danièle Le Coz of the BIPM.

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Legal metrology

We are well aware of possible deficiencies and omissions in this

document. To those who read it, we ask for their comments which,
no doubt, will prove to be useful.

In any case, responsibility for the contents of this publication lies

solely with the authors.

June 2003

viii
PRESENTATION

In every country, no matter its size or its level of development,

Government has among its mandates to watch over the health and
safety of its population, the preservation of the environment, and fair
trade.

Current globalisation processes are making available to all, in any

country, a wide range of goods and services, either produced locally
or imported.

All these require the establishment of laws and rules, standards and
technical regulations, and the implementation of the mechanisms
needed for compliance. Usually, to ensure compliance demands
carrying out quantity measurements of diverse types, and the
availability of instruments, procedures or systems of measurement
capable of ensuring accuracy and reliability of the results.

This requires a national system that can support quantity

measurements within the legal framework of the country – that is, a
legal metrology system.

Organisations related to metrology in the Western Hemisphere have

taken up this issue and they think it is necessary to have a wider
diffusion of the main principles and of the current trends of legal

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Legal metrology

metrology. This book has been written with that purpose in mind, it is
addressed to non-specialists and seeks to give them the essential
elements for knowledge of this field of endeavour.

Oscar Harasic
Regional Coordinator of the Project Interamerican System for
Metrology, Standardization, Accreditation and Quality,
Organization of the American States, OAS.

x
SYNOPSIS

It is a known fact that any activity in human organised life is done

under the rules of law. Many human relations involve exchanges
and imply quantity measurements; the application of the law in some
aspects of exchange is the subject matter of Legal Metrology.

The bases of Metrology as the science of measurement were set up

thousands of years ago and this required considerable scientific,
technical, political, administrative, legal and economic efforts. In time,
Metrology has become very important; the complexity of life in
developed countries as well as relations between countries demand
ordinances to rule exchange relations, particularly those requiring
quantity measurements.

These ordinances came about in answer to specific needs but

nowadays, thanks to the good will of governments and the current
communication facilities, there is a legal structure concerning
Metrology that is fairly developed and homogeneous.

One of its consequences is the existence of organisations such as

the international office of weights and measures, BIPM (Bureau
International des Poids et Mesures) and the International
Organisation for Legal Metrology, OIML (Organisation Internationale
de Métrologie Légale).

The legal structure of metrology in a country can be found by studying

its legal framework, as shown in the following diagram.

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Legal metrology

Legal structure of metrology

xii
 Sinopsis

Governments have advanced legal structures, some centralised, or

based on several organisations, others independent. Which of these
trends will prevail is influenced by the characteristics of the economy.
As an example, it is current practice in the European Union to revise
laws and procedures with the objective of realisation of the internal
market while keeping national structures.

Legal Metrology should preferably be structured as a whole system;

however, practice has been to solve problems as they appear.
Nowadays, with market integration due to globalisation, once a need
has been identified it becomes urgent to satisfy it with laws,
regulations and other resolutions, according to international practices.
This while considering the actions that are being regulated, the
organisations in charge, the laws creating those organisations and
their links and dependence, as well as the international treaties and
conventions.

The actions of legal metrology require access to proper measurement

standards for base units, verifications that the measuring instruments
and the measurement procedures in daily trade use are correct, and
the verification of measurement results when public interest is
involved. These actions can be done directly by a legal metrology
organisation or they can be delegated in part in a national system of
metrology and accreditation (Chapter 1).

Actions will differ whether they are applied to measuring instruments

that are going to be manufactured, approved and sold on the market,
or to instruments and measurement methods already in use
(Chapter 2).

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Legal metrology

The impact of legal metrology can be felt in fair trade and consumer
protection, personal health and safety, preservation of the
environment, and in the performance of producers of goods and
services (Chapter 3).

Laws related to metrology are not identical, as they must fit within
the national legal structure. In legal metrology, the authorities with
specific responsibility can act either as a group or individually, and
they have to cover rulings, responsibility for the metrological
infrastructure, technical activities, supervision, penalties. There are
schemes for laws on metrology which have been prepared and
discussed at the OIML and that can be adapted to different situations
in different countries (Chapter 4).

Administration of legal metrology varies between countries and so

do the responsibilities of each type of organisation involved. However,
it is possible to outline some general ideas on administrative
procedures and financial aspects including charges for services and,
eventually, for penalties, in some countries of Europe and America
(Chapter 5).

From a technical point of view, everything that will allow legal

metrology to do its work has to be studied. This includes, for instance,
the setting up and operation of physical facilities, the procedure
manuals with details of the recommendations, protocols, and
standards to be used, scientific and technical expertise of personnel
to guarantee the quality and credibility of all actions of legal metrology
(Chapter 6).

xiv
 Sinopsis

The International Organisation for Legal Metrology, OIML, sets the

general principles and the international harmonisation of legal
metrology. Other similar organisations work towards harmonisation
and co-ordination of legal metrology at a regional level; such are the
Inter American Metrology System, SIM, with its Legal Metrology
Working Group, and the European Co-operation in Legal Metrology,
WELMEC (Chapter 7).

In Europe there is a very strong trend towards what is called the

New Approach to product regulations and the Global Approach
to conformity assessment. Based on these approaches, the European
single market fixes only those essential requirements that will
guarantee the certainty of measurement in instruments and the safety
of persons and the environment. Responsibility is placed step by
step with the manufacturer of the measuring instruments as long as
he can show that he has a quality system in place, recognised by a
certification body (notified body) and supervised at regular intervals
by said body. This is a way of legislating in metrology that could be
profitably studied by other countries and regions (Chapter 7).

Technical progresses in measuring instruments and procedures are

bringing about deep changes that will globalise legal metrology,
resulting in a stronger international harmonisation and mutual
agreements between countries and metrological organisations, with
the purpose of avoiding both unnecessary duplications and the
creation of non-tariff barriers to trade (Chapter 8).

Keeping in mind efforts such as the New Approach and the Global
Approach, all those who are involved in legal metrology, whether

xv
Legal metrology

they are government officials or not, can modify, create or adapt

fundamental basic laws of legal metrology, identify their main needs,
and satisfy them in harmony with the target markets.

xvi
1. General aspects

Legal metrology is basic to guarantee correctness and

equity in commercial transactions and to protect the health
and well-being of the members of society, as well as the
environment.

Everyone benefits from the availability and implementation

of a legal metrology system: individuals, both as
consumers and as entrepreneurs, and Government.

The actions of legal metrology require the guarantee of

access to proper measurement standards for the base
units, verification that instruments and measuring
procedures of daily commerce are correct, and checking
of measurement results whenever the public interest is
involved. These actions can be carried out directly by a
legal metrology entity or be partially delegated in the
framework of a national system of metrology and
accreditation.

This is an introductory book. Because much in it will be new:

vocabulary, concepts, purpose, etc., we have limited its contents
to what was deemed essential and accessible. Our aim is to make
it useful to people from different fields who share an interest in
legal metrology such as lawyers, lawmakers, metrologists,
government officials, entrepreneurs, consumers, etc.

1
Legal metrology

Broadly, we can say that legal metrology is that branch of

Metrology whose purpose is to verify the observance of technical
and legal standards related to measurement units, methods and
procedures of measurement, measuring instruments and
materialised units. Its aim is to guarantee correctness and equity
in commercial relations and to protect the health and wellbeing of
the members of society, as well as the environment.

We are all of us familiar with weights and measures but we do not

always stop to reflect that their correct application is essential to
protect us as consumers and to maintain fair competition between
enterprises. Legal metrology is one of the basic services that a
country’s government can offer to its population, whether we see
them as consumers or as elements of the productive and
commercial community.

Legal metrology infrastructure is a national asset; its influence

may be diffuse and not obvious but it represents a significant
contribution to a country’s development. As a public service, it is
extremely useful to science, industry, commerce, health and the
environment. If it is often not recognised as such, this is due in
part to the fact that as a service activity it is evaluated indirectly
through its applications. Thus, it can be difficult to clearly justify
its existence and the support it demands.

In the present state of affairs, there are trends towards

globalisation of world commerce, internationally distributed
manufacture, a growing complexity of products and services as
well as a growing concern for health and the safety and

2
 General aspects

conservation of the environment. These subjects point to the

growing importance of worldwide uniformity in measurements with
the concurrent presence of systems for accreditation and mutual
recognition of measurements.

Commercial agreements between countries and regions may

require signatories to accept the results of measurements carried
out by the other parties. This in turn influences the design and
work of the metrology organisations of a country and must be
considered by authorities when evaluating needs and future
actions.

When there is no clear understanding in government and the

productive sector of the role of metrology and particularly of legal
metrology, the corresponding organisations find themselves
continuously scrutinised and subject to revisions of their purpose,
their goals and their programmes of work. In the long run, no one
is well served: neither government, nor industry or commerce,
nor the population who, directly or indirectly, pays for the actions
and should benefit from them.

Practically all developed countries have an infrastructure that

includes a metrology laboratory. More and more developing
countries are feeling the need of a metrological infrastructure,
even if minimal, taking into account the precision level of
measurements required according to the properly identified needs
of each country.

3
Legal metrology

In legal metrology it will always be necessary to determine if the

expected benefits justify the expenditures made by the
government and by the users of measuring instruments. This is
particularly important for small countries facing the establishment
of an infrastructure and of a level of metrological services that up
till now have been non-existent or deficient. This requires
identifying clearly what are the real needs, defining proper
priorities, and addressing initially those actions with a stronger
impact on the population.

A national metrology organisation must also become well known

and of easy access to all, and it must become the main reference
for all questions having to do with measurements.

The first questions to ask are: is legal metrology necessary? for

whom? why?

We will try to give some answers to these questions.

1.1. Is legal metrology necessary?

By nature, Man tends to live in small or large groups, from family

through tribe up to state. The group cohesion cannot be properly
kept if everyone does as he wishes; to live together it is necessary
to accept a certain amount of discipline and whoever goes against
the rules must know he is liable to suffer a certain penalty. This
has given birth to a legal structure on which modern societies are
based.

4
 General aspects

The search for the public interest in everything as pertains to

measuring instruments and the use of national and international
standards, requires a legal basis. The laws and regulations
enforced by Government are the field of legal metrology and the
Government acts directly when called upon to ensure correctness
of measurements for the public good. In general terms, whenever
there can be conflict of interests or whenever incorrect
measurement results can be detrimental to individuals or to
society, everyone can trust the correctness of the measurement
results thanks to a governmental guarantee.

Legal metrology is the link between user and supplier that guards
the interests of both. A judge may be called upon by either party
or by a third party. Thanks to legal metrology, he will be able to
establish the real amount of merchandise or product, to determine
the conditions of the measuring instruments used, or to take the
necessary provisions to avoid unfair practices or to impose legal
penalties on infractors.

Properly applied, legal metrology promotes economic and social

benefits. For instance:

- it avoids unjustified payments by consumers for the thousands

of tons of products which are not received annually when
weighing instruments do not comply with legal requirements
or pre-packaged products do not have the correct amount,
when fuel pumps are outside permissible tolerances, energy
meters do not give correct readings, taximeters do not function

5
Legal metrology

correctly, clocks in parking meters do not register time properly,

etc.
- it helps to avoid unfair practices and competition by
encouraging ethics in all transactions and strengthening the
principles of competitiveness,
- it avoids social tensions by helping any person to obtain
effective protection of its interests and rights in relations
between persons and between them and the Government,
- it strengthens the function of Government in the procurement
of justice,
- it encourages entrepreneurs to comply with resolutions on
manufactures and services, etc.

Most governments have understood that one of their

responsibilities is to develop and maintain the basic elements of
a national system for measurements and to see that it is properly
used.

There is no single model for a national system of metrology and

policy should address the objectives for the country rather than
adopt traditional forms without the necessary study. Each country
must decide its priorities, whether consumer protection or fair trade
or environmental protection. In any case, the system should be
stimulant, not repressive, with reasonable taxes and rational use
of available resources.

Metrology is becoming more and more complex so that the only

option when faced with growing expenses is to do a serious and
drastic evaluation of traditional priorities.

6
 General aspects

To avoid solutions that may turn out to be too ambitious, particularly

for measurement standards and equipment, the situation of the
country should be studied in depth.

1.2.For whom is legal metrology necessary?

There is a mistaken trend to believe a priori that the only purpose

of legal metrology is to protect defenceless citizens from
unscrupulous traders. This is not the case. Legal metrology seeks
to make sure that in each and every case involving measurements
and their results, they will be reliable no matter who turns out to
be favoured. Modern metrology is based on universal scientific
principles and as such is free from partialities. Legal metrology
has to establish and coordinate the legal system that will guarantee
there is no distortion of this impartiality.

On the other hand, it is true that buyers do not always have the
means or the knowledge to protect their own interests. When a
trader buys from another a certain product, most of the time both
have their own means of verifying the amounts involved in the
transaction. The final consumer may not have this opportunity;
he must thus rely on inspections carried out by the Government
to ensure that transactions are correct – legal metrology protects
those who cannot protect themselves.

Buyers with the lowest buying capacity are precisely those who,
out of necessity, buy in small quantities and in relative terms this
is very important when incorrect measurements are detrimental

7
Legal metrology

to them. Some countries have begun programmes to verify that

the prices stored in the computers of bar code reading systems
are the same as the prices that appear on the products themselves
or on the labels or stickers on the stacks.

At home, people consume electricity, drinking water, gas, heat,

all of them measured by meters whose reliability is tested and
approved by organisations within the legal metrology system. This
is to ensure that these measuring devices will give correct results
and that the specified error limits will be maintained during a period
of predefined duration (38).

Legal metrology also strives to protect all elements of society in

aspects that are not strictly commercial when, as an example, it
verifies measuring instruments used in medical diagnoses and
treatments, instruments used in measurements having to do with
the quality of water, of air and generally of the environment.

But, legal metrology is a universal protection; the trader loses if

he gives larger amounts than those agreed upon and paid for,
and the manufacturer loses if he is unable to measure properly
his raw materials, his processes and his end products.

Because the true function of legal metrology lies in protecting the

interests of all those who take part in a transaction, a measuring
instrument which is detrimental to the trader must be rejected as
strongly as when the rights of the consumer are those involved.

8
 General aspects

Legal metrology also promotes and protects industry and

commercial development by reducing unfair trade or prohibiting
the selling of products that do not comply with standards and
regulations in force.

This means that it not only prevents undesirable behaviours, it

also regulates commercial use and cares for strategic areas that
encourage production and competitiveness.

A first step should be to make an inventory of the legal metrology

needs of a country, taking into account the scope of the
organisations charged with enforcement, the requirements
established by existing and future laws and regulations, and the
available resources.

Two thirds of the member countries of the International

Organisation of Legal Metrology, are developing countries. This
organisation advises (79), as the starting point of the infrastructure
for a legal metrology system, to carry out a careful inventory of
local needs taking into account the number and types of
instruments to be calibrated or verified, including their measuring
range, precision and where they are.

It is also important to develop a certain metrological point of view

in everyone and this is better done at the basic schooling level.
Programmes of study for primary and secondary education should
include aspects on quantities and their measurements.

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Legal metrology

1.3. Why is legal metrology necessary?

There are many examples showing that for thousands of years

back the leaders of human groups have felt the need of
establishing certain measurement standards and regulations for
the use of resources of common interest. There is, for example,
documentary evidence (99) that, under Tiglatpileser, Assyrians set
up rules that can be seen as a nascent system of legal metrology:

- “measurements are made based on the amount of barley

grains necessary to sow a given area”;
- “irrigation channels are carefully drawn and kept, under the
surveillance of public authorities”;
- “landmarks are protected by severe penalties against whoever
moves them”.

Today, we have the advantage of not having to worry about

differences, fluctuations or exchange rates of values for physical
measurements as we still have to do with currencies. We have a
stable system, internationally agreed upon, the International
System of Units, SI.

However, legal metrology varies between countries in aspects

such as:

- the scope or extent of application,

- the nature of the organisations responsible for implementation,
- the nature and contents of the requirements and their
application,

10
 General aspects

- technical and economic development of the country as well

as the importance and resources that are assigned to legal
metrology.

Nowadays commercial transactions, industrial cooperation,

telecommunications, are more and more internationalised. The
result is that it becomes mandatory for all parties to use the same
references, assign the same meaning to measurements, interpret
the charges similarly, agree on tolerances for raw materials and
end products.

The same rigour must be applied to criteria on aspects of:

- safety (for instance in road traffic and in preventive measures

for disasters such as fires)
- medical analysis and dosages (measurement errors in
diagnoses and in therapy can cause death and, for good or
bad, we rely more every day on measurements related to
health), and
- environmental protection (for instance, to keep pesticides and
heavy metals residues inside set limits).

Unfortunately there will always be persons, even if only a few,

who will resort to fraudulent practices and harm given sectors of
society. Also, either through ignorance or negligence, there are
non-intentional frauds due to incorrect use of measuring
instruments and their negative impact is also significant. We must
keep in mind that an erroneous measurement is damaging to the
injured party, whatever its cause.

11
Legal metrology

Legal metrology seeks to create trust and transparency between

involved parties, based on tests and assays carried out by
impartial, competent and authorised organisations.

Metrology authorities guarantee accuracy by type approval and

by verification of measuring instruments. Within the limits of an
assured probability, the owners of the measuring instrument and
their clients can trust this accuracy and refer – in case of doubt –
to a test of the instrument done by the State.

The importance to a community of a correct supervision of

measures and measuring instruments cannot be underrated. If
commercial transactions and the economy itself are not to become
unruly, the Government has to regulate the use of measuring
instruments and to exert a reasonable control of their users.

This is very important in developing countries where the economy

is based on a limited number of agricultural or mineral products,
petroleum, etc. and who have to import most of the manufactured
products and basic services they need. Sellers of such products
and services know quite well how to protect themselves from
measurement uncertainties and this can mean that they may take
advantage of the buyers.

On the other hand, it can be the seller who is the loser. In Bolivia,
as an example, there were cases where producers or sellers of
raw sugarcane argued that the weighing instruments at the sugar
mills did not give the correct amount.

12
 General aspects

When products are subject to taxes, legal metrology helps to reach

a fair appraisal of their value and a fair payment of taxes, with the
consequent benefits both to the national income as to the taxpayer.

At a personal level, legal metrology looks after the protection of

consumers, contributing to a higher well-being and a better use
of their buying power.

Manufacturing industry requires an increasingly higher precision.

Many new technologies in common use are based on practical
applications of recent discovery in physics. We can mention the
use of lasers and optical fibre, positioning and navigation systems
that use signals from satellite atomic clocks which demand
dimensional tolerances of 0,1 mm or less and time tolerances of
a few nanoseconds.

In 1993 (90) , tolerances for the production of pistons in some

automobile motors were already on the order of about 7 mm,
similar to that required in the manufacture of mechanical watches;
what does this imply for repair shops?

Producers can voluntarily make use of the legal metrology system

to verify their instruments and their measuring procedures. This
is of particular importance when deviations from specifications
are corrected in real time. Systems where the product is examined
after its manufacture and there is a given percentage of rejections
cannot compete with those systems where all the products are
within specifications (90).

13
Legal metrology

1.4. What is the scope of legal metrology?

Anyone who faces a measuring problem should be able to know

what is going to be measured, how to measure it and how to
evaluate and report the results.

There are three different points of view: public authorities,

professional sectors, and public opinion. When creating a legal
metrology system and its organisations, responsibilities and
authorities must be clearly defined.

To study future needs in legal metrology, one must know what

services areas might be required. A list, althought incomplete,
can include:

- industries, manufacturing and others,

- commerce,
- health and safety,
- environmental protection,
- science,
- communications and transportation,
- enforcement of government regulations,
- energy generation and distribution,
- surveying and navigation,
- military services.

Main subjects of interest for the ruling legal metrology organisation

are centred on:

14
 General aspects

- the protection of persons from incorrect measurements

significant for health or safety, or to the economy of the country,
through either direct actions or supervision,
- equal conditions for competitiveness derived from correct
measurements,
- national, regional and international metrological harmonization
- improvement of metrological capabilities in small and medium
sized industries,
- traceability of measurements units in use to national and
international measurement standards,
- dissemination of knowledge on measurement units to industry,
commerce and the people at large,
- availability of competent specialized personnel for everything
relating to legal metrology,
- regulation of expenses involved in measurements and their
supervision in accordance with set requirements,
- use and promotion of uniform and equivalent procedures for
tests and supervision of measurements,
- regional and international cooperation.

All aspects of measurement standards maintenance, traceability

systems, personnel training, and legal metrology, should be
developed within a system that will ensure the necessary
coherence between the different metrological activities of the
country.

This requires a metrological infrastructure that includes

information, education, expertise, physical resources, facilities for

15
Legal metrology

verification and calibration. At different levels, most countries

already have a certain metrological infrastructure in place.

Basic elements of such an infrastructure can include:

- adoption of a system of units to be used throughout the country,

- implementation of a national metrology laboratory or institute
to develop, maintain and disseminate standards and to transfer
new measurement techniques to users,
- implementation of a legal metrology organisation to advise
Government of legal and regulatory matters and to take charge
of metrological supervision; this organisation may eventually
be at the national metrology laboratory,
- a system for accreditation of tests and measurements
laboratories that satisfy preset criteria.

Decision-makers need to have a better understanding of the role

of metrology and the need of assigning to it the appropriate
resources; in developing countries this means defining needs and
financial sources.

With the goal of offering the expected services within available

resources, the national laboratory or institute of metrology, the
legal metrology organisation, and the accreditation system require
planning. A careful inventory of the needs in all areas is thus
mandatory. It should be done, not only from the point of view of
the type of instruments and their required precision, but also in
regard to the annual number of verifications and their geographical
distribution keeping in mind that quite a number of instruments

16
 General aspects

that require regular verification cannot be easily transported to

the central laboratory. The number of instruments to be subject to
legal control must be estimated for each category.

A fact that should not be overlooked is that, whatever the initial

cost of implementing a metrology laboratory, in the long run the
highest impact on its budget will be for qualified personnel and
operation costs.

In large companies, investments towards good metrological

practice are easily amortized; in small and medium sized
companies they can become an important component of costs.
The more so in countries that do not have a metrological
infrastructure and where, as a consequence, this cost can
negatively influence competitiveness.

A developing country is advised (79) to base its planning of official

metrological facilities on a scheme that should include, in a slightly
higher measure, metrological supervision based on verification
of instruments that would not be subject to control in developed
countries.

1.5. Study of the situation of legal metrology in the

country

There are two roads for the study of the situation and the needs
for legal metrology: a study of the legal framework or the
identification of elements subject to legal metrology.

17
Legal metrology

1.5.1. Study of the legal framework of metrology

What is done here is an analytical study of all legal elements

applicable to quantity measurements; it can be based on the
following diagram.

Legal framework of metrology

18
 General aspects

1.5.2. Identification of elements subject to quantity

measurements

In this option, the analysis is done on the elements that are

subject of quantity measurement, according to the different
branches of economic activity.

19
Legal metrology

20
2. Basic concepts

Legal metrology works with several elements whose

meaning must be clearly understood.

We will be using the following:

- metrology,
- legal metrology,
- type or model approval,
- verification,
- certification,
- accreditation,
- SI units,
- calibration,
- traceability,
- intercomparisons,
- penalties,
- metrological evaluation,
- maintenance,
- conformity assessment,
- control of prepackages,
- metrological control,
- market surveillance.

In metrology, as in any human activity where information is

exchanged through communication, words should not only be
known to all parties, they must also have the same meaning for
all. Because we are in a new field, with its own techniques and its
own vocabulary, it is convenient to go through some of the terms

21
Legal metrology

that will be used even if they are explained in more detail later on
in the text. Rather than simple definitions, we try to make clear
what is understood by specialists for each term; whenever
possible, we have used internationally accepted definitions (34,103)
or those used by organisations internationally recognised in
metrology.

2.1. Metrology

Metrology is the science of measurements.

Metrology involves all aspects, theoretical and practical, of

measurements independently of their uncertainties and in all fields
of science and technology.

Particularly, it has to do with:

- the theory of measurements,

- the measurement units and their physical realisation,
- the methods and procedures of measurements,
- the characteristics of measuring instruments,
- people and organisations involved in measurements.

2.2. Legal Metrology

There are several definitions of legal metrology, formal and

informal, which are not contradictory although they differ slightly:

22
 Basic concepts

The International Organisation of Legal Metrology, OIML, on its

Internet web page, tells us that: legal metrology is the entirety of
the legislative, administrative and technical procedures
established by, or by reference to public authorities, and
implemented on their behalf in order to specify and to ensure, in
a regulatory or contractual manner, the appropriate quality and
credibility of measurement related to official controls, trade, health,
safety and the environment.

The International Vocabulary of Terms in Legal Metrology,

published by OIML itself (34), defines legal metrology as that part
of metrology relating to activities which result from statutory
requirements and concern measurement, units of measurement,
measuring instruments and methods of measurement and which
are performed by competent bodies.

The Academy of Sciences of the Institut de France (9), establishes

that legal metrology, the modern form of weights and measures
control, is the activity through which the State decides to take
regulatory action over certain categories of measuring instruments
(those used for commercial transactions) or over certain
measurement procedures (public health, public safety,
environmental protection).

For the Physikalisch-Technische Bundesanstalt, PTB, in Germany

(21)
: metrology controlled and regulated by State resolutions is
qualified as “legal metrology”. Legal metrology covers those areas
where there is a special public interest for correctness in
measuring devices and the corresponding values. These areas

23
Legal metrology

cover all official measurements carried out, for instance, for

customs and taxes matters or traffic surveillance or, particularly,
commercial transactions that involve weighing devices, electric
meters, instruments to measure liquids, etc. It also looks after
aspects related to health and environment protection.

To some people, legal metrology is that part of metrology which

acts when there are possibilities for conflict, specially when the
damaged party does not have the possibilities or the expertise to
evaluate the measurement results.

2.3. Type or model approval

What is known as type or model approval consists basically of

judging if a particular type or model of measuring instrument is
adequate to carry out the functions for which it has been designed
and manufactured.

Model approval can be applied to instruments that, by law, require

mandatory verification, or it can be done at the request of the
manufacturer.

The purpose of the tests is to find out if the instrument will probably
comply with the requirements set for its correctness and reliability
during the validity period specified in the verification.

24
 Basic concepts

2.4. Verification

The terms verification and certification are not always used with
the same sense in all countries. Because of its clarity, we prefer
the meaning as used by PTB in Germany and we will be using it
from now on in this document.

Verification of an instrument or of a materialised measure consists

of technical tests carried out according to regulations by a
competent authority, and of the corresponding markings.

By a materialised measure we mean a device intended to

reproduce or supply, in a permanent manner during its use, one
or more known values of a given quantity. Examples of
materialised measures are weights, a standard electric resistor,
and a reference material in chemistry.

Verification is a preventive measure by which instruments are

examined to see if they comply with the characteristics of the
approved model and with the prescribed error limits.

By means of verification, the competent metrological authorities

ensure that the instruments are adequate and the measurements
correct. It brings confidence in independent and supervised
examinations as well as in protection from manipulations once
the instrument has been examined. One of the main tasks of legal
metrology is to see that citizens can be confident of the correctness
of measuring instruments.

25
Legal metrology

The duration of validity for verification is normally limited so those

instruments must have markings indicating the expiration date of
the verification.

There are systems for verifications subsequent to the initial

verification and they take into account the type of instrument under
study.

2.5. Certification

Certification differs from verification in that an accredited centre

or laboratory does the official tests.

2.6. Accreditation

According to the Inter American Accreditation Co-operation, IAAC,

accreditation is the procedure by which a recognised authority in
the subject gives formal recognition to a person or institution about
their competence to carry out a specific task.

Accredited centres can be associated to manufacturers or public

services organisations. In all cases, the accredited centres are
inspected at regular intervals by the accreditation body.

Even when accredited bodies are private companies, from the

moment they accept delegation of given powers from the State,
they represent State interests.

26
 Basic concepts

2.7. SI units

A unit of measurement is a particular quantity, defined and adopted

by convention, with which other quantities of the same kind are
compared in order to express their magnitudes relative to that
quantity.

In particular, the General Conference on Weights and Measures

(Conférence Générale des Poids et Mesures, CGPM) sets the
units of the International System of Units, SI. This is a body that
groups all countries signatory of the International Convention of
the Metre Treaty - also known as the Metre Convention - and that
has been active since 1875, presently with 51 State Members
and 16 Associated States.

Measurements must be expressed in terms of units such that

results can be repeatable at a long range and will be coherent
with other measurements done in any field of science and
technology. Because of these requirements, base units are no
longer based on artifacts (with the current exception of the
kilogram) but rather on the physical constants known as
fundamental.

Currently, the SI system is used almost universally in trade, science

and technology. Even in the United States of America, considered
by some as the last bastion of the pound-foot-second system,
there is a trend towards gradual adoption of the SI.

27
Legal metrology

When users do not have their own means of doing direct

materialisation of units, practical application of the SI is done
through a national system based on materialised units, kept at a
national laboratory of metrology that is usually the national body
for scientific metrology.

2.8. Calibration

Calibration (103) is the set of operations that establish, under

specified conditions, the relationship between value of quantities
indicated by a measuring instrument or measuring system, or
values represented by a material measure or a reference material,
and the corresponding values realised by standards. These values
realised by standards are commonly understood to be the true
(conventional) values attributed to the standards and equipment
used as reference during calibration.

The calibration certificate includes data of the results of the

calibration and is a guarantee, when so stated, that the calibrated
measuring instrument can be traced to national measurement
standards.

2.9. Traceability

Traceability is understood to be the property of the result of a

measurement or the value of a standard whereby it can be related
to stated references, usually national or international standards,

28
 Basic concepts

through an unbroken chain of comparisons all having stated

uncertainties.

Put more simply, measuring instruments are evaluated against

given working standards to determine they are within accepted
limits of accuracy; these working standards are evaluated against
national standards that are the determinant standards at the
national level and which, in turn, are evaluated against
international standards to make sure that measurements will be
internationally valid. Throughout this chain, the characteristics of
the instruments are determined and documented.

2.10. Intercomparisons

Intercomparisons are done mostly, but not exclusively, in the field

of chemical and biological analysis. The involved laboratories do
the same determination or receive an equivalent sample for its
analysis, and the results of all laboratories are compared. With
this system it becomes possible to identify common errors with
the same technique, to determine which laboratories carry out
analytical procedures that give consistent results, and to evaluate
reference materials. When there are difficulties for calibration,
such as in the field of telecommunications (10), laboratory
intercomparisons are an alternative to calibration systems.

If standards calibration and verification of measuring instruments

is a vertical hierarchical structure, intercomparisons can be seen
as a horizontal structure that can complement or substitute the

29
Legal metrology

use of national standards. It is through intercomparisons that it is

possible to reach Mutual Recognition Agreements/Arrangements,
commonly called MRAs. With these agreements, an instrument,
a measurement procedure, a measurement result, accepted in
one of the countries signatory of the MRA, is also valid in the
other signatory countries; this avoids costly and troublesome
repetitions of tests such as when, for example, those tests are a
requirement for commercial transactions between the countries
of the agreement.

2.11. Penalties

It is a function of legal metrology to see to the observance of laws

and regulations that are somehow related to measurements; thus,
it also has to decide what to do when these laws and regulations
are not observed.

This can be the case when electricity or water meters have been
intentionally manipulated to give wrong readings, as well as
alterations in records, documents, stamps or labels of measuring
instruments.

Pre-packaged products where the correct amount is not filled in

or declared properly or whose presentation and labelling are
misrepresentations, are also considered a punishable offence.

Normal practice is to put in place a penalty system that will

discourage such practices.

30
 Basic concepts

2.12. Metrological evaluation

We will call metrological evaluation a verification requested by a

person who has substantiated doubts about the correctness of a
measuring instrument, and that is done, either by the verification
authority or by an accredited body under direct supervision of the
accreditation authority.

Metrological evaluation is most often requested for electricity, gas,

heat, and water meters.

In Germany, as an example, if the instrument is correct, the person

who requested the metrological evaluation has to bear all
expenses. If, on the other hand, the instrument is shown not to
be working correctly, the applicant does not have to pay for
expenses and may even claim damage compensatory payments.

2.13. Maintenance

Sometimes, correctness of a measuring instrument can be

guaranteed only if the instrument undergoes regular maintenance
such as repairs, changes of components or units, or adjustments.
In such cases, maintenance can substitute secondary verifications.

To have the validity of a verification, the maintenance has to be

done by maintenance services that are officially recognised,
authorised and supervised by the competent authorities, and using
standards traceable to a national standard.

31
Legal metrology

2.14. Conformity assessment

In the European Union, responsibility for the correctness of

instruments can be delegated by the State to the manufacturer,
by means of conformity assessment, applicable in the regulated
and in the non-regulated field.

In fact, it is perceived that verification by a competent authority

will be replaced more and more by conformity assessment tests
done by the manufacturer. The State will work less on testing
measuring instruments and more on the control of the quality
systems of the manufacturer so that the conformity tests it
performs can have the required legal validity.

2.15. Control of pre-packaged products

When speaking of pre-packaged products we refer to all products

that are not subject to a measurement at the time of the
commercial transaction. An obvious example is that of all
packaged products sold in shops or supermarkets: bottled oil,
flour in packages, dairy products, canned sardines, cereals in
boxes, marmalades, toothpaste, cosmetics, cleaning products,
etc. But the term can also be applied to medicines, paints, cement,
barbed wire, fertilisers, pesticides … the list could be very long.

With pre-packaged products, the controls seek to guarantee that

the buyer will in fact receive the quantity that is written down on

32
 Basic concepts

the package, within certain limits that are set according to the
product and to the type of package.

This control can be done at the factories where the product is

being packaged or by samples taken at several different selling
points.

2.16. Metrological control

Metrological control can include:

- design and type approval,

- initial verification,
- verification after repairs or modifications,
- periodic verification,
- surveillance and inspection.

The State sets up metrological control to watch over the

correctness and accuracy of measurements; to assist the health
and safety of citizens through control of biomedical instruments;
to avoid frauds damaging to the consumers, with special attention
paid to the metrological control of pre-packaged products.

33
Legal metrology

2.17. Market surveillance

To some legal metrology enforcers, market surveillance is focused

not so much on the models or types of instruments but on the
inspection of the individual instruments that are in use.

34
3. Scope and impact of legal metrology

Legal metrology comprises all official rulings and it acts by

means of the proper bodies to enforce laws related to
measurements. In particular, it has to make sure that:

- the units are of common use, in accordance with

national and international rules,
- the corresponding standards are properly kept,
- the types of measuring instruments in use are of
officially approved types or models,
- the measuring instruments are verified at preset
periods,
- the bodies in charge of control actions are properly
accredited and they carry out their duties under
proper supervision,
- measuring instruments and devices in use in the
country comply with current legal regulations,
- previously packaged products sold on the market
comply with regulations on quantity or number of their
contents.

Impact of legal metrology may be felt in commerce, in the

health and safety of persons, the preservation of the
environment and in the behaviour of producers of goods
and services.

Legal metrology addresses the assurance of the quality of quantity

measurements through control of the instruments and procedures
used in measurements.

35
Legal metrology

It originated in the need for fair trade but then evolved towards
other applications of metrology, such as public health and safety
and protection of the environment. Many countries also regulate
other aspects of metrology - traceability to national standards is
one example - so that these aspects also fall within the scope of
legal metrology.

Usually, legal metrology is implemented by means of general

application regulations but it can also appear in contracts signed
by a limited number of parties.

It mainly applies to measuring instruments by specifying their

performance requirements and the procedures for their use and
verification; it can also be applied to measurement results by
specifying accuracy and acceptance requirements.

It should be stressed that there is no single model for the

application of legal metrology; it will depend on the political and
legal structure of each country, its social and economic conditions,
and its environment. For instance, during recent years, countries
of the European Union have had to modify their legislation and
administration of legal metrology in the light of the directives of
the European Union. Later we will go into this in more detail.

Legal metrology is a modern, enlarged form of the control of

weights and measures. It is the activity by which the State
intervenes through regulations on a given category of measuring
instruments (mainly those used for commercial transactions) or

36
 Scope and impact

on certain measuring operations (related to public health, public

safety, and environmental protection).

It extends in several directions:

- the quality of instruments used in commercial transactions

with the purpose of ensuring reliability of measurement and
avoid fraud; it is a tool of economic regulation,
- it also works in function of the State by ensuring that state
controls are safe, fair and effective,
- it helps the productive sector to be able to use reliable
measuring instruments according to its needs.

We should make it clear that the term “measuring instruments

used in commercial transactions” has today a very wide meaning
and includes such aspects as traffic control (radar in roads,
speedometers on trucks and public transport) or public health
(thermometers and scales for medical use, blood pressure
devices).

Generally speaking, there are three major situations where control

is carried out:

- when the measuring instrument is designed, by design

approval,
- when the measuring instrument is manufactured and sold,
with conformity assessment or primary verification,
- while the instrument is in use, by periodic verifications.

37
Legal metrology

We can also differentiate two types of metrological activities. The

first is to investigate and verify equipment used in commercial
measurements, and can be considered a mechanical metrological
activity. The second looks to the uses of this equipment and
includes all supervision activities.

In mechanical activities it is the duty of the metrologists to inspect

and compare with the measurement standards, at regular
intervals, all measuring instruments and devices used in
commercial transactions in their jurisdiction.

Supervision includes such activities as verification of goods stored

for sale or pre-packaged, verification of cargo in products sold in
bulk (fuels, sand, gravel and others), investigation of denunciations
of unfair practices, education of buyers as to their rights and
obligations in accordance with metrological laws.

Normally, what we have called mechanical activity should have

precedence over supervision – without proper and correct
equipment a trader cannot be asked to use the instruments
correctly. However, it is advisable not to forego all supervision in
favour of mechanical activities (46).

This does not mean that the organisation in charge of legal

metrology has to be responsible for all these tasks.

In fact, many countries have ministries or secretariats with direct

responsibilities in trade, health, justice, customs, environment,
etc. where many activities are carried out that fall within the field

38
 Scope and impact

of action of legal metrology; this often is not seen clearly and the
necessary co-ordination does not exist between the different
involved parties, a fact which does not make for a sound, coherent
development of legal metrology.

3.1. Official rulings

Ideally, the study of the legal framework for metrology should start
with a reading of the Constitution or Charter of the State; the
titles or chapters will show which are the government bodies and
the laws that regulate the functions of each of them.

The text of the laws themselves will show the institutions in charge
of specific tasks as well as indications of the regulations that make
operative both these laws and these institutions.

A perusal of laws and regulations will show the general structure

of government and from this it is possible to infer the structures of
ruling activities which involve quantity measurements.

As we are interested in the institutional and operative profile of

metrology, this revision identifies the government entities in charge
of the different aspects of quantity measurements.

Identification of metrology related institutions and laws gives a

general mapping. To show coherently the legal framework of
metrology it is necessary to classify by subjects all information
that is contained in this map.

39
Legal metrology

Let us for instance suppose that the Constitution establishes that

health is a function of the Executive branch and that it assigns it
to a Ministry or Secretariat of Public Health; this, in turn, is ruled
by a law and its regulations. Complementary laws and regulations
will specify activities such as for example hospital affairs, food
control, epidemics control, etc. and the study will show which
entities are in charge of which specific activities, which quantity
measurements should be made, to what products and services,
and how. Regulations will include specifications, measurement
standards, procedures, conventions, etc.

Let us look at another field, Communications and Construction,

hypothetically assigned by the fundamental laws to a Ministry or
Secretariat of Communications. The mapping of activities derived
from the founding law and its bylaws of such a Ministry as well as
the complementary laws and their bylaws, will show matters of
communication having to do with physical transport (roads, road
transport vehicles, railroads, sea and river harbours, airports, etc.),
with construction (locations, designs, materials such as concrete
and steel, etc.), with telecommunications. Each of these activities
will probably be ruled by specific laws and their bylaws and will
imply, directly or indirectly, measurements and their control. For
instance, in the field of telecommunications there are currently
discussions, at the Western hemispheric level, for the
harmonisation of a set of matters having to do with standardisation,
certification procedures, and mutual recognition agreements (10).

40
 Scope and impact

The role of Government in metrology can be defined as the

obligation to ensure the existence and correct operation of a
national system that will basically include:

- acceptance and definition of measurements units to prevent

the use of incompatible units,
- maintenance of national measurement standards for the base
units, with the proper traceability to international standards,
- organisation of the chain of traceability between measurement
procedures and measurement standards, both national and
international,
- establishment of legal metrology with its diverse functions,
- establishment of accreditation systems for metrology
laboratories,
- participation in research, training and information on metrology.

In the particular case of legal metrology, legal control is exerted

on all devices that measure quantities in commercial transactions
or in aspects related to public health and safety or the environment.
These devices can be inspected either individually or on samples
taken by statistical analysis on homogeneous lots.

Legal metrology considers that a measuring instrument complies

with legal regulations if the value it shows is less or equal to the
maximum permissible error when the verification test is done by
a verification body, under standard conditions and the uncertainty,
at a probability level of 95%, is small compared to the prescribed
error limit.

41
Legal metrology

It should be stressed that, if scientific metrology seeks a

measurement as accurate as possible, legal metrology seeks that
the measurement be as accurate as necessary.

3.1.1. Maintenance of measurement standards and transfer

of units

National measurement standards are normally subject to an initial

calibration, at the national metrology laboratory of the country
where they were manufactured or, occasionally, at the BIPM
(Bureau International des Poids et Mesures).

The body responsible for maintenance of the standards must make

sure that they are kept and used correctly.

Need for a new calibration can be determined by:

- the accuracy required by the country,

- possible changes in time in the value of the standard, due to
local atmospheric conditions,
- possible or suspected changes in the value of the standard
due to its use.

The legal metrology authority is also responsible for the transfer

of the units, materialised in the national measurement standards,
to the complete chain of reference standards and working
standards so that any measurement may be traced to the

42
 Scope and impact

corresponding national standard and, thus, to international

standards.

3.1.2. Type or model approval

Type approval of measuring instruments is done on both locally

manufactured instruments and on imported instruments. It is a
first preventive measure, taken by the Government, to protect
citizens from the effects of incorrect measurements.

Type approval is an administrative act whereby the measuring

instruments subject to mandatory verification are approved for
national verification (or in its case primary regional verification) at
request of the manufacturer.

Normally, the measuring instruments subject to mandatory

verification are those used in commercial transactions, official
affairs, traffic, manufacture and analysis of medicines,
occupational and environmental safety, medical measurements.

The tests are done to determine if the instruments can be expected

to comply with the set requirements of accuracy and reliability
during the validity period specified for the verification. An important
criterion for the test is the resistance of the measuring instrument
to environmental influences such as temperature, humidity,
vibrations, and electromagnetic fields. Also, the instruments must
be sufficiently protected against falsifications of the measurement
values through handling errors or intentional manipulations.

43
Legal metrology

Once the tests are successfully completed, the manufacturer

receives an approval certificate, with the approval marking that
must be placed, in a clearly visible place, on all measuring
instruments of that particular model.

The granted approval represents a confirmation of quality and is

an important factor in the sale of the instruments.

Presently, in Europe, measuring instruments that have been type-

approved and verified in one of the states of the European Union,
may be imported and used in any other member state without
being re-examined.

Also in Europe, if a Directive of the European Union for a category

of measuring instruments exists, reference is made to it so that
the Directive will be transferred into national law.

An OIML Certificate System was established in 1991, for issuing

certificates for types of instruments which fully meet the
requirements of the relevant Recommendations and which have
been tested according to the procedures described in these
Recommendations.

It is also possible to have what we might call a “disapproval” of a

type, when law prohibits use of a given model of measuring
instrument. As an example, a decree published in Uruguay in
1994 forbids use, starting in 1995, of scales known as “báscula
de pilón” and the corresponding authorities have been granted
faculties to seize and destroy such instruments.

44
 Scope and impact

3.1.3. Controls (verifications, certifications, conformity

assessment, etc.)

When a type has been approved, the instruments can be placed

on the market. Individual instruments of the approved type are
verified by the verification authorities or certified when this
verification is delegated to an accredited body.

The measuring instrument is examined to see if it conforms to

the corresponding regulations or ordinances and if it complies
with the type requirements and approval. The most important
criterion is usually the observance of permissible maximum errors
as set down on the regulations.

Accuracy of a measuring instrument may change over time

caused, for instance, by wear or age. For this reason, the validity
duration is limited and reflects the type of instrument. As an
example, in Germany verification of taximeters has validity
duration of one year, countertop scales and fuel pumps in gas
stations of two years, water and electricity meters of 6 and 16
years respectively and both can be further extended.

For extension of the verification validity when dealing with

measuring instruments which are installed in large numbers such
as gas meters, water meters, electricity meters, a test by sampling
may be done instead of a secondary verification. This method
can reduce considerably the testing costs for the supplying
companies.

45
Legal metrology

Again in Germany, gas, water, electricity and heat meters are

verified in testing centres officially recognised by the State. Most
of these centres are located at the companies supplying water or
electricity or in some of the companies that manufacture these
instruments. Correctness of the testing procedures is guaranteed
by the use of measuring devices tested at the PTB and by the
metrological control of the testing centres carried out regularly by
the verification authorities.

All these services are subject to specific fees.

When the manufacturer of the measuring instrument does

verification we speak of conformity declaration or conformity
testing. In this case, it is the manufacturer himself who certifies
that his measuring instruments conform to the type approval. The
company must usually have in place a quality system that complies
with the requirements of regional or international standards and
this quality system is supervised periodically.

Subsequent verifications may be substituted by maintenance or

by comparison measurements done by qualified operators.

This way of proceeding is being used more and more in Europe,

to transfer to the manufacturer the responsibility for the correctness
of the measuring instruments.

46
 Scope and impact

3.1.4. Supervision of organisations in charge of specific

control activities

Concrete forms of metrological supervision must take into account

the economic system of the country, the organisation of its legal
system, its territorial organisation, and other features and specific
conditions.

Use of computer controlled measuring instruments with functions

largely determined by software will require new methods for initial
and subsequent verification.

It is probable that in the future conformity testing by the

manufacturer of the measuring instruments will become more
common. This will result in a shift in the tasks of the verification
authorities; they will perform fewer testing activities but they will
have to increase their supervision of manufacturers.

In some countries, such as Colombia (97), it is “mandatory to have

calibration laboratories accredited by the Superintendent of
Industry and Commerce at all companies supplying domiciliary
public services in which measurements are required for billing,
and these companies shall also have their measuring instrument
periodically qualified”.

Now, there can be conflicts of interest when a supplier or

manufacturer is in charge of verification tasks and this is why a
strong and effective supervision is necessary.

47
Legal metrology

To determine if a measuring instrument is working properly is not

necessarily a task for the user. The subsequent verifications are
still the responsibility of the metrology authorities as are also the
supervision of certification bodies, or the maintenance and repair
with a consequent certification.

3.1.5. Accreditations

Accreditation is the formal recognition that a certification or

inspection organisation, or a testing or metrology laboratory, has
the required technical competence and fitness to carry out those
specific functions for which accreditation has been granted.

Accreditation is a guarantee for the user that the accredited body

is independent and competent and that its services are rendered
effectively in terms of time and cost.

Accreditation organisations, on their part, are subject to regular

surveillance by a body with the required authority, frequently a
government body.

Laboratory accreditation is a way of determining that a laboratory

has the required competence to carry out specific tasks of tests,
measurements or calibrations. Whoever needs to check or
calibrate a product, a material or an instrument, can thus have a
reliable source. The laboratory itself can determine if it is working
correctly, under the appropriate standards. Manufacturers can also
use laboratory accreditation to make sure that the tests done
internally on their products are correct.

48
 Scope and impact

Adoption of the international guide ISO/IEC 17025 ensures a

uniform way of determining the competence of a laboratory and it
permits international agreements for the recognition of
accreditation systems.

3.1.6. Market surveillance

By market surveillance we understand the determination of the

generalised compliance of the relevant regulations by individual
measuring instruments.

The European Union (23) considers the purpose of market

surveillance to be the guarantee of compliance with the resolutions
contained in the directives applicable to all member countries.
Citizens are entitled to an equivalent level of protection in the
whole Single Market, independently of the origin of the product.
Market surveillance is also of importance for the interests of
economic agents as it helps to eliminate unfair competition.

To the Europeans, market surveillance has two main aspects:

- national surveillance authorities must supervise that marketed

products comply with national laws that have transposed the
New Approach directives, and
- later, and as required, they must adopt measures to ensure
conformity.

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Legal metrology

From the point of view of legal metrology, surveillance measures

applied to manufacturers, importers, traders, maintenance
services, repair services and users, have as their goal to guarantee
that the measuring instruments conform to requirements, that they
are tested and marked according to regulations, and that they
are used properly.

Ignorance of the law is an unacceptable excuse for not complying

with it. The owner of the instrument is responsible for having
regular servicing that will maintain its operating capacity within
prescribed tolerances in compliance with applicable specifications.

Similarly, a packager must use accurate standards to make

adjustments to his packaging equipment and he must have a
quality control system that will keep individual variations in
packages within acceptable limits so that the average weight of
the product will comply with the declaration of quantity.

Market surveillance should ensure that all measuring instruments

subject to verification are verified and it should be done under the
direct supervision of authorities (100) .

One thing to keep in mind is that the main purpose of legal

metrology is not to make money. It includes technical and
surveillance tasks and it is usual for the technical services to
generate income that can then be used to cover the expenses of
surveillance; this, in fact, is an argument sometimes used against
total privatisation of legal metrology services.

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 Scope and impact

3.1.7. Control of pre-packaged products

In legal metrology, pre-packaged (or pre-measured, or

conditioned) products, often called pre-packages, are those
products that are packed in packages of different types, forms
and sizes and closed before they reach the consumer. In these
packages the quantity of product contained cannot vary unless
the package is opened or considerably altered.

Pre-packages must be clearly labelled with information on their

contents in terms of quantities, whether mass, volume, length,
area, or number of units. The packages must be so designed that
they do not appear to contain more of the product than they really
do, a practice known as deceptive packaging.

As measuring instruments become less used in direct sales to

consumers, verification of pre-packages is gaining in importance.

Regulations concerning labelling of pre-packages specify

requirements that at least the following items should appear
clearly:

- the identity of the product,

- the name and address of the manufacturer, packer, distributor
or importer,
- the net quantity of product, according to the type or product
and its presentation,

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Legal metrology

the types and sizes of letters and numbers to indicate contents

are also specified.

This does not preclude other labelling requirements such as

nutrition facts in food products or warnings in products that can
be dangerous.

For technical reasons, it is now very common for pre-packages

verification to be done instead of the verification of packaging
units and equipment.

For this purpose, tests are done, based on statistical sampling,

usually at the packaging facilities. Criteria such as the following
are commonly applied:

- the average content of the packages must be equal to, or

greater than, the nominal quantity,
- only 2% of the tested packages can be below the first tolerance
limit, TL1,
- no package can be below the second tolerance limit, TL2.

This control can be done at the factories where the product is

being packaged or by samples taken at several different selling
points.

***

52
 Scope and impact

So far, we have been looking at legal metrology from the point of

view of its functions; let us now review briefly its impact on the
activities over which it acts by law.

3.2. Commerce

The citizen seen as a client in the retail trade is possibly the person
most often associated with legal metrology. And in fact, the impact
of a few grams per person in each commercial transaction can
become many kilograms when these transactions are added up.

Weighing devices in all their forms are among the measuring

instruments most often used in commercial transactions. Modern
supermarkets use electronic scales, sometimes for self-service
by the client, that can be part of a combined system and are
connected to the cash desk and the central computer.

These systems of measuring instruments connected to cash desks

as they are used in retail trade must comply with the same
requirements as those of any equivalent measuring instrument.

With pre-packages such as sugar, flour, canned beverages, milk,

etc., the client is not able to follow the measuring process during
packaging of the product. For this reason, verification authorities
have to verify the content of the packages according to the
requirements of the regulations for pre-packaged products.

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Legal metrology

Other important items of the domestic budget are filling the fuel
tank of a vehicle, buying liquefied gas for domestic use, and the
payment of public services such as water and electricity.

3.3. Health

When legal metrology is at work in the field of health one thinks

immediately of verification and control of apparatus such as:
clinical monitors, medical thermometers, blood pressure devices,
electrocardiographs, devices to measure pulse rhythms,
audiometers, etc.

There are more dramatic situations when there are problems

derived from an excessively high or too low a dose of therapeutic
radiation that can cause death or an insufficient treatment of the
disease. The frequency of controls will depend on the extent of
the danger that an incorrect function of the instrument would
represent for a patient.

But there are also less obvious situations where a correct

measurement can impact health. For example, correct
determination of the levels of deafness to approve retirement of a
worker or the control and regulation of noise now its long-range
negative effects are known. In some cities (58), granting of a license
for a certain type of business, restaurants for instance, is
conditioned to their having adequate protection to prevent noise
from being a nuisance to their neighbours.

54
 Scope and impact

The effect can sometimes be indirect as with the correct

determination of aflatoxins in feeds given that their metabolite
(M1 aflatoxin) will be present in milk; in European Union countries,
powdered milk has limits of 0,01 mg l-1 of M1 aflatoxin as well as
traces of heavy metals such as cadmium, lead and mercury (90).
This also shows that incorrect measurements can result in a
product being rejected for import because it does not comply with
quality requirements.

In Europe, starting January 1st 1995, European Directives have

been transformed into national law. A medical measuring
instrument can be marketed or put in use only if it conforms to the
requirements of the law on medical devices and if it carries the
CE marking.

Currently under discussion are international regulations that will

rule food labelling and ingredients derived from genetically
modified organisms, an aspect over which there are differences
of opinion between several countries.

3.4. Safety

To contribute to public safety, legal metrology acts over several

sectors.

One of these is road traffic. Everything that is related to correct

adjustment of vehicles (tire pressure, motor performance, driving
system, braking system, electrical system, emergency signals)

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Legal metrology

requires some type of measuring instrument. In some States of

the United States of America, a used car must undergo an
inspection before it can be put on sale. When speaking of public
road transport we have to add the weighbridges to determine
potential overloads that can cause accidents. Traffic lights (red
lights) must be synchronised. Measuring instruments used by the
police, such as alcoholmeters to measure the amount of alcohol
in the blood or speed meters for speed control on roads and on
streets, also require periodic verification. We can also mention
control of the operating conditions of cargo and passenger
aeroplanes, weighing of cargo and baggage, instruments in the
air traffic control towers.

Safety in the working place also demands measurements that

are directly or indirectly verified through the system of legal
metrology. To be approved and given maintenance, personal or
collective safety equipment such as protectors, barriers, special
clothing, smoke detectors, fire extinguishers, emergency exits,
etc. must conform to standards, and verification of compliance
with these standards requires diverse measurements.

3.5. Environment

Everyone is exposed in a greater or lesser degree to pollutants

that are not only annoying but can be detrimental to health. On
the other hand, it makes no sense to limit by law these pollutants
if they cannot be measured correctly. A correct measurement is

56
 Scope and impact

essential when the result can be the basis for a decision taken by
a court of law or an authority.

In modern life we are all subject to pollution by:

- exhaust gases and soot from vehicles,

- radiation from nuclear medicine applications and handling of
the equipment,
- noise from traffic or at the working place or in the vicinity of
airports and railroads,
- waste waters not properly treated,
- pollution of drinking water, of rivers and seas, by cleaning
agents and solvents, and its impact on the fauna,
- soil pollution and the resulting effects on agriculture in terms
of health and economics,
- high radon concentrations in basements and underground
parking lots,
- excessive ultraviolet radiation, particularly in the tropics, from
damage to the ozone layer or from soldering work,
- low frequency electromagnetic fields when operating electrical
appliances or by high-frequency broadcasting.

Pilots and air traffic controllers, interpreters and sound engineers,

are prone to suffer occupational diseases caused by the noise
level to which they are exposed. With the current availability of
portable sound apparatus and mobile phones, there are everyday
more persons exposed to excessively loud noise.

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Legal metrology

3.6. Development of enterprises

We must keep in mind that both as consumer and as businessman,

every person has the right to be protected against incorrect
measurements.

Metrology supports national industry by making available a

technical basis, with the right accuracy for its needs, to calibrate,
check and verify its measuring and control instruments and by
guaranteeing calibration of measuring instruments and equipment
at industrial testing and assay laboratories. It can also provide
reference materials duly homologated and certified for
autocalibration of equipment and it can also carry out studies,
tests, assays and special measurements, determination of
physical constants, at the request of government or private
organisations as well as giving technical assistance on industrial
measurement problems.

In industry, legal metrology acts on instruments such as callipers,

micrometers, comparison clocks, gauge blocks, micrometers,
pressure gauges, industrial thermometers, thermocouples,
pyrometers, analytical scales, etc. as well as assay instruments,
chemical analysers and many more.

There are private companies that supply public services such as

electricity, gas, heat, and water to homes, industries and other
concerns.

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 Scope and impact

The farmer uses the right type of scale for cereals or cattle, liquid
or volume measures for milk, butirometers to determine the
content of fat in milk; in cereals, humidity and apparent bulk load
density are important criteria.

Quality of cement is important both for the solidity of a building

and for the price of concrete and in construction the relative
quantities of materials must be carefully measured.

Measuring instruments are used to determine properties of

components and of manufactured products and they are becoming
common to control, regulate, automate and monitor processes.
Measurements are used to verify manufacturing tolerances and
functional reliability of the products. They have become an
important component of quality assurance.

Industry needs measurements of force, pressure, vacuum, flow,

length, areas and volumes, angles, gears and cylinders,
roughness, temperatures, viscosity, density, DC and AC current,
high frequencies, time, reference materials for magnetic data
media, ionising radiation, etc.

A legal metrology system, with a sound metrology infrastructure,

can be of great help to industry by making accessible such services
as calibration and verification, standards and reference materials,
with the confidence that such services follow international
standards and regulations and can thus contribute to the
competitiveness of local enterprises.

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Legal metrology

60
4. Legal metrology in the juridical system of a
country

Metrology laws are not the same in all countries because

they must agree with the national legal structure. In legal
metrology the involved parties, with specific responsibilities,
and whether integrated or not, are:

- the normative authority,

- those responsible for the metrological
infrastructure,
- the executive authority,
- the supervisory authority,
- the penalty authority.

There can be a single general law covering all aspects of

metrology and/or laws concerning specific aspects such
as a law on legal metrology.

OIML has currently under preparation and discussion a

document containing the essential elements of a law on
metrology; several aspects of this document are included
in this chapter.

We have mentioned before the importance of studying the

Fundamental Charter or Constitution of the State to know clearly
the different government bodies of the country and the laws ruling
them.

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Legal metrology

It is through a study of the laws that it becomes possible to identify

institutions in charge of specific tasks, and the study of the
corresponding law’s regulations will identify activities that require
quantity measurements and, thus, the fields where legal metrology
is bound to act within the legal structure - always keeping in mind
that the goals of legal metrology for universal protection can be
met by using both prevention and punishment.

To be also taken into account is the fact that Law is in constant

evolution; we can mention as examples the unipersonal societies,
condominia, new payment techniques particularly those using
electronic media, the new available reproduction techniques and
their impact on intellectual property rights, etc.

In legal metrology, the involved parties, having specific

responsibilities, are:

- the normative authority,

- those responsible for the metrological infrastructure,
- the executive authority,
- the supervisory authority,
- the penalty authority.

According to the legal system in each country, these

responsibilities can be concentrated in a single body or they can
be partially or totally decentralised. One of the difficulties that can
arise from decentralisation is that the several entities may be
insufficiently linked among themselves with the result that each

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 Juridical system

tries to fulfil its duties without taking into account what the others
are doing.

We will try to make clearer this crucial aspect.

When, for instance, the normative authority is separate from the

executive authority, it can set out requirements that cannot be
met due to technical or local circumstances. This is the case with
some environmental standards having to do with maximum
permissible limits of dioxin, a chemical whose correct analytical
testing requires accuracy not available in most laboratories. If the
tests cannot be done to support an effective supervision, what
sense is there is approving standards that require those tests?

Another situation arises when those responsible for the

metrological infrastructure do not have, by law, the faculty of
imposing penalties. There can be laws setting the official
measurement units and the approved measuring instruments but,
if there is no functioning system for supervision and penalties to
transgressors, these laws will never be more than dead letters.

The authors are familiar with a case where, by law, the legal
system of units is the SI International System. However, drinking
water is billed in cubic meters while fuels are sold in gallons. Road
distances are given in kilometres but building lots are sold by
square “varas” (slightly smaller than square yards), agricultural
land by “manzana” (around 7 000 m2) or “caballería” (450 000
m2), some crop extensions are measured in “cuerdas” (which is a
linear measure) while fabrics are bought by the yard but electric

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wire is bought by the metre. In retail trade onions and tomatoes

are sold by the pound … and so on.

4.1. The law on metrology, other related laws and

resolutions

As could be expected, metrology laws are not identical between

countries, as they must fit into the national legal structure.

Let us look at a few cases. In Mexico (45), it covers standardisation,

accreditation, certification, surveillance, penalties and resources.

In Spain (53), a constitutional mandate assigns to the State the

exclusive competence to legislate on weights and measures (the
old concept of “weights and measures” being superseded in the
new laws by that of “metrology”) and it also determines official
time in Spain.

In the United States of America (101) there is no national metrology

law as such but the States have adopted, among others, a
common law on weights and measures.

Generally speaking, whether it is a single metrology law covering

all aspects, or several related laws, they must take into account
at least the following:

- the legal and authorised measurement units, their physical

representation and their field of application,

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 Juridical system

- the national body in charge of custody of the measurement

standards or of the realisation of the units,
- the properties of measuring instruments,
- the type of activity that requires legal control of measurements
and of measuring instruments,
- aspects of manufacture, sale, repair and maintenance of
measuring instruments,
- the type of activity requiring metrological control of the quantity
of product (pre-packaged products are an example),
- national bodies in charge of metrological control,
- procedures for legal control (type approval, verification stamps
or markings, legal powers),
- treatment of transgressions and legal procedures.

These laws and regulations address the general public and the
courts of law and they must be in a language appropriate for the
legal authorities of the country.

As there is usually quite a lapse of time between formulation of a

law and its enactment, the text should not include technical
elements that may be subject to change. For instance, it is better
not to include in the law the scientific definitions of the base units
which are better included in an annex, together with possible
conversion tables, while derived units would be better in the
regulations of the law.

As to specific laws regarding the several categories of measuring

instruments, it is advisable to follow the OIML International

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Legal metrology

Recommendations that are model regulations with an

internationally approved basis.

4.2. The OIML model for a Law on Metrology

The OIML published in 1975 a model law on metrology; this

document is currently being revised and updated and it has been
placed for international discussion under the title Elements for a
law on metrology (62) . It is not yet considered a definitive
document and it covers all of metrology not exclusively legal
metrology, but as it is put out by the recognised legal metrology
international organisation, it is used as the basis, sometimes
verbatim, for the rest of this section.

The laws for which the document gives advice may be a general
law covering all aspects of metrology, as well as laws related to
some specific aspect of metrology, such as a law on legal units, a
law on traceability, a law on legal metrology, etc., or provisions
related to metrology in more general laws such as a law on
consumer protection or a law on conformity assessment.

Governmental regulatory responsibilities include health, safety

and environmental law. While these functions are disparate in
nature, a unifying feature is that compliance with the law depends
upon measurement results. Therefore, the process of
measurement is of direct concern to the government. Providing
the laws and regulations, controlling measurement through market
supervision and/or surveillance and developing the infrastructure

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 Juridical system

supporting accuracy of these measurements (e.g. through

traceability) is essential to fulfilling the government’s role.

The importance of accurate and reliable measurement results is

ever increasing due to rapid technological development and the
emergence of the information society. Consumers must make
decisions every day, based on measurement results, which affect
their economic and personal well-being, as well as judging the
actions and efficiency of public authorities.

Since the manufacturers and sellers of most products control the

measurement process used in trade, buyers (persons as well as
companies) are at a potential disadvantage regarding
measurement results and their interpretation. This places buyers
in a weak and risky position.

The international community has adopted systems of units,

measurement standards and requirements for measuring
instruments through treaty organisations (i.e. the Metre
Convention and the OIML). In addition, regional metrology
organisations are harmonising requirements throughout their
member economies. The intent of these organisations is to
facilitate trade and exchange of measurement results. Documents
and recommendations published by these organisations are a
primary resource for structuring a national metrological
infrastructure.

Adoption of a document, such as a law on legal metrology, may

occur in one of several ways including:

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Legal metrology

- adoption by reference to a specific edition,

- adoption by including the verbatim text in the regulations,
- adoption by including identical requirements, but no identical
text,
- adoption by including compatible but not identical
requirements.

Proposals will have to be considered, selected and adapted by

each country according to the specific needs, then dispatched
among laws, government acts, ministerial acts, according to the
constitution of the country. For example, the relevant issue related
to metrology may be included in a single law, or may be distributed
in a law on legal units, a law on conformity assessment and a law
on legal metrology.

Several issues are recommended by OIML to be considered in a

law on metrology.

Metrology policy should include:

- definition of units of measurement,

- developing, maintaining and disseminating the national
measurement standards and making sure of their international
compatibility,
- support to the development of metrological infrastructure,
• scientific and technological development,
• development of the economy,
• protection of consumers and citizens,
- directing and financing of metrology research activities,

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 Juridical system

- development of education and training for metrologists,

industry and the public,
- development and adoption of metrological regulations,
- enforcement of metrological regulations,
- assessment of conformity to metrological legal requirements,
- informing the public on metrological issues.

Metrological infrastructure means laboratories, certification bodies,

training centres, documentation centres, consultancy, regulations
and enforcement, etc. in order to provide the necessary services.

The definition of the legal measurement units, their multiples and

subdivisions, their notation, shall be laid out in national standards.
It is recommended to put these definitions in documents adopted
at the most appropriate level to facilitate their updating and to
avoid unnecessary details in the acts submitted to the legislation
authorities.

The law will determine the legal measurement units and also their
realisation and the fact that they are obligatory.

Units other than the legal units may be authorised, in particular

when they are specified in the standards and their use is justified:

- by the needs of international trade,

- when they are used in international standards,
- for specific uses such as air or maritime navigation,
- for human health,
- for customary, household or non-commercial purposes.

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Legal metrology

The national measurement standards shall be traceable to the

international standards or to other recognised national standards,
or realise the definition of the legal units. Traceability may be
established through a national accreditation system or by legal
recognition of traceability to other signatories of the CIPM MRA
(Comité International des Poids et Mesures – Mutual Recognition
Agreement).

When a national metrology institute, NMI, is set up by law it has

the following objectives:

- to establish the national system of units,

- to keep and maintain the national measurement standards,
- to carry on appropriate intercomparisons to ensure their
international coherence
- to direct research work for the improvement of the national
measurement standards
- to organise transfer of technologies from research teams to
industry,
- to study the needs of society for improving and disseminating
measurements standards,
- to be the national reference for the national accreditation
system of calibration laboratories, regarding competencies and
measurement standards,
- to provide appropriate calibration and measurement services
to meet the needs of users,
- to advise the government on technical issues in metrology,
- to participate in international and regional work,

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 Juridical system

- to provide consultancy to the relevant bodies and to the public,

on metrological issues and on the importance of
measurements,
- to provide and/or organise training for trainers in metrology,
for education and improvement training bodies,
- other objectives consistent with the intent of the law.

The NMI shall be impartial and its operating resources can be

obtained from several sources:

- subsidies of the government for missions of general interest,

- contracts with the government for identified tasks required by
the government,
- verification fees for legal control activities,
- commercial services,
- grants from various organisations.

The NMI – whether public, private or a public co-ordination agency

– should be in charge of metrological research and legal metrology
technical activities, particularly the study of technical requirements
for new regulations and the type tests and approval.

This NMI can also direct the technical work for the enforcement
of legal metrology by:

- the study and propositions for the technical regulatory

requirements on the different categories of measuring
instruments,

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Legal metrology

- issuing national and OIML type approval certificates,

- the definition of the recommended equipment and technical
procedures to be applied by the local metrology authorities,
- the organisation of technical training for the staff of the central
metrology authority and the local metrology authorities,
- the training of legal metrology officials and the establishment
of minimum training and performance requirements to be met
by all legal metrology officials,
- the development and dissemination of public education
programs to support implementation of assigned
responsibilities.

In the particular case of legal metrology, our main interest, the

purpose of the resolutions must be:

- to protect the interests of persons and enterprises,

- to protect the interests of the Nation,
- to protect public health and safety,
- to protect the environment,
- to regulate measurements such as:
• sale of products by mass,
• temperature conversions for certain transactions on oil
products,
• measurement of the actual calorific power of natural gas for
certain transactions,
• measurement of surface areas for lots and buildings offered
for sale,
• measurement and information of performance of industrial
products (fuel or electrical consumption, noise levels, etc.),

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 Juridical system

• measurement and label data on the composition of food

products, etc.
- regulations for pre-packaged products,
- regulations for measuring instruments.

Legal metrology takes into account:

- punishable offences,
- liability of persons and corporate bodies, and infringements,
- evidence in prosecution.

The law on metrology must also consider the financial provisions,

that is, where will the funds come from and their management.

In some regions, because of treaties, regional texts may have

pre-eminence over national laws and regulations. This is the case
in the European Union, where European Regulations and
European Directives are higher in the hierarchy than national texts.
New members must take the necessary measures to ensure that,
from the moment of adhesion, they comply with European
directives and decisions.

These regional texts may be of direct application when it is not

necessary to transcribe them into national laws, or of indirect
application when they have first to be transcribed into national
texts.

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Legal metrology

The application can be total when national regulations must be

strictly identical to the regional texts or optional when they can be
different as long as they are compatible with the regional texts.

From the point of view of metrology authorities, in countries where

institutes outside the administration exist and have sufficient
competencies, the tasks of the administration may be reduced to
the essential actions of enforcement and monitoring. When, on
the other hand, the technical competencies lie in the
administration, it will have to direct the technical activities.

The level of centralisation or decentralisation is an essential issue

of the political organisation of the country. In the law on metrology,
it will be defined in accordance with the fundamental texts
(Constitution), with the political and administrative organisation
and with the general policy of the country. These higher principles
will have to guide the delegation of powers and missions in legal
metrology between the central authorities and the local authorities.

Metrology policy should be managed or at least co-ordinated by

one single central authority of the country (CMA). It will establish
the regulations to implement the law on metrology and will be in
charge of international relations.

Local metrology authorities can be:

- local offices of the ministries, under the authority of the CMA,

- services of states in a federal organisation or services
depending on locally elected authorities.

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 Juridical system

Their mission must be clearly defined and, when they are not
directly under the authority of the CMA, the law should include
provisions to direct the co-ordination by the CMA.

There will be laws, decrees, regulations, and dispositions, related

to the law on metrology. Examples could be specific aspects on
verification, calibration, accreditation, technical regulations, and
standards.

The general law can focus mainly on measurement units,

metrology bodies, measurement standards, instruments, and
violations of the law. Other related laws and regulations, procedure
manuals, and the like can focus on such things as: weighing
instruments, weights and their verifications; capacity
measurement, flow measurement (fuel pumps), length measures,
electric energy counters, alcoholmeters, electrocardiographs,
emissions of exhaust gases, digital clinical thermometers, digital
sphygmomanometers, pneumatic manometers, labelling, pre-
packaged or pre-measured products, labelling of food products,
liquefied gas cylinders, cosmetics including aerosols, oil,
kerosene, bottles; registers of manufacturers, importers and
repairers of measuring instruments, periodic verifications, fees
and tariffs for type approval and for primary and subsequent
verifications, technical and administrative procedures.

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Legal metrology

76
5. Administrative aspects

The actions of legal metrology are usually

dispersed among several bodies, official,
semiprivate or private, and each country follows
its own scheme according to its political and
administrative structure.

We look at aspects of such organisations in some

European and American countries and, very
broadly, at the tasks for each type of body involved.

We will then comment on administrative

procedures and some financial matters such as
fees and fines.

Most governments have set up a national legal metrology

organisation but very often a large number of responsibilities are
delegated to the States or the Municipal governments and
practically limited to commercial aspects. In most Caribbean
countries weights laws and some verification standards were
originally with the local police and, in the case of imported
merchandises, with the customs offices.

No matter what its political and administrative structure (federal

states, provinces, prefectures, cantons, municipalities), in several
countries legal metrology is centralised and there are no local

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Legal metrology

verification offices. This is the case for instance in Barbados, Costa

Rica, Ecuador, Holland, Jordan, Peru, Singapore (42,43).

There are many more governmental bodies that are involved in

metrology, often not explicitly, in areas such as consumer
protection, health, environment, communications, and agriculture.

There is today a tendency towards privatisation and deregulation

of legal metrology. This could bring about an increase in the
number of bodies acting in legal metrology and result in regulations
being substituted by other conditions with the consequence of
non-tariff barriers to trade. This point of view, if it prevails, will
require a very strong international harmonisation.

5.1. Public authorities involved in legal

metrology – some models

This is not a study on the situation of legal metrology in several

countries; they are mentioned simply to show some of the
differences and similarities in the administration of legal metrology
in countries with different political and juridical organisations.

Brazil:

In Brazil, the Metrology Institute, INMETRO, is responsible for

proposing policies and directives, co-ordinating and supervising
legal metrology activities in the country, and for the weights and

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 Administrative aspects

measures institutes – state organisations in charge of ensuring

compliance with metrological technical regulations.

Canada:

Measurement Canada, MC, of Industry Canada, is the national

organisation for legal metrology and is in charge of local and
regional verification. The National Research Council, NRC, is the
custodian of the national measurement standards and is
responsible for the maintenance of reference measurement
standards. Both entities have systems in place for the calibration
and evaluation of measuring instruments.

Chile:

The National Consumer Service (Servicio Nacional del

Consumidor) in Chile is in charge of:

- the definition of the measurement units used in the country

and their scope of application,
- the organisations who must verify and approve measuring
instruments and the reference measurement standards,
- the definition of legal procedures in those cases where the
law is not complied with,
- appointment of the organisations in charge of realisation,
custody and dissemination of national measurement
standards,
- the definition of accreditation procedures,

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Legal metrology

- specification of procedures for metrological control and control

of pre-packages.

France:

The national metrology office, Bureau national de métrologie,

BNM, created in 1969, became at the end of 1994 a group of
public interest associating the related five primary laboratories
and the two ministry departments (Industry and Research, and
Higher Education).

The five primary national laboratories in charge of measurement

standards or materialisation equipment are ascribed to five
different organisations:

- the National Metrology Institute (BNM-INM) at the

Conservatoire National des Arts et Métiers (CNAM); mass (up
to one kilogram), length, temperature, acoustics,
spectroradiometry, photometry and some derived units;
- the National Testing Laboratory (BNM-LNE) whose primary
activities are related with amount of matter, several mechanical
units, mass over one kilogram and derivatives, temperature,
radiometry, acoustics;
- the Primary Laboratory for Electricity and Magnetism (BNM-
LCIE) in the fields of electricity, magnetism and X-rays;
- the Primary Laboratory of Ionising Radiations (BNM-LPRI) for
measurement of radionuclides activity and dosimetry of
ionising radiations

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 Administrative aspects

- the Primary Laboratory for Time and Frequencies (BNM-LPTF)

whose activity is centred on frequencies and time.

The chains of measurement standards are managed by the

Comité Français d’Accréditation, COFRAC, with three traceability
levels: primary laboratories, authorised standards centres,
authorised metrology services.

According to the French themselves(1) this dispersal in the

metrology system results in a lack of visibility, the more so for
legal metrology, distributed among the twenty four research and
industry regional directorates (Directions régionales de l’industrie
et de la recherche, DRIRE), increased by the fact that not all of
them interpret identically the legal texts and that the interested
party does not always know where to turn to.

Also in France, differently from other countries, legal metrology is

totally independent from the National Metrology Office, BNM.

For this reason, the French assert that metrology is one area
where a reasonable centralisation is preferable, a fact which has
been recognised by countries with a federal structure such as
Germany or the United States of America.

Legal metrology in France is under the Sous-Direction de

Métrologie, at the ministry in charge of industry. This Sous-
Direction has several responsibilities:

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Legal metrology

- to prepare national legal metrology policy,

- to maintain the capacity required to carry out its mandates
and to see it is transferred to the bodies in charge of
implementation,
- to prepare the regulations having to do with measuring
instruments,
- to represent French legal metrology at international fora,
- to co-ordinate and direct all activities related to legal metrology.

On their part, the twenty four DRIRE have the responsibility for
control and surveillance of manufacturers, repairers, installers and
users of the measuring instruments in their respective regions,
and they must direct the activities of those regional bodies to
which they delegate legal metrology tasks. They must also ensure
coherence and complementarity between legal metrology activities
and others, particularly technical control and industrial
development.

Some groups in France (1) are of the opinion that, in Europe, there
is a gradual weakening of the role of national legal metrology and
a trend towards a European legal metrology.

Germany:

In Germany, legal regulations include the Metrology and

Verification Act (Eichgesetz) that is the equivalent of a national
law on metrology, ordinances (verification and pre-packages, for
instance) and the Directives of the European Union.

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 Administrative aspects

Responsibilities for legal metrology actions are distributed between

the Federation and the Federated States. The Federated States
(Länder) are responsible for implementation of regulations, with
the Physikalisch-Technische Bundesanstalt, PTB, as the federal
authority for metrology in Germany.

The PTB:

- sets the basic principles of scientific, technical and legal

metrology,
- carries out supervisory functions harmonisation of metrology
and safety,
- is in charge of the realisation of the legal metrological units,
- tests measuring instruments and equipment,
- co-operates with technical and legal bodies in matters
pertaining to measurements, standardisation and tests, quality
and safety assurance,
- carries out research and development work in metrology.

Germany has a Committee of the Federated States to advise the

Federal Ministry of Economy on matters related to verification
with possible legal, economic and political consequences.

The German Academy of Metrology trains those who will be

carrying out verification tasks.

Many test centres for electricity, gas, water and heat meters are
private centres, accredited by government organisations on the
basis of ISO requirements.

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Legal metrology

Spain:

The Spanish Metrology Centre (Centro Español de Metrología)

CEM, created in 1985, is transformed by law, in 1990, into an
independent commercial and industrial organisation with the
following functions:

- custody and maintenance of national measurement standards,

- setting up and development of official chains of calibration,
- State administration in metrological control for the State and
the European Community,
- official qualification of laboratories for metrological verification,
- metrological control registry,
- research and development projects in metrological matters,
- training of specialists in metrology.

The CEM is the custodian for national measurement standards

for the base units of mass, length, electric current intensity, and
thermodynamic temperature, and for the derived units for
pressure, force, volume, plane angle and density of solids.

Spain has begun a limited network of Associated Laboratories;

those that fulfil technical requirements as established for each
case, are officially declared custodians of a given measurement
standard and recognised as Laboratories Associated to the Centro
Español de Metrología.

Through agreements with the National Accreditation Organisation

(Entidad Nacional de Acreditación, ENAC) it ensures traceability

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 Administrative aspects

for the calibration laboratories accredited or with accreditation

under way, and it co-ordinates the national comparisons judged
necessary to confirm the technical competence of the accredited
calibration laboratories.

There has been a reordering of the legal metrology responsibilities.

CEM keeps the exclusive legislation capacity, the Metrological
Control Registry, and representation of the country in Community
and international matters while metrological control is carried out
by the several regional autonomous communities “Comunidades
Autónomas”.

Some of these Comunidades lack the required laboratories to

carry out the tests so that CEM acts as the supporting technical
laboratory for the regional services.

CEM carries out some activities that can be considered as purely

commercial:

- verification of ethylometers, dynamometer, opacity meters,

- testing of medical measuring instruments,
- general calibration of measuring instruments,
- Certificates of conformity to standards or tests, and OIML
Certificates,
- contracts for measurement assurance.

In particular in legal metrology, CEM does the tests for gas meters
and the State metrological control of measuring instruments or

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Legal metrology

systems for fluids other than water, as well as characterisation

and certification of electromagnetic compatibility, EMC.

United States of America:

In the United States most of the authority over legal metrology is

given to the State Weights and Measures Laboratories.

Also, diverse agencies exert authority over specific classes of

products. As an example, medicines are seldom tested, as there
are other government agencies that see to medicine safety
including accuracy of content and doses. Measuring instruments
used by service companies – electric counters, water meters,
gas meters - are regulated by other state agencies.

To promote uniform laws, regulations and standards (tests and

tolerances for measuring instruments and the procedures for
inspection of pre-packages), the National Institute for Science
and Technology, NIST, sponsors the National Conference on
Weights and Measures, NCWM.

The 50 States have adopted NIST Handbook 44 “Specifications,

tolerances and other technical requirements for weighing and
measuring devices” as recommended by the NCWM, as the legal
code governing weighing and measuring devices.

There are diverse laws and regulations throughout the nation.

However, NIST Handbook 130 “Uniform laws and regulations”

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 Administrative aspects

provides a general guide to the types of laws and regulations to

be enforced.

The need for uniformity in weights and measures was recognised

during the second meeting of the NCWM, in 1906. The following
year, basic outlines of a model law were developed and the first
“Model Law” as such, was formally adopted by the Conference in
1911.

With a single exception, the Uniform Weights and Measures Law

is automatically updated and adopted annually by all States thus
becoming, in fact, a national law. This is not the case for other
related laws that are not strictly the same among the States.

The goal of the NCWM regarding these laws and regulations is to

achieve their acceptance in all States and local jurisdictions that
have authority over such matters. The purpose of the uniform
laws and regulations is to achieve, to the maximum extent
possible, standardisation in weights and measures laws and
regulations among the various States and jurisdictions in order to
facilitate trade between the States, permit fair competition among
businesses, and provide uniform and sufficient protection to all
consumers in commercial weights and measures practices.

To ensure accurate, traceable measurements, and observance

of national and international standards, NIST manages the State
Laboratory Program.

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Legal metrology

5.2. Assignments

Total harmony and co-ordination are essential between the

National Metrology Institute (NMI) and the legal metrology body
when they do not belong to the same organisation. As legal
metrology tasks expand, they require new technical capabilities
which may not yet exist but for which the National Metrology
Institute can be prepared. Examples are the capacity of measuring
microwaves to evaluate interference and compatibility in
measuring instruments, and the new applications of high
frequencies. The legal metrology body can, in turn, help the NMI
to identify and solve legal problems related to the promotion of
uniform measurements throughout the country.

Inspection and verification are not easy to concentrate at a national

level but private enterprises, when they take care of these tasks,
must be supervised by an independent entity.

Legal metrology is global and normally cannot be assigned to a

single Ministry. This can be the case for health or the environment
when they have their own Ministry.

Standardisation can also be separated from legal metrology and

when this is the case strong harmonisation between both should
be the goal.

Let us look again at a few examples in diverse countries:

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 Administrative aspects

Brazil:

Changes are expected during the next years, particularly through

revision of the law creating the Metrology System, implementation
of metrological control, and a new relationship with the delegated
bodies.

Presently, metrological control carried out by INMETRO is done

by means of:

- regulations,
- standards of procedures,
- model technical evaluation and approval.

Delegated bodies are in charge of:

- verifications, both primary and subsequent,

- control of pre-packages,
- surveillance.

Canada:

Measurement Canada has the responsibility for:

- ensuring fairness in trade of goods and services,

- defining measurement units,
- calibrating and certifying measurement standards,
- examining and approving measuring instruments,

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Legal metrology

- verifying the accuracy and correct use of measuring

instruments used in trade,
- verifying net quantity products,
- handling customer complaints.

Accredited bodies have to undergo surveillance audits from

Measurement Canada.

France:

Co-ordination in metrology was assigned in 1969 to the Bureau

National de Métrologie (BNM) who also had to fund the primary
metrology laboratories and to organise the chains of measurement
standards in the country. This last is, since 1994, the responsibility
of COFRAC (Comité Français d’Accréditation), while BNM
continues to have scientific responsibility in accreditation
commissions.

First level tasks (measuring instruments) are more and more

delegated to private enterprises, supervised however, by the State
(ISO 9001 quality assurance, COFRAC accreditation). It is
estimated that there are around 3000 such bodies (77). Every two
years they undergo a thorough inspection in addition to an
unexpected one during the same period. The private bodies cover
the expenses of this supervision.

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 Administrative aspects

Germany:

Supervisory verification authorities have been assigned to:

- verification, metrological evaluation and special tests on

measuring instruments,
- accreditation and supervision of accredited testing centres for
measuring instruments for electricity, gas, water, and heat, as
well as the examination of technical competence of the staff
of such centres,
- supervision of pre-packaged goods and of licensed
commercial containers,
- appointment and technical competence examination for those
in charge of public weighing machines,
- recognition of measuring instruments repairing and
maintenance services,
- supervision of manufacturers who carry out conformity
assessment testing,
- inspection of the owners of measuring instruments.

The system of testing centres has been extended from electric

counters to measuring instruments for gas, water, and heat.
Accreditation of a centre requires that it have facilities and
equipment approved by the PTB. Germany considers that (48),
given the legal requirements in force, there is no need for an
additional confirmation on the capacities of the verification
authorities.

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Legal metrology

Calibrations are assigned to competent laboratories, also

accredited by the PTB but who carry out their tasks under their
own responsibility.

Spain:

We have already mentioned the main responsibilities of CEM.

In addition, CEM represents Spain in several regional and

international organisations: the Convention of the Metre, the OIML,
EUROMET, WELMEC, and the European Commission, IMEKO.
In the framework of the Convention of the Metre it has signed a
Mutual Recognition Agreement, whereby under set conditions,
national measurement standards and calibration certificates are
recognised by the member countries.

It prepares training activities to bring metrology to enterprises

and other economic agents who nowadays, due to implementation
of the ISO 9000 standards, require basic knowledge of
metrological matters.

Accreditation of test centres corresponds to a national body, the

Entidad Nacional de Acreditación (ENAC).

Although metrological control is done by the Comunidades

Autónomas, the municipalities carry out certain controls according
to municipal ordinances, such as for example everything pertaining
to road traffic that is handled by the Police.

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 Administrative aspects

5.3. Administrative procedures

Some countries, Brazil and Mexico to mention just two of them,

have procedure manuals with details, among others, such as:

- regulations,
- staff assignments,
- supervision,
- fees for metrological services (tariffs),
- documentation (formats),
- gauging for each type of measurement,
- measurement units,
- quantity labelling in packages,
- who is responsible for quality defects,
- what constitutes a quality defect,
- what is the cost of a quality defect,
- pre-packaged goods,
- surveillance of pre-packages,
- infractions and penalties,
- etc.

As an example of the degree of detail of such procedure manual,

we will look at a few sections of a manual in use in Brazil (55):

“Merchandises the main use of which is based on linear extension

must be traded in legal (SI) units of length; those based on surface,
in area units; those that are solid or granulated at 20 ° C in mass
units; those that are liquid or paste at 20 ° C in volume units;
those traded in units, in effective number of units.

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Legal metrology

“It is mandatory for packages or containers to have an indication

of the net content.

“All those who participate in the chain until merchandise reaches

the consumer are responsible for defects of quantity. There is a
defect of quantity when the net content or the number is lower
than that which is stated. Net content refers to the main product
on sale.

“No merchandise (including special offers) other than that for which
the package is destined may be included.

“All glass containers manufactured for sale of beverages must

have an indication of their capacity, stated in litres”.

5.4. Fees, fines, financial aspects

The legal metrology organisation will find it difficult to be self-

supporting, as it has to carry out many tasks of supervision and
consultancy for which it cannot charge. In addition, very often the
fees go to the national budget and are not directly assigned to
the legal metrology organisation. Even in highly industrialised
countries, verification authorities can generate only around 80%
of their operation costs.

Fees are usually charged for model approval, verification both

primary and subsequent, accreditation of test centres and
maintenance services, and supervision.

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 Administrative aspects

Fines are collected for infractions, which can be:

- use of non authorised measure units,
- use of instruments whose verification is no longer valid,
- breaking, violating or making unusable markings or control
seals,
- sale of pre-packaged products with a net content lower than
legal tolerances or than what is written on the label,
- use of packages for pre-packaged products that do not show
the net amount or do so using units not legally authorised,
- use of devices or instruments that exceed maximum tolerable
errors, detrimental to the consumer,
- non compliance with resolutions on the installation of
measuring devices or counters,
- disablement of measuring devices or counters.

The law establishes the penalty for each type of infraction.

As there are insufficient resources to inspect instruments and

businesses with the ideal frequency, state inspectors and officials
keep records of the correctness of individual instruments and of
the history of compliance of the business. Businesses with a bad
history in keeping their instruments working correctly or in
complying with the requirements for net contents in their packages
will be inspected more frequently. Constant violation of regulations
can bring about very high fines.

Those businesses and instruments with a bad history can be

inspected up to twice a year. In Germany, for instance, some
States follow a policy whereby if an instrument is rejected as

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inaccurate, the inspector must perform another inspection at a

specified later date.

Any activity contrary to regulations is an administrative offence.

For example, to pretend that an instrument has been verified or
certified when this is not true, is considered an administrative
offence. This is one reason why terminology must be used carefully
for metrological tests.

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6. Technical aspects

Technical aspects include everything related to the

setting up and operation of the physical facilities for legal
metrology tasks.

There must also be procedure manuals with details of the

protocols, standards and recommendations to be used,
and the scientific and technical training of the staff to en-
sure quality and credibility of all that pertains to legal me-
trology.

There are many documents that give recommendations

and technical criteria for all technical aspects of legal me-
trology.

Many technical issues must be taken into account when designing

and implementing a national metrology system.

Scientific and technical issues concern the characteristics of the

laboratories to keep the conditions required by the measurement
standards, the unit realisation techniques and the verification
techniques, and they include among others: building location,
stability of terrain, type of construction, estimates for the spaces
required by each activity, air conditioning, electrical supply,
equipment, installation, testing activities, accessories (79).

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Legal metrology

Some documents can be used as guides for the selection of

equipment for the most usual verification tests (69) related for
instance with mass, volume, length, angles, temperature, electric
measurements, pressure measurements, physicochemical
measurements. Progress in instrumentation requires constant
updating in the selection of equipment but it is important to follow
as much as possible the international recommendations or those
from national metrology institutes of recognised scientific and
technical competence.

The ways to carry out tasks must also be set down, usually in
procedure manuals, including protocols and standards for
instrument verification and technical application of regulations,
sample selection for statistical sampling verification, protocols for
intercomparisons, etc.

The International Organisation for Legal Metrology, OIML, has

several International Recommendations. A complete list can be
seen on its Internet web page and a few are listed in the
Bibliography. They include such things as:

- classification of measuring instruments based on their

accuracy,
- physical characteristics and metrological requirements for
different classes of weights,
- procedures for verification of commercial weights,
- metrological and technical requirements for liquid in glass
thermometers,

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 Technical aspects

- tests for model approval and primary verification of thermal

energy counters,
- reports on tests done on audiometers,
- labelling requirements for pre-packaged products,
- etc.

similar documents are also available from national metrology

institutes such as CENAM in Mexico, NIST in the United States
of America, and INMETRO in Brazil.

In a joint effort, the International Bureau of Weights and Measures,

BIPM, the International Electrotechnical Commission, IEC, the
International Federation of Clinical Chemistry, IFCC, the
International Organisation for Standardisation, ISO, the
International Organisation of Legal Metrology, OIML, the
International Union of Pure and Applied Chemistry, IUPAC, and
the International Union of Pure and Applied physics, IUPAP,
prepared a guide that sets the general rules for evaluation and
expression of uncertainty in measurement, applicable to many
different fields.

Technical tasks require staff with the appropriate education and

training and in this there must be no improvisation.

This is why efforts are done all over the world to set up
recommendations for metrology engineers, technicians in legal
metrology, contents of programs of study, as well as a wide
diffusion of the study and training possibilities and the available
bibliography.

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Legal metrology

Whatever its organisation, the national legal metrology system

must be able to guarantee the quality and credibility of its
measurements. Quality of measurements as we have already
mentioned requires the proper equipment, under proper
conditions, used by competent staff. To obtain international
recognition, it must also be able to guarantee traceability of its
measurement standards.

Credibility of the system will follow from its impartiality, from its
not making any difference between traders, producers, consumers
or government offices.

Laboratory accreditation, among others, seeks to ensure that tests

and measurements done at these laboratories, in the scope of
their accreditation, are accurate and reliable in the ranges required
by the user.

Trust cannot be legislated; all those involved in the procedures

of legal metrology must act in such a way that the system will
be trusted.

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 Regional and international...

7. Regional and international legal metrology

The International Organisation of Legal Metrology, OIML,

sets the general principles and the international harmoni-
zation of legal metrology. Its work is disseminated mainly
through its International Documents, its Recommendations
of normative status, and its Certificate System.

Other groups such as the European Co-operation in Legal

Metrology, WELMEC, and the Inter American Metrology
System, SIM, with its Working Group on Legal Metrology,
are also working towards regional harmonisation and co-
ordination of legal metrology.

Relevant today in Europe are what is known as “The New

Approach” on product regulation and “The Global Ap-
proach” to conformity assessment.

7.1. The International Organisation of Legal Metrology,

OIML.

The main international organisation for legal metrology is the

International Organisation of Legal Metrology, OIML, based in
Paris, France.

One of the tasks of OIML is to establish general guiding principles

for legal metrology. OIML advises governments on the most
convenient ways of developing sound metrology policies,

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Legal metrology

integrated into infrastructures with a wide scope. Its role is not to

interfere with government prerogatives but rather to see that
national and regional policies conform to international harmonised
guides.

Harmonisation has two objectives:

- to eliminate technical barriers to trade of measuring

instruments,
- to facilitate commerce of products and services with a
commercial value based on measurements.

OIML International Documents are prepared with the purpose of

guiding activities of the national metrology services. OIML
International Recommendations are considered as international
standards and focus on the metrological performance and the
testing procedures, not the design or manufacture of measuring
instruments.

Because of the wide variety of measuring instruments, OIML has

instrument oriented Recommendations that specify performance
requirements and testing procedures for specific instruments, and
results oriented Recommendations having to do with the
evaluation of the results of measurements.

Countries member of OIML are morally bound to transfer

international recommendations into their national regulations,
insofar as the contents of the Recommendations refers to their
legally regulated metrological sphere.

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 Regional and international...

OIML International Recommendations are the basis for European

Union Directives and thus, for the Member States, this moral
obligation becomes a legal obligation.

OIML has established a system of Certificates, of voluntary

application, referring to the types or models of instruments, not to
the individual instruments manufactured according to said models.

National legal metrology services of more and more countries

accept to accelerate the granting of national or regional model
approvals on the basis of OIML certificates and associated test
reports.

For developing countries, the OIML Certificate System is vital.

Those countries that do not have facilities to carry out model
evaluation can replace these evaluations with the acceptance of
the OIML certificates and they only have to solve the problem of
primary verification of individual instruments.

Concerning developing countries, the Development Council of

the OIML has set up a specific activity that includes identification
of technical and financial assistance and experts necessary for
the development of legal metrology.

The specific Secretariat (SP25 Developing Countries) has five

under-secretariats:

- principles, legal and administrative matters of legal metrology,

- structure and operation of a national legal metrology service,

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Legal metrology

- necessary equipment for the operation of a national legal

metrology service,
- recommendations from the point of view of developing
countries,
- teaching of legal metrology.

An OIML directory (42,43), updated online, provides the following

information for each of its 58 members and 51 corresponding
members:

1. laws of metrology
2. legal units of measurement
3. instruments subject to legal control
4. metrological control of quantities
5. services responsible for metrology
5.1. national service of legal metrology
5.2. local verification services
5.3. laboratories responsible for maintaining national
measurement standards
5.4. instrument calibration and evaluation systems
6. accreditation and certification systems
6.1. accreditation systems for legal metrology,
calibration and testing laboratories – traceability
to national, regional, international or foreign
measurement standards
6.2. legal and applied metrological activities in
product certification

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 Regional and international...

6.3. legal and applied metrological activities in ISO

9000 quality management systems.

***

At a regional level there are co-ordination efforts by large blocks:

Europe, Central and Eastern Europe, Asian Pacific,
Commonwealth, Western Hemisphere. We will briefly mention
two of them: the European and the American.

7.2. Europe

7.2.1. Regional organisations in Europe

Members of WELMEC, (Western European Legal Metrology

Cooperation) presently called the European Co-operation in Legal
Metrology, consider their most important task to harmonise and
co-ordinate the national and regional activities concerning all the
technical problems of legal metrology in order to facilitate free
trading within Europe.

The principal aim of WELMEC is to establish a harmonised and

consistent approach to European legal metrology in the light of a
number of important developments:

- accumulated experience of the operation of the non-automatic

weighing instruments Directive,

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Legal metrology

- prolonged discussion of proposals for a measuring instruments

Directive,
- the progress of a number of applicant countries towards
European Union membership,
- increasing international trade in measuring instruments and
measured goods,
- the different coverage of legal metrology in various countries.

7.2.2. The New Approach and the Global Approach in Europe

The European Single Market is an economic space where goods,

services, capital and labour can circulate freely (23). The European
Union has developed original and innovative instruments to
remove the barriers to free trade and this is one of the cornerstones
of the Single Market. Two of these instruments stand out:

- the so-called New Approach to product regulation,

- the Global Approach to conformity assessment.

The working mechanism of the New Approach is based on:

- prevention of new barriers to trade, for instance by avoiding

adoption of diverging national technical standards and
regulations,
- mutual recognition, based on the following key elements:
• products legally manufactured or marketed in one member
state should in principle move freely throughout the

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 Regional and international...

Community if they meet equivalent levels of protection,

• in the absence of Community measures, Member States
are free to legislate on their territory,
• barriers to trade which result from differences between
national legislations, may only be accepted, if national
measures:
< are necessary to satisfy mandatory requirements,

< serve a legitimate purpose,

< can be justified with regard to the legitimate purpose and

are proportional with the aims,

- technical harmonisation is based on the following principles:
• legislative harmonisation is limited to essential requirements,
• technical specifications of products are laid down in
harmonised standards,
• application of harmonised European standards remains
voluntary and the manufacturer may always apply other
technical specifications to meet the requirements,
• products manufactured in compliance with harmonised
standards benefit from a presumption of conformity with the
corresponding essential requirements.

The Global Approach to conformity assessment is based on the

following guiding principles applicable in the regulated and in the
non regulated fields:

- the use of modules for the various phases of conformity

assessment procedures and laying down of criteria for the
use of these procedures,

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Legal metrology

- generalised use of European standards relating to quality

assurance (EN ISO 9000 series) and of the requirements to
be fulfilled by conformity assessment bodies,
- promotion of setting up of accreditation systems and the use
of intercomparison techniques among Member States,
- promotion of mutual recognition agreements concerning
testing and certification in the non-regulatory sphere,
- minimisation of differences in the existing quality
infrastructures,
- promotion of international trade through mutual recognition
agreements, co-operation and technical assistance
programmes.

Conformity assessment is based on:

- manufacturers’ internal design and production control activities,

- third party type examination combined with manufacturers’
internal production control activities,
- third party type or design examination combined with third
party approval of product or production quality assurance
systems, or third party product verification,
- third party unit verification of design and production,
- third party approval of full quality assurance systems.

Before placing a product on the Community market, the

manufacturer must subject the product to a conformity assessment
procedure provided for in the applicable directive, with the view
to affixing the CE marking.

108
 Regional and international...

Member States must presume that products bearing the CE

marking comply with all provisions of the applicable directives
providing for its affixing. Accordingly, Member States may not
prohibit, restrict or impede the placing on the market and putting
into service in their territory of products bearing the CE marking
unless the provisions relating to CE marking are incorrectly
applied.

New Approach directives are of total harmonisation and Member

States must revoke any contradictory national legislation. The
directives are binding in regard to the results to be obtained but
they leave the Member States at liberty to select ways and means.

In brief, we can say that in the European Single Market,

responsibility is transferred step by step to the manufacturer of
measuring instruments, as long as he has in place a quality system
recognised and supervised at regular intervals by a certification
body (notified body) designated by the member state.

In the case of measuring instruments, with the New Approach

only the essential requirements to ensure measuring certainty of
the measuring instruments will be laid down in the European Union
Directives and they will be based on OIML activities. Technical
requirements to be met by measuring instruments will be laid down
in the respective European standards (CEN and CENELEC).

However, there cannot be free circulation of goods and a

liberalised access to markets without the proper control of

109
Legal metrology

measurements and this entails an obligation for market

surveillance on the part of the Member States as laid down in the
EC directives.

7.3. America

In the Western Hemisphere the Inter American System of

Metrology, SIM, has been created to promote metrology in
America.

SIM groups the countries of the Western Hemisphere in five large

regions: NORAMET for the countries of North America, CAMET
for those of Central America, ANDIMET the Andean countries,
SURAMET the countries of South America, and CARIMET the
Caribbean countries.

SIM has established a Legal Metrology Working Group with two

subgroups. Both have as their objective the harmonisation of legal
metrology requirements and activities in the Americas in
consideration of OIML Recommendations and Documents.

Subgroup 1 addresses Laws and Regulations and its scope is to

contribute to developing and maintaining mutual confidence
between Legal Metrology Services in the Americas through:

- harmonising elements of legal metrology regulations,

- promoting the consistent interpretation and application of
legal metrology regulations.

110
 Regional and international...

The scope of Subgroup 2, Metrological Control of Measuring

Instruments and Pre-packaged Products is to contribute to
minimise technical barriers to trade through:

- providing confidence in measuring instruments under legal

metrological control used for carrying out measurements for
equity in trade, public and worker health and safety, and
environmental protection,
- developing a regional mutual acceptance arrangement for
accepting and utilising type evaluation,
- providing harmonised means and procedures for verification
and tests.

For instance, a recent survey among SIM members showed there

is still no uniform application of requirements for metrological
control of pre-packaged products and that, particularly, not all legal
metrology services are using the corresponding OIML
Recommendation. Currently, SIM members are actively working
to modify this situation and to attain a better regional
harmonisation.

111
Legal metrology

112
8. The future of legal metrology

It is necessary to be prepared for the new

challenges faced by legal metrology, that
will come from the deep changes brought
about by new technologies and technical
progress.

In September 2002 an international seminar sponsored by the

OIML was held in Saint-Jean-de-Luz (France) under the title What
will legal metrology be in the year 2020. This seminar reviewed
the evolutions that legal metrology is facing, and the long-term
perspectives in the context of which the goals of legal metrology
will have to be attained.

Some of the relevant points reported in its Conclusions and Report

(63)
are:

“In the not too distant future, it is likely that all technical progress
and all new technologies in measuring instruments will emanate
from a limited number of multinational manufacturers and used
worldwide, and very often at a lower cost than traditional
technologies. National manufacturers will probably limit their
activity to adapting these international products to specific local
needs.

113
Legal metrology

“Metrology is often considered as a necessity for industry that

should be financed by the private sector, and legal metrology is
too often considered as an old fashioned regulatory task that could
be replaced by standardisation and the promotion of quality, both
voluntary… However, some international organisations
(essentially the WTO and UNIDO) have understood that an
adequate metrological infrastructure is necessary for
development.

“’Stand-alone’ instruments will give way to systems that are

integrated in networks, perform complex functions, associate
different kinds of measurements and manage numerous
measurement results. The elements of these systems will not be
complete instruments but sensors, modules of instruments and
data processing systems, all of which will interact with each other.

“Instruments and systems will be able to carry out tasks that are
presently reserved only for metrology or other specialized bodies;
self-verification, maintenance assistance and adaptation of their
behaviour to environmental conditions or to measuring conditions.
Future instruments and systems may even be able to develop
relatively intelligent fraudulent behaviour and to prevent such
behaviour from being detected by legal metrology officials.

“The scope of these measuring systems will be considerably

enlarged. They will cover a wide variety of measurements and
quantities in nearly all fields of human activity. The integration of
measuring devices in global networks, often using the Internet,

114
 The future

will require legal metrology to address the entirety of these

networks.

“At national level, legal metrology authorities will have to face up

to the new, considerably higher stakes of metrology. They will
have to carry out their tasks with limited or partial resources, and
still address a wider scope of measurements and advanced
technologies. They will need new skills to deal with these new
fields and technologies, probably with fewer staff. They will have
to demonstrate the utility of legal metrology to political decision-
makers whose awareness of technical issues will be very low.

“International harmonisation, mutual confidence and mutual

recognition among legal metrology bodies and authorities are not
only a necessity for trade facilitation, but also for fulfilling the
missions of legal metrology at national level. Legal metrology work
will have to be globalised, or it will be ineffective.

“The OIML must also urgently begin to study the general structure
of conformity assessment procedures in order to adapt them to
new technologies, to the new structure of measuring systems
and to that of production and maintenance. An OIML Document
should be produced to give guidance on the new skills required
by enforcement authorities and conformity assessment bodies.
Such skills are required for legal metrology authorities,
enforcement officers and conformity assessment officers, due to
the evolution in technologies.”

115
Legal metrology

116
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