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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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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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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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- 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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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, Asi an Paci fi c,
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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- 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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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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- 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,
- mi ni mi sati on of di fferences i n the exi sti ng qual i ty
infrastructures,
- promotion of international trade through mutual recognition
agreements, co-operati on and techni cal assi stance
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.
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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
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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.
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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
metrol ogy servi ces are usi ng the correspondi ng OIML
Recommendation. Currently, SIM members are actively working
to modi fy thi s si tuati on and to attai n a better regi onal
harmonisation.
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