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Mr. Gerard Faber's Speech
Legal Metrology in the World and in the Regions
-Working on Mutual Acceptance of Test Results
Legal metrology supports development
Legal metrology and economic development are closely interrelated, and facilitating such development requires a coherent network of scientific, technical, transport, commercial, educational and social infrastructures. All these infrastructures are in need of metrology, as they extensively use measurements whose reliability is dependent on a national metrological infrastructure.
If we look at the commercial and social aspects of these infrastructures, we see that legal metrology has quite an important role to play in the metrological infrastructure in supporting economic development.
For domestic trade to function correctly, confidence and fair competition are essential elements to consider.
Legal metrology aims at developing confidence in the measurement results used in trade. Without such confidence in recognized measurement results, the economic actors would tend to duplicate measurements, which would lead to a considerable number of disputes and result in weak domestic trade.
Legal metrology ensures that no false measurements can affect fair competition. Measurement results allow the comparison between product qualities and quantities, and their price. In this way, legal metrology is not only a tool for consumer protection, but also ensures fair operation of the domestic market.
The development of international trade requires that the interests of the national importers and exporters are protected. Here again, legal metrology is able to provide the confidence needed by importers and exporters.
The protection of health, safety and the environment is an essential element of social welfare, which has to accompany economic development. Legal metrology participates in this kind of protection by providing reliable measurement results for health, safety and the environment.
Metrology in general is necessary for the individual development of companies, but legal metrology brings more to a country. Legal metrology renders the development of trade and industry beneficial to society as a whole.
Development results in needs for legal metrology
On the other hand, economic development results in the development of measurements, in the use of sophisticated technologies in everyday life, in commercial transactions based on more complex measurements, and in health, safety and the environment being subject to more and more kinds of advanced measurements.
A typical consequence of economic development is the development of utility metering (gas, water, electricity). Confidence in utility metering has then to be addressed by legal metrology.
Another example is the trade of cereals. With economic development, instead of only measuring the volume of grain, not only international transactions but also progressively domestic transactions are based on the measurement of mass, density, humidity, impurity content, protein content, pesticides, etc. Even the detection of genetically modified organisms may be an aspect of the required measurements.
With economic development, protection of health and the environment increases and requires the measurement of pollutants in water, pollutants and toxic substances in food products, quality and non contamination of medicines and vaccines, etc.
Individuals cannot possess the technical competence to evaluate the level of reliability of all these measurements, which expand the scope of legal metrology as they develop.
Globalization and international trade require confidence in measurements
Globalization renders economies more and more inter-dependent. The proportion of GNP spent on imports as well as that resulting from exports is growing. The specialization of economies makes the trade of commodities more intensive, and industrial products are now manufactured for a global worldwide market.
International trade is facing developments similar to that which domestic trade faced in the development of economies. The same issues regarding confidence, protection of weaker parties and fair competition are now to be considered in international trade as they were considered at the national level.
Globalization requires the establishment of confidence between companies at international level, buyers, suppliers and subcontractors, and the establishment of state confidence in these measurements. This calls for a global measurement system in which measurements are traceable to international measurement standards or national standards of recognized equivalence.
This also calls for an appropriate level of protection of the weakest parties in international transactions. At the international level, companies and countries play the roles that are played at domestic level by companies, local authorities, customers and citizens. The weakest parties are companies located in countries where the technical facilities are not available, or the countries themselves. Weakest parties may also be companies which buy products or commodities from a company or a country occupying a dominant or monopolistic position.
A global legal metrology system at international level still has to be devised. But already the cooperation of legal metrology authorities within the OIML, the harmonization of national legal metrology regulations, assistance in the development of national legal metrology systems, are essential actions by which the OIML sets the first elements of such a global legal metrology system.
WTO TBT agreement calls for recognitions
The agreement on Technical Barriers to Trade (TBT), in the World Trade Organization (WTO), contributes to the development of international trade respecting fair competition. There are two ways of eliminating barriers due to different national technical regulations: eliminating these regulations when they are not justified, or harmonizing them and developing mutual recognitions. Obviously it is not possible to envisage the suppression of technical regulations in a number of fields where these technical regulations aim at protecting health, safety or the environment, or at protecting consumers.
Harmonization is then an essential tool for eliminating these barriers. The TBT agreement specifies that countries should base their technical regulations on recognized international standards. International standard-setting organizations are consequently of major importance, and are recognized as observers by the WTO TBT Committee and participate in several studies with the TBT Committee secretariat, such as thoughts on the way to facilitate developing countries access to their standardization work.
The main purpose of the international standardization bodies (ISO, IEC) is to harmonize standards so that the technical relations between industry and buyers, manufacturers and users of products, can be facilitated. The OIML also has this goal, but fundamentally and primarily the OIML aims to harmonize legal metrology regulations. International standardization bodies bring together national standardization bodies, and these national bodies try to reach a consensus between producers, users and consumers. The OIML directly addresses the goals of the WTO TBT agreement, by bringing together and committing national regulatory authorities who are in charge of balancing the interest of all concerned parties. The necessity of reaching a consensus among all the interested parties is a method of work recommended by the OIML.
But harmonization is not sufficient to eliminate technical barriers to trade, and must be completed by the elimination of all unnecessary duplication of testing and legal certification. This is why mutual recognitions are of great importance for the facilitation of international trade. Technical barriers to trade in the field of legal metrology will be eliminated when an instrument or a measurement which is recognized as being acceptable in one country will be ipso facto recognized as being acceptable in other countries. Two ways of achieving this are possible: either developing mutual recognitions among the widest possible group of countries, or setting up an international certification system recognized by these countries.
Such an international certification system would be the beginning of a global worldwide legal metrology system. But it cannot be installed without establishing mutual confidence. The development of mutual recognition agreements is the first step towards this global system, it can provide experience and confidence in working together on the same harmonized requirements, and it answers the immediate needs for the facilitation of international trade. The OIML has set up the first element of such a global system by developing the OIML Certificate System, which is a voluntary system under which issuing authorities designated by the CIML Members accept to follow general rules and issue certificates of conformity of types of instruments with the applicable OIML Recommendations. This first element has to be completed by the elements necessary for mutual confidence, and then by elements concerning the certification of individual instruments.
Countries are revising their laws on metrology
Most countries have identified the importance of metrology and the need to adapt their metrological infrastructures to technological progress, to the evolution of economic and social needs and to that of international relations. Although all the stakes of metrology and legal metrology are not always fully understood and are rarely evaluated, the necessity to restructure national metrology systems is clear.
Many countries are revising their national law on metrology, or intend to revise it shortly. This may be due to various situations:
developing countries want to set up a national metrology system in order to be recognized as a partner by other developed countries, and to help their producers to have better access to the international market,
countries in transition need to adapt and modernize their legislative structures for metrology in order to adapt them to a market economy,
developed countries need to address the technological evolutions in their national metrology system.
Mutual recognitions may sometimes be prohibited - or at least rendered quite difficult - for legal reasons. This situation is quite an important opportunity for the OIML to encourage these countries to introduce those elements in their legislative system which will allow and facilitate the harmonization of regulations, mutual recognitions and more generally the development of mutual confidence.
Regions are increasingly active in legal metrology
Regional activity in metrology and legal metrology is increasing. Most Regions have set up an organization for cooperation in metrology, often within the framework of a more general regional cooperation (APEC, SADC, EU, OAS). Some of these regional organizations are globally dealing with metrology, with a specific subgroup for legal metrology (COOMET, SIM), while others are distinct organizations for scientific and for legal metrology (EUROMET-WELMEC, APMP-APLMF, etc.).
The objectives of RMOs and RLMOs are globally to foster the development of metrology in the regions and to build mutual confidence. Concerning legal metrology, these objectives include actions such as:
developing mutual information on the national metrology systems,
harmonizing the practices in testing and evaluating measuring instruments,
developing training courses on testing and evaluating measuring instruments,
organizing regional intercomparisons,
developing mutual recognition agreements at regional level,
studying specific regional issues of legal metrology (grain moisture for example),
developing regional contributions to the work of the OIML,
studying the regional needs for facilities and the possibility of sharing facilities,
supporting developing countries in the Region (training, fellowship, etc.).
It must be noted that these actions do not compete with those of the OIML, but are complementary. The work undertaken by the RLMOs cannot be efficiently done at the OIML level and it is of major importance that these regional organizations contribute to the goals of the OIML by such activities.
Mutual recognitions are being developed in most fields related to metrology
The international community of metrology and accreditation recognized the need for mutual recognitions years ago. Each international organization has developed or is developing mutual recognition agreements to set up sound bases for the elimination of technical barriers to trade. In addition to the OIML draft MAA, three agreements or arrangements will be soon applicable and will form a coherent set:
The CIPM mutual recognition arrangement, which is being put into application, describes the degree of equivalence of the national measurement standards and of the calibration capacities of the national metrology institutes. This is the first level in the hierarchy of recognitions.
The ILAC MRA will establish the equivalence of accreditation of calibration laboratories and of testing laboratories. Starting from mutually recognized national measurement standards, the accreditation of the traceability chains will then provide consistent and recognized laboratory measurements and test results.
The IAF MRA will establish the equivalence of the accreditation of product certification bodies and quality systems certification bodies. The test results utilized in the product certification being covered by the above mentioned agreements, the product certification bodies may then be granted international confidence, under the IAF MRA.
These three mutual agreements allow confidence to be developed internationally in the services of accredited laboratories and in the performances of certified products. Metrology forms one essential basis of these mutual recognitions, and is necessary for allowing recognitions and free trade.
These agreements can result in considerable facilitation of international trade, providing that accreditation attains its goals which are to provide adequate confidence in the services of accredited bodies. Metrology and traceability provide a sound basis to the accreditation system for developing confidence. The two questions which now need to receive a positive answer are the following:
Do all accreditation systems presently inspire sufficient confidence to the decision makers in the different countries, so that they just rely on accredited laboratories' services and on products certified by accredited bodies?
Will this level of confidence be kept when implementing the MRAs, that is to say will these decision makers trust their accreditation bodies to recognize only reliable accreditation bodies?
These two questions are key issues for the success of the above-mentioned MRAs and to some extent also for the OIML mutual acceptance arrangement which is being developed. If the answer to these questions is not positive, then the accreditation bodies will loose the confidence of their stakeholders and will simply run the risk of disappearing. Accreditation bodies may be tempted to easily accept mutual recognitions in order to be recognized and to obtain a good commercial position from this. But to accept recognitions too easily may affect their credibility and weaken their position.
This dilemma is quite difficult to solve and will require close attention from the accreditation bodies. Although it has not been expressed in these terms by the CIML Members, this dilemma is also an essential question which lies behind the present work on the OIML MAA and makes this project so difficult.
Accreditation and recognitions in legal metrology
The three mutual recognition agreements developed by the CIPM, ILAC and IAF, could be considered as being almost sufficient to allow mutual recognitions in legal metrology. The principles envisaged would be the following:
the OIML sets up harmonized technical requirements and test procedures,
the CIPM MRA ensures a recognized basis for traceability,
the ILAC MRA ensures the traceability of calibrations and confidence in test results,
the IAF MRA ensures the recognition of type approvals and initial verifications.
Such an approach would indeed be logic, simple and consistent and ideally should provide international recognition of the legal control of manufactured instruments. In this case the OIML would not need to study a specific mutual agreement system, and would just have to focus on the harmonization of requirements and test methods and on providing the technical expertise required by the accreditors.
In practice, this approach faces three difficulties for legal metrology.
A general problem which is linked to the culture of regulatory authorities is that those responsible for laws and regulations are generally not keen on delegating powers to bodies working in the voluntary field. Charging the international community of accreditors, who are not enforcement authorities, to designate by accreditation the bodies who will issue type approvals and perform initial verification, is not thinkable in a number of countries. This would imply such major changes in the laws on legal metrology or weights and measures that the missions, nature and very existence of the legal metrology authorities would be considered as questionable.
In the same way as setting up regulatory requirements cannot be delegated to national standardization bodies and likewise harmonizing regulations cannot be delegated to international standardization bodies, designating bodies for performing legal controls cannot be put into the sole hands of accreditors, who are not responsible for implementing the regulations.
The second problem is technical. Legal metrology requirements cannot be as descriptive as the requirements generally used for product certification. Certified products generally have to comply with specified performance requirements when installed and used in specified conditions. The behavior of certified products when installed or used outside the specified conditions is not taken into consideration in the usual standards and in the usual product certification.
On the contrary in legal metrology, an instrument has to comply with general performance requirements whatever the user may do or whatever the conditions may be. Without prejudice to the measurements, instruments must withstand or react adequately to errors of manipulation, fraud attempts, tampering, extreme climatic, electromagnetic or electrical conditions, internal failures, shocks, etc. Such perspectives never occur in usual product certification, and up to now, accreditations have not be designed for such product evaluations.
The third aspect is the confidence of national legal metrology authorities in the national accreditation bodies and the relations between them. They vary considerably from one country to another. There are two extreme cases:
In some countries, the accreditation body was directly or indirectly founded by authorities in charge of technical regulations (including legal metrology) and has become independent while keeping close relations with these authorities. The culture of the accreditation body is close to the culture of the legal metrology authority and the level of confidence is generally good.
In some other countries, the accreditation body has been set up at the initiative of laboratories and certification bodies, and has been more or less considered as a counter-power to the regulatory authority. In this case the level of confidence of legal metrology authorities in the accreditation body is low.
The three MRAs mentioned above are a very important tool for mutual recognitions and must be utilized for the OIML mutual recognition project. However, these three MRAs are not sufficient to give mutual confidence in legal metrology certifications and controls, and must be complemented by specific provisions in the OIML system.
The draft OIML MAA
The ideal situation in the future would be to have an OIML system under which measuring instruments certified in one country could be put into service in other countries without any additional national type approval or initial verification, and measurements performed under an appropriate supervision would be recognized. This is what is expected from a Global Measurement System.
Two ways of achieving such a system are envisageable: either the mutual recognition of national measurement systems or the establishment and recognition of an international certification system driven by the OIML with the participation of regional and national bodies. In both cases mutual confidence is necessary. Legal metrology controls in all countries include the following activities:
For allowing instruments to be put into service:
type testing and type evaluation test results,
certification of conformity of a type of instrument with the specified requirements,
individual instrument testing and test results,
certification of the conformity of individual instruments with the type.
In addition, for the required confidence in measurement results:
supervision of maintenance, integrity and traceability in service, and of the use of the instruments.
The development of mutual recognitions or acceptance of type certifications and individual certification may require adaptation of laws and regulations in some countries in order to allow this acceptability.
In any case the progression towards a Global Measurement System requires in the first place mutual confidence in test results and recognition of these results. This is a first step which has to be achieved before envisaging further developments. This is why the OIML draft Mutual Acceptance Arrangement, which initially aimed at recognizing OIML certificates, is now limited to the acceptance of test reports and test results associated with OIML certificates.
Three issues have raised difficult debates in this draft MAA:
The nature of the commitment and the respective role of the different bodies involved (CIML Member, issuing authorities, etc.) had to be clarified.
The scope covered by the words "test results" might be differently understood in different countries. As explained earlier, tests in legal metrology are not all described by a test procedure and their results are not always quantitative. The examination of fraudability, for example, cannot be as fully defined as the evaluation of measurement errors may be. Comparison of practices and results of such examinations cannot be performed easily and mutual confidence on such issues is more difficult to develop. Therefore some countries do not consider the conclusions of these examinations as test results.
The way to develop mutual confidence has been a central debate in this draft. As explained earlier, there are differences in the level of confidence of Members in the capacity of accreditation bodies to assess the competences in legal metrology. Two alternative ways of developing mutual confidence had to be included in the draft MAA: using accreditation or using the judgment of legal metrology bodies. The ways to define the alternative to accreditation were studied: self declaration, self assessment, peer review, peer assessment, peer evaluation, intercomparisons, etc. The wording and the meaning of these different methods were of major importance in the discussions.
Further progress towards a Global Measurement System
The first step achieved with the OIML MAA will be followed by other projects in order to progress towards a Global Measurement System. Most developing countries import measuring instruments produced in industrialized countries, and do not have the necessary facilities locally to control these measuring instruments. They have to rely totally or partly on tests and controls performed in other countries to ensure the conformity of the types with the requirements and of the individual instruments to the types.
The MAA will develop confidence in type testing and will facilitate national type approval for these developing countries. But type approval without appropriate means of ensuring the conformity to type of individual instruments is useless. It is then necessary to set up an OIML system for the certification of individual instruments, including conformity to type and testing for initial verification.
This will first require the questions related to non standardized examinations and evaluations in the process of OIML certificates to be fully clarified: fraud, reliability, software examination, etc. The present MAA will allow countries and bodies to sign declarations of mutual confidence in the near future, but these kinds of examinations may not be recognized in the frame of this MAA. Confidence in the results of these examinations must be developed, by developing guides and procedures (for software examinations for example), and/or by mutual exchanges and mutual knowledge, by peer visits and reviews, by intercomparisons, etc.
Initial verification should be addressed. This requires ways of ensuring the conformity to type of individual instruments to be defined, and also the individual or statistical tests to be performed. This step will interfere more deeply with the organization of legal metrology in the Member States, than the present MAA does. Recognition of test results may be applied in all kinds of organizational schemes of legal metrology. The body in charge of type approval evaluations may, if it is allowed to, accept and utilize the test results provided by other participants of the MAA. When considering initial verification, questions of principle are raised: the acceptance of evidence of conformity provided by the manufacturer and the conditions under which this evidence may be accepted, the legal acceptability of statistical control, etc. The system to be defined and put in place by the OIML must be legally acceptable in the countries. In a number of cases, this could require changes in the laws and regulations of the countries. In order for this project to succeed, it will probably be necessary to develop and adopt an OIML document describing in a consistent way the procedures of conformity assessment recommended by the OIML.
Recognition of measurement results is an outstanding issue for trade of commodities. This does not need in all cases legal recognition of the type approval and initial verification of the instruments used for these measurements (these instruments are not installed in the country that envisages recognizing measurement results, but in the other country). But it needs confidence in the conformity and traceability of the instrument, as well as confidence in the maintenance of the instrument and in its good use.
A plan and a work program for working out all these future developments will be necessary. To work out all these issues one after the other would require too lengthy delays that the OIML Members could not accept. A number of issues will have to be studied in parallel in order to obtain results in a reasonable time.
The role of the Regions in OIML recognitions
When implementing a mutual agreement which includes many countries from all the Regions, it is not possible to undertake all the work in a centralized way at international level. This is why Regional Metrology Organizations play an essential role in the CIPM MRA and run regional activities which complement the centralized activities. In a similar way, the implementation of the OIML MAA will call for the active involvement of the Regional Legal Metrology Organizations.
A first general consideration is that mutual confidence in legal metrology needs frequent direct contacts, and technical exchanges on common practical issues. Such contacts and exchanges cannot be easily developed at international level, but much more easily at regional level. In WELMEC for example, a type approval agreement could be signed without any formal procedure of accreditation or peer review, due to:
the very frequent contacts between all the national legal metrology bodies,
the fact that the same type of instruments are currently type approved and used in all the WELMEC Members and that exchanges of information about these instruments were already well developed.
The OIML can in no case organize enough exchanges between all its Members, but can build bridges between the Regions, through some Members and by facilitating the coordination of regional activities.
The implementation of the MAA will require technical experts to participate in the accreditation work and in the peer assessment work. These experts should come mainly from the region of the applicant, in order to keep the costs of the MAA implementation down to a reasonable level. The RLMOs should then identify the available competent experts for these tasks.
When intercomparisons will have to be organized, they should be organized in the same way as the Meter Convention does: a limited international intercomparison complemented by regional intercomparisons. This will also be an essential role of the RLMOs.
The RLMOs will also have to promote the MAA regionally and help their members to participate in this MAA. The participation in the MAA may require technical assistance for the preparation to accreditation or peer assessment, training, etc.
The feedback from the RLMOs concerning the operation of the MAA and of the declarations of mutual confidence will be of major importance. The RLMOs should take care of the representation of their region in the "ad-hoc Committee for Participation Review" which will assure the operation of each declaration of mutual confidence. The RLMOs will be able to identify the shortcomings of the system and to have them taken into account and solved either at the level of the ad-hoc Committee or at the level of the OIML when the MAA document has to be revised.
The role of the RLMOs will of course become more and more important as the further developments mentioned above progress and come into force.
Conclusion
OIML technical work aims at harmonizing regulations, with the objective of eliminating technical barriers to trade due to differences in national legal metrology requirements. In this perspective, the development of OIML Recommendations is not sufficient to eliminate these barriers and must be complemented by a system of mutual recognitions.
We are at the beginning of this work, the OIML Certificate System already being in place, and a system of mutual recognitions of type approval test results being defined. This Mutual Acceptance Arrangement will be discussed at the next CIML Meeting, with a view to proceeding with its adoption as soon as possible. The role of Regional Legal Metrology Organizations will be of major importance for spreading this system of mutual acceptance and for ensuring its correct implementation.
This process of developing mutual recognition systems will continue towards recognition of initial verifications and recognition of measurement results in international trade, and will require a more and more active role on the part of the Regional Legal Metrology Organizations.
By this cooperation within the OIML and with the Regional Legal Metrology Organizations, and by the cooperation with International and Regional Organizations of metrology and accreditation, we shall progress towards a Global Measurement System.
In this perspective, the OIML has tightened its links with other Organizations such as the Metre Convention and ILAC, and started new common work:
the revision of OIML Document No. 1 "Law on Metrology", which will give advice to the Member States for the evolution of their legislation to facilitate their participation in the Global Measurement System and to support the economic and social development,
the setting up of a Joint Committee for the Coordination of Technical Assistance to Developing Countries.
The coordination with the Regional Legal Metrology Organizations also has to be intensified, and proposals will be discussed in the CIML , in particular with the project of setting up a Council for RLMO Coordination within the OIML structures.
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