International Organization of Legal Metrology Organisation Internationale de

International Organization of Legal Metrology Organisation Internationale de Métrologie Légale The OIML and legal metrology International harmonisation in the regulation of measuring instruments Ian Dunmill Assistant Director, BIML 1

Metrology, not meteorology! Metrology is the science of measurement 2

Who looks after metrology at the international level? Scientific metrology § Bureau International de Poids et Mesures § Established in 1875 § Sèvres, France Legal metrology § Organisation Internationale de Métrologie Légale § Established in 1955 § Paris, France 3

Metrology infrastructure § Scientific metrology – carries out research in metrology – establishes the SI – realises and disseminates definitions of units § Legal metrology – sets up regulations on measuring instruments and measurements – organises and carries out regulatory control – assesses the implementation of regulations 4

Metrology infrastructure § Scientific metrology – carries out research in metrology – establishes the SI – realises and disseminates definitions of units § Legal metrology – sets up regulations on measuring instruments and measurements – organises and carries out regulatory control – assesses the implementation of regulations 5

Definition of legal metrology “Legal metrology is the practice and the process of applying regulatory structure and enforcement to metrology. It comprises all activities for which legal requirements are prescribed on measurement, units of measurement, measuring instruments and methods of measurement, these activities being performed by or on behalf of governmental authorities, in order to ensure an appropriate level of credibility of measurement results in the national regulatory environment…. ” (OIML D 1: 2012 “Considerations for a law on metrology”) 6

Definition of legal metrology “Legal metrology is the practice and the process of applying regulatory structure and enforcement to metrology. It comprises all activities for which legal requirements are prescribed on measurement, units of measurement, measuring instruments and methods of measurement, these activities being performed by or on behalf of governmental authorities, in order to ensure an appropriate level of credibility of measurement results in the national regulatory environment…. ” (OIML D 1: 2012 “Considerations for a law on metrology”) 7

Scope of legal metrology § Measurements may fall within the scope of legal metrology when: – those affected have conflicting interests – those affected do not have the competence or the possibility to evaluate the reliability of the measurement results – legal evidence is needed of measurement reliability – health & safety require reliability of measurement 8

Scope of legal metrology § Measurements may fall within the scope of legal metrology when: – those affected have conflicting interests – those affected do not have the competence or the possibility to evaluate the reliability of the measurement results – legal evidence is needed of measurement reliability – health & safety require reliability of measurement 9

Why do we need legal metrology? § In legal metrology: – measuring instruments are designed for operators with no competence in measurement – measurement procedures are described simply in the instrument’s operating manual – environmental conditions are not controlled, so instruments must be designed for a range of environmental conditions and disturbances – operator impartiality cannot be assumed, so instruments must be protected against fraud § Confidence in a measurement is based on confidence in the instrument and on regulatory surveillance 10

Legal metrology in society § Consumer level – shops / filling stations / utilities / health / environment Affects everyone’s daily life § Industrial level – processed / packaged products – trade in measuring instruments Affects a large number of companies in a given country § National level – international trade in raw materials / fuels / public health / environment Affects national economies 11

How does legal metrology affect you? § § § § When you buy fruits, vegetables, meat, fish … When you buy products in a box, a can, a jar. . . When you use utilities at home – electricity, gas, water. . . When you fill your car with fuel. . . When you drive – speed, alcohol, emission controls. . . When you visit the doctor or hospital. . . When you go to work – levels of light and noise. . . Do you think about these things? . . . or does “somebody look after them” for you? 12

Who looks after these things? § If you live in an industrialised country, you don’t think of these things: – “Somebody” looks after all that! – “Somebody” regulates that, – “Somebody” has standards of weight, volume, … § If you live in a country without a legal metrology system, you still don’t think about these things, but: – “Somebody” doesn’t look after all that! – There may be no regulations! – The standards may not even exist in your country! 13

How can legal metrology help a society to develop? Trade § Makes it fairer § The poorest get the right quantity for the little money they have – staple foodstuffs § Farmers get the correct payment for their work § The economic conditions of the country improve, and poverty is reduced 14

How can legal metrology help a society to develop? Export of bulk raw materials § Ensures measurement of products is fair and that correct price is paid § Ensures governments receive correct taxes on exported products § Improves national economy 15

How can legal metrology help a society to develop? Surveillance of prepackaged products § Excessive under-filling is very common § Example – a study in Jordan showed that many cans of olive oil which should contain 2. 7 L only really contained 1. 8 L! § Again, fairer trade, better economic conditions 16

How can legal metrology help a society to develop? Road safety § Overloaded lorries § Speeding § Blood alcohol level § Road accidents are very expensive, and often affect the youngest / poorest § In Vietnam, the cost of road accidents is estimated to be 5 % of GDP 17

How can legal metrology help a society to develop? Health § Improvements in basic healthcare § Improvements in the health of the poorest § Reduction in costs to public finances 18

The OIML § § The OIML is an intergovernmental organisation established by treaty in 1955 The members of the OIML are countries (Member States) One country = one vote Each country is represented – in the OIML Conference, by a delegation designated by their government – in the International Committee of Legal Metrology (CIML), by a CIML Member designated by their government § § The CIML Member is normally the person responsible for national legal metrology The OIML is considered as an “international standardising body” by the WTO 19

OIML Membership 62 Member States 65 Corresponding Members 20

OIML structures International Conference of Legal Metrology (government delegations) International Bureau of Legal Metrology (BIML) International Committee of Legal Metrology (CIML) President (government appointed members) Presidential Council Technical work structures

What does the OIML do? § § Produces OIML International Recommendations – Model regulations – Member States have a “moral obligation” to use these if they regulate an instrument category – WTO TBT requirement to base technical legislation on “relevant international standards” Produces OIML International Documents – § Best practice Produces other publications – Vocabularies, guidance, seminar reports, expert reports 22

The work of OIML Project Groups Project Group Convener: Country F P-members: A, B, C, D, E, F, G, H O-members: I, J, K, L Develops one publication Part 1 Metrological and technical requirements Part 2 Test procedures Part 3 Test report format (for type approval, verification and inspection) WD WD WD 1 CD 1 CD 2 CD 2 CD 3 CD. . .

The work of Project Groups CD approved by Project Group CIML preliminary ballot CIML approval Publication Conference sanction Five-yearly review

OIML Recommendations 25

National system of metrological control National policy and legislation Responsibility for regulation policy Responsibility for legislation – implementation of OIML Recommendations Advice on metrology legislation and on relevant standards “Enforcement” Pre-market Post-market Type approval Market surveillance (import and distribution) Testing and evaluation for type approval Testing for market surveillance Conformity to Type • Pre-market verification • Testing by authorised persons • Testing to support self-declaration Verification • Initial verification on putting into use • Reverification In-service inspections 26

Quality infrastructure § DCMAS – international network on metrology, accreditation and standardisation § Founded in 2003 to coordinate activities in favour of developing countries by international organisations § – Metrology: BIPM, OIML – Standardisation: IEC, ISO, ITU, UNECE – Accreditation: IAF, ILAC – Capacity building: ITC, UNIDO Changing environment: – Conformity assessment is also an important component – No longer just “developing countries”, but countries with developing Quality Infrastructure 27

Quality infrastructure § Changed to International Network on Quality Infrastructure – INet. QI § Joined by § – World Bank Group – World Trade Organisation Based on agreed definition of Quality Infrastructure 28

Quality infrastructure The system comprising the organizations (public and private) together with the policies, relevant legal and regulatory framework, and practices needed to support and enhance the quality, safety and environmental soundness of goods, services and processes. The quality infrastructure is required for the effective operation of domestic markets, and its international recognition is important to enable access to foreign markets. It is a critical element in promoting and sustaining economic development, as well as environmental and social wellbeing. It relies on § metrology, § standardisation, § accreditation, § conformity assessment, and § market surveillance. 29

The role of metrology in supporting the UN’s 2030 SDGs 30

OIML involvement in health-related measurements R 7: 1979 Clinical thermometers R 16: 2002 Sphygmomanometers R 26: 1978 Medical syringes R 78: 1989 Westergren tubes R 89: 1990 Electroencephalographs R 90: 1990 Electrocardiographs R 104: 1993 Pure-tone audiometers R 114: 1995 Clinical electrical thermometers (continuous) R 115: 1995 Clinical electrical thermometers (maximum device) R 122: 1996 Equipment for speech audiometry R 133: 2002 Liquid-in-glass thermometers R 145: 2015 Impression and applanation tonometers 31

Problems and future of OIML work in the field of health-related measurements § Health-related Recommendations not so widely used as those which are trade-related – problem that different ministries are often involved – problem of conflicting national and regional legislation § Almost all are older than the five-year review requirement § OIML will be surveying members to consider future work in the field of health § The OIML proposes to improve liaison with the WHO, especially to work on the reviews and revisions of 32

Cooperation with the WHO § § § Cooperation has reduced in recent years Joint proposal to improve cooperation, especially to work on the reviews and revisions of high-priority instruments: – Sphygmomanometers – Medical thermometers – Medical syringes These are important contributions in promoting and achieving SDG 3 and therefore SDG 1 33

Thank you Any comments or questions? www. oiml. org www. worldmetrologyday. org ian. dunmill@oiml. org 34