Government of Montenegro

STRATEGY OF METROLOGY DEVELOPMENT IN MONTENEGRO

for period 2016 – 2018

Podgorica, December 2015

ABBREVIATIONS AND DEFINITIONS USED IN THE STRATEGY:

Abbreviations:

ABM – Accreditation body of Montenegro

BIPM – Bureau International des Poids et Mesures

(International bureau for weights and measures

CELEX – Europeae Lex

(European Union law database)

CEN – European Committee for Standardization

CENELEC – European Committee for Electrotechnical Standardization

CGPM – Conférence Générale des Poids et Mesures

(The General Conference on Weights and Measures)

CIPM – Comite International des Poids et Mesures

(International Committee for Weights and Measures)

CIPM MRA – L’Arrangement de reconnaissance mutuelle du CIPM

(CIPM Mutual recognition Arrangement)

CMC – Calibration and Measurement Capabilities

CMRS – Center for International Cooperation and Development

DI – Designated Institutes

EA – European Accreditation

EA MLA – The EA Multilateral Agreement

EFTA – European Free Trade Association

EMPIR – European Metrology Programme for Innovation and Research

EMRP – European Metrology Research Programme

ETSI – European Telecommunications Standards Institute

EU – European Union

EURAMET – European Association of National Metrology Institutes

CAA – Croatian Accreditation Agency

IAEA – International Atomic Energy Agency(

IMT – Institute for Metals and Technology

IPA – Instrument for Pre – Accession Assistance

JCRB – Joint Committee of Regional Bodies

KCDB – Key Comparison Database

MID – Measurement Instruments Directive MIRS – Metrology Institute of the Republic of Slovenia

NAWI – Non-automatic weighing instruments Directive

NMI – National Metrology Institute

NGO – Non-governmental organizations

OIML – International Organization of Legal Metrology

PEER REVIEW – Mutual proficiency assessment by the equals from the same field

PT – Proficiency Testing

PPCG 2015-2018 – Montenegro’s Programme of Accession to the European Union 2015-

2018

RMO – Regional Metrology Organization

SI – Le Système international d'unités

(International system of units)

SIDA – Swedish International Development Cooperation Agency

SWOT – Strengths, Weaknesses, Opportunities, Threats

TAI – Temps atomique international

(International atomic time)

TC-EM – Technical Committee for Electricity and Magnetism

TC-F – Technical Committee for Flow

TC-IM – Technical Committee for Interdisciplinary Metrology

TC-L – Technical Committee for Length

TC-M – Technical Committee for Mass and related Quantities

TC-T – Technical Committee for Thermometry

TC-TF – Technical Committee for Time and Frequency

TC-Q – Technical Committee for Quality

TFEU – Treaty on the Functioning of the European Union

UTC – Temps universel coordonné

(Universal coordinated time)

WELMEC – European Cooperation in Legal Metrology

Definitions:

Effectiveness – The degree to which planned activities are successful in producing a desired result

Efficiency – Relation between achieved results and resources used Standard – Materialized measure, measuring instrument, reference material or

a measuring system intended to define, realize, preserve or

reproduce a unit, or one or more quantity values so in order to

serve as a reference

Information – Relevant data Calibration – Operation, carried out under specified conditions, establishing the

relation between quantity values provided by a measuring

instrument or a measuring system, or values indicated by a

materialized measure or reference material and corresponding

values indicated by standards

Quality – Degree to which the totality of appropriate features fulfill implied requirements

Competence – Proved ability to apply knowledge and skills User – Organization or a person receiving a good Quality management – Coordinated activities for managing an organization with regard

to quality and managing the organization in terms of quality

Metrology – Science of measurements and its appliance Measuring – Process of experimental obtaining one or more quantity values

that can be reasonably attributed to the quantity

Measuring instrument – Device intended for measuring, individually or within an additional device i.e. devices

Supervision – Systematic repetition of conformity assessment activities as a foundation for maintaining the statement of conformity valid

Quality assurance – Part of a quality management focused on the ensuring the affiance that the quality requirements are fulfilled

Assessment of

conformity with the

prescribed metrological

requirements

– Activity which directly or indirectly determines if a measuring instrument fulfils prescribed metrological requirements for

measuring instruments

Verification of measuring – Procedure that includes evaluation and hallmarking, i.e. issuing

instruments the certificates on measuring instruments verification, whereat

assessment of conformity with prescribed metrological

requirements is asserted and confirmed

Review – Activity undertaken to determine conveniences, adequacy and effectiveness of the subject matter for achieving the set goals

Prepacked products – Products that are packaged in the absence of customer, and the quantity of these goods cannot be changed without opening

them, which would make a considerable damage, or without

changing the package Procedure, method – Determined manner for performing an activity or a process Control – Systematic, independent and documented process for obtaining

a proof of control and its objective evaluation in order to

determine a degree to which control criteria are fulfilled

Management system – The framework for establishing policies and objectives, and for the realization of these objectives

Quality management

system

– Management system that is, from the stand point of quality, used for managing and leading an organization

Traceability – Property of a measurement result or of a standard value, by which standards can be related to the stated references, national or

international standards, through an unbroken chain of

comparison, each having the stated measurement uncertainties

Type-approval

/certificate of conformity

– Decree or a document issued on the basis of previous examination, which confirms that the measuring instrument type is

in conformity with prescribed metrological requirements and that

the measuring instrument is suitable for usage for a certain period

Validation – Confirmation by providing an objective proof that the requirements for a certain usage or appliance are met

Requirement – Stated need or an expectation that are as a rule implied or mandatory

Legal

measuring instrument

– Measuring instrument that meets requirements prescribed by the Law on metrology („Official gazette of MNE“, no. 79/08 and 40/11)

CONTENTS

FOREWORD

1. INTRODUCTION…………………….………………………………………….…….... 1

2. METROLOGY SYSTEM IN MONETENGRO……..…..….......................................... 3

2.1 HISTORY OF METROLOGY IN MONTENEGRO……………………..…….............. 3

2.2 LEGISLATIVE FRAMEWORK..………………………..…………............................... 6

2.3 INSTITUTIONAL FRAMEWORK……………………………...………………............. 11

2.4 ASSESSMENT OF DE FACTO SITUATION SWOT ANALYSIS….............................. 23

3. CONFORMITY WITH EU LEGISLATION................................................................. 25

4. INTERNATIONAL AND REGIOANL METROLOGICAL ORGANIZATIONS……….. 28

4.1 INTERNATIONAL METROLOGY INFRASTRUCTURE.….......................................... 28

4.1.1 METRE CONVENTION……………………………………………………….............. 28

4.1.2 CIPM MUTUAL RECOGNITION ARRANGEMENT................................................. 29

4.1.3 OIML……………………………………………………………………………………... 30

4.1.4 NATIONAL METROLOGICAL INSTITUTES......… ……………………...................... 31

4.1.5 REGIONALNE INTERNATIONAL METROLOGICAL ORGANIZATIONS…….......... 31

4.2 EUROPEAN METROLOGICAL INFRASTRUCTURE……………............................... 32

4.2.1 EEURAMET………………………………………………………………….................... 32

4.2.2 WELMEC………………………………….....………………………………………….. 33

5. STRATEGY DESIGN PROCEDURE AND STRATEGIC PLANNING….……………... 34 6. STRATEGIC GOALS………..……………………………………............................... 36

Strategic goal 1. Effictient metrological system in Montenegro..….............. 36

Strategic goal 2. Conformity with EU legislative….......................................... 48

Strategic goal 3. Ensuring metrological traceability……............................... 53

Strategic goal 4. Improvement of procedures for conformity assessment

of legal measuring instruments......................................................................... 58

Strategic goal 5. Improvement of the calibration procedures regarding

standards/measuring instruments used in the industry as well as in the

processes of examination and production....................................................... 64

Strategic goal 6. Reinforcement of metrological supervision..................…. 71

Strategic goal 7. Promotion of the role and significance of metrology in

Montenegro……………………………………………………………………........... 74

Strategic goal 8. International recognition of Montenegrin metrology

system ………………………………………………...……….................................. 77

ANNEX………………...……………………………………………………................. 87

LITERATURE………………….…………………………………………......………....... 117

FOREWORD

As part of preparations of negotiations for accession of Montenegro to the

European Union in the field of free movement of goods (negotiation chapter 1)

there has been drafted a Strategy of Montenegro for implementation of the

acquis communautaire in the area of free movement of goods from 2014 to

2018, adopted by the Government of Montenegro in October 2014. The key

priorities of the Strategy of Montenegro for the implementation of the acquis

communautaire in the area of free movement of goods 2014 – 2018 are related

to harmonization of the general principles and the EU acquis, defining priorities

in this area, which is determined by the articles 34 to 36 of the Treaty on the

Functioning of the European Union, improving the coordination of all horizontal

activities, strengthening the administrative capacity of the Ministry of Economy

and of quality infrastructure institutions, as well as in the field of market

supervision.

For the execution of vertical measures in the field of "new approach" and

- "old approach" Strategy of Montenegro for implementation of the acquis

communautaire in the area of free movement of goods from 2014 to 2018

stipulates deadlines, plan to strengthen administrative capacity for the adoption

and implementation of regulations by the end of 2018. year, as well as the

allocation of funds. Within the Strategy of Montenegro for implementation of the

acquis communautaire in the area of free movement of goods from 2014 to 2018

in the field of procedural measures, it was defined that Montenegro will fully

implement checks at external borders, the notification of technical regulations

and standards, conformity assessment procedures and information society

services.

Strategy of Montenegro for implementation of the acquis communautaire

in the area of free movement of goods from 2014 to 2018 includes detailed plan

of administrative capacity, target dates and clear responsibilities for undertaking

and efficient implementing of laws for the specified period. Based on the time-

frame and the activities given in this Strategy, it is expected that Montenegro will

take over and implement the entire acquis in the area of free movement of

goods by the end of 2018.

Montenegro’s Programme of Accession to the European Union 2015-2018

(PPCG 2015 - 2018) is the key document which defines the objectives, activities

and dynamics of realization of activities on Montenegro's path towards EU

membership. In this document, the strategic, legislative and administrative

objectives and activities are given. Strategy for the development of metrology in

Montenegro, for the period 2016 - 2018, a detailed analysis was presented and

strategic objectives and actions for the development of metrology in

Montenegro were defined, which among other things includes the legislative

and administrative framework that matches the one given in PPCG 2015 - of

2018.

Being that the developed metrology system, as part of the national quality

infrastructure, provides adequate protection of the health, environmental

protection, consumer protection and safety, within the framework of the

Strategy of development of metrology in Montenegro based on the analysis of

the existing metrology infrastructure, fulfilment of obligations provided by the

Montenegro’s Programme of Accession to the European Union 2015-2018 and

Strategy of Montenegro for implementation of the acquis communautaire in the

area of free movement of goods from 2014 to 2018, as well as the characteristics

of the metrology system that is essential to Montenegro, strategic objectives for

further development of metrology in the period 2016-2018 are defined.

The realization of the planned activities will enable continuous realization,

preservation, maintenance and development of national standards and

provision of metrological traceability in Montenegro; maintaining a high quality

of existing services and providing new services for calibration of measuring

instruments and standards in accredited laboratories of the Bureau of Metrology

for the needs of customers from Montenegro, but also from outside of

Montenegro; improving activities in the field of legal metrology in Montenegro

i.e. provision of accuracy of measurement in the fields in which measurements

affect the transparency of economic transactions, health and safety; reliable

control of pre-packaged products; strengthening of the metrological

supervision, as well as active participation in international and regional projects.

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1. INTRODUCTION

Metrology, the science of measurement, includes definition of units, the

realization of standards of measurement units, the development of measuring

instruments and the scope of their application, establishing a chain of

traceability of measurement results, as well as other theoretical and practical

problems associated with the measurement.

Measuring is present in human society since ancient times, and as such

affects all aspects of people’s life. It is believed that people were first interested

to understand time while watching the periodic natural phenomena, and then

the length i.e. distance. Although the measuring and measuring units have

been changing throughout the history, the goal is always the same - make the

measurement as accurate as possible.

Trade, a very important segment of economic stability, cannot be

imagined without measurements. It is known that the ancient Greeks knew the

measures used by people from other areas with whom they develop trade

relations. In order to make trade as efficient as possible, local measuring

instruments of length, mass and volume could be found at markets in the Middle

Ages. History has left us with important information on the adoption of the

decrees and laws on measures, as well as the declarations of national standards

by rulers. Therefore, today we should not be surprised by the fact that taxes,

weights and measurements have become part of everyday life.

Metrology enables us to examine the air we breathe, the water we drink,

the food we eat. Accurate measurement ensures the safety and efficacy of a

medical treatment. Sports activities and top sports results that follow anti-doping

control cannot be realized without measurements.

Measurements with known degree of uncertainty are the basis of industrial

quality management and of the increase of the value and quality of products.

Accurate measuring promotes energy systems efficiency and ensures

proper calculation. Exploring the possibility of transforming the existing fossil fuels

in a more acceptable form of energy, research in order to discover new and

renewable energy sources, as well as the improvement of energy efficiency are

very important topics for metrologists worldwide.

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Metrology is the basis of all scientific research. Monitoring changes in

temperature, climate change, registration of seismic activity, astronomy, etc.,

cannot be imagined without measurements. Moving the boundaries of the

possible and documenting the results obtained by research implies the

existence of effective measurement devices.

Global economy depends on reliable measurements that do not present

technical barriers to trade. Equivalence of standards, as well as demonstration

of an acceptable level of compliance with the relevant standards allows

comparison measurements carried out in different countries.

Metrology is continuously evolving and affects the development of

various processes in the industry of instruments, automotive industry, aerospace

industry, outer-space industry, but also the research and production of new

materials, development of electronics, new communication technologies,

environmental protection, research of new and renewable energy sources,

improvement of security , organic food production, efficient application of

diagnostic and therapeutic methods, as well as the development of new

technologies, in order to improve health care, etc.

World Metrology community expects that on the basis of the conducted

research, redefining the SI unit system will be undertaken in the future, which is

another indicator that metrology is a complex science that affects our daily

lives.

Metrology can be viewed in three categories with different levels of complexity

and accuracy:

• Scientific metrology (relates to the organization and development of

measurement standards, as well as to maintaining them at the highest level);

• industrial metrology (should ensure the proper functioning of measuring

instruments used in industry, as well as in production processes and testing);

• legal metrology (relates to the accuracy of measurements in the areas

in which measurements affect the transparency of economic transactions,

health and safety).

The highest levels of accuracy within certain areas are indicated by

fundamental metrology, for which there is no international definition.

Fundamental metrology can be described as a branch of scientific metrology

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of a highest level, complemented by parts of legal and industrial metrology that

require scientific competence.

The development of metrology is an important stimulus for economic and

social development of every country. The foundation of the metrology system in

Montenegro is represented by the Bureau of Metrology, which was established

by the Government of the Republic of Montenegro on the 14th of September,

2006, with the aim of establishing a unified measuring and ensuring the

traceability of the measurement results.

Reforming the metetrological infrastructure inherited from the State Union

of Serbia and Montenegro, as well as changes of legislation and harmonization

with EU legislation, are activities that are constantly being implemented in

Montenegro.

2. METROLOGY SYSTEM IN MONTENEGRO

2.1 HISTORY METROLOGY IN MONTENEGRO

As early as from the Middle Ages there was a measurement system in

Montenegro. Thus, in the Charter of Balsa III to monastery Moracnik on Skadar

Lake, threshing floor of salt and a bucket of salt were mentioned, as a donation

to the monastery.

The charter of Ivan Crnojevic, from 1485, says that each household brings

three bundles of firewood to the monastery at Cetinje. According to the

available documentation in Montenegro, the following measurements were also

mentioned: cubit, span, fathom, thumb i.e. inch, yardstick, load (100kg),

footstep, foot, ’vagan’ – a measurement for wheat (61kg), ‘krblja’, scythe (of a

meadow), oka or okka (an ottoman measure), plough (of arable land), hoe (of

digging), a bucket (of milk), ‘žban’(of water), vlaka (of hay), sack (of wheat). In

the occupied territories of Montenegro, were used measures of the ruling

countries, as for example col, meter and similar. This is witnessed throughout the

extensive literature relating to the measures used since the Roman times.

Metric system was adopted in France by the end of the XVIII century. The

need for the usage of the universal metric system in other countries as well,

becomes evident in the middle of the XIX century. In 1875, representatives from

17 countries in Paris, at a diplomatic conference on meter, have signed a treaty,

4

named “Meter Convention”. The states parties have decided to found and

finance a permanent scientific institute “The International Bureau of Weights and

Measures” (Bureau International des Poids et Measures - BIPM). The application

of the metric system in Montenegro was introduced by a Decree of January the

1st 1888, but based on the available archival records one can see that the “new

(French) meter measurements” were used even in the first half of the XIX

century. The term “meter” has been mentioned for the first time in the letter of

Petar Petrovic Njegos, from 1835, where he informs district captain from Kotor,

about a deal, made by some Montenegrins, for the delivery of “80 pieces of

nets and two hundred meters of rope.” There can be found other cases of the

usage of kilogram and meter in the second half of the XIX century Montenegro:

according to a document from 1879, commander of the Montenegrin army in

Metohia, has ordered for army to receive flour measured in kilos, and not in “an

easy Montenegrin steelyard” (as they were probably using the okka). The record

of mountains, hills and other important places in Montenegro was drawn up and

printed in1881, where the altitudes i.e. the above sea levels, was marked with

meters. In 1894, The Ministry of Finance at Cetinje, has issued The Guidelines for

Surface Measuring.

Development of the trade with the surrounding countries where the metric

system was used, have significantly influenced the legislative regulations of the

application of the metric system in Montenegro. After the legislative

introduction of the metric system in Montenegro, in certain towns the prices

were immediately regulated according to the metric system, which was also

introduced into the primary school textbooks. However, according to the

Guidelines for Surface Measuring, certain units which didn’t belong to the metric

system were used. Thus, plough and scythe were used as surface area units,

while cubit was used for length.

The Ministry of Internal Affairs, on the 11th of November, 1903, for the

purpose of control of the metric system implementation in Montenegro, issued

the Regulations on measures and measuring, according to which, merchants

using their own measures, were obliged to submit their measures to the annual

control, once the municipal governance decide. The projected control of the

measures was done by a special committee comprised of one municipal

governance commissioner, one clerk and one expert appointed by the

municipal governance. The Ministry of Internal Affairs has also announced

Proclamation of the 25th of May 1906, where, according to the Law on

regulation of the town municipalities, these authorities are obliged to “to

5

supervise if the measures are correct and to control them, hence they are

obliged to put a signet on it.” Based on the Decree on jurisdiction of the

administrative authorities, “usage of the wrong measures” at the countryside,

was under the supervision of the rural serfs and captains of the tribes. Penalties

were provided for the contempt of the given regulations: fines, confiscation of

goods, permanent or temporary bans from conducting the activities,

imprisonment.

The application of the measurements system in the region has been

regulated by regulations since the time of the Kingdom of Serbs, Croats and

Slovenians, through the ex-Yugoslavian federation after the Second World War,

until the contemporary Montenegro.

In 1919, in the Kingdom of SCS, there was formed a Department for

measures and measurements, with headquarters in Belgrade, which as the main

objective had “measures law enforcement and execution of other laws and

regulations.” The Department for Measures and Measurements was a foundation

for the various future kinds of centralized metrological institution.

In the State Union of Serbia and Montenegro, the state functions in the

field of metrology were executed by the Bureau for Measures and Precious

Metals, with its headquarters in Belgrade, while in Podgorica, there was one out

of the eight bureau’s branch units – The Control of measures and Precious

Metals (formed at the beginning of ‘60s). The rudimentary tasks of The Control of

measures and Precious Metals Podgorica were: examination s of the national

standards and measuring instruments, surveillance and verification of the

measuring instruments, ensuring that all the requirements laid down for the

examination of the measuring instruments at requesters are fulfilled, obtaining

the professional support, issuing the certificates on accuracy of the measuring

instruments, investigation and verification of precious metals articles, defining

conditions for issuing decision on the mark of a manufacturer, as well as the

metrological surveillance.

The Control of the Measures and Precious Metals – Podgorica, has realized

necessary metrological activities until the foundation of the Metrology Center,

on the 17th of July, 2006. that was under the jurisdiction of Ministry of Economy.

Metrology Center conducted the administration in the field of Metrology until

the foundation of the Bureau of Metrology.

6

On the 14th of September, 2006, the Government of the Republic of

Montenegro has founded Bureau of Metrology which establishes, maintains and

develops unique metrological system in Montenegro, and contributes to the

creation of technical prerequisites for entering the international market of goods

and services.

2.2 LEGISLATIVE FRAMEWORK

Law on Metrology (“”Official gazette of MNE”, no. 79/08 and 40/11)

applies in the field of Metrology in Montenegro, regulates system of

measurement units and standards of Montenegro, procedures of assessment of

conformity of the measuring instruments with the prescribed requirements,

authorizations in the field of metrology and other issues relevant to metrology.

The field of metrology in Montenegro is organized to:

• making the system of legal units of measurement uniform with the

International System of Units;

• establishing a system of national standards and ensuring their

traceability to international standards;

• establish metrological uniformity in Montenegro and credibility of

measurement results performed for the purpose of consumer protection of lives,

health of people and animals, environmental protection, general safety and

protection of natural resources;

• support the development of appropriate metrology infrastructure that

ensures traceability of measurement results;

• encourage free trade and remedy potential obstacles to the trade;

• directing and financing of metrology research activities;

• prepare, adopt and implement metrological regulations;

• implement the procedures for assessment of conformity with the

requirements of legal metrology;

• provide information from the field of metrology.

Article 5 of the Law on Metrology (“Official gazette of MNE”, 79/08 and

40/11) stipulates that the measuring results related to health, general safety,

7

environment and the economy, shall be available to public in conformity with

the regulations.

The Law on Metrology (“Official gazette of MNE”, 79/08 and 40/11) was

drafted based on:

• the relevant EU directives and the legal framework for adoption of

subordinate legal acts that are in conformity, or will be, with EU legislation in the

field of metrology;

• Agreement on Technical Barriers to Trade of the World Trade

Organization regarding the implementation of the assessment of conformity of

measuring instruments with prescribed metrological requirements so that

regulations adopted pursuant to the Law on Metrology ("Official Gazette", Nos.

79/08 and 40/11) shall not constitute unnecessary barriers to trade, and shall be

equally applied to persons and goods originating from other countries and to

local persons or goods;

• Document OIML D1 - Elements for a Law on metrology, issued by the

International Organization of Legal Metrology (OIML).

Regulations adopted pursuant to the Law on Metrology ("Off. Gazette of

MNE", no. 79/08 and 40/11) are based on the practices and experiences of

relevant international and European organizations and institutions and do not

create unnecessary barriers to trade, instead they allow regulation of legal,

industrial and scientific metrology. Subordinate legal acts that apply in the field

of metrology in Montenegro, which transpose EU directives in this area are:

Decree on legal units of measurement (“Official Gazette of MNE”,

no. 22/09), that transposes EU Directive 80/181/EEC;

Rulebook on requirements applied to the devices and systems with

measuring function – MID (“Official Gazette of MNE” no. 29/13), that

transpose EU Directive 2009/23/EC;

Rulebook on non-automatic weighing instruments – NAWI (“Official

Gazette” no. 29/13), that transposes EU Directive 2009/23/EC;

Rulebook on pre-packaged products (“Official Gazette” no. 56/11),

that transposes EU Directive 76/211/EEC and 2007/45/EEC;

Rulebook on bottles used as measuring containers (“Official

Gazette” of MNE no. 56/11), that transposes EU Directive

75/107/EEC.

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Following regulations, pursuant to the Law on Metrology (“OG of MNE”,

no. 79/08 and 40/11):

Regulation on legal measuring instruments that are mandatory

subjected to verification i.e. measuring instrument type approval

(“Official gazette of MNE”, no. 81/09);

Rulebook on deadlines for the regular verification of the measuring

instruments (“Official gazette of MNE”, no. 81/09);

Rulebook on the types, forms and method of affixing marks that are

used in the verification of instruments, as well as more detailed form

and content of the certificate of the verification of measuring

instrument and the certificate of the type approval of the measuring

instrument (“Official gazette of MNE”, No. 80/90);

Rulebook on the method of determining the conformity with the

metrological requirements for legal measuring instruments (“Official

Gazette of MNE”, No. 04/10);

Rulebook on detailed procedure and method of type approval

examination of measuring instruments (“Official Gazette of MNE”,

No. 10/10);

Decree on the amount and the manner of payment of fees in the

field of metrology (“Official Gazette of MNE”, No. 73/10);

Rulebook on extraordinary checks of legal measuring instruments in

use (“Official Gazette of MNE”, No. 73/10);

Rulebook on deadlines for calibration standards used for verification

of legal measuring instruments ("Official Gazette of Montenegro",

no. 33/11);

Rulebook on metrological requirements for the basic clocks within

telephone exchanges used for the calculation based on the call

data records (“Official Gazette of Montenegro”, no. 06/10);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of water

meters for verification (“Official Gazette of Montenegro”, no. 44/09);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of mass

measuring instruments for verification (“Official Gazette of

Montenegro”, nos. 65/09 and 09/13);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of

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taximeters for verification (“Official Gazette of Montenegro”, nos.

74/09 and 09/13);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of fuel

dispensers and devices for liquefied petroleum gas for verification

(“Official Gazette of Montenegro”, nos. 15/10 and 09/13);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of

measuring systems for quantities of liquids other than water for

verification (“Official Gazette of Montenegro”, nos. 15/10, 81/10 and

09/13);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of

electricity meters for verification (“Official Gazette of Montenegro”,

nos. 20/11 and 09/13);

Rulebook on fixed tanks (“Official Gazette of Montenegro”, no.

02/14);

Certain metrological regulations, which are still effective in Montenegro,

which will cease to be valid after the adoption of new regulations in

accordance with the activities of Montenegro in implementing its obligations

under Articles 34 and 36 of the Treaty on the Functioning of the European Union

(TFEU) are:

Rulebook on metrological requirements for ethylometers („Official

gazette SFRJ“, no. 42/91);

Rulebook on Doppler radars („Official gazette SFRJ“, no. 03/85);

Rulebook on metrological requirements for manometers for

measuring tire pressure („Official gazette SFRJ“, nos. 20/86 and

10/87);

Rulebook on metrological requirements for manometers for

measuring blood pressure („Official gazette SFRJ“, no. 20/86);

Rulebook on metrological requirements for manometers, vacuum

meters and mano-vacuum meters („Official gazette SFRJ“, no.

30/86);

Rulebook on metrological requirements for measuring instruments

used to measure loop impedance („Official gazette SFRJ“, no.

31/84);

10

Rulebook on metrological requirements for measuring instruments

used to measure loop impedance („Official gazette SFRJ“, no.

31/84);

Rulebook on metrological requirements for measuring instruments

for electrical resistance of insulation („Official gazette SFRJ“, no.

03/98);

Rulebook on metrological requirements for measuring instruments

for electrical resistance of grounding („Official gazette SFRJ“, nos.

34/98 and 40/98);

Rulebook on metrological requirements for semiconductor counters

– gamma-ray spectrometer („Official gazette SFRJ“, no. 22/91);

Rulebook on metrological requirements for scintillation detector –

gamma-ray spectrometer („Official gazette SFRJ“, no. 31/93, 42/93

and 44/93);

Rulebook on metrological requirements for Geiger-Muller counters

(„Official gazette SFRJ“, no. 56/94);

Rulebook on metrological requirements for scintillation detectors of

alpha-ray radiation („Official gazette SFRJ“, no. 56/94);

Rulebook on metrological requirements for proportional counters –

working standards („Official gazette SFRJ“, no. 76/94);

Rulebook on metrological requirements for plastic scintillation

counters („Official gazette SFRJ“, no. 34/96);

Rulebook on metrological requirements for automatic liquid level

gauges in fixed tanks („Official gazette SFRJ“, no. 76/90);

Rulebook on metrological requirements for sound level meters

(„Official gazette SFRJ“, no. 27/01);

Rulebook on metrological requirements for housings of road and rail

balances („Official gazette SFRJ“, nos. 31/87 and 39/90);

Rulebook on metrological requirements for road and rail

weighbridges („Official gazette SFRJ“, no. 72/99);

Rulebook on metrological requirements for standard weights from

50 kg to 5000 kg („Official gazette SFRJ“, no. 44/88);

Rulebook on metrological requirements for weights of nominal

weight from 1 mg to 50 kg („Official gazette SFRJ“, no. 54/88 and

06/89);

Rulebook on metrological requirements for measurement

transformers for electrical energy meters („Official gazette SFRJ“, no.

66/84);

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Rulebook on metrological requirements for reactive electrical

energy electric (static) meters accuracy class 1 and 2 („Official

gazette SFRJ“, no. 47/98);

Rulebook on metrological requirements for milk cooling tanks (lacto

freezers), milk meters and measuring vessels(„Official gazette

SFRJ“, no. 29/91);

2.3 INSTITUTIONAL FRAMEWORK

Pursuant the Law on State Administration („Official Gazette of RMNE“, no.

38/03 and „Official Gazette of MNE“, no. 22/08 and 42/11 ), Decree on the

Organization and Manner of Work of State Administration („Official Gazette of

MNE“, no. 05/12, 25/12, 44/12, 61/12, 20/13, 17/14 and 06/15), as well as the Law

on Metrology („Official Gazette of MNE“, no. 79/08 and 40/11), the Bureau for

Metrology performs expert and related administrative affairs, while applying

scientific methods and knowledge in the field of metrology. Ministry of Economy

performs supervision and monitoring of the execution of the affairs from the field

of metrology.

Pursuant the Decree on the organization and manner of work of state

administration („Official Gazette of MNE“, no. 05/12, 25/12, 44/12, 61/12, 20/13,

17/14 and 06/15), Bureau of Metrology conducts work related to:

• ensuring the application of the system of legal units of measurement;

• realization, preservation, maintenance and improvement of standards

of Montenegro;

• Provision of metrological traceability for laboratories standardization, as

well as for research and control laboratories;

• organizing activities of calibration (calibration);

• conformity assessment of standards with metrological requirements;

• give expert opinion for accreditation of laboratories for verification of

measuring instruments;

• represent Montenegro in international and regional metrological

organizations and to establish cooperation in the field of metrology;

• control of precious metals articles as well as other activities within its

jurisdiction.

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Pursuant the Law on metrology („Official Gazette of MNE“, no. 79/08 and

40/11), the Bureau of Metrology performs further business affairs:

• ensuring that the system of legal measurement units in Montenegro;

• realizes, preserves, maintains and improves national standards;

• ensures metrological traceability;

• organizes calibration activities;

• conducts conformity assessment of measuring instruments with

prescribed metrological requirements: type approval and certification of

standards;

• conducts a review of pre-packaged products;

• gives expert opinion on the authorization of persons to perform tasks in

the field of metrology;

• represents Montenegro in international and regional metrological

organizations and establishes cooperation in the field of metrology;

• cooperates with the competent inspection bodies and provides expert

assistance in the field of metrology;

• decides in administrative procedures in the field of metrology;

• prepares expert foundation for drafting the regulations in the field of

metrology;

• ensures metrological information and issues official publication;

• performs other tasks in the field of metrology.

Regulations on internal organization and systematization of the Bureau of

Metrology, adopted by the Government of Montenegro at the conference on

31st of July 2014, established the internal organization and systematization of civil

servants and state employees. Internal organizational units of the Institute are:

• Department for metrological traceability and national standards;

• Department for certification of standards;

• Department for precious metals;

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• Department of General Affairs, Finance and Information Systems.

Outside the organizational units, activities carried out are related to the

establishment, maintenance and improvement of the quality system.

Rulebook on amendments to the Rulebook on internal organization and

systematization of the Bureau of Metrology, adopted by the Government of

Montenegro at its session of 16 July 2015, jobs for a total of 52 executors

including the elder Institute were systematized. The total number of employees

in the Metrology Institute in 2015 was 36.

Within the Bureau of Metrology national calibration laboratories are

established and developing: Laboratory for Mass, Laboratory for Large Masses,

Laboratory for Length, Laboratory for Temperature, Laboratory for pressure,

Laboratory for Electrical Quantities, Laboratory for Time and Frequencies,

Laboratory for Small Volumes and Laboratory for Large Volumes.

The most important role of the metrological laboratories of the Bureau of

Metrology is the establishment and maintenance of metrological traceability in

Montenegro. After the proclamation of independence of Montenegro in 2006,

the Directorate for Precious Metals in Serbia, standards based on the previous

common state were retained, which meant the termination of traceability in

Montenegro. This was followed by activities for resolution of the problem. First

metrological traceability chain in the field of weight and length was established.

In the period from 2008 to 2011, the secondary and working standards in the

field of electrical quantities, metrology of pressure, temperature, length

metrology and high frequencies were used, which the Bureau of Metrology took

over from the military metrology laboratories during 2007.

Metrological traceability chain in the field of mass, length, temperature,

pressure, volume, electrical quantities, as well as the time and frequency, in

Montenegro is based on equipment that has been delivered to the Institute

within the framework of the IPA 2007: Development of quality infrastructure in

Montenegro, programme IPA 2011: development of quality infrastructure and

metrology in Montenegro, as well as the equipment provided by the Institute

from its own funds. Calibration of standards at the Bureau of Metrology is carried

out in the laboratories of the national metrology institutes or authorized Institutes

(EURAMET Designated Institutes) who have published CMC in BIPM KCDB or are

accredited by an accreditation body signatory to the EA MLA Agreement.

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The main responsibility of Laboratory for mass, established within the

Bureau of Metrology, is the realization, preservation, maintenance and

improvement of the national mass standards and ensuring metrological

traceability in the field of mass ranging from 1 mg to 20 kg in Montenegro.

Continuous provision of the necessary equipment, staff training and continuous

improvement of work processes, in the period since the establishment in 2007,

have enabled the good results in inter-laboratory comparisons in the field of

weight, as well as providing services in the field of calibration of gauges /

standards, certification of standards / the implementation of standards and tests

in order to issuance of the type of standard, to date. Traceability chain in the

field of mass measuring in Montenegro is shown in the image P1 (attached).

Laboratory for large mass implements activities in order to ensure

traceability of measurement in the field of mass in Montenegro, in the range

from 50 kg to 500 kg. Calibration of weights of a lower accuracy class shall be

conducted by the equipment of the laboratory for mass, where the unit of mass

by direct comparison method is being transferred to the standards of lower

accuracy class, over which the mass unit is transferred to the user in

Montenegro. Laboratory for large mass conducts calibration and verification of

weights ranging from 50 kg to 500 kg. Traceability chain in the field of large mass

measuring in Montenegro is shown in the image P2 displayed (attached).

Laboratory for length preserves and maintains the national standard for

length, caring about establishing the traceability in length measuring in

Montenegro and performs transfer of the length unit to the end users. The

laboratory provides services for the calibration of measuring instruments and

standards of length, verification of measuring instruments for length which are

the subject of legal metrology and performs tests in order to implement the

issuance of measuring instruments type approval. All activities that the staff, at

laboratory for length, implements are aimed at providing high quality, reliable

and traceable measuring results. Chain of traceability in the field of measuring

of length in Montenegro is shown in the image P3 (attached).

In the Laboratory for temperature the national standard for temperature is

realized, preserved and maintained, together with the standard platinum

resistance thermometer (SPRT) for temperatures up to 650 ° C, thermocouple

(TC) for temperatures above 650 ° C, as well as the standard for relative humidity

dew-point meter (DP) for the temperature range from 10 ° C to 70 ° C and a

relative humidity of 10% RH to 95% RH. These standards owns the best

15

metrological properties in Montenegro, along with other equipment are used as

the basis for the provision of metrological traceability in the field of temperature

and relative humidity, and to assign value to units of temperature and relative

humidity to end users. Traceability chain in the field of temperature

measurement is shown in the image P4 (attached) and of relative humidity in

Montenegro is shown in image P5 (attached).

Primary competence of Laboratory for pressure is ensuring the

metrological traceability in the field of pressure measuring in Montenegro, i.e.

transfer of pressure units to the lower level laboratories. Laboratory for pressure

provides service in the field of calibration and verification of pressure gauges,

and performs the assessment of conformity with the prescribed technical and

metrological requirements with aim to determine the type of measuring

instrument. The image P6 (attached) shows the chain of traceability in the field

of pressure measurement.

Laboratory for electrical quantities is responsible for the provision of

metrological traceability in the field of electrical quantities in Montenegro, and

transfer of units of measurement of electrical quantities to the lower level

laboratories. Laboratory for electrical quantities is capable of providing

calibration and verification of measuring instruments for electrical quantities.

Chain of traceability in the field of measurement of electrical quantities is shown

in the image P7 (attached).

Laboratory for Time and Frequency is responsible for realization,

preservation and maintenance of national standards of time (frequency), the

realization of traceability of unit of time (frequencies) to the international system

of units and transmission of the unit of time (frequency) to end users. Laboratory

for Time and Frequency is responsible for the realization of the national time

scale and its distribution as well as participation in the calculation of TAI (Temps

Atomique International) and UTC (Universal Time Coordinated) time scales. The

laboratory for time and frequency has fulfilled all the necessary requirements for

participation in the calculation of UTC time and filed an application for inclusion

in the CCTF-K001.UTC key comparison in June 2014. The Bureau of Metrology

officially began to send data to the BIPM ftp server in July 2014, and the results

of the Bureau were first published in September 2015 in a monthly bulletin

magazine Circular T, which publishes deviation of local realization of UTC from

UTC time, what ensures the realization of the formation of Montenegrin time -

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Montenegrin seconds. The traceability chain in the field of measuring of time

and frequency in Montenegro is shown in image P8 (attached).

Laboratory for small volumes is responsible for ensuring the traceability of

metrological measurements in the field of small volume in Montenegro.

Laboratory for small volume provides services for calibration of standards /

measuring instruments for the industry, health institutions, the pharmaceutical

industry, biochemical laboratories, and laboratories in the field of genetic

engineering and other specialized laboratories. The chain of traceability in the

field of measurements in Laboratory for small volumes by gravimetric method in

Montenegro is displayed in the image P9 (attached).

Laboratory for large volume ensures metrological traceability of the

measurement in the field of large volume in Montenegro. The laboratory for

large volume provides calibration by gravimetric and volumetric method

standard for overflow pipettes and standard for containers of metal. Traceability

for gravimetric method is provided internally through the traceability of

Laboratory for mass. Chain of traceability in Laboratory for large volume by

gravimetric method in Montenegro is displayed in P10 image (attached).

Traceability for volumetric method is provided by the national standard volume,

standard overflow pipettes of metal with traceability of the results of the

calibration to laboratories of national metrology institutes. Laboratory for large

volume implements procedure of the assessment of conformity with prescribed

technical and metrological requirements for determination of the type of

measuring instruments.

Competence of the Bureau of Metrology for performing calibrations that

are specified in the determined scope of accreditation, was confirmed by the

Accreditation Body of Montenegro (ABM), which on March 4, 2014 awarded a

Certificate of Accreditation (Lk14.02) and Croatian Accreditation Agency (CAA)

of 16 April 2014 issued a Certificate of accreditation (no. 2451) which establishes

that the Bureau of metrology is qualified for calibration of measuring instruments

for mass, temperature and length.

In November 2014, Croatian Accreditation Agency and the Accreditation

Body of Montenegro confirmed that the Department of Metrology meets

requirements of MEST EN ISO / IEC 17025: 2011 standard, and that it is competent

to perform calibration of weights, weights with free nominal masses and non-

automatic weighing instruments, calibration of temperature measuring

instruments and calibration of standards and measuring devices for length. The

17

accreditation scope for the Laboratory for mass was expanded in the terms of

calibration of weights of free nominal masses from 1 mg up to 50 kg.

Being confirmed, competence enables Laboratories for mass, length

laboratories, laboratories for temperature, pressure Laboratories, Laboratories for

the electrical size and laboratories for time and frequency, calibration service

delivery benchmarks and standards and customers outside the borders of

Montenegro.

Confirmed competence, enables Laboratory for mass, Laboratory for

length, Laboratory for temperature, Laboratory for pressure, Laboratory for

electrical quantities and Laboratory for time and frequency, to provide services

of calibration for measuring instruments and standards to customers outside of

Montenegro.

At the Bureau of Metrology were also established and are being

developed, Laboratory for electrical power and Laboratory for verification of

measuring instruments for speed of a moving vehicle.

Following activities are performed at the Laboratory for electrical power:

• Provision of metrological traceability in the field of electrical power in

Montenegro, or transfer of units of electrical power to end users;

• Verification of electricity meters (accuracy class 0.2S, 0.5S, 1 and 2, active

electrical energy and accuracy class 2 and 3 reactive electrical energy).

Laboratory for electrical power achieves traceability via a standard

device for testing of electricity meters, the manufacturer MTE, PCS400.3 type,

accuracy class of the device is 0.02. The work capacity of the Laboratory for

electrical power is limited because there is only 3 measuring points, but it is

important to note that a review of electricity meters of accuracy class 0.2S used

for indirect connection to high voltage network, at the systems for power

transmission by high voltage lines. Laboratory for electrical power also conducts

extraordinary inspection of electricity meters in use at the request of interested

parties (Montenegrin Electric Enterprise, consumers).

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In the Laboratory for verification of measuring instruments for speed of a

moving vehicle inspection is realized in order to determine conformity with the

requirements of metrology, i.e. verification of the following measuring

instruments for speed of a moving vehicle:

• Measuring instruments for speed on the principle of the Doppler effect;

• Laser measuring instruments for speed by measuring the round-trip time

for light to reach a vehicle and reflect back to the instrument;

• measuring instruments for speed working on the principle of measuring

the length of the past distance in relation to time;

• measuring instruments for speed by measuring the time upon the

passage of the vehicle between at least two fixed points at a known

distance.

Verification of measuring instruments for speed of a moving vehicle refers

to:

• measuring instruments that measure the speed from a stationary point

(the scale is not in motion)

• measuring instruments that measure the speed from a mobile point

(scale is in motion).

For the verification of measuring instruments for speed of vehicles,

measuring equipment is used, for which calibration is carried out in the

laboratories of the national metrology institute (NMI) or authorized Institutes

(EURAMET Designated Institutes) who have published CMC in the database of

the BIPM or are accredited by an accreditation body of signatories to the EA

MLA Agreement.

The Bureau of Metrology represents Montenegro at the international and

regional metrological organizations. The Bureau of Metrology is:

A full member of European Association of National Metrology

Institutes (EURAMET), since June 7, 2011;

A corresponding member of International Organization of Legal

Metrology (OIML), since November 2007;

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An associate member of European Cooperation in Legal Metrology

(WELMEC), since January 2009.

An associate member of (The General Conference on Weights and

Measures) (CGPM), since August 1, 2011.

Vision of the Bureau of Metrology

National metrology institute internationally recognized as a center of an

efficient metrology system in Montenegro.

The Bureau will professionally, objectively and impartially realize the

metrological services, assuring reliable measuring on the territory.

Mission of the Bureau of Metrology

Mission of the Bureau is accomplishment of high quality of services provided in

the field of legal and industry metrology, gaining the trust in the measuring system,

development of scientific metrology,and establishing an efficient metrology system

in Montenegro. The Bureau realizesits mission through expert work and researches,

innovation of services, as well as constant improvment of methods and procedures in

work and management proceses.

20

The Law on metrology ("Official Gazette of MNE", no. 79/08 and 40/11)

stipulates that work in the field of metrology, in addition to the Bureau of

Metrology, is carried out by companies, other legal entities and entrepreneurs

who are authorized to perform the tasks of metrology. Article 8 of the Law on

Metrology ("Official Gazette of Montenegro", no. 79/08 and 40/11) stipulates

that persons who meet the prescribed requirements in the field of metrology

can perform the following tasks:

1) national laboratory for calibration for certain quantities;

2) verification of certain types of measuring instruments;

3) the preparation of measuring instruments for verification.

The Ministry of Economy evaluates the conformity with the requirements

and decides on approval of authorization to perform specified tasks, after

obtaining the opinion the Bureau of Metrology.

Requirements for the authorization for preparation for the verification are

prescribed for: water meters, measuring instruments for mass, taxi meters,

devices for liquid fuels and liquefied petroleum gas, measuring systems for liquids

other than water as well as electricity meters. The requirements that the

The policy of the Bureau of Metrology is aimed at achieving the following

objectives:

• establishing and maintaining good professional practice and quality

of services;

• meet the requirements of the users;

• continual review of the quality of provided services;

• establishing and implementing the necessary actions to improve the

quality of services;

• ensuring data confidentiality;

• respect for ethical standards;

• motivation and permanent training of employees, encouraging

creativity and innovation.

21

applicant must meet, as well as the manner and procedure for issuing the

authorizations, are regulated by the following bylaws:

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of water

meters for verification (“Official Gazette of Montenegro”, no. 44/09);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of mass

measuring instruments for verification (“Official Gazette of

Montenegro”, nos. 65/09 and 09/13);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of

taximeters for verification (“Official Gazette of Montenegro”, nos.

74/09 and 09/13);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of fuel

dispensers and devices for liquefied petroleum gas for verification

(“Official Gazette of Montenegro”, nos. 15/10 and 09/13);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of

measuring systems for quantities of liquids other than water for

verification (“Official Gazette of Montenegro”, nos. 15/10, 81/10

and 09/13);

Rulebook on technical and metrological requirements and the

procedure for authorization of persons for the preparation of

electricity meters for verification (“Official Gazette of Montenegro”,

nos. 20/11 and 09/13);

Activities included in the authorization procedure are illustrated in Figure 1,

and the data on authorized persons to prepare standards officer in Montenegro

are listed in Table P1 (attached).

22

Figure 1. Activities included in the authorization procedure

Measuring instruments for which it is not rational to obtain conditions for

review, here in Montenegro, verification is carried out by competent and

authorized laboratories abroad, i.e. verification is carried out based on the

recognition of documents of foreign institutions in accordance with international

agreements signed by Montenegro.

A very important segment for the functioning of the metrology system in

Montenegro represents metrological-control supervision. Pursuant the Law on

Metrology ("Official Gazette of MNE", no. 79/08 and 40/11) metrological-control

is supervision over the transport, installation, use, maintenance and repair of

measuring instruments, performed in order to verify that the they apply in

accordance with this law and other regulations in the field of metrology, as well

as the verification of the accuracy of the quantities indicated and contained in

23

pre-packaged products, as well as undertaking administrative and other

measures and activities in order to comply determined irregularities with the

regulations.

The manner and procedure of metrological-inspection control is carried

out in accordance with the Law on Inspection Control (“Official Gazette of

MNE”, no. 39/03 and “Official Gazette of MNE”, Nos. 76/09, 57/11, 18 / 14 and

11/15) and the Law on General Administrative Procedures (“Official Gazette of

MNE”, no. 60/03 and “Official Gazette of MNE”, no. 32/11).

Metrological-control supervision was the responsibility of the Bureau of

Metrology until 2012. After the change of the organization and the manner of

work of State Administration in 2012, affairs related to control in the field of

metrology is performed by the Administration for Inspection Affairs.

2.4 ASSESMENT OF DE FACTO SITUATION BY SWOT ANALYSIS

When drafting the Strategy of metrology development in Montenegro

SWOT analysis (Figure 2) was applied, showing that the strategy should:

• Recognize the power on which to develop activities to achieve the

objectives;

• To indentify the weaknesses and indicate the measures to reduce them;

• take advantage of identified opportunities in the best and most efficient

way;

• Identify threats, examine the possibilities for their removal and point out

alternative solutions.

24

Figure 2. SWOT analysis

25

3. CONFOMITY WITH EU LEGISLATION

The requirements of the European Union in the field of metrology are

primarily related to the harmonization of national metrology regulations with the

EU directives in the subject area and strengthening the metrological

infrastructure. The European Union in this regard provides a contribution to the

projects for pre-accession assistance (IPA), which provides professional and

technical assistance to strengthen the capacity of metrology.

Directive of the European Union je a legally binding document for the

Member States, with the individuality of form and methods for their

implementation, through which the legal systems of the Member States are

approximating each other. There are directives of “old approach" and

directives of "new approach". Unique marking system known as CE, towards

which directives of the "new approach" act, was introduced in 1985.

Basic specifics of the Directive of "old approach" are:

• Do not include CE marking;

• A high level of technical requirements for products, detailed

specifications;

• Legislation Member State may apply simultaneously;

• National standards and regulations "faster" than the finalization of the

directives;

• Member States are responsible for the conformity of the product.

Basic characteristics directives of the "new approach" are:

• CE marking;

• The minimum level of technical requirements for products, general

specifications;

• The conditions in terms of safety, quality and design;

• Manufacturers are responsible for the conformity of the product;

• Notified bodies carry out conformity assessment;

26

• Technical requirements for products, in the harmonized European

standards issued by CEN, CENELEC, ETSI;

• Checking conformity with technical conditions:

1) Manufacturers - who themselves certify products based on the

conditions of the relative directive,

2) The Notified bodies - appointed by the Member States which

carry out tests and approval of the product.

Directives of "new approach" allow so-called "modular approach" i.e. 8

modules divided into the phase of development and production phase, of

which 3 modules are based on the introduced quality system.

Directives of the European Union in the field of metrology, for which the EU

Member States have an obligation to transpose into national legislation, in order

to harmonize the regulations, are the following ones:

CELEX 31980L0181, Council Directive 80/181/EEC of20 December, 1979.

on the approximation of the laws of the Member States relating to units of

measurement and abolition of Directive 71/354/EEC;

CELEX 32009L0003, European Parliament and Council Directive 2009/3/EC

of 11 March, 2009. Which amends Council Directive 80/181/EEC on the

approximation of the laws of the Member States relating to units of

measurement;

CELEX 32009L0034, European Parliament and Council Directive

2009/34/EC of 23 April 2009, relating to common provisions for both

measuring instruments and methods of metrological control;

CELEX 31976L0211, Council Directive 76/211/EEC of 20 January 1976, on

the approximation of the laws of the Member States relating to the filling

by weight or by volume of certain prepackaged products;

CELEX 32007L0045, European Parliament and Council Directive

2007/45/EEC of 5 September 2007, that defines rules on the range of

nominal quantities for prepacked products., abolishes Council Directive

75/106/EEC and 80/232/EEC and amends Council Directive 76/211/EEC;

CELEX 31975L0107, Council Directive 75/107/EEC of 19 December 1974,

on the approximation of laws of the Member States relating to bottles

used as measuring containers;

27

CELEX 32014L0032, European Parliament and Council Directive 2014/32/EU

of 26. February 2014, on the harmonization of the laws of the Member

States relating to making available on the market of measuring

instruments (MID);

CELEX 32014L003, European Parliament and Council Directive 2014/31/EU

of 26, February 2014, harmonization of the laws of the Member States

relating to making available on the market of non-automatic weighing

instruments (NAWI).

MID and NAWI regulations represent a novelty in the legislation pertaining

to metrology, since the national type approval procedures and the first national

verification do not apply to measuring instruments included in these regulations,

but the applicable European type testing is in accordance with the MID and

NAWI and the valid marking (initial verification) is the one carried out by the

manufacturer. The subject regulation only treats the placing of the measuring

instruments on the market (initial verification), the manufacturer / importer is

responsible for the conformity of measuring instruments, and the manufacturer

chooses the assessment procedure for the measuring instruments.

Application of MID and NAWI regulations implies active cooperation with

EU bodies for conformity assessment for measuring instruments, as well as

correspondence with the relevant EU institutions.

Basic problems in the process of transposing EU directives in the field of

metrology into the national legislation are:

• legal character dilemmas;

• lack of experience;

• lack of highly qualified professional staff and technical capacity;

• lack of clarity of certain provisions of the Directive;

• the lack of a precise translation into Montenegrin language.

In addition to the harmonized area, which includes legal unity and

synchronization between the Member States, there is a non-harmonized field,

i.e. an area where each member state has its own unique legislation in a

28

particular area, provided that it cannot prevent the trade, and the free flow of

people, goods and services, which is handled by clauses on mutual recognition.

4. INTERNATIONAL AND REGIONAL METROLOGICAL ORGANIZATIONS

4.1 INTERNATIONAL METROLOGICAL INFRASTRUCTURE

4.1.1 METRE CONVENTION

The basic idea from which the metric system has originated - a system of

units based on the meter and the kilogram - was created during the French

Revolution when the first two reference standards were made - for meter and

kilogram, made of platinum, and then located in the French National Archives in

Paris in 1799. – and that is how they later became known as the archive meter

and the archive kilogram. French National Assembly then ordered the French

Academy of Sciences to develop a new system of units that would be used

throughout the world

The advantage of using the French measures became apparent in

Europe, despite the ongoing wars at that time. Finally on 20 May 1875,

representatives of the governments of 17 countries, have signed the Treaty in

Paris called "Metre Convention" in order to ensure a uniform system of

measurement units in the world. Adopted were the unit of length - the meter

and the unit of mass - kilogram, and the International Bureau of Weights and

Measures (BIPM) was established, based in Sevres near Paris. The Metre

Convention was slightly modified in 1921.

Representatives of the governments of the Member States meet every

fourth year at the General Conference on Weights and Measures (CGPM), to

discuss the activities carried out by national metrology institutes and the BIPM, to

make recommendations concerning the new fundamental metrological

guidelines, while they also analyze the other matters important for the

functioning of the BIPM.

CGPM elects up to18 representatives to the International Committee for

Weights and Measures (CIPM),that meets once a year. CIPM supervises the BIPM

on behalf of the CGPM and co-operates with other international metrological

organizations. CIPM is supported by 10 consultative committees.

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4.1.2 CIPM MUTUAL RECOGNITION ARRANGEMENT

CIPM Mutual Recognition Arrangement (CIPM MRA) is an agreement

between the national metrology institutes, signed in 1999, and to some extent

revised in 2003 with regard to some technical issues. CIPM MRA consists of two

parts. The first part refers to establishing the degree of equivalence of national

measurement standards, and the other on mutual recognition of certificates of

calibration and measurement issued by participating institutes. CIPM MRA may

sign only one national metrology institute (NMI) as a representative of a country,

while the other institutes from that country that keep nationally recognized

standards (authorized institutes), can participate in the CIPM MRA through the

signatory NMI.

National Metrology Institute may choose to join only part of the overall

agreement or CIPM MRA. National Metrology Institutes of associate states of the

Metre Convention can join the CIPM MRA only through their regional metrology

organization. CIPM MRA does not extend nor replace any part of the Metre

Convention and is a technical arrangement between the directors of the

national metrology institutes, not a diplomatic treaty.

OBJECTIVES of CIPM MRA are:

to establish the degree of equivalence of national measurement

standards maintained by NMIs;

to provide governments and other parties with a secure technical

foundation for wider agreements related to international trade,

commerce and regulatory affairs.

These objectives are achieved by the implementation of the following

processes:

review of the declared measurement and calibration capabilities (CMC)

of the national metrology institutes (NMI) of the participants and the

designated Institute (DI);

credible participation of the national metrology institutes in international

standards comparisons (key comparisons or supplementary comparisons);

reviewing the quality system and demonstration of competence of the

national metrology institutes participants and authorized institutions.

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The end result of these processes is declaring measurement and calibration

capabilities (CMC) of an each national metrology institute and the designated

institutes and publication of the results of comparison in the database

maintained by the BIPM and publicly available on the web at:

http://kcdb.bipm.org/appendixC/default.asp

CIPM MRA is coordinated by BIPM and consultative committees. Regional

metrology organizations and BIPM are responsible to implement processes to

achieve the objectives of the CIPM MRA, while Joint Committee of the Regional

Metrology Organizations and of the BIPM is responsible for analyzing and

approving the data to be entered into the database.

4.1.3 OIML

The International Organization of Legal Metrology (OIML) is an

intergovernmental treaty organization founded in 1955., based on the

convention, that was changed in1968. The objective of OIML is to promote the

global harmonization of legal metrology procedures.

OIML has created a technical structure at the global level that provides

for Member States with metrological guidelines for the development of national

and regional requirements concerning the manufacture and use of measuring

instruments used in legal metrology. OIML issues international recommendations

that provides for members with an internationally agreed basis for the adoption

of national legislation for different measuring instruments. Draft

recommendations and documents are prepared by the OIML technical

committees or subcommittees assembled of representatives composed of the

Member States.

The system of beliefs at OIML which was introduced in 1991, enables

producers to obtain the Certificate and Report of the OIML test, as a proof that

a given instrument type complies with the requirements of relevant international

recommendations OIML. Certificates are issued by OIML member states which

have for that purpose set up one or more organs that are responsible for

processing applications from manufacturers needing their instrument to be

approved. Acceptance of these certificates in the field of the national

metrology services is voluntary.

http://kcdb.bipm.org/appendixC/default.asp

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4.1.4 NATIONAL METROLOGICAL INSTITUTES

National metrology system represents a technical infrastructure that enables

the implementation of accurate and reliable measurements. The metrology

system must be adapted to the needs of the country but also internationally

acceptable.

National Metrology Institute (NMI) is the institution that is authorized by

national decision to develop and maintain national standards of one or more

quantities.

Many national metrology institutes realize primary standards of the base and

derived units at the highest achievable international level, while some national

metrology institutes realize some units using secondary standards which are

traceable to other the national metrology institutes.

National metrology institutes are responsible for the following:

• dissemination of the SI units to accredited laboratories, industry, legal

authorities, etc.;

• research in metrology and the development of new and improvement of

standards (primary and secondary), and measurement methods;

• participating in comparisons at the highest international level;

• maintaining the general structure of the national hierarchy regarding

calibration / traceability (National Metrology System).

4.1.5 REGIONAL METROLOGICAL ORGANIZATIONS

At the regional level, the National Metrology Institutes cooperate in the

framework of the Regional Metrology Organization (RMO). Activities of the RMO

depend on the specific needs of the region, but usually include:

coordination of the comparisons of national standards, and other

activities CIPM MRA;

cooperation in metrology research and development;

to facilitate traceability to the SI primary achievements;

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cooperation in the development of metrology infrastructure of the

Member States;

joint trainings and counseling;

joint use of technical equipment and facilities.

Regional metrology organizations play an important role in the CIPM

Mutual Recognition Arrangement, since they are responsible for the review

described in the section 4.1.2, as well as the presentation of the results of an

organization in the Joint Committee of Regional Bodies JCRB.

4.2 EUROPEAN METROLOGY INFRASTRUCTURE

4.2.1 EURAMET

Cooperation between the national metrology institutes in the European

Union and the European Commission (EUROMET) was established as a joint forum

for cooperation in the field of national standards by signing a Memorandum of

Understanding in 1987. Increase of the level of integration, planning and

implementation of metrological research and development created the need

of establishment of a legal entity for coordinating activities in the field of

European metrology. European Association of National Metrology Institutes

(EURAMET) was founded in January 2007, replacing the EUROMET as the

European regional organization on 1 July 2007. Today EURAMET coordinates

cooperation between national metrology institutes with nearly 6,000 employed

metrologists for the development of European metrology infrastructure and

services. EURAMET is a regional metrology organization on European level and

represents Europe in international metrology forum CGPM.

One of the main aims of EURAMET is a coordinated European research in

metrology, i.e. analysis of common future needs in metrology, definition of

common goals and programs, planning and execution of joint research

projects. Into the European metrology research program (EMPR), launched in

2008, was invested 400 million Euros. The report on the research conducted

within the EMRP is expected during 2017. The continuation of this successful

program is a European research and innovation program in the field of

metrology (EMPIR), which is an integral part of Horizon 2020 (Horizon 2020), the

European Union's Framework Programme for research and innovation. Horizon

2020 is aimed at strengthening and expanding the base of the European Union

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to consolidate research area in order to make innovation and research system

more competitive on the global level. EMPIR has a clear objective - ensuring

competitiveness and well-being of European citizens, so that the main

challenges are the following areas: health, energy, environment, industry, as

well as the progress in fundamental science of measurements.

4.2.2 WELMEC

West European Cooperation in Legal Metrology (WELMEC) was established

in 1990, when representatives of 15 European Union Member States and 3 EFTA

Member States, signed the Memorandum of Understanding relating to the

preparation and implementation of the directives of the "new approach". The

organization in 1995 received a new name European cooperation in legal

metrology, but it retained the term WELMEC. At the time an associate

membership in the WELMEC was accepted for the countries that have signed

agreements with the European Union. WELMEC members are the national

authorities for legal metrology in member states of the EU and EFTA, while the

associate members of WELMEC are national authorities for legal metrology in

those countries that are in the process of negotiations on accession to the

European Union.

The goals of WELMEC are to:

• develop mutual trust between the authorities for legal metrology in Europe;

• harmonize legal metrology activities;

• exchange of information between interested parties.

WELMEC advises the European Commission and the Council regarding

the application an further development of relevant metrology directives.

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5. STRATEGY DESIGN PROCEDURE AND STRATEGIC PLANNING

Strategy Draft for the Development of Metrology in Montenegro is a

planning document, consisted of eight (8) strategic objectives as shown in the

figure 3, as well as the guidance with activities for achieving the operational

objectives in the period from 2016. to 2018.

Figure 3. Strategic objectives for the development of Metrology

The management of the Bureau of Metrology, staff representatives

from the Bureau for Metrology and representatives of the Ministry of Economy in

the preparation of the Draft Strategy for the Development of metrology in

Montenegro participated and the main metrology inspector was also consulted.

Preparation of the Draft Strategy for the development of metrology in

Montenegro implied the formation of a working group, which carried out the

collection, preparation and analysis of information necessary for the design of

the strategy, in line with the mission and vision of the Bureau of Metrology, as

well as the needs of the Montenegrin society, economy and science. Through

the development of strategic objectives and action plans the planning

document was established, aiming to provide consistent service delivery in the

field of metrology, that fulfill the relevant requirements of the user and

applicable laws and regulations. The processes necessary for the development

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of the quality management system, as well as their application in the "new"

areas of metrology, were identified. During the period of implementation, the

Ministry of Economy and management of the Bureau of Metrology, guided by

the principle of permanent improvements, shall exercise the review and analysis

of the strategy on an annual basis, as shown in Figure 4. The Ministry of Economy

and management of the Bureau of Metrology, in order to harmonize strategies,

policies, processes and resources for the achievement of its objectives, defines

interested parties and reviewed information on all interested parties and