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Abbreviations: EU European Union
WTO World Trade Organization
QI Quality Infrastructure
NQI National Quality Infrastructure
MoE Ministry of Economy
MS Member State
BI Beneficiary Institution
ISS Serbian Institute for Standardization
ATS Accreditation Body of Serbia
DMDM Directorate for Measures and Precious Metals
CEFTA Central European Free Trade Agreement
EA European Accreditation
CEN European Committee for Standardization
CENELEC European Committee for Electrotechnical Standardization
ETSI European Institute for Electrotechnical Standardization
WELMEC European Legal Metrology
EURAMET European Association of National Metrology Institutes
GIZ ACCESS German bilateral program support for Quality Infrastructure
WTO/TBT WTO Agreement on the removal of technical barriers to trade
CAB Conformity Assessment Body
NPAA National Programme for Adoption of the Acquis Communautaire 2013-2016
CA Conformity Assessment
MID Directive on Measuring Instruments 2004/22/EC
NAWI Directive on non-automatic weighing instruments 2009/23/EC
ATEX Directive on Equipment and protective systems intended for use in
potentially explosive atmospheres 94/9/EC
LIFTS Lifts Directive 95/16/EC
RTTE Directive on Radio equipment and Telecommunications Terminal Equipment
(1999/5/EC)
PCP Product Contact Points
NLF New legal framework
LTRPCA Law on Technical Requirements for Products and Conformity Assessment
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STANDARD TWINNING PROJECT FICHE
1. Basic Information
1.1 Publication notice reference: EuropeAid/ 136-447/IH/ACT/RS
1.2 Programme: IPA 2013
1.3 Twinning Number: SR 13 IB EC 01
1.4 Title: Strengthening capacities of National Quality Infrastructure (NQI) and
conformity assessment (CA) services in the Republic of Serbia
1.5 Sector: Private Sector Development
1.6 Beneficiary country: Republic of Serbia
2. Objectives
2.1 Overall Objective(s):
Overall objective of this project is to increase the competitiveness of Serbian enterprises and
industry in the EU market.
2.2 Project purpose:
Project purpose is to improve level of recognition of Serbian National Quality Infrastructure
(NQI) system through strengthening capacities of authorities in charge of quality
infrastructure (QI) and providers of conformity assessment (CA) services.
2.3 Contribution to National Development Plan/Cooperation agreement/Association
Agreement/Action Plan
The Stabilization and Association Agreement (SAA) entered into force on 1st September
2013, after the European Union (EU) informed Serbia that the ratification procedure is
successfully completed. Based on Article 77 of the SAA, Serbia is obliged to undertake
necessary measures in order to gradually achieve conformity with Community technical
regulations and European standardization, metrology, accreditation and conformity
assessment procedures. Parties shall seek to:
a) Promote the use of Community technical regulations, European standards and
conformity assessment procedures;
b) Provide assistance to fostering the development of quality infrastructure:
standardization, metrology, accreditation and conformity assessment;
c) Promote the participation of Serbia in the work of organizations related to standards,
conformity assessment, metrology and similar functions (e.g. CEN, CENELEC, ETSI,
EA, WELMEC, EUROMET);
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d) Where appropriate, conclude an Agreement on Conformity Assessment and
Acceptance of Industrial Products (ACAAs) once the legislative framework and the
procedures of Serbia is sufficiently aligned on that of the Community and appropriate
expertise is available.
The European Partnership for 2008 defined that Serbia should „continue to align the legal
framework on standardization, certification, metrology, accreditation and conformity
assessment with European standards. Continue to develop standardization and prepare for full
membership of the European standardization organizations”.
Progress report Serbia 2014 states that Serbia has continued implementation of legislation
with the EU acquis and that Quality Infrastructure Strategy remains to be adopted. The
administrative capacity of the Ministry in charge of horizontal coordination remains to be
strengthened.
In the area of standardisation, the Institute for Standardisation of Serbia (ISS) has adopted
almost 94.5 % of all European standards (ENs). Serbia has not yet applied for membership of
the European Committee for Standardisation (CEN) and the European Committee for
Electrotechnical Standardisation (CENELEC).
In the area of conformity assessment, more than 20 conformity assessment bodies have been
designated in accordance with the Rulebooks transposing relevant EU Directives.
In the field of accreditation, the Accreditation Body of Serbia (ATS) signed the International
Laboratory Accreditation Co-operation (ILAC) Mutual Recognition Agreement for the field
of calibration, testing, and inspection, and the International Accreditation Forum (IAF)
Multilateral Agreement for product certification fields. New fields of accreditation were
established for several New Approach Directives.
National legislation in the area of metrology is in line with the acquis and Serbia has already
started preparations for adopting new acquis in this area. The number of internationally
recognised national standards for calibration and measurement is now 142.
A new law on market surveillance remains to be adopted. The Product Safety Council
continued its regular operations. The administrative capacity of the line ministry remains
weak in the area of market surveillance.
In the field of ‘Old Approach’ product legislation, Serbia has aligned its legislation with
the acquis on textiles and footwear. It has yet to align its legislation in a number of other
areas, including emissions of pollutants from non-road engines and crystal glass.
As regards ‘New and Global Approach’ product legislation, Serbia has adopted legislation
transposing the Measurement Instruments Directive. Further alignment is needed in the areas
of construction products, cableway installations, recreational craft, cosmetics and toy safety.
As regards procedural measures, Serbia has yet to align its legislation with the acquis on
civil firearms and the return of cultural objects unlawfully removed from the territory of an
EU Member State.
National Program for Adoption of EU Acquis (NPAA, 2013-2016), adopted in the
beginning of 2013, goes more in detail regarding fulfillment of the SAA. In the chapter
regarding the ability of taking over obligations arising from the EU membership, in the field
of Free Movement of Goods, a precise plan for harmonization of legislative system of Serbia
with EU-rules and full implementation of technical legislation is presented. The revision of
NPAA is ongoing and revised plan will cover period from year 2014 to 2018.
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Draft Quality Infrastructure Development Strategy/Program for the period 2014-2020 is
prepared. Development priorities in the QI domain identified in this document have been
harmonized with the relevant strategic priorities defined in: Industrial Development Strategy
(2011-2020), Competitive and Innovative SMEs Development Strategy (2008-2013), Fiscal
Strategy for 2013 with projections for 2014 and 2015, Market Surveillance Strategy (2010-
2014), National Strategy for the EU-accession and National Program for Integration of the
Republic of Serbia to the EU–NPI, Stabilization and Accession Agreement (Art.77) and
CEFTA Free Trade Agreement in Southeast Europe.
An important instrument for enhancing competitiveness of Serbian industry, recognized in
the Industrial Development Strategy and Policy of the Republic of Serbia for the period
2011-2020, is reflected in the harmonization of technical regulations and standards with
international, i.e. European rules, and strengthening relevant institutions as an important
prerequisite in creating business environment that would enable export of Serbian products to
foreign, primarily EU markets. In order to achieve a balanced development of quality
infrastructure in accordance with the Serbian industry needs, i.e. provide adequate services to
the industry, this document recognized need to establish a mid-term strategic framework for
further QI development as one of the elements underlying implementation of this Strategy.
Fiscal Strategy for 2013 with projections for 2014 and 2015, in its part referring to
structural reforms aimed at intensifying business activities, has identified, inter alia, the need
for improvement of national quality infrastructure, including: full harmonization of the most
relevant standards for the industry competitiveness and their translation into Serbian; full
participation of the Serbian Institute for Standardization in the regional and international
standardization activities; full integration of Serbia in the international measurement system;
capacity building of the national metrology institution to directly respond to the private sector
needs; improved testing and certification, establishment of testing laboratories and
environmental protection, as well as conformity assessment bodies for the product
certification; strengthening the national accreditation body in assessing conformity
assessment bodies’ qualifications to render services of conformity assessment in the areas of
testing, inspection and the certification of products, systems and personnel.
Market Surveillance Strategy (2010–2014) emphasizes the importance of the improvement
of non-food product safety related legal framework, as well as the role of Market
Surveillance in enforcement of technical regulation aiming at health and safety protection,
environmental protection and other aspects of public interests.
This project is important for the implementation of the Free Trade Agreement for South East
Europe (CEFTA, signed 2006), too. CEFTA focuses on elimination of technical barriers to
trade primarily through harmonization of technical regulations and standards. The final goal
of these measures is to facilitate trade of products and services in the CEFTA region by
elimination of non-tariff barriers through mutual recognition of Conformity Certificates,
respectively.
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3. Description
3.1 Background and justification:
Competitiveness of Serbian enterprises is closely connected with their ability to produce
quality and safe products, conformed to the requirements of relevant technical regulations
and standards. An efficient and internationally recognized national quality infrastructure
(NQI) system that provides Serbian enterprises and industries with better conditions for
implementation of technical regulations and standards for products and management systems
(for: quality, environment protection, health and safety at work) is one of the prerequisites for
the competitiveness of the Serbian economy.
Developed NQI system with internationally recognized conformity assessment (CA),
metrology and accreditation system ensure safety of products placed on the market and helps
economic operators to accomplish requirements of the EU market i.e. related legislation
dealing with free movement of goods.
NLF “Package” contains the major principles for regulating this comprehensive area, and it
consists of:
- Decision No 768/2008/EC of the European Parliament and of the Council of 9 July
2008 on common framework for the marketing of products, and repealing Council Decision
93/465 EEC Text with EEA relevance- Official Journal L 218, 13/08/2008- P. 0082-0128;
- Regulation (EC) No 765/2008 of the European parliament and of the Council of 9
July 2008 setting out the requirements for accreditation and market surveillance relating to
the marketing of products and repealing Regulation (EEC)No 339/93 text with EEA
relevance –Official Journal L 218, 13/08/2008 P. 0030-0047;
- Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9
July 2008 laying down procedures relating to the application of certain national technical
rules to products lawfully marketed in another Member State and repealing Decision No
3052/95/EC.
NLF Package, together with Directives of the “Old” and “New Approach” which regulate
requirements regarding product safety, is the basis of the Single EU Market (harmonized
area). List of the most relevant sectoral EU regulations in the field of free movement of goods
is annexed in Annex IIb.
The Ministry of Economy, Sector for QI is the authority in charge of the elaboration of the
development policy in the areas of metrology, standardization, accreditation and conformity
assessment and coordination of the competent public authorities responsible for drafting and
implementing technical regulations (Law on Ministries, Official Gazette of RS, No. 44/14).
Metrology, standardization, accreditation and conformity assessment make a national quality
infrastructure system. Establishing and efficient functioning of a national quality
infrastructure system is very important because it is a prerequisite for:
a) Placing safe and quality products on the market and ensuring high level of consumers’
rights protection;
b) Free movement of goods and removing technical barriers to trade;
c) Easier access of national producers to international markets;
d) Achieving higher level of industry innovations and competitiveness;
e) Sustainable economic development and environmental protection.
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Quality infrastructure system in Serbia consists of the Serbian Metrology Institute
(Directorate of Measures and Precious Metals - DMDM), Accreditation Body of Serbia
(ATS) and Institute for Standardization of Serbia (ISS), and numerous conformity assessment
bodies (CABs) - economic operators mainly private entities.
The Directorate of Measures and Precious Metals (DMDM) is responsible for carrying
out specialized activities from the field of scientific and legal metrology and acts as the
National Metrology Institute (NMI).
Pursuant to the Law on Accreditation (Official Gazette of RS, No. 73/10), Serbia has a
legally established system of accreditation and the Accreditation Body of Serbia (ATS) as
the only national accreditation body. The accreditation system in Serbia includes, in addition
to the ATS accredited conformity assessment bodies (CABs), authorized and designated
CABs, accreditation rules and procedures.
The national system of accreditation in Serbia was peer evaluated by the regional
organization for accreditation (EA - European Cooperation for Accreditation), that led to
signing of the multilateral agreement (MLA) between ATS and EA in May 2012 for
accreditation of CABs performing testing, calibration, inspection and certification of products
and in 2014 for certification of persons and certification of management systems.
Furthermore, in October 2012 ATS signed IAF MLA (International Accreditation Forum)
and ILAC MRA (International Laboratory Accreditation Cooperation) and became an IAF
member and ILAC full member. This means that mutual trust and acceptance of reports and
certificates issued by Serbian accredited CABs (testing laboratories, medical laboratories,
calibration laboratories, inspection bodies and certification bodies performing certification of
products) has been achieved and that the Serbian accreditation system is regarded as
equivalent to those of all other signatories to EA MLA, IAF MLA and ILAC MRA.
The low level of industry competitiveness comes also from low level of quality and
compliance of products with relevant technical requirements, which disable companies to
participate in international product chains and markets. According to the findings of analysis
of QI system in Serbia, done within GIZ ACCESS project, the reasons are: insufficient
implementation of standards, lack of technical knowledge in companies, lack of industry
awareness about importance of fulfillment of requirements from international product and
management system standards, lack of testing facilities (for example: missing designated
CABs for implementation of new technical regulations, missing accredited labs used by
market surveillance authorities etc.) what causes that products are tested abroad (i.e. in the
region), which is time consuming and causes higher production costs in economically
difficult times. The level of consumers’ understanding of marks of conformity,
technical/safety requirements that products have to meet, and meaning of different labels and
marks put on the products is also poor.
In order to overcome these difficulties, it is crucial to increase awareness of enterprises and
industry about importance of fulfillment of technical requirements for ensuring safety and
quality of products on national market and their better competitiveness on the European
market. The project activities will raise industry awareness about importance of fulfillment of
technical requirements, by using products’ and processes’ standards for improvement of their
national and international competitiveness. This will be carried out by providing public
awareness activities to representatives of manufacturers, retailers, but also to the consumers,
to be able to understand and implement EU technical regulations at company level, it means
to meet the EU’s product and production requirements (CE marking and national mark of
conformity), aiming to better prepare them to benefit from future ACAAs.
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On the other side, it is very important to strengthen Serbian CA system, as one of the major
element of NQI and a basic tool of checking whether products, services, materials, processes,
systems and personnel measure up to the requirements of standards, regulations or other
specifications. From well-developed CA system, beside of manufactures, benefits also
exporters, service providers, consumers and regulators.
Furthermore, conformity to the EU standards creates confidence and facilitates access to
other markets. The main aim of developing harmonized conformity assessment (CA)
infrastructure on the EU level is to avoid duplication and overlapping in testing of products
which are prepared to be placed on the internal market. Certificates for products issued by a
conformity assessment body (CAB) accredited from national accreditation body
(Accreditation body of Serbia - ATS) recognized by European Cooperation for Accreditation
(EA)1 is a prerequisite for placement of products on the EU market. It means that a CA
system in a candidate country like Serbia has to be aligned and internationally recognized.
For this to be achieved, it is necessary to provide further support to DMDM and a number of
CABs, potential notified bodies in order to build their capacities to fully implement new
technical regulations, standards, test methods, extend the scope of their accreditation etc. This
project should enhance the CA system and capacities of providers of requested testing and
certification services in respect to industry needs (for example MD, LVD, MID, NAWI, PED,
PPE, CPD/CPR, ATEX and other directives).
It means, after intensive legislative activity in Serbia in the field of QI carried out from 2008
to 2012, which resulted with harmonized horizontal legislation and transposed New
Approach Directives for number of products, and remarkable results in institutional capacity
building in this area, it is important to continue with further capacity building, trainings and
other forms of support in order to achieve full harmonization and operability of the
established system, in line with the industry needs.
The focus has to be put on further improvement of compliance with EU requirements but also
on the enhancement of non-harmonized area. Alignment of technical regulations in non-
harmonized area should be implemented and number of technical regulations have to be
reviewed and/or changed (according to articles 34-36 of the Treaty on functioning of the EU
i.e. and Directive 98/34). This project will help MoE to coordinate process of overcoming
possible contradictions in national legislation in order to secure that technical regulations
justified on grounds of public morality, public policy or public security, the protection of
health and life of humans, animals or plants, shall not preclude prohibitions or restrictions on
imports or exports, as stipulated by Article 36 of the Treaty functioning of the EU.
MoE created Enquiry point which now acts also as notification point according to CEFTA
rules. When Serbia becomes a member of WTO, Sector for QI will be obliged to notify all
draft technical regulations and to inform foreign companies and institutions about Serbian
technical regulations in preparation phase, as well as domestic companies and institutions
about foreign technical regulations in preparation phase (function of notification).
Since all functions of existing Enquiry point are not fully operational, this project will
enhance capacities of Sector for QI to provide answers to enquiries of economic operators on
EU directives transposed in Serbia, relevant national legislation, relevant harmonized
1 EA's Mission: EA exists to coordinate and lead the European accreditation infrastructure to allow the results
of conformity assessment services in one country to be accepted by Regulators and the market place in another
country without further examination, for the benefit of the European community and the global economy."
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standards, classification of products concerning legal compliance (identification of relevant
product legislation), choosing the right CA procedure, etc.
Existing Enquiry Point in MoE will be a part of future System of Product Contact Points in
Serbia, according to EU Regulation 764/2008/EC, which has to provide EU companies with
information on relevant Serbian technical regulations. It is crucial for facilitation of free
movement of goods. Capacities of MoE to implement requirements of Regulation
764/2008/EC (in terms of Product Contact points) will be strengthened.
The project will focus on activities aimed at further strengthening of Serbian QI capacities
and implementation of the harmonized EU legislation covered by Chapter 1 - Free Movement
of Goods which is one of the largest and most important chapters.
There is a strong commitment in Serbia to progress in Free Movement of Goods and it is vital
that great efforts continue to be made, so that many of the mentioned Chapter 1 requirements
will be achieved by the support of this project. It will contribute to the efficiency and
internationally recognition of Serbian quality infrastructure system and thus raising the level
of the competitiveness of the Serbian economy.
3.2 Linked activities (other international and national initiatives):
Technical assistance to Quality Infrastructure Institutions in the Republic of Serbia
(from October 2008 to December 2010) (CARDS 2006). The overall objective of project was
to assist Republic of Serbia in meeting the requirements of the SAA in the area of free
movement of goods. The purpose of project was to assist Republic of Serbia with the
adoption of the policies and legislation harmonized with EU Acquis. Project had 4
components: 1. Assistance to the Ministry of economy (MoE), 2. Standardization – support to
the Institute for Standardization of Serbia (ISS), 3. Accreditation – support to the
Accreditation Body of Serbia (ATS) and 4. Metrology – support to the Directorate of
Measures and Precious Metals (DMDM).
Realized project activities:
First component comprised of following activities - assistance to internal reorganization of
Sector for QI in MoE, drafting of Law on Accreditation and performed training activities.
Within second component following activities were performed - development of document
management system (detailed technical specification and software) prepared ISS for full
implementation and certification of ISO 9001 and ISO/IEC 27001; ISS participated as an
observer in selected CEN/CENELEC Technical Committees and enhanced skills of ISS staff,
trough performed training activities.
Third component – Accreditation – implementation of corrective actions from the first pre
evaluation report which means that ATS was fully prepared to sign the EA MLA; in
cooperation with component 4. Metrology, a joint accreditation assessment was performed
(ATS + internationally recognized EU accreditation body - ESYD); prepared and performed
awareness raising campaign.
Fourth component – Metrology – design and implementation of long-term plan of inter-
laboratory comparison covering all physical and chemical quantities of relevance to DMDM
and its customers; 4 inter-laboratory comparisons were performed; DMDM was prepared for
two accreditations and enhanced skills of DMDM staff, through training activities.
Project Quality Infrastructure in the Western Balkans and Turkey (this project started in
the frame of CARDS 2006, and then was extended within MB IPA 2008 and MB IPA 2011)
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is focusing to facilitate harmonisation of legislative framework and implementing
mechanisms in field of free movement of goods. In addition, the Project enhanced trade
amongst CEFTA parties and between the beneficiaries of the project and EU with a view to
improving the competitiveness of the regional economy pre-accession. Following activities
was performed:
1. Independent expert assessments of progress in main QI fields;
2. Conducting regional proficiency testing exercises by inter-laboratory comparisons in
priority sectors;
3. Practical training courses in various QI fields;
4. Work of cooperation committee and other networking-building activities.
Some conclusions, in the almost seven years of regional project activities, after completion of
project within IPA 2008, are: Progress is evident throughout the region in all project sectors
but there is a still a lot to be done specifically in the fields of market surveillance (MS) and
CA. Moreover, awareness was raised on the new issues of QI and cooperation has started also
among the administrations of the countries involved in the project. The capacity and skills of
their staff was enhanced, and more participants than expected took part in the process. The
Single market as a real growth engine within the European economy remains a clear political
priority of the EU. The New Legislative Framework is one of the visible sign of this policy,
who emphases on reforms to accreditation and market surveillance within the EU. Improving
coordination systems, increasing political importance given to transposition of the Single
Market Directives, developing incentives for timely and correct transposition, correct
application and better enforcement of the single market legislation are considered crucial. At
regional level, this needs greater emphasis on ensuring transparency and smooth co-operation
between the ministry with most responsibility in this area (generally the ministry of economy
or equivalent) and those other ministries with responsibility for transposition and
implementing EU technical regulations. In the new economic strategy “Europe 2020”, the
European Commission reiterated as a key priority the further reduction of the transposition
deficit of Single Market Directives, the cornerstone of Chapter 1, which includes the QI
system. Candidate and potential countries preparing for accession to the EU must further
develop their administrative and technical capacities needed to support the implementation of
the Acquis in the QI fields and it is recommended that this should continue to be strongly
supported by the EC.
Development of National Strategy for Quality Infrastructure Project financed through
long-term GIZ ACCESS Private Sector Development Program (I phase which covered 3
years from 2011 to 2013 is finished and additional 3 years phase has been agreed), is
focusing on enhancement of the QI through enhancing policy making capacities of the MoE
related to the EU accession process and industry needs, and strengthening the services of QI
institutions for selected sectors.
First phase of the project comprised two components:
Component 1: Preparing long-term QI development document based on findings of overall
analysis of current situation (analysis of industry needs with regard to CA services („demand
side“), analysis of CABs capacities for implementation of the new technical legislation
(“provider side”); assessment of the NQI Institutions and analysis of functionality of a new
legal system of NQI).
Component 2: Benchmarking of NQI with EU countries - overview of QI in Europe –
institutional and legal framework; awareness raising activities; assistance to MoE in
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transposition of MID, NAWI and Pre-packages Directives and preparation for ACAA
negotiation process. It also includes technical support to the Serbian Metrology Institute
(DMDM), Serbian Accreditation Body (ATS) and Serbian Standard Institute (ISS).
Continuation of the GIZ ACCESS Program (second phase) for the period 2014-2016, was
approved by German Government in summer 2013 and finally agreed in beginning of 2014.
New Program will also have Component on Quality Infrastructure which will comprise
number of activities that will be aimed at implementation of main recommendation given by
NQI Strategy/Plan. Together with the assistance implemented by PTB-German Metrology
Institute and GIZ ACCESS, who will support Ministry, ATS, ISS and DMDM, during the
implementation of twinning project, it will be necessary to provide close cooperation between
two projects.
Second phase of the GIZ ACCESS project, is based on first phase project findings and as a
continuation of the first successfully implemented phase, will cover legislative activities in
harmonized and non-harmonized area such as revision of Serbian decree on notification of
national regulations beyond EU regulated area, review of legislation in non-harmonized area
in order to make analysis and recommendations for systematic plan on elimination of
contradictions with principles of free movement of goods, etc. It will also further
strengthened QI institutions, first of all support to ISS to become full CEN/CENELEC
member, better linked with industry/private – especially SME sector, to establish fully
operational training centre. Besides that, ACCESS will provide consultancy to industry
operators through clusters, BMOs, SME-portal, pilot companies, as well as to the selected
CABs to become more customer and market oriented. Part of ACCESS activities aimed at
support to ATS and DMDM will be provided by German Metrology Institute PTB, and it
includes: training for improving market surveillance of measuring instruments, transfer of
experience regarding authorization of bodies in charge of verification of measuring
instruments and surveillance on their work, training of ATS related to the accreditation of
CABs active in the regulated area where accreditation is intended to be used for the purpose
of notification for directives on PPE, ATEX, NAWI and MID.
To avoid overlapping with this Twinning fiche, detailed project contents defined within
Concept note include:
Component 1. Legislation framework in QI: (in the view of EU-screening process of Serbian
legislation)
1.1 Legislation framework QI – non-harmonized area: (GIZ)
systematic analysis and procedures to remove “barriers to trade” with free movements of
goods in line with Article 34-36 TFEU, related to 98/34 regulation in the non-harmonized
area. (Accordingly Action plan and partial implementation shall be conducted within IPA
2013 twinning project);
1.2 Legislation framework QI - harmonized area: (GIZ)
revision and redrafting of Serbian decree on notification and designation (national regulation
beyond regulated area). Unified procedures for designation/notification (EU accession
process chapter 1) and analysis of product technical legislation revised after the adoption of
New package of goods 2008 - To accelerate the process of bringing product harmonisation
legislation in line with the reference provisions of Decision 768 the Commission adopted an
“Alignment Package”.
Support should lead to recommendations of amendments on existing Serbian rulebooks,
review of horizontal legislation and implementing by-laws and suggestions for potential
amendments.
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Component 2. Institutional strengthening
2.1. Support to ISS (GIZ) towards ISS is CEN/CENELEC membership, likening with
industry/private sector, events and increased operation of ISS training centre operates,
additional lecturers, coaching of presenters, work package to be agreed with ISS and
Standardization expert;
2.2. Support to ATS (PTB, except organic sector, GIZ). The following activities are related to
the accreditation of CABs active in the regulated area where accreditation is intended to be
used for the purpose of notification. A combination of theoretical training, observation of first
assessments performed by experienced assessors from abroad, joint assessments and
assessments performed by ATS assessors observed by experienced assessors from abroad,
which has successfully been introduced in the last project period for selected New Approach
directives, will be performed at least for the following directives on Personal Protective
Equipment (PPE), Equipment and Protective Systems intended for use in potentially
explosive Atmospheres (ATEX).
Support to new and existing accreditation services shall be provided in the following
international standards: ISO/IEC 17024, ISO/IEC 17043, ISO/IEC 17020, ISO/IEC 17065,
ISO 15189, ISO/IEC 17025, ISO/IEC 17021, and more details shall be agreed upon after
further discussions between both sides. For activities requiring the identification of certain
participants or beneficiaries in case of pilot projects joint decisions based on transparent
criteria shall be taken.
2.3 Support to DMDM and MoE: (PTB) - According to the preliminary planning, activities
are planned for the implementation of directives, improving traceability capabilities in new
areas of measurement, market surveillance and verification etc.
Component 3. Awareness/Consulting/Training
Trainings for selected labs are customer and market oriented (GIZ);
Five designated CABs (remaining technical long term support, prepared for
Notification) (GIZ);
CABs (preferably LABs association) established - member in EU counterparts (in
cooperation with Chamber or legal entity of association itself) (GIZ, or GIZ+PTB);
Consultancy to the industry (through clusters, BMOs, SME-portal, pilot companies)
(GIZ);
Awareness campaign for implementation of directives such as MID, NAWI, etc.
(publications-guidelines for directives plus road-show, outline of adopted Strategic
paper, etc.) (PTB);
Awareness campaign for implementation of directives such as ATEX (publications-
guidelines for directives plus road-show outline of adopted Strategic paper, etc.)
(PTB);
Notifying Authority prepared (GIZ);
One lab expands scopes/services based on demand (GIZ);
One lab for product-certification in EE delivers services (GIZ);
Advisory platform established (GIZ).
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More details shall be agreed upon further discussions between both sides. For activities
requiring the identification of certain participants or beneficiaries in case of pilot projects
joint decisions based on transparent criteria shall be taken.
Strengthening of the Serbian system of Market Surveillance for non-food and food
products (IPA 2010) - the purpose of this multi stakeholder’s project (started on 16 July
2012) is to contribute to the market surveillance system (MSs) in Serbia to be able to
effectively and efficiently perform its tasks and responsibilities under the new legislation for
product and food safety, and to protect against products that pose serious threats to health,
safety and the environment. Expected results of project are: enhancing the technical capacity
of beneficiaries to implement new rules and regulations for product safety in Serbia, aligned
with EU Acquis; facilitating and managing change in strategy development of MS authorities
and improving cooperation as well as coordination; facilitating and managing change in the
operational field by enhancing the market inspectors’ (practical, general, legal, risk
assessment, inspection skills, etc.) understanding of legal and theoretical aspects of the new
regulations. In regard to QI, to achieve above mentioned results, it is plan to perform
following project activities:
- Activity 1.1: Capacity-building of Ministry staff on transposed EU directives and
regulations and training of market inspectors for implementation Serbian rulebooks
for LVD, EMC, MD, what will support preparation for future ACAA agreement.
- Activity 1.2: Transposition of EU directives - transposition of “Old Approach”
directives covering textile, footwear and crystal-glass.
- Activity 2.2: Development and partly implementation of MIS (Management
information system) as an instrument for improvement of daily market inspection
activities and cooperation with policy and decisions makers.
In the field of quality infrastructure till November 2013 following results were achieved by
IPA10 MS project:
1) Project experts helped the MoE to transpose Textile and Footwear directives through
seminars and consultancy within the work of Ministry’s working groups. Ministry prepared
draft Serbian rulebooks on textile and on footwear. Public debate is finished and the process
of obtaining an opinion from the relevant institutions is ongoing. After that they will be sent
on Government for adoption.
Regarding the Directive on Crystal glass, one seminar was held within the MS project and the
plan is, according to the NPAA, to work on transposition of this directive in 2014.
2) Representatives of MoE took part in training activities on implementation of LVD, EMC
and MD Directives, through explanation of the relevant Serbian rulebooks to the market
surveillance inspectors and through answering to the most frequent questions from practice.
As there are several donors co-operating with the BI, it is of great importance to liaise with
them on a regular basis in order to avoid duplication of activities or even contradictory
activities. Overall donor coordination of EU and bilateral support in the area of QI is carried
out by Unit of the Sector for QI, MoE, relying on national structures for development and
implementation of assistance, with significant role of SEIO, IPA unit of the Ministry of
economy and CFCU. In this way special attention is given to the indentification of priorities
in this area, respecting the principles of no-overlaping, in the frames defined by national and
European program documents such as CSP, NAD, MCSP, NPAA etc.
13
3.3 Results:
The results of this project should contribute to the achievement of the following higher level
objectives:
At sector objective level indicator:
Serbia’s ranking in the Global Competitiveness Report improved for at least 5 places
At sector support objective indicator:
Export of goods and services (% GDP)
Result 1. Improved enforcement of technical legislation by further harmonization with EU
product legislation
Indicators:
At least 3 EU Directives from the Chapter 1 – Free Movement of Goods, in line with
the NPAA, transposed (rulebooks drafted and adopted by relevant ministries);
Technical regulation on Pre-packed products, out of the scope of PP Directive, drafted
and adopted by the minister of economy;
Action plan for non-harmonized area prepared and approved by the MoE and other
relevant stakeholders;
First phase of the Action plan for non-harmonized area implemented;
Number of national technical regulations from non-harmonized area repealed or
aligned with Article 36 of the Treaty.
Result 2. Improved capacities of Sector for QI for providing services/assistance to industry
Indicators:
Situation analysis on current Enquiry point database and recommendations for their
improvement developed;
Procedure and guidelines for functioning of Enquiry point developed and approved by
MoE;
Procedures and guidelines for establishment and functioning of Network of Product
Contact Points (PCPs network) developed and approved by MoE.
Result 3. Strengthened capacities of QI institutions (DMDM, ATS and CABs) for
implementation of technical regulations and standards
Indicators:
At least 3 new accreditation schemes and/or procedures developed for the purpose of
designation of CABs;
At least 4 CABs and DMDM trained for the purpose of extension their scope of
accreditation and designation for performing CA according to European standards;
At least 4 accredited CABs in accordance with new accreditation schemes and
procedures for accreditation (except for ATEX, PPE or other regulation covered by
similar projects);
10% increased annual number of market surveillance controls of measuring
instruments;
14
At least 7 new product groups covered with testing/certification capacities in Serbia;
Number of established official contacts/networking with European laboratories or
notified bodies.
Result 4. Public awareness regarding the importance of EU technical regulation improved
Indicators:
At least 7 info sessions conducted;
Number of participants (industry representatives) on info sessions;
At least 3 promotional TV broadcasts campaign conducted;
Number of publications disseminated.
3.4 Activities:
The below activities are the minimum indicative requirements to achieve the above results.
The MS will take these into account when developing its own methodology and complement
them with its own and other relevant best practice experience and examples so that the above
results can be sustainably achieved.
Activities related to the Result 1:
1.1. Assistance to the MoE with drafting revised legislation to ensure full harmonization and
compliance with EU acquis in the field of metrology and pre-packed products, transposition
of EU directives and preparation of manuals for their implementation;
1.2. Assistance to the MoE for preparation of Action plan for non-harmonized area;
1.3. Revision of legislation in non-harmonized area in accordance with Article 36 of the
Treaty functioning of the EU, based on adopted Action plan;
1.4. Trainings and consultancy for raising capacities of MoE for full enforcement of the
Regulation 764/2008/EC and implementation of principles of Directive 98/34/EC.
Activities related to the Result 2:
2.1. Preparation of situation analysis of current Enquiry point database and recommendations
for upgrade of existing software;
2.2. Preparation of recommendations for improvement the Enquiry point within Sector for
QI;
2.3. Trainings and consultancy for strengthening capacities of Sector for QI to provide
answers to enquiries of economic operators on EU directives transposed in Serbia;
2.4. Development of plan for establishing the Network of Product Contact Points (PCPs
Network) and proposal for comprehensive database for exchange of information between
creators and implementers of technical regulations. Additionally, it will be necessary to
prepare needed manuals for functioning of PCPs Network with operational procedures.
Activities related to the Result 3:
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3.1. Trainings and consultancy to DMDM for implementation of MID, NAWI and
Prepackages, extension of the accreditation scope, improvement of existing Serbian
measurement standards, obtaining new calibration and measuring capabilities;
3.2. Trainings to designated CABs potential notified bodies, building their capacities to
implement new technical regulations;
3.3. Establishment of official contacts/networking with European notified bodies;
3.4. Support to ATS in development of new accreditation schemes and procedures for the
purpose of designation of CABs;
3.5. Trainings of the ATS staff and assessors on EC legislation and on how to conduct
assessments on notified bodies relevant to the EC Legislation and EN standards.
Activities related to the Result 4:
4.1. Organization of TV broadcast campaign targeted to manufacturers, retailers and
consumers on new approach, technical harmonization and CE and other markings;
4.2. Organization of info sessions targeted to industry on importance of fulfillment of
technical requirements and implementation of product/process standards for their national
and international competitiveness (such as products covered by textile, footwear, LIFTS,
RTTE, etc.);
4.3 Preparation and dissemination of publications on further priority areas: selected EU New
Approach Directives; conformity assessment modules/procedures and conformity marks; EC
Declaration of Conformity and CE marking, national marking requirements; Use of
harmonized standards and explanation of requirement from standards.
At least two major visibility events will be organized in the course of the implementation of
the project: Kick-off meeting at the start of the implementation and the Final meeting at the
end of the implementation of the project activities.
3.5 Means/Input from the MS Partner Administration:
3.5.1 Profile and tasks of the Project Leader
The MS Project Leader will manage the project team of selected member state(s) and co-
ordinate the implementation of activities.
PL tasks:
Overall management and coordination of the project with MS, NQI, other partners
and stakeholders;
Project reporting;
Ensuring backstopping and financial management of the project in the MS;
Ensuring timely, effective and efficient implementation of the project and
achievement of results, through proposed activities;
Coordination of deployment of short-term experts;
Coordination with RTA, from the Member State side, the Project Steering Committee
meetings, which will be held in Serbia every three months;
Participation at the Project Steering Committee meetings (every three months);
16
Assuring compatibility with EU requirements.
PL profile:
Requirements:
University degree in a relevant discipline (e.g. engineering, law, economic,
management);
High-ranking civil official with ability to call on short term experts in support of the
efficient project implementation;
At least 10 years of professional experience in Administration of selected MS;
At least 5 years in the field of EU legislation, especially free movement of goods;
Project management experience;
Working knowledge of English language;
Computer literacy.
Assets:
Experience with twinning rules and procedures;
Experience of current EU and WTO policies relating to the quality infrastructure.
3.5.2 Profile and tasks of the RTA
The Resident Twinning Advisor (RTA) works on a daily basis with the BC staff to
implement project, support and coordinate activities in the beneficiary country.
RTA must have broad/general knowledge in the field of free movement of goods/quality
infrastructure, which will enable him/her to organize interdisciplinary team for successful
implementation of the project. The duration of his/her secondment will last 20 consecutive
months.
RTA tasks:
Responsible for monitoring project implementation and proposing corrective
management actions if required;
Support and coordination of all project activities in BC in line with the agreed work
programme to enable timely completion of project results and delivery of the outputs;
Advise on related EU policies and best practices, legislation and regulation;
Establish and maintain cooperation with all beneficiaries involved in the
implementation of the project and other related projects (ensuring the avoidance of
overlapping), in close co-ordination with the Project Leader;
Nomination, mobilization and supervision of the short-term experts, together with the
Project Leader;
Facilitation of the contacts with peer institutions in EU member states in order to
stimulate a proper exchange of information and data;
Organization of visibility events (kick-off and final event);
Responsible for organization of the Project Steering Committee meetings and
reporting on the project progress;
Identifying and reporting to the Contracting authority, at early stage, all difficulties
that may jeopardize the implementation of the project and the achievement of its
results
17
RTA profile:
Requirements:
University degree in a relevant discipline (e.g. engineering, law, economics,
management);
At least 3 years of working experience in governmental competent authority (Ministry
or Agency) in an EU Member State responsible for Quality Infrastructure;
Experience in the EU policies dealing with free movement of goods;
Experience in development of major strategic documents and/or legal frameworks;
Proven contractual relation to public administration or mandated body, as defined
under twinning manual 5.4.5;
Project management experience;
Computer literacy;
Working knowledge of English language;
Assets:
Experience as team leader/RTA/key expert of at least one EU funded project,
preferably in the field of quality infrastructure;
Experience of current EU and WTO policies relating to the QI.
3.5.3 Profile and tasks of the short-term experts (STE)
The twinning partners will decide on the profile, number and involvement of short term
experts during the drafting of the project work plan. There should be a pool of short term
experts to ensure smooth implementation of the project during the overall implementation
period. STEs should be identified by the Project Leader/RTA and have to be agreed with the
beneficiary administration in the course of designing and delivery of the project. Team of
short-term experts should be mobilized according to agreed work plan.
Short-term experts’ tasks:
Pool of short-term experts should be comprised of the experts from the following areas:
Legal approximation;
EU and WTO rules and policy;
Private sector development.
Short-term experts profile:
Requirements:
University degree in a relevant discipline (e.g. law, economics, management,
engineering);
At least 3 years of professional experience in the field of the following indicative
areas:
- Legal expertise in the various fields related to free movement of goods;
- Technical expertise specialized for different product groups;
- Technical expertise in metrology and accreditation;
- Economic expertise – marketing and preparation of broadcast TV shows;
- Expertise in development of the seminars and trainings, providing capacity
building of CABs;
Experience in development of major strategic documents and/or legal frameworks;
Experience in organizing and providing training;
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Experience with twinning rules and procedures;
Proven contractual relation to public administration or mandated body, as defined
under twinning manual 5.4.5;
Computer literacy;
Working knowledge of English language.
3.5.4 Project assistant for the RTA
The RTA should be assisted by a full time project assistant for providing translation and
interpretation services on a daily basis and for performing general project duties. The costs of
the RTA assistant are funded by the Twinning contract and this has to be indicated in the
Twinning work plan and the corresponding estimated costs must be included in the project
budget.
RTA assistant must not have had, at least during the 6 months preceding their recruitment,
any contractual relation with the beneficiary administration.
The scope of the work and required qualifications of the project assistant for the RTA will be
defined in Inception phase.
4. Institutional Framework
The free movement of goods/quality infrastructure system of Serbia is overseen by the
Ministry of Economy (MoE) which acts as a coordinator in this field (Chapter 1 of EU
Acquis). The MoE is responsible for all horizontal issues in the field of standardization,
accreditation, metrology, technical regulations of conformity assessment. Its coordination
role, in the field of technical regulations and quality infrastructure (standardization,
accreditation, metrology and conformity assessment) arises from the Law on Ministries.
In accordance with the Law on Technical Requirements for Products and Conformity
Assessment (LTRPCA – Official Gazette of RS, No. 36/09), an approach regarding
preparation and adoption of technical regulations has been decentralized. This Law (Article 6,
paragraph 1) stipulates that each ministry, within its competence, is responsible for
promulgating technical regulations, which is in accordance with the Law on Ministries that
specifies that ministries within their competence perform public administration activities
referring to the preparation, adoption, and proposal of technical regulations. However, the
Ministry of economy, in line with Article 2 of LTRPCA, carries out specific activities in a
centralized manner (provisions of the LTRPCA governing the notification of the designated
or authorized bodies for conformity assessment, keeping the registers referring to technical
regulations and notification of draft technical regulations).
In order to perform activities relating to technical regulation and strategy in the field of free
movement of goods, more efficiently, i.e. to coordinate all activities in the field of
standardization, technical regulations, accreditation, metrology, Sector for Quality
Infrastructure was established at the Ministry in charge of economy in middle of 2008. The
Sector currently has 22 employees, with the following organizational structure:
- Section responsible for the creation and implementation of the development strategy and
policy of standardization, accreditation and metrology, and for the preparation and
implementation of technical regulations for industrial products covered by the scope of the
19
Ministry. This Section has got 4 Groups: Group for Standardization and Accreditation, Group
for Metrology, Group for Technical Regulations and Group for Conformity Assessment.
- Section acting as the Enquiry point for technical regulations and conformity assessment
procedures, and for notification of draft technical regulations towards the WTO and EC, as
well as a single-point for notification of the designated/authorized bodies for the conformity
assessment. This unit is also responsible for the preparation and monitoring of development
aid projects in the field of quality infrastructure and for the coordination of activities in the
negotiation Chapter on free movement of goods.
It shows that the Ministry of Economy, in the past few years gradually increased its capacity,
but in some ministries there is still insufficient number of competent experts who would
perform only activities related to the technical legislation for products. In a few ministries
there are organizational units responsible for enacting technical requirements and their
conformity with EU directives, and in certain ministries there are no employees who would
be solely responsible for such issues.
There are functioning bodies responsible for metrology, accreditation and standardization.
The Directorate of Measures and Precious Metals (DMDM) was established in 2007, as an
authority within the MoE, which continued carrying out all activities of the former Bureau for
Measures and Precious Metals, organization with an over 130-years long tradition.
Nowadays, DMDM is in charge of legal, industrial and scientific metrology as an authority
within the ministry competent for metrology and it acts as the National Metrology Institute
(NMI). Metrology system in the Republic of Serbia has been established in accordance with
international and EU trends, and it consists of the following subjects: The Ministry
responsible for metrology activities which is Ministry of economy; Directorate of Measures
and Precious Metals (DMDM); Metrology Council; designated conformity assessment
bodies, authorized bodies for measuring instruments verification and accredited calibration
laboratories. The DMDM headquarters is located in Belgrade, but it also possesses facilities
where Control and Surveillance Sections mainly carry out their activities, and these are
located in Subotica, Novi Sad, Zrenjanin, Krusevac and Nis. The total number of employees
in the DMDM is 112.
Pursuant to the Law on Accreditation, Serbia has a legally established system of accreditation
and the Accreditation Body of Serbia (ATS) as the only national accreditation body. The
accreditation system in Serbia includes, in addition to the ATS accredited conformity
assessment bodies (CABs), authorized and designated CABs, accreditation rules and
procedures. The accreditation system is in full compliance with the requirements of
Regulation (EC) 765/2008 which was verified by the European cooperation for Accreditation
EA that led to signing of a multilateral agreement on recognition (MLA) between of ATS and
the EA in May 2012. ATS has a total of 36 employees.
Pursuant to the Law on Standardization (Official Gazette of RS, No. 36/09), Institute for
Standardization of Serbia (ISS) has a public institution status operating in accordance with
regulations laying down the legal status of public services to perform adoption, publication,
review and withdraw of Serbian standards and related documents, as well as other activities
related to standards and standardization. ISS strategic goal to complete the harmonization of
80% of all EU standards was achieved by the end of 2012. After that ISS continues with
efforts to meet all other conditions (i.e. fulfillment of legislative, organizational, technical and
20
technological requirements) necessary for obtaining full-member status in CEN and
CENELEC. ISS has been a full member of the International Organization for Standardization
(ISO) since 1950 and a full member of the International Electrotechnical Commission (IEC)
since 1953. Furthermore, ISS acts as a Codex Contact Point for Serbia, in the framework of
cooperation with Codex Alimentarius Commission. Total number of ISS’s staff is 66.
There is a large number of testing laboratories, calibration laboratories, medical laboratories,
certification and inspection bodies, many of which are accredited (more than 500), but only a
few of them are designated by authorities according to the requirement from the harmonized
legislation. Competent ministries, within their respective scope of work, are responsible for
issuing authorizations (Old Approach) and designation (New Approach) of conformity
assessment bodies. The Ministry of economy is responsible for notification of designated
conformity assessment bodies. A total number of designated conformity assessment bodies in
Serbia amounted 27 (according to the register kept by the Ministry of economy).
The results of the project will not affect a change of the institutional framework as described.
Updated details on institutional framework and state of the art in the area of QI can be
found on: www.tehnis.privreda.gov.rs
The Project Steering Committee (PSC) will be established for the direct control and
supervision of the project implementation. The PSC will be responsible for the overall quality
of project implementation and provide strategic direction. PSC will ensure that the project
outputs and goals are met in time, approve work plans and reports, offer guidance and advise
on project activities. PSC will: provide guidance and decide on all strategic issues related to
the project, provide opinions and recommendations upon request by the Project Leader,
ensure overall coordination of the project, discuss and approve the main outputs of the
project, ensure access to the necessary information.
The PSC will encompass the Project Leader, RTA as well as their respective BC
counterparts, representative of the Department for Contracting and Financing of EU Funded
Programmes (CFCU), Ministry of Finance, representatives of the Serbian European
Integration Office (SEIO) and the representatives of other key partners from other QI
institutions. The exact composition of the steering committee will be determined in the
Twinning contract. Whenever necessary, representatives of other institutions, donors or key
experts should be invited to join the steering committee meetings as observers.
The PSC will meet every three months and ad hoc as required will be chaired by the BC
Project Leader. The draft quarterly reports will be discussed at the PSC before their
submission.
5. Budget
The maximum budget allocated to this Twinning project is 1 Million EUR.
Strengthening capacities of National
Quality Infrastructure (NQI) and
conformity assessment (CA) services in
the Republic of Serbia
IPA
Community
Contribution
National Co-
financing TOTAL
Twinning Contract 900,000 € 100,000 € 1,000,000 €
21
The co-financing requirement foreseen under IPA will be considered fulfilled according to
the provision of the relevant Financing Agreement.
The Ministry of Economy as a main Beneficiary will provide the twinning partner with
adequate office space for RTA and experts, meeting rooms and equipment necessary for
relevant everyday activities and training foreseen in twinning fiche.
Interpretation and translation costs for training, documentations and project activities will be
up to 6% of the budget and will be financed from the budget.
6. Implementation Arrangements
6.1 Implementing Agency responsible for tendering, contracting and accounting
Ministry of Finance
Department for Contracting and Financing of EU Funded Programmes (CFCU)
3-5 Sremska Street
SRB - 11000 Belgrade
Ms. Nataša Šimšić, Programme Authorising Officer (PAO)/Head of CFCU
Phone: + 381 11 2021 389
Mr Darko Vasić, Quality Control Office
Phone: +381 11 2021 412
E-mail: [email protected]
6.2 Main counterpart in the BC:
Ministry of Economy
20 Kneza Milosa Street
SRB – 11000 Belgrade
Senior Programme Officer (SPO)
Ms. Katarina Obradović Jovanović, Head of Division for Development of Small and
Medium-Sized Enterprises and Entrepreneurship
Ministry of Economy, Sector for Development of Entrepreneurship and Competitiveness
20 Kneza Miloša Street
11000 Belgrade
Phone: +381 11 3642 735
E-mail: [email protected]
BC Project leader: Ms. Jelena Popović, Assistant Minister
Ministry of Economy, Sector for Quality Infrastructure
24 Resavska Street
11000 Belgrade
Phone: +381 11 33 43 363
E-mail: [email protected]
Web: www.tehnis.privreda.gov.rs
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RTA Counterpart
Mr. Miodrag Dugandžija, Head of Division for registers, projects and cooperation with
international organizations
Ministry of Economy, Sector for Quality Infrastructure
24 Resavska Street
11000 Belgrade
Phone: +381 11 3343 368
E-mail: [email protected]
Web: www.tehnis.privreda.gov.rs 6.3 Contracts
The project will be implemented through one twinning contract.
7. Implementation Schedule (indicative)
7.1 Launching of the call for proposals: Fourth quarter of 2014
7.2 Start of project activities: Third quarter of 2015
7.3 Project completion: 21 months
7.4 Duration of the execution period: 21 months + 3 months
The execution period of the contract (legal duration) shall enter into force upon the date of
notification by the Contracting Authority of the contract signed by all parties.
8. Sustainability
Sustainability will be provided through the transfer of expertise in all needed specific areas to
local counterparts. The project is designed according to the needs and abilities of the BI,
which should be re-checked during the contracting phase. The recommendations and lessons
learnt from previous projects should be taken into account.
Direct practical benefit from the project inputs for the actual tasks and work processes of the
BI should ensure sustainability. Therefore it is important that a large part of BI staff
participates in project activities or is familiarized with their outcome. It is recommended to
promote the project actively within the BI and encourage participation.
The system for certification and testing needs to be truly open and transparent to have mutual
recognition and confidence by all major interested parties and applied in a uniform way
through the EU and candidate countries. This project will strengthen the system of
accreditation which is known to be the best way to achieve mutual recognition and technical
trust between all actors. Procedures developed by ATS for accreditation of CABs for the
purpose of notification for a number of directives will be implemented after the project has
been finished. Know-how and methodology for the development of such procedures can be
used for other new approach directives.
Capabilities of DMDM and selected CABs will enable introduction of new services that will
serve to enterprises after the project is finalized. Efficient and sustainable capacity of Serbia’s
23
quality infrastructure to carry out conformity assessment activities and promote introduction
of technical standards among industry will be developed.
Know-how and all material related to industry awareness activities and promotion activities
will be transferred to employees of MoE and other QI institutions in order to be able to
perform those activities regularly after project completion.
In terms of multiplier effects, many other negotiating Chapters of the Acquis require reliable
quality infrastructure, not only free movement of goods but also regional development,
agriculture, environment, food safety, consumer protection, customs, etc. The prospect of
becoming an EU Member State requires the capacity to measure, test and inspect with a view
of enforcing legislation in all these areas.
The establishment of an informal working group encompassing other donors active within the
scope of the project is encouraged.
Sustainability issues should be a standard item on the agenda of every meeting of the project
steering committee. This includes a checking of the effectiveness of mechanisms installed by
the BI to disseminate and consolidate the results of the project among its own staff and
external stakeholders.
9. Crosscutting issues
Cross-cutting issues will be addressed in the project so as to comply with the best EU
standards and practice in that area and in a way which demonstrates how they will be dealt
with within the project’s framework, its activities and outputs.
Equal Opportunity
The project will be implemented in a way which provides equal opportunities for
participation for those within the Ministry of Economy, Quality Infrastructure institutions and
those in other participating Line Ministries. No discrimination will be made on the basis of
gender and activities such as training will be organized in a way which makes them
accessible for both men and women. The number of men and women participating in training
events will be monitored during the project and this information will be used to identify any
potential discrimination. Principle of gender equality will be implemented in all project
activities. The project will result in procedures and measures that will implement this
principle.
Environment
Since the project supports implementation of technical requirements and product standards, it
will make sure that all procedures for its use will be implemented in a way which is as
environmentally friendly as possible. To protect the environment and save natural resources,
this Twinning project should in principle be based on a paperless work environment. This
means, in particular, minimizing paper use during project implementation through: use of e-
mails, establishing a project website and electronic project databases.
Minorities
The project will be implemented in a way which does not discriminate against any individual
on the grounds of their gender, ethnic origin, race or religion. Training will be organized in a
way which makes events accessible for all potential participants. Information on the
24
individuals receiving support under the project will be monitored during the project and this
information will be used to identify any potential discrimination.
Civil Society/Stakeholders involvement
Support under this project will concentrate on building capacity of various interested parties,
including main QI institutions, CABs, industry and consumer organizations, with the aim to
improve the understanding of importance of technical regulation and product standards
implementation for the economy of the country and for the society, particularly regarding
consumer protection and potential threat of unsafe products.
Based on the principle of equality, participation in the project will be guaranteed on the basis
of equal opportunity and without discrimination. This will be included in the Twinning
contract as a joint responsibility of the MS partner and the BI.
10. Conditionality and sequencing
No preconditions need to be satisfied prior to the start of this project.
ANNEXES TO PROJECT FICHE
1. Logical framework matrix in standard format
2. List of relevant Laws and Regulations
25
ANNEX I Logical framework matrix
Title: „Strengthening capacities of National Quality Infrastructure (NQI) and
conformity assessment (CA) services in the Republic of Serbia”
Program name and number:
IPA 2013 National Programme/Component I
Total budget:
1.000.000 EUR
IPA budget: 900.000 EUR
National co-financing: 100.000 EUR
Contracting period expires 3 years after the
signature of the Financing Agreement
Disbursement period expires 6 years after the
signature of the Financing Agreement
OVERALL
OBJECTIVE
Objectively verifiable
indicators
Sources
of verification
Overall objective of this project is to
increase the competitiveness of Serbian
enterprises and industry in the EU
market.
• Serbia’s ranking in the Global
Competitiveness Report improved for at
least 5 places
Statistical Publications (Statistical Yearbook)
EC Progress Reports
SPECIFIC PROJECT
PURPOSE
Objectively verifiable
indicators
Sources
of verification Assumptions
26
Project purpose is to improve level of
recognition of Serbian National Quality
Infrastructure (NQI) system through
strengthening capacities of authorities
in charge of quality infrastructure (QI)
and providers of conformity assessment
(CA) services.
• Export of goods and services (%
GDP)
Project Reports
EC Progress Reports
NPAA Progress Report
Ministry Reports
RESULTS Objectively verifiable
indicators
Sources
of verification Assumptions
27
Result 1. Improved enforcement of
technical legislation by further
harmonization with EU product
legislation
- At least 3 EU Directives from the
Chapter 1 – Free Movement of
Goods, in line with the NPAA,
transposed (rulebooks drafted and
adopted by relevant ministries);
- Technical regulation on Pre-
packed products, out of the scope
of PP Directive, drafted and
adopted by the minister of
economy;
- Action plan for non-harmonized
area prepared and approved by the
MoE and other relevant
stakeholders;
- First phase of the Action plan for
non-harmonized area
implemented;
- Number of national technical
regulations from non-harmonized
area repealed or aligned with
Article 36 of the Treaty.
Official Gazette of the Republic of Serbia
NPAA Progress Report
Project reports
Ministry reports
www.tehnis.privreda.gov.rs (official web page
of Serbian Quality Infrastructure system)
28
Result 2. Improved capacities of Sector
for QI for providing services/assistance
to industry
- Situation analysis on current
Enquiry point database and
recommendations for their
improvement developed;
- Procedure and guidelines for
functioning of Enquiry point
developed and approved by MoE;
- Procedures and guidelines for
establishment and functioning of
Network of Product Contact Points
(PCPs network) developed and
approved by MoE.
Ministry reports
www.tehnis.privreda.gov.rs (official web page
of Serbian Quality Infrastructure system)
29
Result 3. Strengthened capacities of QI
institutions (DMDM, ATS and CABs)
for implementation of technical
regulations and standards
- At least 3 new accreditation
schemes and/or procedures
developed for the purpose of
designation of CABs;
- At least 4 CABs and DMDM
trained for the purpose of
extension their scope of
accreditation and designation for
performing CA according to
European standards;
- At least 4 accredited CABs in
accordance with new
accreditation schemes and
procedures for accreditation
(except for ATEX, PPE or other
regulation covered by similar
projects);
- 10% increased annual number of
market surveillance controls of
measuring instruments;
- At least 7 new product groups
covered with testing/certification
capacities in Serbia;
- Number of established official
contacts/networking with
European laboratories or notified
bodies.
Project reports
Ministry reports
www.ats.rs
(official web page of Accreditation body of
Serbia)
www.dmdm.rs
(official web page of Directorate of Measures
and Precious Metals)
Commitment of all relevant QI institutions
Readiness of CABs to cooperate
30
Result 4. Public awareness regarding
the importance of EU technical
regulation improved
- At least 7 info sessions
conducted;
- Number of participants (industry
representatives) on info sessions;
- At least 3 promotional TV
broadcasts campaign conducted;
- Number of publications
disseminated.
Project reports
Ministry reports
www.tehnis.privreda.gov.rs (official web page
of Serbian Quality Infrastructure system)
National TV station/TV stations covering
majority of Serbian territory
Readiness of National TV station to
cooperate
31
ACTIVITIES Means and costs Sources
of verification Assumptions
Activities related to the Result 1:
1.1. Assistance to the MoE with
drafting revised legislation to ensure
full harmonization and compliance
with EU acquis in the field of
metrology and pre-packed products,
transposition of EU directives and
preparation of manuals for their
implementation;
1.2. Assistance to the MoE for
preparation of Action plan for non-
harmonized area;
1.3. Revision of legislation in non-
harmonized area in accordance with
Article 36 of the Treaty functioning of
the EU, based on adopted Action plan;
1.4. Trainings and consultancy for raising
capacities of MoE for full enforcement of
the Regulation 764/2008/EC and
implementation of principles of Directive
98/34/EC.
- Twinning project leader
- Resident twinning adviser
- Experts from relevant member
state institutions (short and
medium term)
- Language/ Project assistant for
the RTA
- Workshops, seminars, study tours
- Indicative budget : 1M€
- IPA Contribution: 0.9M€
- National Contribution: 0.1M€
Project reports
Ministry reports
www.tehnis.privreda.gov.rs (official web page of
Serbian Quality Infrastructure system)
National TV station/TV stations covering
majority of Serbian territory
Availability of EU experts in the required field
32
Activities related to the Result 2:
2.1. Preparation of situation analysis of
current Enquiry point database and
recommendations for upgrade of
existing software;
2.2. Preparation of recommendations for
improvement the Enquiry point within
Sector for QI;
2.3. Trainings and consultancy for
strengthening capacities of Sector for QI
to provide answers to enquiries of
economic operators on EU directives
transposed in Serbia;
2.4. Development of plan for
establishing the Network of Product
Contact Points (PCPs Network) and
proposal for comprehensive database for
exchange of information between
creators and implementers of technical
regulations. Additionally, it will be
necessary to prepare needed manuals for
functioning of PCPs Network with
operational procedures.
33
Activities related to the Result 3:
3.1. Trainings and consultancy to
DMDM for implementation of MID,
NAWI and Prepackages, extension of
the accreditation scope, improvement of
existing Serbian measurement standards,
obtaining new calibration and measuring
capabilities;
3.2. Trainings to designated CABs
potential notified bodies, building their
capacities to implement new technical
regulations;
3.3. Establishment of official
contacts/networking with European
notified bodies;
3.4. Support to ATS in development of
new accreditation schemes and
procedures for the purpose of
designation of CABs;
3.5. Trainings of the ATS staff and
assessors on EC legislation and on how to
conduct assessments on notified bodies
relevant to the EC Legislation and EN
standards.
34
Activities related to the Result 4:
4.1. Organization of TV broadcast
campaign targeted to manufacturers,
retailers and consumers on new approach,
technical harmonization and CE and other
markings;
4.2. Organization of info sessions targeted
to industry on importance of fulfillment of
technical requirements and implementation
of product/process standards for their
national and international competitiveness
(such as products covered by textile,
footwear, LIFTS, RTTE, etc.);
4.3. Preparation and dissemination of
publications on further priority areas:
selected EU New Approach Directives;
conformity assessment
modules/procedures and conformity
marks; EC Declaration of Conformity and
CE marking, national marking
requirements; Use of harmonized standards
and explanation of requirement from
standards.
35
ANNEX II a
Horizontal legal framework for quality infrastructure in the Republic of Serbia was
established by passing four framework laws in the areas of technical requirements for
products and conformity assessment, standardization, metrology, accreditation, as well as
passing all by-laws for their implementation.
Law on Technical Requirements for Products and Conformity Assessment (Official
Gazette of RS, No.36/09) represents a basic legal framework for transposition of European
technical legislation into the domestic legal system, unless stipulation of technical
requirements for products has been prescribed by specific laws. At the same time, it also
provides the legal framework for the stipulation of national technical regulations for products
not comprised by the harmonized regulations at the EU level.
Law on Standardization (Official Gazette of RS, No. 36/09) asserts establishing Serbian
standards based on European and international standards, as well as making the application of
standards voluntary. This Law regulates general standardization covering the broadest range
of users and not the branch standards applied in specific areas (rail, air and river traffic,
defense, etc.).Likewise, it provides conditions for a more rapid and efficient adoption of the
EU standards, and fulfillment of requirements for full membership in European organizations
for standardization.
Law on Metrology (Official Gazette of RS, No. 30/10) represents a basic legal framework
for organizing the metrology system in the Republic of Serbia, which means organizing
metrology tasks, legal measuring units, standards of the Republic of Serbia, putting in
circulation, use and legal inspection of measuring instruments. During the making of this law,
documents of the International Organization of Legal Metrology – ОIМLD1 and ОIМLD9,
and EU regulatory rules on metrology, were taken into account.
For the enforcement of this law, 15 by-laws were adopted, which inter alia describe more in
detail the following: measuring instruments subject to metrology market surveillance,
methods and preconditions for authorization and designation of conformity assessment bodies
and verification of measuring instruments respectively, conducting metrology market
surveillance, recognition of foreign certificates, marks and signs of conformity and other
issues related to metrology system. Besides that this law provides a legal basis for the
adoption of European directives in the field of Metrology, namely MID (regulating 10 types
of measuring instruments), NAWI (dealing with non-automatic weighing instruments) as well
as directive on pre-packaged products. Furthermore based on this law requirements for
measurement devices in the non-regulated area are defined.
Law on Accreditation (Official Gazette of RS, No. 73/10) comprehensively regulates the
accreditation system, which in addition to national accreditation body contains accredited
conformity assessment bodies, designated/notified conformity assessment bodies, as well as
rules and procedures for accreditation, establishing competencies of conformity assessment
bodies (testing, calibration, inspection and certification of products, management systems and
persons).
All four laws have adopted solutions from the EU “new goods package”
A number of by-laws for implementation of these framework laws were passed.
By-laws of the Law on Technical Requirements for Products and Conformity
Assessment are:
36
1. Regulation on Manner of Performing Conformity Assessment, Content of the
Document of Conformity, and Shape, Appearance and Content of Mark of Conformity
(Official Gazette of RS, No. 98/09). This order was passed in order to allow efficient,
professional and economical implementation of product conformity assessment with the
requirements of technical regulations. It defines various procedures (modules) of product
conformity assessment, in accordance to EU Decision 768/2008/EC on a common framework
for the marketing of products, which are usually, individually or in combination, prescribed
by technical regulations.
2. Regulation on the Manner of Designation and Authorization of Conformity
Assessment Bodies (Official Gazette of RS, No. 98/09). It prescribes what conditions CABs
are to meet in order to be designated or authorized for conformity assessment tasks in
accordance with requirements for designation and authorization from technical regulations.
3. Regulation on the Manner of Recognition of Foreign Documents and Marks of
Conformity (Official Gazette of RS, No. 98/09). This Regulation sets out the manner of
recognition of validity, in the Republic of Serbia, of documents of conformity issued by
foreign conformity assessment bodies, and marks of conformity issued in other countries.
4. Regulation on Manner of Providing Information and Notification of Technical
Regulations, Conformity Assessment and Standards (Official Gazette of RS, No. 45/10). This
Regulation sets out the notification procedure for technical regulations, standards and
conformity assessment procedures in accordance with ratified international agreements
signed by the Republic of Serbia and rules of the European Union.
5. Rulebook on Manner of Affixing Marks of Conformity on Products, and Use of
Marks of Conformity (Official Gazette of RS, No. 25/10) prescribes the manner of affixing
marks of conformity on products which are in conformity with the requirements of technical
regulations, before placing the product on the market and/or use, as well as use of marks of
conformity. Mark of conformity affixes manufacturer, its representative or importer in
accordance with the technical regulation, after the completion of conformity assessment.
6. Rulebook on Content and Manner of Keeping Registers referring to Technical
Regulations (Official Gazette of RS, No. 33/10) stipulates centralized manner of keeping of
five types registers referring to technical regulations, as follows: Register of valid technical
regulations, Register of draft technical regulations, Register of designated conformity
assessment bodies, Register of authorized conformity assessment bodies and Register of
foreign documents of conformity and marks of conformity which are valid in the Republic of
Serbia. Registers are kept in digital form by the Ministry, as public registers. Data from
registers is published on the website of the Ministry.
7. Rulebook on the Content of the Form Issuing a List of Serbian Standards Referred to
by the Technical Regulations (Official Gazette of RS, No. 69/09 and 14/12). This regulation
prescribes the content of the form used for publishing a list of Serbian standards transposing
harmonized European standards that refer to any technical regulation transposing the New
Approach Directives of the EU into the legal system of the Republic of Serbia.
By-law of the Law on Standardization is the Decision on the Amendments to the Act on
the Establishment of the Institute for Standardization of Serbia (Official Gazette of RS, No.
88/09). This decision harmonizes the establishment act with the regulations of the new law
and regulates in detail establishment, organization and work of the institute.
By-law of the Law on Accreditation is the Decision on the Amendments to the Act on the
Establishment of the Accreditation Body of Serbia (Official Gazette of RS, No 14/2011).
This decision harmonizes the establishment act with the regulations of the new law and
regulates in detail establishment, organization and work of ATS.
37
Very important laws that encompass horizontal legal framework of QI in the Republic of
Serbia are Law on General Safety of Products (Official gazette of RS Nr. 41/09) and Law on
Market Surveillance (Official gazette of RS Nr. 92/11).
ANNEX II b
Relevant European directives/regulations cited in the Official Journal
dealing with product groups
2000/9/EC Cableway installations
(EC) 1907/2006 Chemical substances (REACH)
89/106/EEC Construction products (CPD)
(EU) 305/2011 Construction products (CPR)
(EC) 1223/2009 Cosmetics
92/42/EEC Ecodesign – hot-water boilers
2010/30/EU Ecodesign and energy labeling
2009/125/EC Ecodesign and energy labeling
(EC) 1221/2009 Eco-management and audit scheme (EMAS)
2004/108/EC Electromagnetic compatibility (EMC)
94/9/EC Equipment for explosive atmospheres (ATEX)
93/15/EEC Explosives for civil uses
2009/142/EC Gas appliances (GAD)
2009/128/EC Inspection of pesticide application equipment
95/16/EC Lifts
2006/95/EC Low Voltage (LVD)
2006/42/EC Machinery (MD)
2004/22/EC Measuring instruments (MID)
93/42/EEC Medical devices (MDD)
90/385/EEC Medical devices: active implantable
98/79/EC Medical devices: in vitro diagnostic
(EC) 765/2008 New legislative framework (NLF)
2009/23/EC Non-automatic weighing instruments (NAWI)
94/62/EC Packaging and packaging waste
89/686/EEC Personal protective equipment (PPE)
38
97/23/EC Pressure equipment (PED)
2007/23/EC Pyrotechnic articles
1999/5/EC Radio and telecommunications terminal equipment (RTTE)
2008/57/EC Rail system: interoperability
94/25/EC Recreational craft
2011/65/EU Restriction of the use of certain hazardous substances (RoHS)
2009/105/EC Simple Pressure Vessels
2009/48/EC 2009/48/EC Toys safety
