Support for quality infrastructure in Georgia

ENPI 2008 project

Twinning Project Fiche

1.Basic Information

1.1.Programme: ENPI 2008

1.2. Twinning number: GE10/ENP-PCA/TR/09

1.3. Title: Strengthening accreditation infrastructure according to the best practice in the EU member states.

1.4. Sector: Trade and Industry

1.5Beneficiary country: Georgia (Ministry of Economy and Sustainable Development of Georgia, Georgian Accreditation Centre).

2.Objectives

2.1 Overall Objective

Development of trade related national quality infrastructure in Georgia

2.2 Project Purpose

Accreditation system strengthened so it is ready to apply for full membership in the European co-operation for Accreditation (EA) and InternationalLaboratory Accreditation Committee(ILAC).

2.3 Contribution tothePartnership and Cooperation Agreement and ENP Action Plan:

Article 51 of the EU-Georgia Partnership and Cooperation Agreement (PCA) adopted in April 1996 and entered into force in July 1999 promotes cooperation between the contracting parties in the field of standards and conformity assessment. ‘This cooperation shall promote alignment with internationally agreed criteria, principles and guidelines followed in the field of quality. The required actions will facilitate progress towards mutual recognition in the field of conformity assessment, as well as the improvement of the quality of Georgian products. To this end the parties shall seek to cooperate in technical assistance projects which will promote appropriate cooperation with organisations and institutions specialised in these fields (i), promote the use of Community technical regulations and the application of European standards conformity assessment procedures (ii), permit the sharing of experience and technical information in the field of quality management (iii).

In the framework of the European Neighbourhood Policy, an Action Plan has been adopted for Georgia in November 2006. The Twinning Project will be particularly relevant for Chapter 4.5 of the Action Plan “Trade- related issues, market and regulatory reform” and its section on “Standards, technical regulation and conformity assessment procedures” with a focus to “Ensure effective cooperation in order to establish and strengthen in Georgia a modern institutional system of technical regulation, standardisation, metrology and accreditation.”

This Twinning project should contribute favourably to the above Action Plan priority actions and objectives through concrete and measurable results. The project aims at building upon previous technical assistance activities. Through the support of a well-established Member State Institution, Georgian Centre for Accreditation(GAC) will, inter alia, be able: 1.to perform as a modern and effective institution in accreditation field; 2.participate in international work of international and regional accreditation organisations; 3.improve business environment through application of European standards in quality field.

3.Description

3.1 Background and justification:

Area of Technical Barriers to Trade (TBTs) has been considered as one of the key priorities in the preparatory process for future negotiations of DCFTA between the EU and Georgia. To the overall EC assessment “Georgia made limited progress in the implementation of the objectives in the area of regulatory approximation to the trade and investment related EU legislation contained in the PCA and in the ENP Action Plan which is crucial for Georgia to achieve a better practical access to the EU market. “ (SEC(2008) 393), “In the reporting period Georgia overall achieved some progress in its preparations for a possible future DCFTA, but it still needs to make additional progress in several areas.” (SEC(2009) 513/2).

By the end of 2005 essential and substantive amendments were made in relevant laws regulating the systems of technical regulation for transition period considering further revision thereof in line with international practice. The legislative reform introduced a number of innovations in line with international practice: a single accreditation body was established, transition from mandatory standardization system to voluntary one made. In the field of traceability of measurements, substantial efforts were made by National Agency for Standards, Technical Regulations and Metrology (GEOSTM) in setting up calibration services and participation in international or regional interlaboratory comparisons with positive results.

To be ready for the DCFTA negotiations, Georgia is requested to accelerate legislative approximation and improvement of the quality infrastructure. Specifically, the actions are to concentrate to (1) achieve progress in the strengtheningof a domestic institutional system in the area of technical regulation, standardisation, accreditation, metrology, conformity assessment and market surveillance; and (2) adopt and start implementing a government programme of adoption of technical regulations in line with the EU acquis in the priority industrial sectors.

For this purpose, the Georgian Government has provided a Strategy in Standardisation, Accreditation, Conformity Assessment, Technical Regulation and Metrology and a Programme on Legislative Reform and Adoption of Technical Regulations to the European Commission services. The Strategy and the Programme have been approved by the Commission services in May 2010 and adopted by the Government Resolution in August, 2010. They are therefore the reference documents for the Georgian Government forundertaking institutional and legislative reforms.

On international scale, Georgian Centre for Accreditation(GAC) is an affiliate member of International Organisation for Laboratory accreditation (ILAC) from 2007,as well itapplied to the European Organization for Accreditation (EA) for membership and signed a contract on co-operation in 2009. At the moment GAC has not signed any mutual recognition arrangements in accreditation field.

Up to present, the GAC was one of the beneficiaries supported by the EU Technical Assistance2008, which aimed mostly at setting upbasic infrastructure in the accreditation scope with setting quality system to ISO/IEC 17011 in the Georgian Centre for Accreditation as well as series of training and study visits for the lead assessors and technical experts of the GAC. More information is stated in 3.2 of the fiche.

During the drafting of this project fiche the main recommendations given in the reports of the EU Technical assistance project, German-Georgian bilateral project ‘Support of Quality Infrastructure in Georgia with particular consideration of Metrology’and others were taken into account:

  1. Developing of the necessary legislation
  2. Improving knowledge of local lead assessors and technical assessors
  3. Improving infrastructure for conformity assessment

Georgian Accreditation Centreis established on the basis of Georgian Laws on Certification of Goods and Services andLegal Entities of Public Law in 2005. Its main tasks are organizing and realizing theaccreditation in the field of conformity assessment.

GAC is a Georgian Public Institution –Legal Entity of Public Law. The bylaws of the GAC were approved by the order No. 272 of the Government of Georgiain 2005. The accreditation centre independently realizes its activities, under the state supervision of the Ministry of Economy and Sustainable Development. The Centre in its activities is directed by the Georgian legislation, standards and guideline documents internationaly usedin the field of accreditation.

GAC has its own professional staff including regularly trained assessors. GAC uses the relevant experienced persons, employed on a short term contract basis as itsassessors and experts. Head of GAC is the GAC General Director. GAC is fully responsible for its activities.Top management of GAC consists from the GAC General Director and Deputy of General Director (ref. Annex II).

With the support given through EUTechnical assistance project, US AID and bilateral Georgia-German co-operationproject and in view of experts’ opinion, there are challengesonthe level of basic requirements for accreditation infrastructure ending up in international recognition of the accreditationsystem. As a means, training of Georgian experts in MemberState’s institutions should be seen as an important step into European work methods. Increasing number of businesses interested in traceable calibrations and testings, high level of conformity assessment for products and services, requests for further development of accreditation field due to the need for application of international standards.To cope with highly demanding tasks to be performed by GAC, an involvementof its staff in the project activities shall be made to the widest possible extent. Seminars for industry, calibration and testing laboratories, inspection bodies, public institutions interested in quality issues, non governmental organisations and other interested parties are seen to contribute to increasing the awareness of accreditation and its benefits in the country. Nevertheless, this does not necessary mean to increase the overall number of GAC personnel, but is mostly aimed at ensuring sustainability of the results of the project in the long term.

3.2 Linked activities

In the recent years, a number of projects financed by different donors have been contributing for development and strengthening of the Georgian quality infrastructure institutions (standardisation, metrology, and accreditation). Below is a summary of the main interventions.

EUTACIS project “Support to Implementation art. 51 (Quality Management System) of PCA” (started in July 2008, extended from July 2010 to March 2011) covers three main elements of quality infrastructure - standardization, metrology, accreditation. Within the framework of the project seminars, trainings and study-visits in EU member countries are carrying out in order to get experience on advance practices and methods. In the framework of the project reference laboratory in the field of physical-chemical measurements will be created which will provide services in conformance with requirements of international and European standards, inter alia, in agriculture (inter alia reference materials for food sector) and oil-gas sector. Specific seminars on conformity assessment, chemical analysis, biological, inspection bodies are still panned to be carried out by the end of the project. The project foresees (a) training of Georgian accredited bodies and/or bodies interested in accreditation in the field of the relevant standard requirements and criteria, (b) providing of consultation and aid to the accredited conformity assessment bodies concerning implementation and proper operation of their management systems, (c) providing support for establishment of a system of Georgian Proficiency Testing Providers and Pilot Labs, (d) Manage of visits of GAC representatives in European co-operation for Accreditation General Assemblies and/or relevant working committees and provide aid in the field of cooperation with ILAC and IAF, (e) further help to GAC in implementation and operation of its management system, providing help: in its internal auditing system, trainings, work with its advisory bodies and consultation concerning its technical activities (f) enable GAC cooperation with TURKAK in this field (visit of TURKAK expert in GAC),(g) revision of state of art and advices concerning improvement of contemporary IT system of GAC.

BilateralGeorgian-German co-operation project2007-2013 ‘Support of Quality Infrastructure in Georgia with particular consideration of Metrology’involved trainings for the GAC assessors and invited technical experts according to international standards ISO/IEC trainings.

GAC assessors visited Physikalisch Technische Bundesanschtalt PTB (German national metrology institute). During the study visit the main focus was made on the issues of calibration of the measurement instruments and their traceability to the primary standards.

EU funded project “Georgian-European Policy and Legal Advice Center – GEPLAC” (ongoing until February 2012)assisted the Georgian National Agency for Standards, Technical Regulations and Metrology to harmonize the Law on Standardization with WTO TBT and EU legislation and drafting of secondary legislation. This assistance took place in 2006. The GEPLAC Project has delivered training sessions on technical regulations.

In the framework of USA project “USAIDWorld Learning Forecast”Latvian and Norwegian assessors visited GAC and assessed Quality Management system and Quality Manual of the GAC prepared according to International Standard ISO/IEC 17011 and GAC assessors visited Latvian Accreditation Body “LATAK”.During the study visit main focus was made on implementation of the ISO/IEC 17011 and international requirements into GAC Quality Management System.

It should be highlighted that the Twinning Project must as well be fully coordinated with the European Commission's activities, notably with regard to the preparation for a Deep and Comprehensive Free Trade Agreement and other donors’ initiatives.

Foreseen Twinning Project ‘Strengthening of the metrology and standardisation infrastructure according to the best practice in the EU Member States’ aims to provide expertise in the field of transposition of legislation, training to ISO 17025, ISO 9001, ISO 17020 standards, calculation of uncertainty of measurements in the selected fields, as well as strengthening of WTO TBT point.

3.3 Results:

Three mandatory results have been identified for the twinning project,which are grouped in two main headings as follows:

Results relating to the legal approximationfollowing with the model employed/in line with in the organisation of the EU’s internal market:

1. Rules and procedures of Georgian Accreditation Centre are in line with appropriate (EU, EA, ILAC, and IAF) requirements,

Results relating to the infrastructure capacity building implementation and improving quality management system:

2. Relevant harmonised standards (ISO17025, 17020, 17021, 17024 and ISO 15189) are applied in accreditation process in the way recognised by the regional or international accreditation organisations;

3. Awareness about accreditation is raised through improved relations with stakeholders.

3.4. Activities

The Twinning will allow for the development of a close relationship with anAccreditation body of an EU Member State[1]. The listed activities and the proposed means for achieving the activities are indicative and can be revised in the framework of the preparation of the contract between the twinned institutions.

A.0 General Activities

A.0.1 Kick-off Workshop

Method

The first month of the project will be used to allow the installation of the Resident Twinning Adviser (RTA) in Georgia. The RTA will have to be installed in his/her office at the GAC. S/he will be introduced to the BC stakeholders of the project and to his counterparts and staff. He will also hire an Assistant (RTA Assistant) through an appropriate selection procedure.

A one-day kick-off meeting will be organised in the first month aiming at launching and presenting the project to the stakeholders, the media and the public at large. In order to guarantee large public information about the start of the project, the meeting will be concluded with a press conference and a press release.

Benchmarks:Stakeholders, media and public informed about the start and content of the project by start of month 2

Resources:RTA, PL, translation, rent of premises.

A.0.2 Final Closing Conference

Method

During the last two months of the project, a closing conference will be organised at which the results of the project will be presented. The state of play in the areas of the project’s interventions will be discussed with the beneficiary, line ministries, the Government of Georgia, the civil society, NGOs and associations and other donors. The conference will be concluded with some recommendations for possible follow-up and lessons learnt for similar projects.

Benchmarks:Closing Conference organised,

Recommendations and Lessons learnt formulated and discussed

Stakeholders, media and public informed about the results of the project at its end.

Resources:RTA, PL, translation, rent of premises

Legal Approximation activities

The following activities group is linked to the achievement of the result 1‘Rules and procedures of Georgian Accreditation Centre are in line with appropriate (EU, EA, ILAC, and IAF) requirements.’:

1.1.Seminar on the role of accreditation in view of ensuring free movement of products and services especially in relation to the EU legislation.

Method

General awareness about the accreditation needs to be improved among Georgian legislators. EU experts will develop necessary material and carry out seminar on how EU regulations relevant to accreditation are transposed and implemented in several EU member states with the aim of emphasizing mandatory and voluntary fields for accreditation activities, use of international standards and guidance documents etc.

Benchmarks:Seminar carried out, material distributed.

Resources:RTA, STEs, translations, rent of premises

1.2. Review of legal acts of GAC.

Method

EU experts will revise the existing relevant accreditation documents in force in Georgia, will submit written considerations and proposals for improvement and provide necessary explanations to the staff of the GAC. The experts will take into account the relevant EU legislation - EC regulation 765/2008, decision 768/2008as far as related to accreditation, framework partnership agreement with the EU Commission and experience in transposition and implementation of the new approach directives as far as it may have influence over development of national accreditation infrastructure. Afterwards, a team consisting of GAC staff and a short term expert or experts will prepare drafts of horizontal accreditation documents. They will submit drafts of regulations to the BC authorities. After review and discussion, the team will finalise the draft new documents and submit it for approval to GAC’s general director.

Benchmarks:Revised/developed regulations accepted by the Beneficiary.

Resources:STE, translation, printing costs for material.

1.3. Study visits to at least 2 member state accreditation bodies for Georgian specialists on legislation, management and peer evaluation experience issues.

Method

During the implementation period of activities 1.2 and 1.3,four specialists in charge of this task in the GAC will be given an opportunity of a study visit in two similar institutions of the EU. They will use this period to discuss the draft laws and regulations and discuss enforcement issues, organisation and management of conformity assessment, accreditation, testing fields. As a part of mission, due attention to peer evaluation experience will be paid. In addition, an exchange of information shall take on experience in training of lead assessors and technical experts.

Benchmarks:Study visit report (to be submitted in two weeks after the visit).

Resources:4 flight tickets for experts, 48 per diems

Infrastructure capacity building activities

The following activities group is linked to the achievement of the result 2 ‘Relevant harmonised standards (ISO 17025, 17020, 17021, 17024 and ISO 15189) are applied in accreditation process in the way recognised by the regional or international accreditation organisations’:

2.1 Development of a training program and performing training on ISO/IEC 17025 with a focus on traceability of measurements and ISO 15189 including relevant EA and ILAC documents for GAC and external experts as well as personnel of the (to be) accredited laboratories.

Method

EU experts will discuss the existing needs with the beneficiary, develop necessary training material on relevant issues, such as uncertainty of measurements for calibration and testing laboratories with practical examples in at least three fields and carry out training. GAC, relevant conformity assessment bodies and other staff will participate in the training event.