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Support for quality infrastructure in Georgia ENPI 2008 project

Twinning Project Fiche

1. Basic Information

1.1. Programme: ENPI 20081.2. Twinning number: GE10/ENP-PCA/TR/091.3. Title: Strengthening accreditation infrastructure according to the best practice in the EU member states.1.4. Sector: Trade and Industry1.5 Beneficiary 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 International Laboratory Accreditation Committee (ILAC).

2.3 Contribution to the Partnership 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

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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 strengthening of 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 for undertaking 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 it applied 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.

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Up to present, the GAC was one of the beneficiaries supported by the EU Technical Assistance 2008, which aimed mostly at setting up basic 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 Centre is established on the basis of Georgian Laws on Certification of Goods and Services and Legal Entities of Public Law in 2005. Its main tasks are organizing and realizing the accreditation 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 Georgia in 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 used in 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 its assessors 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 EU Technical assistance project, US AID and bilateral Georgia-German co-operation project and in view of experts’ opinion, there are challenges on the level of basic requirements for accreditation infrastructure ending up in international recognition of the accreditation system. As a means, training of Georgian experts in Member State’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 involvement of 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

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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.

EU TACIS 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.Bilateral Georgian-German co-operation project 2007-2013 ‘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 “USAID World 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.

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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 approximation following 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 (ISO 17025, 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 an Accreditation body of an EU Member State1. 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

MethodThe 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.

1 Several MS, in case of a consortium

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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 discussedStakeholders, 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.MethodGeneral 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.MethodEU 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 768/2008 as 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

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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.MethodDuring 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.MethodEU 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.Benchmarks: Training carried out, certificates issued.Resources: STEs, translation, rent of premises, costs of printing material

2.2. Development of a training program and training on ISO/IEC 17020 including relevant EA and ILAC/IAF documents for lead assessors and technical assessors and experts as well as personnel of the relevant bodies,

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MethodEU experts will discuss the existing needs with the beneficiary, selection procedure of the experts to be trained, develop necessary training material on relevant issues with practical examples and carry out training. GAC and external experts will participate in the training event.Benchmarks: Training carried out, certificates issued.Resources: STEs, translation, rent of premises, costs of printing material

2.3. Development of a training program and training on ISO/IEC 17021 including relevant EA and IAF documents for lead assessors and technical assessors and experts as well as personnel of the relevant bodies.MethodEU experts will discuss the existing needs with the beneficiary, develop necessary training material on relevant issues with practical examples and carry out training. Training on evaluation of a notified body should be based on real examples. GAC and external experts will participate in the training event.Benchmarks: Training carried out, certificates issued.Resources: STEs, translations, rent of premises, costs of printing material

2.4. Development of a training program and training on ISO/IEC 17024 including relevant EA and IAF documents for lead assessors and technical assessors and experts.MethodEU experts will discuss the existing needs with the beneficiary, develop necessary training material on relevant issues with practical examples and carry out training. Training on evaluation of a notified body should be based on real examples. GAC and external experts will participate in the training event.Benchmarks: Training carried out, certificates issued.Resources: RTA, STE, translation, rent of premises, costs of printing material

2.5. Support in strengthening internal audits and management reviews.MethodEU expert will assess the existing situation in the GAC with regard to the state of art of the quality management system, discuss the existing needs with the beneficiary, do SWOT analysis, participate in internal audits and management reviews. Jointly the GAC and the expert will fill in the key performance indicators.Benchmarks: SWOT analysis performed, key performance indicators submitted.Resources: RTA, STE, translation, costs of printing material

2.6. Identification of priority bodies for witnessing both in Georgia and in Member States.MethodGAC and EU experts will agree on the list of priority accredited bodies to be jointly visited for evaluation and witnessing purposes in the focus areas in both Georgia and a Member State (or states in case of consortia). The EU experts will witness, discuss and make written recommendations on the implementation of harmonised ISO/IEC standards in the selected

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priority laboratories. These written recommendations shall be summarised in the report and discussed with the beneficiary. Task groups will be established with the aim of improving procedures if necessary. Benchmarks: Recommendations and task groups.Resources: RTA, STE

2.7. Advice on evaluation of local PT and ILC providers. Method EU experts will assess the existing situation in Georgia, discuss the existing needs with the Centre of Accreditation, develop necessary training material based on international standards and provide relevant background through a means of a seminar on organisation of PT schemes in priority areas. The priority areas shall be described in the recommendations and submitted in written form together with draft evaluation procedure. Discussion should be held for the finalisation of the list. Benchmarks: Recommendations and training.Resources: STE, translation, rent of premises, costs of printing material 2.8. Revision of all necessary quality management documents in the GAC in the beginning and the end of the project. MethodIn order to develop a comprehensive quality management system in line with the ISO 17011 in the GAC, EU experts will assess the existing situation in the GAC, discuss the existing situation with the beneficiary, and develop the first set of comments. After the discussion and input of the task groups of the beneficiary, the final set of comments will be submitted for the acceptance. The documents shall be provided in both English and Georgian. At least two visits of 2 experts will be necessary for the implementation of the activity. Benchmarks: Draft documents and recommendations.Resources: RTA, STEs, translation,

2.9. Study visits to a Member State or states MethodFollowing implementation of the part of the activity 2.6 in Georgia, four specialists of the GAC will be given an opportunity of study visit to the member state or states for witnessing and discussion of the accreditation process in inspection or other bodies. In addition, one of the institutions for a visit should be a notified body to the relevant conformity assessment procedures according to a New Approach directive. They will draft a report in which they will underline the benefit of the new practices introduced and, if relevant, propose amendments to the draft documents of the GAC quality management system.Benchmarks: Study visit report (within two weeks after return).Resources: 4 international flights, 56 per diems

2.10 Performing of preliminary peer evaluation according to ISO 17011 and EA rules, MethodEU experts will carry out the preliminary peer evaluation in the GAC following the relevant documents. The recommendations and findings shall be summarised in the report and advice

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given for improvement when necessary. The discussion of findings will be held to achieve mutual understanding of the report and advice.Benchmarks: Recommendations.Resources: RTA, STE, translation, costs of printing material

2.11. Study visits to the meetings of accreditation technical and management committees, participation in international conferences and workshops.MethodGeorgian specialists will have an opportunity to participate in the meetings of international and regional accreditation organisations/bodies or bodies relevant or involved in the accreditation, their technical committees, other training events related to quality management systems, quality infrastructure capabilities. Benchmarks: Study visit reports.Resources: 20 flight tickets, 80 per diems

2.12. Improving accreditation experts’ training system through individual approach and tailor made courses.MethodEU experts will assess the existing training system for staff of the GAC and external auditors and experts with the aim of improving it and focusing on an individual training approach. It should be clarified to which extent tailor made approach in training may be applied and recommendations along with the agreed training material should be provided. Benchmarks: Report, recommendations and training material.Resources: STEs, translation

2.13. A set of training courses on calculation of uncertainty of measurements for calibration and testing purposes, validation of test methods for the GAC and (to be) accredited bodies. MethodEU experts will carry out SWOT analysis, discuss the needs of calibration and testing laboratories and the GAC, and will provide recommendations to the GAC on which fields may be covered for support in establishing procedures in calculation of uncertainty based on actual work of the bodies. Practical examples shall be drawn up and delivered to the GAC staff and the laboratories with a detailed explanation of way of calculation. The courses shall cover 10 examples in calibration, 5 in testing field. Benchmarks: Recommendations and excel sheets with relevant formulae.Resources: STEs, translation, costs of printing material

2.14. Training for staff of the GAC and (to be) accredited bodies on the relevant New Approach EU directives (pressure equipment, transportable pressure equipment, LVD, medical devices, cableway installations, construction products, lifts, machinery safety).MethodThe EU experts will develop training material and perform training for the GA and conformity assessment bodies on the relevant directives (pressure equipment, transportable pressure equipment, LVD, medical devices, cableway installations, construction products, lifts, machinery safety) with introduction to the relevant EU standards and the standard tests.

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Benchmarks: Training material and certificates.Resources: RTA, STEs, translation, costs of printing material.

The following activities group is linked to the achievement of the result 3 ‘Awareness about accreditation is raised through improved relations with stakeholders’:

3.1. Seminar(s) on New Approach and accreditation of notified bodies based on EA-02/17 MethodEU experts will develop necessary material and carry out a seminar (or seminars) about the roles and obligations of notified bodies, manufacturers, importers, especially under New Approach principles, role of the CE marking and other relevant markings, their relation to the technical regulations. Furthermore, documents EA -02/17 shall be explained to the participants in detail, examples of procedures provided. The conference is aimed at the GAC staff, economic operators, conformity assessment bodies, consumer protection organisations, and the other interested parties. Questionnaire concerning satisfaction should be produced and filled in by participants for further analysis. Results of the analysis will allow Georgian counterpart to address important gaps in communication with the stakeholders as well as it will allow keeping training material up-to-date. All relevant material produced by the project will be made available on the website. Benchmarks: Seminar(s) carried out, material distributed and updated.Resources: STEs, translation, costs of printing material, rent of premises

3.2. Preparation of information material on technical barriers to trade, accreditation, conformity assessment and other related issues. MethodEU expert will discuss with the GAC on the kinds of information (relevant conformity assessment modules, accreditation, quality standards etc.) and target groups, agree on the scope of the material and develop draft material and submit it for discussion with the beneficiary and stakeholders. After joint agreement, leaflets and brochures will be printed and disseminated. If found acceptable, CDs/DVDs will be produced instead of paper material. Website of GAC will be improved and updated accordingly. In order to have a wider and better perception of accreditation, a joint team of the experts will produce a questionnaire and will disseminate it to the stakeholders (ministries, public bodies, universities, private bodies etc.) in order to establish the present level of interest and knowledge in accreditation. The initial research should be made in the beginning of the project and the results should be compared with the results of target activities linked to the result No 3 during and by the end of the project.Benchmarks: Information material approved and produced, questionnaire produced.Resources: STEs, translation, costs of producing material

3.3. Organising awareness seminars on “Role of accreditation in international trade”MethodEU experts will develop necessary material and carry out training the role of accreditation in the mandatory and voluntary fields aiming at removal double testing and strengthening international recognition in quality field. Examples from several EU member states must be presented. Questionnaire concerning satisfaction should be produced and filled in by

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participants for further analysis. Results of the analysis will allow Georgian counterpart to address important gaps in communication with the stakeholders as well as it will allow keeping training material up-to-date. Benchmarks: Material developed, seminar carried out, certificates issued.Resources: STEs, translation, costs of printing material, rent of premises

3.4. Workshop on traceability in chemistry in the EU member stateMethodEU expert will come and identify Georgian needs in the area of uncertainty calculation in chemistry area and will develop a training program. Georgian experts will visit accredited laboratories performing tests in chemistry field, a national metrology institute with expertise in chemistry field and will be trained on calculation of uncertainty of measurements. Benchmarks: Study visit reports.Resources: STE, translation, 6 flight tickets, 36 per diems

3.5. Assessment of opportunity to establish associations of accredited bodies in Georgia. MethodEU experts will carry out assessment of the existing situation and will meet relevant representatives in the public, semi-public and private organisations to discuss the ways and opportunities for strengthening co-operation between the GAC and the other stakeholders. Questionnaire concerning satisfaction should be produced and filled in by participants for further analysis. Results of the analysis will allow Georgian counterpart to address important gaps in communication with the stakeholders to facilitate process of establishing associations.Benchmarks: Meetings, reports and recommendations.Resources: STEs, translation, costs of printing material

3.6. Support in organisation of annual conferences on accreditation and other relevant issues to quality infrastructureMethodEU experts will support organisation of annual conferences on accreditation and related issues within quality field through delivery of reports/speeches at the conferences. The presentations should be agreed with the beneficiaries in advance. Questionnaires concerning satisfaction should be produced and filled in by participants for further analysis. Results of assessment of previous activities should be discussed there as well. Benchmarks: Reports, evaluations of the results, presentations.Resources: RTA, STE, rent of premises, translation of material

3.7. Support in organisation of meetings of sector specific technical committees.MethodEU experts will share their experience in organising meetings of sector specific technical committees and perform training for the GAC and relevant personnel after performing needs analysis. Support in preparation of rules of meetings. Questionnaire concerning satisfaction should be produced and filled in by participants for further analysis. Results of the analysis will allow Georgian counterpart to address important gaps in communication with the stakeholders in order to strengthen interest of accredited bodies and other relevant organisations to contribute to accreditation activities.

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Benchmarks: Training material, seminar.Resources: STE, translation, rent of premises, translation of material.

3.5 Means/Input from the MS Partner Administration

3.5.1 Profile and tasks of the Project Leader (PL)

The PL will be expected to devote a minimum of 3 days per month to the project in his home administration. In addition, he will coordinate, from the Member state’s side, the Project steering Committee (PSC), which will meet in Georgia every three months.

Profile:

at least 10 years experience either in the field of accreditation or conformity assessment with good understanding of other subjects and, during that period, he/she must be in an active senior management position in the Member State institution for at least 3 years; Have experience in the field of project management, institutional issues and organisation of national quality infrastructures to the European requirements;excellent command of English

Tasks: Overall coordination, guidance and monitoring of the project;Preparation of project progress reports with support of RTA;Timely achievement of the project results;Co-Chairing of project steering committees;Provision of legal and technical advice and analysis whenever needed.

3.5.2 Profile and tasks of the RTA One Resident Twinning Adviser (RTA) over a period of 18 months as well as medium/short term experts will implement the above-listed components. The RTA has the responsibility to guide the work of the team and provide support in auditing and peer-evaluation of quality management system of GAC

The RTA shall fulfil the following profile:

Minimum 7 years of experience in the field of accreditation or conformity assessment;Sound knowledge of relevant EU legislative and institutional requirements related to the various components of this project;Wide knowledge of related good practice/EU Acquis and demonstrated experience in accreditation activities;Solid knowledge of accreditation and conformity assessment legislation, work methods and procedures;Previous experience in project management would be an asset;Experience in working on similar projects in transition countries would be an asset;Good training, public speaking, diplomatic and written communication skills;Excellent computer literacy (Word, Excel, Power Point);

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Excellent command of spoken and written English;Fluency in Georgian or Russian would be an asset;Experience in implementation of QMS according to ISO/IEC 17011;Experience in implementation of QMS according to ISO/IEC 17020 would be an asset.

Tasks: Overall supervision of the project implementation and coordination of all activities, as well as management of the project administration;Coordination of the activities of the team members in line with the agreed work programmes to enable timely completion of project outputs;Provide technical input to the project whenever needed and provision of advise in his field of expertise;Liaise with MS and BC Project Leaders and daily contacts with BC RTA counterpart;Co-preparation of project progress reports with Project Leader;Liaison with EU Project Manager; Liaison with other relevant projects and Georgian institutions.

3.5.3 Profile and tasks of the short-term experts

Tasks of medium and short term expertise

Terms of Reference for short-term adviser(s) will be elaborated by Project Leader/RTA at the work plan preparation stage.The exact number of STEs per activity should be agreed during the contract negotiation process.

Profile of short-term expertise

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. The STE's shall have:

a university degree in a relevant subject; a minimum of five years experience in their respective field; an excellent command of written and spoken English; Georgian and/or Russian language knowledge would be an asset; experience in PHARE/ENP-East countries or in other international projects relating to quality infrastructure development/management would be an advantage.

In order to achieve the result No 1, STEs involved shall have experience in drafting legislation, performing impact assessment,

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have good writing and presentation skills and be familiar with various approaches in implementation of the EU legislation as well as international accreditation documents.

In order to achieve the result No 2, STEs shall have training and facilitation skills specific knowledge and experience in setting up and operating quality

management systems to ISO 17025, ISO 17020 and/or ISO 17021, ISO 15189, ISO 17024 where applicable,

experience in coaching/mentoring, experience of external/internal/technical assessors.

In order to achieve the result No 3, STEs shall be good communicators and motivators and should have specific knowledge and experience in conformity assessment of

measuring instruments, experience in New Approach related issues, especially with regard to the interest of economic operators

experience of piloting or running interlaboratory comparisons, good writing, training and presentation skills,

In addition to their missions in Georgia, the short-term experts are expected to contribute actively to elaborating the programmes of the foreseen study visits.

4. Institutional Framework

In terms of the institutional set-up, the former monopolistic system of “Sakstandarti” (‘Georgian standards organisation’), which incorporated all administrative bodies of the technical regulation sphere, was abolished. As a result, Georgian Centre of Accreditation under the Ministry of Economy and Sustainable Development of Georgia was established.

Main objectives of GAC are participation in elaboration and implementation of the state policy on accreditation and conformity assessment.

Furthermore, the other stakeholders as the Ministries, public agencies and private or semi-private organisations such as testing and calibration laboratories will be involved in the execution of the project activities. Universities should also be invited to take part in certain meetings and trainings.

5. Budget

The maximum total budget available of the action is € 1.15 million.

6. Implementation Arrangements

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6.1. Implementing Agency

The European Union Delegation in Tbilisi will be responsible for tendering, contracting, payments and financial reporting, and will work in close co-operation with the beneficiary. The person in charge of this project is:Mr. Erik Eriksen Project Manager Delegation of the European Union to Georgia38 Nino Chkheidze str., 0102 Tbilisi, Georgia. Tel: + 995 32 943 763 Fax: +995 32 943 768 e-mail: [email protected]

PAO will support the TWG Project implementation process together with the EU Delegation. The person in charge of this project is: Mr Roman KakuliaDirectorOffice Address:Project Administration Office (PAO) in GeorgiaOffice of the State Minister of Georgia on European and Euro-Atlantic Integration#7, Ingorokva Street, Tbilisi 0134, GeorgiaOffice tel./fax: (995 32) 99 89 14

6.2 Main counterpart in the Beneficiary Country:

Project leader: Mr. Abesalom Kekelia, First Deputy Minister; Ministry of Economy and Sustainable Development of Georgia, 12 Chanturia Str, Tbilisi, Georgia Phone: +995 32 99-11-34, Fax: + 995 32 99 02 20Email: [email protected]

RTA counterpart:

Mr. Paata GogolidzeDirector of Georgian Accreditation Centre Kazbegi Str 42, 0141 Tbilisi, GeorgiaPhone/Fax: +995 32 61 35 00

Email: [email protected]

6.3. Contracts:

The project will be implemented through one twinning contract.

6.4. Project Steering Committee:

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mailto:[email protected]

mailto:[email protected]


A Project Steering Committee (PSC) will be established for the control and supervision of the project activities and the mandatory results. The Steering Committee will meet at regular intervals and will submit by the end of the meeting (as recorded in the minutes of meeting) an approval/not approval of the project reports. Official minutes of the PSC meetings will be kept in English and distributed to all parties within 15 days after PSC meeting.

In addition, monthly progress monitoring meetings should be held. As a gathering of RTA, RTA counterpart, PAO and EU Delegation representative the meetings are to monitor progress and solve any emerging operational problems on a monthly base. As the outcome, it is recommended to record proceedings of the meetings in one-page minutes.

7. Implementation schedule (indicative) 7.1. Launching of the call for proposals (November 2010)7.2. Start of the project activities (September 2011) 7.3. Project completion (May 2013) 7.4. Duration of the execution period (number of months) 21 months with an implementation period of 18 months (presence of the RTA in Georgia).

8. Sustainability:

The sustainability of the project will be achieved through a smooth and timely implementation of the project activities and availability of trained personnel in the accreditation infrastructure. The workshops, seminars, on-the-job coaching and mentoring should take into account an opportunity for train-the-trainer approach, it may entail a multiplier effect and ensure the sustainability of methodologies developed and the longevity of the standards which are established for the priority areas. It is necessary to apply a training approach characterised by focusing on cases in the local context. Furthermore, needs of the local and international businesses in internationally acceptable certificates as well as needs of public authorities in third party evaluation and participation in (inter)national accreditation activities are expected to contribute to maintaining high level services on a constant basis in the GAC. The training documents, recommendations should be regularly updated beyond the duration of the project. Direct peer-to-peer and expert-to-expert working relations should be established as well. Constant monitoring of developments shall be ensured through provision of short evaluation sheets (or questionnaires) surveying how Georgian participants appreciate of the content, method, applicability and transferability of topics.

9. Cross cutting issues

The principle of equal opportunity will be integrated into all stages of the project implementation.

10. Conditionality and sequencing

There is no precondition set for this twinning project.

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ANNEXES TO PROJECT FICHE

ANNEX I - LOGFRAME PLANNING MATRIX FOR twinning fiche Support for Georgian centre for accreditation

Programme name and number: ENPI 2008

Total budget: €1,150,000

Overall objective Objectively verifiable indicators Sources of Verification AssumptionsDevelopment of trade related national quality infrastructure in Georgia

An MLA concluded in 5 years after project completion,

Decision of regional accreditation organisation Number of regulations/legal acts adopted

National macroeconomic figures, periodical and annual report from the Institute of Statistics

Statistics report (trade sector) EC annual progress report Reports of ministries responsible for trade and

finance Project reports

Project purpose Objectively verifiable indicators Sources of Verification AssumptionsAccreditation system strengthened so it is ready to apply for full membership in the EA and ILAC

Quality management system to ISO 17011 implemented, application prepared

Gaps in legislation eliminated GAC services extended Number of assessors and experts trained Number of interlaboratory comparisons

and/or PTs organised Number of international meetings

attended

Official gazetteManagement review reportInternal and external audits and evaluation reportsProject reports Conference reports

Government and state legislators’ commitment on National Quality Infrastructure system approximation with EU standards and practice continues. Risk for delays in case of legislation preparation/revision and enforcement.Availability of local staff

Results Objectively verifiable indicators Sources of Verification Assumptions

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

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.

Awareness about accreditation is raised through improved relations with stakeholders

Rules and Procedures drafted and submitted for approval. Accreditation body’s documents drafted and adopted.Quality management system in place.

Bodies accredited to the relevant standards.Laboratories participants in PT schemes or ILCs.Private, semi-public and public bodies implementing relevant ISO/IEC conformity assessment standards.Personnel trained.Standards and guidance documents translated.Seminars/workshops run.

Conferences run.Participants trainedQuality system in place.Website improved and operational.

Project reports.Conference reports.Participants reports and certificates.

Report on peer evaluation.Seminar/workshop reports.Project reports.Certificates of training.

Conference reports.Final report.Certificates of training.Informational material.

Availability of human resources and their sufficient knowledge of foreign languages.Availability of sufficient national financial resources for co-financing of the project activities,Sufficient speed of implementation of the quality management systems to ISO 17025 and to ISO 17020 in the relevant institutions,Timely translation of the relevant standards and guidances,Strong co-operation among the Georgian public institutions and other stakeholders,Availability of suitable premises and equipment for project purposes.

Activities/Components or input Means (indicative) Assumptions0.1 Kick-off Workshop0.2 Final Closing Conference1.1. Seminar on the role of accreditation in view of ensuring free movement of products and services especially in relation to the EU legislation.1.2. Review of rules and procedures of accreditation.1.3. Study visits to at least 2 member state accreditation bodies for Georgian specialists on legislation, management and peer evaluation experience issues.

RTA, PL 1x3 m/dRTA, PL 1x3 m/dRTA, STEs 2x5 m/d

RTA, STEs 3x10 m/d4 flights, 48 per diems

Necessary local resources availableDocumentation in place and enforced.

2.1. Development of a 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.

2.2. Development of a training program and training on ISO/IEC 17020 including relevant EA and ILAC documents for lead assessors and technical

STEs 4x5 m/d

STEs 2x5 m/d

Necessary local resources available

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assessors and experts as well as personnel of the relevant bodies.

2.3. Development of a training program and training on ISO/IEC 17021 including relevant EA and ILAC/IAF documents for lead assessors and technical assessors and experts as well as personnel of the relevant bodies.

2.4. Development of a training program and training on ISO/IEC 17024 including relevant EA and IAF/ILAC documents for lead assessors and technical assessors and experts.

2.5. Support in strengthening internal audits and management reviews.

2.6. Identification of priority bodies for witnessing both in Georgia and in Member States

2.7. Advice on joint evaluation of local PT and ILC providers.

2.8. Revision of all necessary quality management documents in the GAC in the beginning and the end of the project.

2.9. Study visits to a Member State or states.

2.10. Performing of preliminary peer evaluation according to ISO 17011 and EA rules.

2.11. Study visits the meetings of technical and management committees, international conferences and workshops.

2.12. Improving accreditation experts’ training system through individual approach and tailor made courses.

2.13. A set of training courses on calculation of uncertainty of measurements for calibration and testing purposes, validation of test methods for the GAC and (to be) accredited bodies.

2.14. Training for staff of the GAC and (to be) accredited bodies on the relevant

STEs 2x5 m/d

STEs 2x5 m/d

RTA, STEs 4x4 m/d

STEs 4x5 m/d

STEs 2x5 m/d

RTA, STEs 40 m/d, 8 flights

8 flights, 48 per diems

RTA, STEs 2x5 m/d

20 flights, 80 per diems

RTA, STEs 1x20 m/d

RTA, STEs 30 m/d, 4 flights

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New Approach EU directives (pressure equipment, transportable pressure equipment, LVD, medical devices, cableway installations, construction products, lifts, machinery safety).

STEs 14x4 m/d

3.1. Seminars on New Approach and accreditation of notified bodies based on EA-02/17.

3.2. Preparation of information material on technical barriers to trade, accreditation, conformity assessment and other related issues.

3.3. Organising awareness seminars on “Role of accreditation in international trade”.

3.4. Workshop on traceability in chemistry in the EU member state

3.5. Assessment of opportunity to establish associations of accredited bodies in Georgia.

3.6. Support in organisation of annual conferences on accreditation and other relevant issues to quality infrastructure in Georgia.

3.7. Support in organisation of meetings of sector specific technical committees.

STEs 2x5 m/d

STEs 2x9 m/d

STEs 4x5 m/d

RTA, STEs 1x5 m/d; 4 flights, 24 per diems

STEs 3x5 m/d

RTA, STEs 4x5 m/d

STEs 2x5 m/d

Necessary local resources available

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Annex II - Structure of GAC

Legal Entity of Public Law The National Body On Accreditation-Center for Accreditation

Ministry of Economic And Sustainable

Development of Georgia

General DirectorAccreditation Committee(internal)

Technical Committees

Deputy Director

Division of Public information

Division of FinanceDivision of Accreditation and Surveillance

Head of the division

Lead assessors8

Head of the division

Lawyer

Accountant

Specialist of Transportation and logistic

Accreditation Council

(external.end of 2010)

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Abbreviations

AP – Action PlanBA – Beneficiary administrationBC – Beneficiary countryCAB – conformity assessment bodyCEN - the European Committee for StandardizationCAB – Conformity Assessment BodyCGPM - General Conference on Weights and MeasuresCIPM MRA - the Arrangement on Mutual recognition of national measurement standards and of calibration and measurement certificates issued by national metrology institutes of the International Committee of weights and measuresDCFTA- Deep and Comprehensive Free Trade AgreementEA – European organisation for accreditationEU – European UnionEC – the European CommissionENP - European Neighbourhood PolicyGAC – Georgian accreditation centre GEOSTM - National Agency for Standards, Technical Regulations and MetrologyIAF – International accreditation forumILAC – the International Laboratory Accreditation CooperationISO – International Organisation for StandardisationMoESD – the Ministry of Economy and Sustainable Development of GeorgiaMLA – Multilateral agreementMRA – mutual recognition arrangement/agreementMS – Member StatePCA –Partnership and Co-operation agreementPL – Project LeaderRTA – Residential Twinning AdviserSTE – short term expertTBT – Technical Barriers to Trade

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