TWINNING PROJECT FICHE

Transcription

1 TWINNING PROJECT FICHE 1 BASIC INFORMATION 1.1 Programme: ENPI Action Programme 2008 for Ukraine 1.2 Twinning Number: UA10/ENP-PCA/TR/ Title: Further development of National Accreditation Agency of Ukraine (NAAU) capacities according to European practices 1.4 Sector: Trade and Industry 1.5 Beneficiary Country: Ukraine 2 OBJECTIVES 2.1 Overall objective The overall objective of the project is to contribute to safer products and services in Ukraine, to improve performance of the Ukrainian economy to produce EU and internationally complaint goods and services, and to increase foreign direct investments by aligning the Ukrainian infrastructure for quality, and specifically its accreditation part, with international and EU regulatory and administrative practices. 2.2 Project purpose The project purpose is the achievement of the international recognition of the National Accreditation Agency of Ukraine (NAAU) in providing accreditation services for Testing Laboratories, Calibration Laboratories, Management System Certification Bodies, Product Certification Bodies, and Inspection Bodies. 2.3 Contribution to the Partnership and Co-operation Agreement and Association Agenda Comprehensive and effective accreditation services are crucial to guarantee the competence and credibility of the national conformity assessment network that encompasses laboratories, inspection and certification bodies. Acceptance of products in the national and foreign markets in many cases depends on the acceptance of quality compliance results of products provided by conformity assessment organisations. Accreditation bodies also assess organisations with responsibilities within the market surveillance area, fostering the official guarantee of safety and compliance of products on the market, thus contributing to the safety of consumers. The National Accreditation Agency of Ukraine (NAAU) is therefore an essential and integral element for the development of Trade and Industry. By contributing to the improvement of the technical competence and capacity of the National Accreditation Agency of Ukraine (NAAU) to deliver high quality accreditation and conformity assessment services, the twinning project at hand will have a significant and positive impact in attaining some of the main purposes established by the Partnership and Co-operation Agreement (PCA) (Title 1

2 VII, Article 56), namely the reduction of technical barriers to trade and the mutual recognition of certification processes. Furthermore, the objectives and activities of the twinning project are aligned with the objectives of the European Neighbourhood Policy (ENP) and EU-Ukraine Association Agenda. Ukraine is a key partner country within the European Neighbourhood Policy (ENP). Negotiations on a new and enhanced agreement between the EU and Ukraine (now confirmed as an Association Agreement) were launched in This agreement will succeed the PCA. The Association Agreement, including the Deep and Comprehensive Free Trade Area (DCFTA) will significantly deepen Ukraine s political association and economic integration with the EU, relying on a strong degree of regulatory approximation as foreseen in the Eastern Partnership. In addition, negotiations on the establishment of a DCFTA were launched after Ukraine became a member of the World Trade Organisation (WTO) in May The DCFTA will be an integral part of the Association Agreement. Negotiations and ratification of the EU-Ukraine Association Agreement will likely take some more years before the full Agreement can enter into force. Consequently, a practical interim instrument was developed to replace the EU-Ukraine Action Plan of This instrument, the Association Agenda, is expected to prepare for and facilitate the entry into force of the Association Agreement. The EU-Ukraine Association Agenda identifies priorities on a sector by sector basis which require urgent action in anticipation of the entry into force of the Agreement. The project will support the implementation of section 3.5 Trade-related matters of the EU- Ukraine Association Agenda, which calls for the development of Ukrainian legislation on technical regulation, standardisation, conformity assessment, market surveillance, metrology and accreditation concerning the provisions and regulating circulation of industrial products in line with the EU acquits in order to eliminate trade barriers between the Parties. Additionally, by assisting the NAAU (and other relevant stakeholders) in contributing to the reform of the regulatory and institutional framework in achieving the international recognition, the twinning project paves the way towards the adoption of the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA). The Action Plan on signing the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) was agreed between the State Committee of Ukraine on Technical Regulation and Consumer Policy and the European Commission's Directorate-General on Enterprise and Industry on 19 December The Action plan called for the alignment of the partners' horizontal and sectoral legislation in the selected priority sectors and for setting up an institutional framework, particularly in the area of quality assurance, including the accreditation body, and the institutions' compliance with key characteristics, including membership or co-operation agreements with European and international bodies. 3 DESCRIPTION 3.1 Background and justification Efforts to modernise the legal and institutional framework for technical regulation and quality infrastructure have been pursued in Ukraine, though unevenly, since In its efforts to accede to the World Trade Organisation (WTO), Ukraine passed more than 20 laws in 2006 to bring its trading regime into consistency with WTO standards, including new laws on standardisation, metrology, conformity assessment, accreditation of conformity assessment bodies, and on consumer protection. In the area of standards and technical regulations, Ukraine has committed itself to ensure full compliance of its legislation with the WTO TBT Agreement and to abide by the provisions of the Code of Good Practice for the Preparation, Adoption and Application of Standards from the date of accession without any transition periods. However, these commitments so far have not led to the reforms in the institutional structures. The main problems to be resolved include the at times excessive concentration of conflicting competences under the auspices of one single body, the State Committee for Technical Regulation and Consumer Policy (DSSU), which for example at the same time exercises functions of standardisation, development of technical regulations, obligatory product certification, market surveillance, metrology etc, without a clear separation of the decision-making process related to each of these functions. On 10 December 2010, the President of 2

3 Ukraine announced the administrative reform, following which DSSU is to be reorganised into the State Service on Technical Regulation. However, as the functions of the new institution have not been defined yet, it is not clear whether the reform will indeed address the long-standing institutional problems in the Ukrainian system of technical regulation. The accreditation function, assuring the evaluation and the recognition of the technical competence of entities (private or public) active in the area of conformity assessment and of testing laboratories, has so far been the only part of the quality infrastructure separated. In February 2002, the activity of DSSU in the area of accreditation came to an end, the adoption of the Law on the Accreditation of Conformity Assessment Bodies followed. In 2001 the National Accreditation Agency of Ukraine (NAAU) was established by the Ministry of Economy (MoE). The EU-Ukraine Action Plan of 21 February 2005 and the joint Action Plan on Conformity Assessment and Acceptance of Industrial Products (ACAA) of 19 December 2005 set the basis for Ukraine-EC cooperation in the area of trade policy and in particular for the elimination of Technical Barriers to Trade (TBT). This framework establishes an institutionalised dialogue between the Government and the Commission on TBT issues and requires, beyond legal approximation in the area of technical regulation, the alignment of the national quality infrastructure, comprising standardisation, accreditation, metrology, conformity assessment and market surveillance, with the EU practices by Although implementation of reforms started rather well on the legislative side, there remains a lack of consistency between provisions found in the different legal acts and their implementation. Placing Ukraine on European and other international markets is increasingly determined by its ability to manufacture products that comply with international and regional standards as well as by its capacity to set up mutually recognized methods of conformity assessment. In the context of the EUs New legislative Framework (Regulations 764/2008/EC, 765/2008/EC and Decision 768/2008/EC) accreditation is given a more prominent role in ensuring that products benefiting from the free movement of goods within the Community fulfill public interest requirements. Regulation 765/2008/EC lays down the principles for accreditation operation and organization and Ukraine and its National Accreditation Agency should comply with its provisions. If the Ukrainian system of accreditation will be organized and operate according to these binding rules this will strengthen Member States' confidence as regards the competence of the Ukrainian conformity assessment bodies and consequently the certificates and test reports issued by them. To demonstrate the equivalence of the level of competence of conformity assessment bodies, to facilitate mutual recognition and to promote the overall acceptance of accreditation certificates and conformity assessment results issued by accredited bodies, it is necessary that the National Accreditation Agency successfully undergoes the rigorous and transparent peer evaluation at EA level. This acceptance will help avoiding multiple testing and certification of Ukrainian products will get increasingly free access to EU internal market. The NAAU is the state non-profit accreditation organisation subordinated to the Ministry of Economy. The NAAU is responsible for testing laboratories, calibration laboratories, bodies for certification of products and services, bodies for certification of management systems and bodies for certification of personnel and inspection bodies. The NAAU will play an important role in the implementation of the Modular Approach principles in Ukraine. Therefore it is important for the NAAU to build up closer relations with European cooperation for Accreditation (EA). According to the EU-Ukraine Action Plan the NAAU submitted to the EA in 2005 an application for recognition in the areas of "Management Systems Certification" and "Personnel Certification. The recognition procedure was successful in the area of Personnel Certification. There are several systemic issues that have to be resolved for the eventual international recognition of the NAAU in the areas of "Calibration", "Testing" and "Certification of Products". The fields in most urgent need of accreditation services first of all in those priorities, New Approach sectors selected for Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) are: Simple Pressure Vessels Directive; (Directive 87/404/EEC) Electromagnetic compatibility (EMC Directive 89/336/EEC ); 3

4 Low Voltage Directive (Low Voltage Directive 73/23/EEC has been replaced with EU Directive 2006/95/EC) Machinery Directive 98/37/EC (Machinery Directive 98/37/EC has been replaced with EU Directive- 2006/42/EC) Implementation of Ukrainian technical regulations equivalent to Community directives should be assured. According to the priorities of ACAA at least one independent conformity assessment body should be functional for above named directives. NAAU should consider it in its accreditation development plan. Nevertheless, other newly adopted Ukrainian technical regulations should be also considered. Competencies for providing accreditation services should be flexible and market orientated. Focused on the market needs NAAU should be able to increase accreditation competencies for example in other following technical regulations: Transportable pressure equipment Pressure equipment Lifts Personal protection equipment Energy Consumption of Refrigerators Toys Non-automatic weighing instruments Appliances burning gaseous fuels Hot water boilers Outside the New Approach, certification of personnel and inspection, the competence and capacity of the NAAU also needs to be increased to assess the competence of relevant laboratories, certification and inspection bodies etc. The NAAU can demonstrate its level of competence through participation in the EA peer evaluation system, the EA Bilateral Agreement (BLA) by which Multilateral Arrangement (MLA) members recognise the equivalence of each other s technical competencies. Taking account of the above mentioned is necessary in the future to strengthen the role of the accreditation of the notified conformity assessment bodies, which will enable free and safe movements of goods in Ukraine, in accordance with the European Approach, which requires testing, certification and inspection of certain products by credible organisations to ensure their compliance with health and safety regulations. Besides this, several proposals of European Regulations and Decisions are presently put forward emphasising the role of accreditation. The twinning project will therefore support the NAAU by providing the knowledge, experience and competence in building its administrative and technical capacities. In particular, the project will contribute to the establishment of criteria, procedures and mechanisms for the operation of accreditation within the prioritised areas mentioned above. In addition, the project will support the NAAU in developing its accreditation capacity in existing and new areas, especially those related to the application of the EU New and Global Approach principles which include the accreditation of: Testing and calibration laboratories Inspection Certification of quality management systems Certification of personnel Certification of products Given the important role of the NAAU in the implementation of the New and Global Approach principles in Ukraine, the NAAU also needs to build up relations with the European co-operation for Accreditation (EA) which is currently arranging measures to establish a closer relationship with ENP countries, particularly by opening its membership to ENP countries. 4

5 The twinning project will therefore facilitate the route of the NAAU towards a closer participation and collaboration with the EA by assisting NAAU s readiness to receive peer evaluations from EA, an essential step to join the EA s Multilateral Recognition Arrangement (MLA). It is important to note that the EA s MLA enables its members to recognise the equivalence of each others technical competences, thus facilitating access to the EU market. Being a party of the MLA also improves access to international markets through the on-going co-operation between the EA, International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF). This twinning project will also aim at fostering the NAAU image as a competent and reliable accreditation body, thus increasing the confidence in conformity assessment organisations operating in Ukraine. This in turn will facilitate exports of Ukrainian products and will simultaneously ensure that Ukrainian consumers have access to a wide range of safer and higher quality locally manufactured and imported products. The positive impact on society and industry of developing a sound quality infrastructure, including its accreditation component, is not yet well-known in Ukraine. Therefore, general awareness of quality related issues must be raised among all stakeholders (e.g. industry and trade, consumer organisations, governmental authorities etc.) to secure the need for public and private investment and to expand the clients base for services provided. Successful experiences in other countries have shown that it is very important to raise and maintain a high level of transparency and awareness about the benefits of an efficient quality infrastructure aimed mainly at the higher management and executive levels, particularly high ranking civil servants and decision makers in the private sector. Consequently, the project will assist the NAAU in development and initial implementation of an effective and sustainable external communications plan. This plan will extend its activities continuously throughout the institutional life of the NAAU and will include awareness activities through the media, visibility conferences, technical seminars, web information and technical and administrative reports. 3.2 Linked activities The project is expected to follow up and consolidate the results of the Twinning project Strengthening the National Accreditation Agency of Ukraine (NAAU), which was implemented between 31 January 2008 and 1 July 2010 by the consortium of the Netherlands Standardization Institute (NEN, the leader), Swedish Board for Accreditation and Conformity Assessment (SWEDAC), The Netherlands Metrology Institute (NMi- VSL) and The Netherlands Accreditation Council (RvA). The objective of this first Twinning project in the sector was to strengthen the capacity of the NAAU to assess the competence of laboratories, certification and inspection bodies etc, in order to fulfil European and international conformity assessment requirements in the following sectors: Electromagnetic Compatibility (EMC); Low Voltage Directive (LVD); Machinery; Simple Pressure Vessels (SPV); Food and agriculture; Environment policy; Medicare; Information security policy; Automotive industry; Inspection and certification of personnel. Activities included: Awareness raising of the importance of accreditation to ensure acceptance and credibility in exported products and services, and on accreditation requirements; Training and internships on the management, organisation and technical aspects of the accreditation process for NAAU staff; Joint accreditations performed by EU and Ukrainian experts in Ukraine and EU countries; Coaching of NAAU staff for peer review with regard to membership in the relevant international organisations European Accreditation (EA), ILAC (International Laboratory Accreditation Co-operation) and IAF (International Accreditation Forum). The project has made a significant contribution to the development of the accreditation function in Ukraine. New skills were introduced, and knowledge of accreditation schemes strengthened. Furthermore, use of accreditation use was improved through greater understanding of the obligations and opportunities of ensuring the parity of conformity Assessment (especially in Medical devices, Automotive area and Construction area). NAAU's Quality Management System and governance framework allowed the initiation and conducting of the process of peer assessment for a Multilateral Agreement with European Co-operation 5

6 for Accreditation (EA) in area Accreditation of laboratories and Accreditation of CAB Quality Management Systems. The remarkable achievement was that in November 2009 the NAAU achieved the long strived-for recognition by the EA, albeit in one area only the NAAU joined the EA's multilateral agreement in the area of accreditation of personnel certification bodies. NAAU has signed Agreement on Mutual Acceptance of Personnel Certification Certificates between the Signatories to the EA Multilateral Agreement and NAAU. The competence of the NAAU was highly assessed by EU experts, although the need for further intensive work was recognised for the areas of EMC, LVD, Machinery and SPV. The following areas for further improvement were identified upon completion of the project: Enlargement of Multilateral Agreement Establishment of schemes for accreditation of calibration laboratories Accreditation of notified Conformity Assessment Bodies for products falling under the EU New Approach Directives Development of strategic organisation for NAAU and Development of the electronic documents circulation system, electronic knowledge database on conformity assessment, electronic registers of laboratories and accreditation experts Support for participation of the NAAU in the cross-border accreditation according to Regulation (EC) No 765/2008 of the European Parliament. Establishment of a pool of experts for cross-border accreditation activities. Communication of the New Approach to all interested partners. Besides the above described project dedicated completely to raising the accreditation capacity, the European Union has funded and is funding other projects in Ukraine, which aim at the reform of the Ukrainian institutional infrastructure for quality and its alignment with European practices, with particular attention to the removal of conflicts of interests built in the present Ukrainian system, Detailed information on these projects is given below. They are relevant to the new Twinning for NAAU, as they affect the overall legal and institutional environment, in which NAAU is operating. For example, on 2 December 2010 the Parliament of Ukraine has adopted two important framework Laws, developed jointly by the EU-funded project "Technical Assistance to Ukrainian Quality Infrastructure" and the Administration of the President of Ukraine: On Market Surveillance and Control of non-food Products and On General non-food Product Safety". This event paves the way to the removal of a number of serious inconsistencies that persisted in the Ukrainian legislation creating technical barriers to trade. This concerns especially the abolition of pre-market control, the abolition of exclusive reference to national standards as criteria for safety, and the elimination of multiple testing, while respecting other EU principles such as the principle of proportionality and of avoiding unjustified burdens to the economic operators. In conclusion, it can safely be argued that the adoption of these drafts will constitute a major step ahead for the conclusion of ACAA. Furthermore, in the framework of these projects NAAU has received specific training, participated in the relevant international events and has been assisted in the process of EA peer evaluations. By the time of the start of the new Twinning project for NAAU, two of the below listed projects will be completed. However, the project will need to co-ordinate closely with the technical assistance component of the Sector Policy Support Programme Promoting mutual trade by removing technical barriers to trade between Ukraine and the European Union. Within this component, a detailed road map for reforming the Ukrainian institutional infrastructure for quality is expected to be designed. Particular attention will be paid to the removal of existing conflicts of interest, notable the one of performing market surveillance and conformity assessment functions by the same organisations. The project is also expected to further develop the legal framework, including strengthening and streamlining the legislation on accreditation. Twinning project Strengthening of Standardisation, Market Surveillance, Metrology and Legal Metrology, Conformity Assessment and Consumers Policy in Ukraine, project duration - 21 September December MS Partner: Consortium of Association for Standardisation of France (AFNOR, the leader) and German Standardisation Institute (DIN). 6

7 The objective of this second Twinning project in the sector was to produce recommendations/plans on how to change the structure of the DSSU and other quality-related bodies, so as to make it compatible with that of the EU. Activities included assessment, mapping of activities and developing recommendations in the following areas: - Standardisation system, i.e. a system for the elaboration of the national standards; - The market surveillance system to be managed by or on behalf of the state; - Legal and scientific Metrology system in order to assure both the traceability of measurements in the country and the loyalty of transactions; - Conformity assessment system of products and/or services active both in the area of the responsibilities of the state for the achievement of its aims and obligations and in the area of the relations of private entities among themselves. This includes the certification bodies and the network of testing laboratories for the evaluation of conformity of products and/or services to the relevant applicable specifications. The project has carried out a mapping of DSSU activities in the components listed above and produced action plans per component. The plans implied separation of standardisation, market surveillance and consumer policy functions from the DSSU. The most detailed plan was the one on the establishment of the independent National Standardisation Body on the basis of the research institute under the umbrella of the DSSU. The DSSU expressed an agreement with the action plans, however the implementation is pending. The other important outputs are the proposals for the new Law on Metrology and Strategy Concept for the introduction of the Ukrainian Market Surveillance System. For the NAAU, the project has provided training on standards for quality systems: ISO/IEC 17025:2005, ISO 9001:2000, ISO/IEC 17021:2006 and ISO/IEC 17024:2003. Technical Assistance to Ukrainian Quality Infrastructure, project duration - 24 June December 2010, Contractor: European Profiles S.A. (GR) This 'Technical Assistance to Ukrainian Quality Infrstructure' project was conceived as a follow-up to the second Twinning project " Strengthening of Standardisation, Market Surveillance, Metrology and Legal Metrology, Conformity Assessment and Consumers Policy in Ukraine ' mentioned above. It was expected to provide the Ukrainian authorities with practical assistance in implementation of the plans produced by the Twinning project. However, it was affected by the lack of implementation of the Action Plans proposed by the Twinning project, and by a rather low priority assigned to the institutional reforms of the Quality Infrastructure system. Consequently, the project adjusted its overall strategy and adopted an approach in terms by which the direct assistance to individual operators of the quality infrastructure system should be dissociated, to the extent possible, from an ex-ante institutional reform. This adjusted strategy is being implemented along the following lines: a) Institutional strengthening of the relevant entities of the quality infrastructure system, in order to make progress on technical issues which can be discussed independently from policy decisions, but with a strong impact on preparing the ground for smooth implementation of future reforms; b) Assistance in the development of the horizontal and technical legislation. The most significant project outputs comprise: Laws on Market Surveillance and General Product Safety; Draft Law on Product Liability; Gap analysis of the selected Ukrainian new Technical Regulations with the New Approach Directives; Training and analytical documents on the support to harmonisation of legal and normative framework in construction industry with the European Building Codes (Eurocodes); Curricula on the issues of technical regulations and quality infrastructure, gap analysis of the legislation on consumer issues; practical support and capacity building for Ukrainian conformity assessment bodies; awareness raising campaign on the EU practices of product quality & safety. For the NAAU, the project has provided support in the association of the NAAU to EA through supporting attendance of EA events and assistance in the organisation of the reviews of the NAAU by the EA. Sector Policy Support Programme Promoting mutual trade by removing technical barriers to trade between Ukraine and the European Union EUR 45 million (39 million of Budget Support plus 6 million for project-mode assistance), project duration December 2009 December The purpose of this budget support programme is to implement policy measures to remove technical barriers to trade between the EU and Ukraine. Such policy measures include harmonisation of the horizontal and technical legislation and modernisation of the institutional framework for quality assurance. The target to be 7

8 achieved by the NAAU is the complete fulfilment by the NAAU within the limits of its competence of eligibility criteria and application for MLA with EA. 3.3 Results The proposed scope of the project directly stems from the priorities listed in section 3.2 above, which were identified upon the completion of the preceding Twinning project in NAAU, and from the obligations in the area of accreditation, assumed by the Ukrainian Government under the Financing Memorandum for the Sector Policy Support Programme Promoting mutual trade by removing technical barriers to trade between Ukraine and the European Union. The areas, which are priorities for further development, are be grouped in three components and seven main results. Based on the status quo, efforts should be concentrated on the following components: 1. Strengthening of the NAAU's accreditation function and further development of co-operation between the NAAU and EA/ ILAC/ IAF 2. Institutional Development and Capacity Building 3. Communication and awareness raising The following Table shows the components and corresponded results: Components Results Component I: Strengthening of the NAAU's accreditation function and further development of co-operation between the NAAU and EA/ ILAC/ IAF Result 1: The NAAU's accreditation function is aligned with relevant international standards. Result 2: The NAAU is advanced towards the recognition by the EA/ ILAC/ IAF in the in the areas of "Calibration", "Testing", "Certification of products" and Certification of management systems. Component II: Institutional Development and Capacity Building Component III: Communication and awareness raising Result 3: Efficiency of NAAU's operations is enhanced through the implementation of information and documents' management systems. Result 4: Capacity of NAAU personnel to accredit the conformity assessment bodies for products falling under the EU New Approach Directives is strengthened. Result 5: Assessment of personals competency in accreditation s and different type of CABs activities conducted. Result 6: The accreditation of calibration laboratories by the NAAU is strengthened in line with EU requirements. Result 7: Communication plan for the NAAU is developed and partially realised through appropriate information materials, publications, public awareness and visibility events. 3.4 Activities Note: The listed activities and the proposed means for achieving the activities and results are indicative and can be revised in the framework of the preparation of the contract between twinning institutions. Component I: Strengthening of the NAAU's accreditation function and further development of cooperation between the NAAU and EA/ ILAC/ IAF. Result 1: NAAU's accreditation function is aligned with relevant international standards. 8

9 The actual NAAU activities will be reviewed in accordance with specific requirements of EU regulation 765/2008/EC, with the aim to achieve compliance with EU regulation 765/2008/EC, ISO/IEC and EA Multilateral Agreement requirements. Activities: A1.1 Review the current accreditation activity of the NAAU and propose improvements in line with the requirements of international standards. Propose concrete recommendations and measures to meet the requirements of international accreditation organisations. A1.2 Prepare a development plan for the NAAU s accreditation function that will support international membership and recognition (focusing on areas selected within the context of the ACAA and DCFTA). A1.3 Organisation of joint accreditation assessments in Ukraine requested by the beneficiary. The assessments will be performed in line with the requirements of ISO/IEC 17025, ISO/IEC 17024, ISO/IEC 17021, ISO/IEC and/or ISO Guide 65. A1.4 Train the trainer training in Ukraine by an international accreditation expert will be organized for key specialists in the accreditation area (5 persons) of NAAU on related standards ISO 17011, ISO 17020, ISO 17021, ISO 17024, ISO and ISO Guide 65. A1.5 Provide guidance and coaching to NAAU staff in their daily work on matters relating to international standards. Result 2: The NAAU is advanced towards the recognition by the EA/ ILAC/ IAF in the in the areas of "Calibration", "Testing", "Certification of products" and Certification of management systems. International recognition of accreditation activities of NAAU is crucial for the development of Ukraine's international trade. Such recognition would ensure that the products conformity assessment documents, issued by accredited Ukrainian bodies, would be accepted in other countries without additional testing requirements being necessary. The sought international recognition is to be achieved and maintained by means of joining formal Multilateral Agreements by the EA, ILAC and IAF. For this purpose, it is necessary that NAAU regularly takes part in the activities of the international organisations, notably, participates in the work of their committees. Pending the legislative amendments to remove the present legal obstacle for NAAU to finance its international activities, NAAU will need support by the project to ensure the said participation. Furthermore, consultancy will be required to pass successfully the procedures of official assessments by the international organisations, Activities: A2.1 Assisting the NAAU in acquiring and translating documents such as interpretation Guides developed by the EA, ILAC and IAF that need to be adopted and made available in Ukrainian to technical experts and assessors. A2.2 Supporting the participation of NAAU experts in meetings and working groups of European and international organisations such as the EA and IAF, on prioritised sectors, in order to align its technical development with regional and international practices. It is needed to ensure participation of the NAAU in the following meetings: EA technical committees - certification committee, inspection committee, laboratory committee twice a year; EA Communication and Publications Committee once a year; EA General Assembly once a year; IAF/ILAC Annual Meeting - annual. A2.3 Supporting the NAAU in obtaining international recognition (ILAC, IAF and EA) by providing assistance during the processes of assessment, implementation of recommendations from assessments, elimination of identified problems and the conclusion of a formal MLA. Component II: Institutional Development and Capacity Building Result 3: Efficiency of NAAU operations is enhanced through the implementation of information and documents' management systems. 9

10 Based on the recommendations in activity A1.2 a development programme for the existing Management system will be agreed. Within the project best practice approach will be used. Experts will assist in modification of relevant documents for a NAAU management system and in the implementation of an electronic documents circulation system. It is expected that the activities will affect the enhancement of NAAU organizational / governance structure and Management System documentation in line with EU regulations 765/2008/EC, ISO/ IEC and appropriate EA guidance. A3.1 Development of the electronic documents circulation system, electronic knowledge database on conformity assessment, electronic registers of laboratories and accreditation experts; provide necessary software. A3.2 Assessing and improving of the NAAU s management system and introducing relevant Management Information System (MIS) applications. Result 4: Capacity of NAAU personnel to accredit the conformity assessment bodies for products falling under the EU New Approach Directives is strengthened. The capacity building of NAAU in accreditation of conformity assessment bodies under the New Approach Directives has started under the preceding Twinning project, however it became clear that further efforts, resources and time will have to be devoted to this subject. Furthermore, the approximation of Ukrainian legislation to the European Directives has advanced since then. Presently, the new Technical Regulations have been adopted for all four priority sectors selected for ACAA. Overall, Ukraine has adopted 31 Technical Regulations based on the New and Global Approach principles, while 21 more Technical Regulations are being drafted. The project will address particularly the technical requirements of EU directives and the EC marking that Ukrainian economic agents need to engage with. Activities: A4.1 Organising joint accreditation assessments by NAAU personnel and experts of Member State (MS) accreditation and certification bodies, covering the following issues: - the implementation of accreditation activities within the framework of the New Approach Directives, - European procedures and methods for assessment/accreditation of conformity assessment bodies, as well as, - observation of the assessment process of bodies seeking notification. A4.2. Classroom training for NAAU personnel on accreditation under the New Approach Directives. The number of trainings to be carried out under this activity builds on the technical training and advice delivered above, as well as on the knowledge and information gained by the beneficiary during study visits abroad. In terms of sectors, the project will give priority to the four sectors selected for ACAA, and for the sectors prioritised in the Sector Policy Support Programme Promoting mutual trade by removing technical barriers to trade between Ukraine and the European Union. The project should be ready to adapt itself in case further priorities will be identified in the course of negotiations on DCFTA. Result 5: Assessment of personals competency in accreditation s and different type of CABs activities conducted On the institutional level one should not only consider technical capacity but also organisational capability. In this respect the NAAU could improve its access to expertise by building a network of experts. Establishing technical committees on specific fields (certification, calibration etc.) in which market parties and conformity assessment bodies as well the authorities are represented to develop accreditation. The twinning project will therefore support the NAAU by providing the knowledge, experience and competence to assist the NAAU in building its administrative and technical capacities and establishment of EU EA harmonization principles in training and evaluation of Personnel in accreditation area. General 10

11 Assembly of EA 2010 undersigned the importance of qualification and re-qualification of accreditation assessors. Given the important role of the NAAU in the implementation of the New and Global Approach principles in Ukraine, the NAAU also needs to build up relations with the European co-operation for Accreditation (EA) and cooperation with accreditation assessors in the form of networking. The twinning project will therefore facilitate the route of the NAAU towards a closer participation and collaboration with the EA and an international network of specialists. Activities: A5.1 Conduct assessment of personals competency in accreditation s and different type of CABs activities and assisting the NAAU in introducing institutional changes and providing support for the improvement of management procedures and work practices concerning competence of accreditation personnel. A5.2 Implementation of a data base for accreditation assessors and personnel with technical competence; A5.3 Providing guidance and coaching to NAAU staff in their daily work on matters relating to qualification of the personnel. NAAU staff becomes acquainted with European practices in Management of personnel and Personnel rights and duties in different kinds of CABs Result 6: The accreditation of calibration laboratories by the NAAU is strengthened in line with EU requirements. There are several systemic issues that have to be resolved for the eventual international recognition of the NAAU in the areas of "Calibration", "Testing", "Certification of products" and Certification of management systems. In particular, it is necessary to ensure the traceability of measuring through the accreditation by the NAAU of all territorial branches of the State Committee for Technical Regulation and Consumer Policy, which provide calibration services. This would be important in the establishment of the Ukrainian calibration network, a network of calibration laboratories which ensures that Ukrainian clients will get easier access to calibration services with certified traceability to national and international measurements standards. This traceability provides the basis for fair trade, increased global market acceptance of test reports and products, enhanced product quality, and demonstration of conformance to such international quality standards as the ISO 9000 series. Activities: A6.1 Set up and appropriately train a new unit within the NAAU s accreditation department for laboratories which will be responsible for performing functions in accreditation of the calibration laboratories; A6.2 Improvement of management procedures and work practices; A6.3 Conduct training for assessors (the NAAU and other organisations); A6.4 Joint Accreditation Assessments of calibration laboratories. Component III: Communication and awareness raising Result 7: Communication plan for the NAAU is developed and partially realised through Appropriate information materials, publications, public awareness and visibility events. As the sole accreditation body in Ukraine, the NAAU has the national market opened to its accreditation services, namely for laboratories, inspection and certification bodies in all sectors of activity. However, it is necessary to further promote the use of accreditation for proving the technical competences of the bodies that are appointed as conformity assessment/certification bodies. 11

12 The development and implementation of a communication plan should facilitate structured relationships with key stakeholders, and ensure transparency, accountability and credibility of the overall system. The approach taken will be in line with the provisions of ISO and EU regulation 765/2008/EC. Activities: A7.1 Development of an external communication plan and assistance in the implementation of this external communication plan; A7.2 Preparation of information booklets and newsletters for distribution to relevant stakeholders A7.3 Building the capacity of staff in communications and external relations; A7.4 Conduct an awareness raising workshop on the EU Internal market, conformity assessment requirements and accreditation; A7.5: Conduct an awareness raising conference for the NAAU, government authorities and stakeholders on the subject of The Role and Place of Accreditation in Ukrainian Trade and Industry. A7.6. Advise on the improvement of the presentation and content management of the NAAU web site. A7.7. Study visit to an EU Accreditation Agency on communication issues 3.5 Means/Inputs from the Member State Partner Administration 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 side, the Project Steering Committee (PSC), which will meet in Ukraine at least every three months. Tasks The main tasks of the MS Project Leader are to ensure: The overall coordination of the project; The achievement of mandatory results; The organisation of working groups, if needed; The organisation of the good communication and coordination with beneficiary and stakeholders; Profile University degree/post-graduate degree in the relevant discipline or equivalent experience Long-term officer from a Member State with 10 years experience in the fields of accreditation or relevant conformity assessment activities. Have education and experience in the field of project management, institutional issues and organisation of national quality infrastructure according to European requirements. PC Computer literacy with significant knowledge of common software applications such as MS Word, Excel and PowerPoint, Experienced skills on management of the project and knowledge and practical experience on Twinning Projects. Excellent command of written and spoken English. A spoken capability in Ukrainian or Russian would be an asset. 12

13 3.5.2 Profile and tasks of the Resident Twinning Advisor (RTA) The Resident Twinning Adviser (RTA) will provide 24 months input on site. Tasks Manage the day-to-day coordination and progress of the activities in Ukraine (office accommodation in NAAU premises) Liaise with the Beneficiary Country (BC) Project Leader and RTA counterpart Report to the MS Project Leader Liaise with the NAAU and other relevant Ukrainian institutions Profile Senior officer from the Member State with extensive experience in accreditation and conformity assessment. Previous experience in project management (preferably also managing a team composed of EU and local experts) Excellent command of written and spoken English. A spoken capability in Ukrainian or Russian would be an asset. 10 years work experience in area of accreditation (in or for an accreditation body) Profile and tasks of the Short-term experts The RTA will be assisted by short-term experts to cover the full range of expertise required. These will be suitably qualified and capable of providing the necessary skills according to the activities mentioned above. Short term experts should have experience in the area of accreditation (worked in or for an accreditation body). The following general requirements are applicable for all international short-term experts: Specific knowledge of the European approach and Quality Infrastructure, associated strategic documents in accreditation; Ability to analyse the different strategies and adapt these to the local environment and understand its constraints and possibilities will be considered as an advantage; Good organisational, communication and presentation skills; Experience in the training of practical issues; University degree in related fields or equivalent experience; Fluency in English and preferably Russian or Ukrainian. Specific requirements, types and profile of short-term experts are listed in the following table. PROFILES of the SHORT-TERM EXPERTS TYPE PROFILE Result 1:The NAAU's accreditation function is aligned with relevant international standards; Result 2: The NAAU is advanced towards the recognition by the EA/ ILAC/ IAF in the in the areas of "Calibration", "Testing", "Certification of products" and Certification of management systems. Result 4 "Capacity of NAAU personnel to accredit the conformity assessment bodies for products falling under the EU New Approach Directives is strengthened." Approach accreditation expert 10 years of experience in the accreditation area (as a staff member of an accreditation body or under a contract(s) with such a body); wide experience of the accreditation under 13

14 New Approach Directives; deep knowledge and practical experience for accreditation of notified bodies in the following areas: EMC Directive 89/336/EEC, Low Voltage Directive 73/23/EEC, Machinery Directive 98/37/EC and Simple Pressure Vessels Directive 87/404/EEC Result 3: Efficiency of NAAU operations is enhanced through the implementation of information and document management systems. Expert in MIS / Business analyst 10 years of experience in the accreditation area ( as a staff member of an accreditation body or under a contract(s) with such a body); practical experience in the analysis of business processes, MIS and electronic documentation. Result 5: Assessment of personals competency in accreditation s and different type of CABs activities conducted. Expert in strategic planning and personnel qualification in the accreditation area 5 years of the experience in the accreditation area ( as a staff member of an accreditation body or under a contract(s) with such a body); Accreditation expert and training expert with wide knowledge and experience in training for quality management systems, lead auditors for accreditation and certification, management of accreditation personnel and assessing of competencies of personnel for different types of conformity assessment bodies. Result 6: The accreditation of calibration laboratories by the NAAU is strengthened in line with EU requirements. Expert in accreditation of calibration laboratories 10 years of the experience in the accreditation area ( as a staff member of an accreditation body or under a contract(s) with such a body); Accreditation expert with wide experience in writing procedures; deep assessment skills on accreditation of calibration laboratories; experience on conducting accreditation trainings for assessors. Result 7: Communication plan for the NAAU is developed and partially realised through appropriate information materials, publications, public awareness and visibility events. Communication Expert 5 years of the experience in the accreditation area ( as a staff member of an accreditation body or under a contract(s) with such a body); Qualified expert with general knowledge on the EU market and knowledge of information activities in Quality infrastructure, New and Global European Approach; experience in developing and implementing communication policies. Only experts whose profiles are in accordance with defined Short Term Expert-profiles will be involved. Overview number of short term experts: Component 1 (Result 1 and 2): 5 experts Component 2 (Result 3, 4, 5 and 6): 8 experts 14