STANDARD TWINNING PROJECT FICHE - Esteri conformity assessment... · Web viewTWINNING PROJECT...

TWINNING PROJECT FICHE

1. Basic Information

1.1. Programme: European Neighbourhood and Partnership Instrument (ENPI)

1.2. Twinning number:

1.3. Title:Strengthening the Capacity of the Accreditation Centre in the Field

of Conformity Assessment of Products of the Republic of Moldova

1.4. Sector: 133150 – Trade related adjustments

1.5. Beneficiary Country:Accreditation Centre in the Field of Conformity Assessment of

Products of the Republic of Moldova

2. Objectives2.1. Overall ObjectivesThe overall objective of this project is to improve the trade competitiveness of the Republic of Moldova (further – Moldova) and to harmonize the quality infrastructure with international and European standards.

2.2 Project Purpose:The purpose of this project is to prepare Moldova’s Accreditation Centre in the Field of Conformity Assessment of Products (further – CAECP) for signing multilateral agreements with the European co-operation for Accreditation and to establish the conditions for the future international recognition of Moldovan accredited test results, calibration certificates, inspection reports and conformity certificates.

2.3. Contribution to National Development Plan/ Cooperation agreement/ Association Agreement/ Action Plan.The EU-Moldova European Neighbourhood Policy Action Plan (ENP AP) is based on the Partnership & Cooperation Agreement (PCA) and encourages and supports Moldova’s objective of further integration into European economic and social structures. A joint EU-Moldova ENP Action Plan lays out the strategic objectives based on commitments to shared values and effective implementation of political, economic and institutional reforms. Partnership and Cooperation Agreement (PCA) Articles 50 and 55 of Moldova’s Partnership and Co-operation Agreement with the EU define in broad terms the steps that need to be taken with regard to the Technical Regulation/Quality Infrastructure. The Parties recognize that an important condition for strengthening the economic links between Moldova and the EU is the approximation of Moldova's existing and future legislation to that of the EU. Moldova shall endeavour to ensure that its legislation will be gradually made compatible with that of the EU. It also recognizes hat cooperation between the Parties shall promote alignment with internationally agreed criteria, principles and guidelines followed in the field of standards and conformity assessment. The required actions will facilitate progress towards mutual recognition in the field of conformity assessment, as well as the improvement of Moldovan product quality.

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In order to align with the internationally agreed criteria, the partied will promote appropriate cooperation with organizations and institutions specialized in these fields, and will promote the use of Community technical regulations and the application of European standards and conformity assessment procedures.By strengthening the institutional and organizational capacities of the Accreditation Centre for the proper performance of its tasks in the context of Regulation 765/2008/EC and the European Union practices the twinning project will create the basis for formal recognition of accredited work and as a basis to increase the confidence in the conformity of goods placed on the domestic and community market with the relevant legislation and mutually agreed specifications. European Neighbourhood Policy Action Plan (ENP AP) The EU-Moldova Cooperation Council adopted a joint ENP Action Plan (ENP AP) in February 2005. The ENP AP’s objective is to share the benefits of the EU’s 2004 enlargement with neighbouring countries in strengthening stability, security and well being for all concerned. This Action Plan still serves as a tool for supporting Moldova's own programme of democratic and economic reform. It contains 2 particular clauses related to the Technical Regulatory and Quality Infrastructure: (28) A commitment to move toward EU and international legislative and administrative practices for standards, technical regulations and conformity assessment by:

Jointly identify priority industrial sectors for legislative approximation (with the possibility to be included in an Agreement on Conformity Assessment and the Acceptance of Industrial Products (ACAA) provided that all the required conditions are accepted and fulfilled) including through consultations with producers and exporters.

Continuing the revision of existing Moldovan standards, removing the mandatory elements and harmonising them with international and European standards.

Reinforcing institutional capacity on standardisation, accreditation, conformity assessment, metrology and market surveillance, integrating the Moldovan institutions, to the extent possible, in the European structures, namely the European Cooperation for Accreditation (EA), CEN, CENELEC and ETSI.

Gaining full membership of the International Standards Organisations ISO, IEC and ITU. Revise the institutional arrangements in this area to avoid the concentration of functions within a single institution.

Approximating legislation on liability for defective products and general product safety. Simplifying procedures to avoid compulsory certification of non-risk products and multiple

testing of products. Developing market surveillance capacities based on best practice of EU Member States.

(29) Elimination of restrictions and streamlined administration (EU non-harmonised areas) facilitate the movement of goods and improve administrative co-operation.

The ENP AP also attaches great importance to the sanitary and phytosanitary issues:(30) Increase food safety for Moldovan consumers and facilitate trade through reforms and modernisation of the sanitary and phytosanitary sectors.

Fully implement the requirements of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) and the Agreement on Technical Barriers to Trade (TBT).

Assess the sanitary and phytosanitary control systems, in particular, at the state border, to compare with EU and international requirements.

Identify national reference laboratories in the sanitary and phytosanitary sectors, with a

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special attention given to the necessary equipment and appropriate methods of analysis (residues of pesticides/contaminants) and their accreditation.”

The twinning project paves the way towards a component for an Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA). The ACAA requires the alignment of the partners' horizontal and sector legislation in the selected priority sectors, and the set up of related implementation infrastructure (standardization, accreditation, metrology, conformity assessment procedures and a post market surveillance system).

3. Description3.1 Background and JustificationMoldova currently plans further alignment with the European Union by implementing its Action Plan within the framework of the European Neighbourhood Policy (ENP) of the EU. The EU Autonomous Trade Preferences (ATPs) granted to Moldova since March 2008 proved to have a positive impact. Continued efforts are however needed to take full advantage of the available quotas in particular for selected agricultural products. Efforts to effectively implement structural reforms, based on a strong European integration government programme aligned with the objectives of the EU-Moldova Action Plan, were stepped up in the last quarter of 2009. To sign the Deep and Comprehensive Free Trade Area (DCFTA), Moldova has to complete the EU-Moldova Action Plan creating conditions for a functioning market economy as well as the capacity to cope with competitive pressure and market forces within the Union. Placing Moldova 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 EU's 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 fulfil public interest requirements. Regulation 765/2008/EC lays down the principles for accreditation operation and organization and Moldova and its National Accreditation Body should comply with its provisions. If the system of accreditation will be organized and operate according to these binding rules this will strengthen Member States confidence as regards the competence of 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 Accreditation Centre successfully undergoes the rigorous and transparent peer evaluation at EA level. This acceptance will help avoiding multiple testing and certification of Moldovan products will get increasingly free access to EU internal market. This twinning project will thus be carried out with the aim of fostering Accreditation Centre image as a competent and reliable accreditation body thus increasing the confidence in conformity assessment organizations operating in Moldova. As EU provisions on accreditation apply also in relation to bodies carrying out conformity assessments in both the regulated and the non-regulated areas the project will devote efforts to upgrade knowledge and competence and to harmonise their practice at national and international level. The issue at stake is the quality of certificates and test reports irrespective of whether they fall within the regulated or the non-regulated area, and no distinction should therefore be made between those areas.

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This in turn will facilitate opportunities for the export of Moldovan products and will contribute to ensuring that Moldavian consumers have access to a wide range of safer and higher quality locally manufactured and imported products.

The current state of affairs in accreditation in Moldova The accreditation system of the Republic of Moldova is exclusively operated by the Centre of Accreditation in the Field of Conformity Assessment of Products (CAECP), playing the role of Moldova accreditation body, under the coordination of the Ministry of Economy. The CAECP was established to implement and develop the state policy in the field of accreditation and products’ conformity assessment with the aim of contributing to the promotion to the free movement of goods, increase national products’ competitiveness, protect consumer’s rights and interests, ensure people and environment safety. Established by the Governmental Decree Nr. 1646/ 31.12.2003 on the “Creation of the Accreditation System of Moldova” CAECP provides accreditation in both regulated and non-regulated area, for:

testing laboratories; calibration laboratories products certification bodies; services certification bodies; quality management system certification bodies; personnel certification bodies; environmental management system certification bodies; inspection bodies.

CAECP is also entitled to organize proficiency testing (PT) and/ or Inter-laboratory Comparisons (ILC.). CAECP is organised and operates according to ISO/IEC 17011. The accreditation process is operated on a voluntary, contractual basis according to documented procedures. Financing of the Centre is from the state budget, revenues from services performed, donations and projects. CAECP accreditation schemes have been developed based on requirements set in ISO/IEC 17000 and EN 45000 series, ISO, EA, ILAC and IAF guidelines and recommendations.

The CAECP has signed a Contract for Cooperation with the European Co-operation for Accreditation (EA). It is member of the EuroAsian Interstate Council –The Interstate Council for Standardization, Metrology and Certification of the Commonwealth of Independence States (CIS) and it has signed cooperation contracts with RENAR, Turkak and NAAU. So far CAECP has granted accreditation for:

22 Certification bodies (products) - against EN 45011 5 Certification bodies (services) against EN 45011 4 Certification bodies (Quality Management Systems) - against EN ISO 17021 2 Certification bodies (Food safety Management Systems) - against EN ISO 17021

combined with ISO/ TS 22003 3 Inspection Bodies (Organic Farming) – against EN ISO 17020 and the Regulation (EEC)

No 2092/91 127 Testing laboratories – against EN ISO 17025.

The credibility abroad of test reports issued by CAECP accredited laboratories is low because test 4

methods’ equivalence with EN or ISO Standards is not established, and the traceability of test/ calibration results cannot be ensured by the national metrological system and laboratories wishing to ensure traceability must find other solutions. As a consequence the credibility of conformity certificates issued by accredited or designated bodies is currently low as accreditation is not proved as being to international standards through Peer Assessment and consequent Multilateral Agreements.Many accreditation schemes have not yet been established as there was no public interest for:

Calibration laboratories Medical laboratories Certification bodies for management systems – Environment, Occupational Health and

Safety, Information security Certification bodies for persons Inspection bodies

Sector schemes against technical regulations are not established. The legal framework is not fully in line with that of the EU, and a number of changes are required to resolve this situation. Accreditation is well established in Moldova and the State supports the proper functioning of the accreditation system. The Accreditation Centre is aiming at the Multilateral Agreement (MLA) to ensure 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. The Accreditation Centre is also seeking membership of both IAF (International Accreditation Forum) and ILAC (International Laboratory Accreditation Co-operation) for the development of confidence and international recognition of the quality and safety of Moldovan products.

3.2. Linked ActivitiesUnder the TACIS programme, the Accreditation Centre benefited from the European Organization for Conformity Assessment (EOTC) programme to promote, among other, transition to market economy. The project Support to harmonisation of Standardisation was implemented from 2003 to 2006 with a budget of 2 million euro. In the framework of this project transfer of expertise and know-how, including training, study visits, cooperation and partnerships for legal approximation and institution building took place. In this period the governmental of Republic Moldova decision on the “Establishment of system of accreditation in the field of products’ conformity assessment” was issued.

World Bank Competitiveness Enhancement Project, CEP In 2006 the World Bank Competitiveness Enhancement Project, started. The overall objective of the project was to assist Moldova in enhancing the competitiveness of enterprises through improvements in the business environment and making adequate standards, testing and quality improvement services available to enterprises. The project was intended to help the Government of Moldova to implement the business regulatory reform that had been started earlier, and it will also assist the government to begin modernization of the national standards and quality system, leading to improved competitiveness of the Moldovan economy in domestic and international markets and more attractiveness for foreign direct investment.

The CEP Project has four components:

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business environment improvement; modernization of measurements, standards, testing and quality (MSTQ) system; facilitation of enterprise access to MSTQ services; facilitation of access to finance.

In its framework the Accreditation Centre of Moldova benefited of support to further develop its knowledge and accreditation skills develop its infrastructure and purchase required equipment. The initial Project implementation period was 4 years, from January 2006 to December 31, 2009 and provided 9.6 million dollars for the MSTQ component. The project was extended up to the 31 st

of December 2010.

Planned EU funded projects / projects under preparationThe EU is currently preparing two additional Twinning fiches relevant to this project. There is a proposal for a twinning project on market surveillance, initiated by the Ministry of Economy, Consumer Protection and Market Surveillance Directorate in the aim of contributing to the implementation of the requirements in the area of internal market, specifically focusing on the creation of a functioning market surveillance system harmonized with European Union practices as per Regulation 765/2008/EC. This project is expected to start in late 2011. Another Twinning project is in tendering phase – Support to Moldova in the field of norms and standards in food safety for plant origin products – expected to start also in late 2011.

A Comprehensive Institution Building Programme (CIB) for Moldova is in preparation by the European Commission with the main objective to provide support to the Government of Moldova and selected institutions to negotiate the Association Agreement and to prepare for a possible future Deep and Comprehensive Free Trade Agreement (DCFTA). The CIB will provide support to implementation of Institutional Development Plans for the selected institutions and the Action Plan for future DCFTA negotiations as of mid-2011.

3.3. ResultsThe project is expected to achieve the following mandatory results.

1. The legal framework enables the Accreditation Centre to fulfil its role with respect to ISO/IEC 17011 and the relevant provisions of EU regulation 765/2008/EC.

2. The Accreditation Centre Quality Management System, governance framework and assessment competences allow initiation of the process of peer assessment for a Multilateral Agreement with European Co-operation for Accreditation.

3. New skills and accreditation schemes are introduced enabling the Accreditation Centre to optimise its support to key areas of Conformity Assessment.

4. Accreditation use is improved through greater understanding of the obligations and opportunities of ensuring the parity of Conformity Assessment.

3.4. ActivitiesNote: The listed activities and the proposed means for achieving the activities and results are indicative can be revised in the framework of the preparation of the contract between twinned institutions.

Component 0 - General (indicative) In addition to the activities related to the 4 components (mandatory results), the project will also carry out the following:

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0.1 Kick off meeting The first month of the project will be used to allow for the installation of the Resident Twinning Advisor (RTA) in Moldova. The RTA will have to be installed in his/her office within the beneficiary. She/he will be introduced to the BC stakeholders of the project and to his counterparts and staff. She/he will also hire an Assistant through an appropriate selection procedure.

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

Benchmarks: Stakeholders, media and public informed about the start and content of the project by start of Month 2.Resources: RTA, PL, translation, rent of premises.

0.2 Monthly MeetingsMonthly meetings will be held to discuss project progress and to solve any emerging problems. Monthly meetings will be attended by the RTA, RTA counterpart and as appropriate a representative of the EU Delegation and PAO, to monitor project progress. RTA Assistant shall produce one page meeting minutes to be shared with Project Leader, RTA counterpart, PAO and EU Delegation.

0.3 Steering Committee MeetingsRegular steering Committee meetings to promote effective management and monitoring of project activities. The Steering Committee (composition detailed under 6.4) will meet at least once every three months (first in month 3). Progress in the areas of the project’s interventions will be discussed with the beneficiary and the members of the Steering Committee.

0.4 Closing ConferenceA closing conference (wrap up meeting) will be held during the last two months of the project at which the results and impact of the project will be presented. The Conference will present recommendations for possible follow-up and lessons learned for similar projects. Project will invite the beneficiary, Moldovan Government, civil society and other donors to the closing conference.

Benchmarks: Closing conference organized, recommendations and lessons learned formulated and discussed. Stakeholders, media and public informed about the results of the project at its end.Resources: RTA, PL, translation, rent of premises.

Component 1: Review of the legal framework to enable the Accreditation Centre to fulfil its role with respect to ISO/IEC 17011 and the relevant provisions of EU regulation 765/2008/EC.

1.1. Assessment of the legal framework and recommendations for improvementThe experts will review the legal framework related to accreditation, conformity assessment, technical regulations and metrology in line with specific requirements of EU Regulation 765/2008/EC. The review will particularly analyse aspects within the legal framework that impede the development of accreditation, and the conformity assessment activities that it accredits against the provisions necessary to achieve compliance with EU regulation 765/2008/EC, IISO/IEC 17011 and EA MLA requirements.

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Benchmark: the outcome of this activity will be a report analysing gaps and weaknesses within the legal framework and prioritised recommendations for amendment.Resources: RTA, short term experts and translation as appropriate.

1.2. Define Memoranda of Understanding with priority competent authorities EU Regulatory Authorities use accreditation as a means to evaluate and demonstrate the competency and equivalence of Conformity Assessment in the fields related to their activities.Support is required to increase the understanding of the relevance of the application of accreditation to competent authorities responsible for regulations, and to define Memoranda of Understanding necessary for the accreditation. The expert(s) will look at the interaction between conformity assessment (testing, inspection etc) and the regulations against which conformity must be demonstrated (which may include food, priority industrial sectors, and other policy areas where competence should be proved to be the equivalent of EU practice.) The experts will assist in promoting the dialogue necessary as defined in EA best practice guidance documentation EA 2-17 and the definition of criteria for resulting MoU’s to formalise agreements with competent authorities.Benchmark: Recommendations for Memoranda of Understanding with priority Competent Authorities, establishing the parameters of how the Accreditation Centre will provide services, and the duties of both parties within the scope of such MoU.Resources: RTA, short term experts and translation as appropriate.

Component 2: Review of the Accreditation Centre Quality Management System, governance framework and assessment competences

2.1. Review and recommendations on CAECP organisation and management system.

The expert(s) will review the current Accreditation Centre Quality Management Systems and Governance Structure against the needs for priority Multilateral Agreements (MLA) with European Co-operation for Accreditation as defined in EU regulation 765/2008/EC, ISO/IEC 17011 and appropriate EA guidance. The review will be based on MLA/ Key Performance Indicators and practices applied during MLA peer evaluations.It will identify non-conformities and opportunities for the adoption of “Best practice” as appropriate to meet the requirements of MLA review. The recommendations will identify improvements to the Accreditation Centre Governance Structure and Quality Management Systems necessary to meet the requirements of MLA review.Benchmark: The outcome of this activity will be a report evaluating the current status of the Governance Structure/Management Systems against EU regulation 765/2008/EC, ISO/IEC 17011 and appropriate EA guidance. It will identify areas of non-conformity and opportunities for the adoption of best practice and make specific recommendations to address the issues identified.Resources: RTA, short term experts and translation as appropriate.

2.2. Enhancement of CAECP management systems to comply with the requirements set in relevant standards, guides and community harmonised legislation. Based on the recommendations of activity 2.1 a development programme of Governance/Management systems and operational policies will be agreed. Project experts will provide support in the implementation of recommendations for best practice and to address non conformities. They will assist in modification of relevant documents for CAEPC management

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system and will provide support in preparing the relevant documents in English to adhere to the EA ad to sign the multilateral agreement with MLA. It is expected that the activity will result in the enhancement of CAECP organizational/governance Structure and Management Systems documentation in line with EU regulation 765/2008/EC, ISO/IEC 17011 and appropriate EA guidance.Where practices and procedures are revised, the experts will provide appropriate guidance in their application, through seminars and mentoring for appropriate staff, enabling records of training necessary for peer assessment.Benchmark: the activity will result in revised organizational/governance structures and documented Quality Management systems and processes that address the non-conformities and opportunities identified.Resources: RTA, short term experts and translation as appropriate.

2.3. Study Tour for Quality Management staffAs a component of the revision of Quality Management System documentation it will be appropriate to organise a study tour for staff responsible for the development and implementation of Quality Management Systems to enable them to observe the functioning of MLA accreditation bodies.The outcome of such a visit will enables them to witness the practical application of Quality Management Systems enabling them to develop and implement such systems within Moldova. One study tour is envisaged for up to 5 appropriate members of the management team, and technical specialists for a maximum of 5 days to observe management practices including the process of “the Accreditation decision”. The Study tour shall cover all aspects pertinent to the activity of CAECP and may include a mixture of methods, including seminars, site visits, observed assessments, and other useful methods.Benchmark: as a result of the study tour the BC staff shall have a clear vision and understanding of the relevant parts of the system of accreditation in general, the application of Quality Management Systems and be able to implement such systems in Moldova.Resources: Tickets, Per Diems as necessary, Translation as necessary.

2.4. Evaluation and recommendations for CAECP competence in accreditationThe experts will analyse the processes of assessment carried out and the competence of CAECP staff in carrying out assessments in chosen areas of accreditation. They will also analyse the formal decision process of awarding accreditation.Analysis of accreditation criteria and practice will be carried out by reviewing files within CAECP offices and observing assessment teams in operation (initial assessment, surveillance and reassessment) in key areas of accreditation.The activity will identify non-conformities, training needs and the opportunities for the adoption of best practice. Recommendations will identify improvements to the accreditation practice, assessor skills and documentation.Benchmark: The outcome of this activity will result in a report evaluating the current competence in accreditation against EU regulation 765/2008/EC, ISO/IEC 17011 and appropriate EA guidance. It will identify areas of non-conformity and opportunities for the adoption of best practice and make specific recommendations to address the areas identified. Training and coaching plan and the needs for technical staff to observe assessments carried out to MLA requirements will be developed on the basis of the findings. Resources: RTA, short term experts and translation as appropriate.

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2.5. Training, coaching and training of trainers to improve CAECP personnel’s knowledge and skills in assessment and continuing monitoring of the competence of conformity assessment bodies. The experts will deliver the training and coaching programme identified in 2.4 to improve CAECP personnel’s skills and knowledge in the assessment and monitoring of CABs. A training of trainers will be carried out to ensure greater sustainability of this activity.Benchmark: Training and coaching materials to enhance skills and knowledge. Report detailing training provided.Resources: RTA, short term experts and translation as appropriate.

2.6. Study Tour for management staffFollowing the enhancement of governance structures and operational policies it will be appropriate to organise a study visits for management to enable them to observe the functioning of the operations of the European Co-operation for Accreditation, of which CAECP aspires for full membership.Such visit will enable initial participation in technical discussions regarding areas such as Certification, Laboratories and Inspection, and will provide essential information enabling CAECP to ensure that its policies and operations are in line with EA best practice, necessary for the implementation of provisions in line with EU regulation 765/2008/EC. One study tour is envisaged for and appropriate member of the management team, to participate in discussions for a maximum of 5 days for mentored visits/meetings to European Co-operation for Accreditation operational/policy and Technical Committee meetings to develop deeper understanding of European practice and policy in the field of accreditation. Benchmark: As a result of the study tour the BC staff shall have a clear vision and understanding of the current specific developments of accreditation in their particular fields of activity and should be able to implement such systems in Moldova, and articulate European Accreditation Policy to stakeholders. Resources: Tickets, per diems as necessary, translation as necessary.

2.7. Study Tour for Technical staffAs a component of the enhancement of assessment capability it will be appropriate to organise study tours for specialists to enable them to observe the functioning of MLA accreditation bodies, and the practices of assessment carried out in MLA accreditation bodies prior to, during and following the assessment visit.Records of such visit provide essential documentation that technical specialists have had the opportunity to observe assessment carried out according to recognised standards, forming an essential component of MLA documentation. One study tour is envisaged for up to 5 appropriate technical specialists for a maximum of 5 days covering. The study tour shall cover all aspects pertinent to the activity of CAECP and may include a mixture of methods, including seminars, site visits, observed assessments, and other useful methods.Benchmark: As a result of the study tour the BC staff shall have a clear vision and understanding of the relevant parts of the system of accreditation in general, and their particular fields of activity and be able to implement such systems in Moldova. Documentary records of observed assessments carried out by technical specialists.

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Resources: Tickets, per diems as necessary, translation as necessary.

2.8. Performance of an audit to check that the accreditation system operated by CAECP is in line with MLA requirements.An impartial expert (i.e. one who has not been involved in activities 2.1 to 2.4) will carry out an assessment of the enhanced Quality Management System and assessment process/competences, to verify that suitable improvements have been made. The audit will be carried out against EA MLA requirements and methodologies to evaluate CAECPs readiness for peer review. The audit will use EA MLA tools (KPIs, check list, etc.) and procedures (EA 2/02) and it will include at least one witnessed assessment per scope of accreditation.Benchmark: Audit report against EA MLA criteriaResources: RTA, short term experts and translation as appropriate.

Component 3: Equipment of CAECP staff with new knowledge and skills related to “Horizontal Harmonization issues” techniques, and definition of New Accreditation Schemes.

3.1. Development of new accreditation schemes according to priority sectors and market demand.The experts will provide support in the development of up to 3 new accreditation schemes to suit market demand and economic needs. Such schemes may cover for example the accreditation of calibration and medical laboratories and Non Destructive Testing providers and will be defined during the contract negotiations.Experts will provide support in the creation of relevant accreditation scheme documentation (procedures etc), training and joint assessments of CABS in Moldova.Benchmark: The outcome of the work will be a set of documents defining new accreditation schemes, training materials necessary for their development and records of training provided.Resources: RTA, short term experts and translation as appropriate.

3.2. Training Needs Analysis (TNA), development of training material and training of trainers in the field of “Horizontal Harmonization issues” and New Accreditation SchemesThe work of EA in response to “Horizontal harmonization issues” raised in the implementation of EU regulation 765/2008/EC is resulting in the development of new practices regarding Cross Boarder Accreditation, covering “Accreditation of multi-site CABs, Multiple accreditation and Flexible scope accreditation” that have been developed at EA to avoid unnecessary burdens of too many assessment visits to CABs. Such new methods apply to CABs performing multiple Conformity Assessment activities (ie testing /calibration /inspection /certification) and for the accreditation of multi-site CABs (e.g. medical laboratories, electrical laboratories, etc.). The implementation of such practices will require the development of new skills and knowledge. Similarly the identification of New Accreditation Schemes will require additional skills and knowledge to provide assessment skills covering the scopes of the new schemes. The experts will carry out an analysis, to the appropriate training needs, and curricula and training materials to fulfil the training needs identified. A training of trainers will be carried out to ensure greater sustainability of this activity.Benchmark: Curriculum and training materials for training of staff and external assessors in new practices and for New Accreditation Schemes.Resources: RTA, short term experts and translation as appropriate.

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3.3. Develop new relevant knowledge and skills to perform based on the TNA carried out earlier. The experts will provide support through a programme of seminars/workshop and joint assessments to introduce new skills and practices identified in the Training Needs Analysis against New Accreditation Schemes. The support will cover training of assessors and decision makers and revision of policies, and documented processes necessary for the implementation of practices. Benchmark: Records of training provided. Manuals and working processes documentation necessary to introduce such methods into Quality Management System.Resources: RTA, short term experts and translation as appropriate.

3.4. Study Tour for New Accreditation SchemesFollowing the development of New Accreditation Schemes and its associated programme of training it will be appropriate to organise one study tour for technical specialists to enable them to observe the operations of the new skills and schemes within an MLA Accreditation Body. One study tour is envisaged for up to 5 appropriate technical specialists for a maximum of 5 days. The study tour shall cover all aspects pertinent to the activity of CAECP and may include a mixture of methods, including seminars, site visits, observed assessments, and other useful methods.Benchmark: As a result of the study tour the BC staff shall have a clear vision and understanding of the organisation and operation of new schemes and their practical application within their particular fields of activity and be able to implement such methodology and schemes in Moldova.Resources: Tickets, Per Diems as necessary, Translation as necessary.

3.5. Develop new relevant knowledge and skills to perform based on the TNA carried out earlier. (Accreditation of multi-site CABs, Multiple Accreditation and Flexible scope Accreditation).The experts will provide support through a programme of seminars/workshops and joint assessments to introduce new skills and practices identified in the Training Needs Analysis against “Horizontal Harmonization issues’. The support will cover training of assessors and decision makers and revision of policies, and documented processes necessary for the implementation of practices. Benchmark: Records of training provided. Manuals and working processes documentation necessary to introduce such methods into Quality Management System.Resources: RTA, short term experts and translation as appropriate.

3.6. Study Tour for new knowledge and skills (accreditation of multi-site CABs, multiple accreditation and flexible scope accreditation)Following the development of new skills it will be appropriate to organise a study tour for technical specialists to enable them to observe the operations of the new skills and schemes within an MLA Accreditation Body. One study tour is envisaged for up to 5 appropriate technical specialists for a maximum of 5 days covering the subjects of Multiple Accreditation practice, Accreditation of multi-site CAB practice and Flexible scope Accreditation.The study tour shall cover all aspects pertinent to the activity of CAECP and may include a mixture

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of methods, including seminars, site visits, observed assessments, and other useful methods.Benchmark: As a result of the study tour the BC staff shall have a clear vision and understanding of the organisation and practical application of new techniques within their particular fields of activity and be able to implement such methodology and schemes in Moldova.Resources: Tickets, per diems as necessary, translation as necessary.

Component 4: Improvement of accreditation use by understanding the obligations and opportunities of ensuring the parity of conformity assessment.

4.1. Support in the enhancement of CAECP partnerships with stakeholders The experts will support the development of an effective approach to structured relationships with key stakeholders, ensuring transparency, accountability and credibility of the overall system. The approach taken will be in line with the provisions of ISO 17011 and EU regulation 765/2005/EC which require an organizational structure ensuring the active involvement of stakeholders in developing strategy and related policies. The experts will support the development of CAECP stakeholder strategy and action plan considering stakeholders’ position and interests and support to workshops, round tables / seminars, on technical issues for CAB personnel and other stakeholdersBenchmark: As a result of the activity CAECP will have a strategy for the development and maintenance of clearly defined and structured relationships with stakeholders, and the resources necessary to maintain relationships during the enhancement of accreditation through and beyond the MLA process.Resources: RTA, short term experts and translation as appropriate.

4.2. Conference to promote accreditation practiceExperts support up to two CAECP conferences/workshops/events promoting the role of accreditation, the benefits of accreditation to MLA and particularly the implications (opportunities and obligations) for CABs (including those already accredited) of improving the standard of accreditation in Moldova to a point where it is recognised in EU. Benchmark: Expert participation in conferences/workshops/events promoting the role, obligations and benefits of accreditation. Resources: RTA, short term experts and translation as appropriate. Rent of premises if appropriate.

4.3. Seminars/Workshops for stakeholders Experts will organize up to 4 Seminars/workshops/events for stakeholders (particularly accredited CABs) providing technical information on the steps necessary to meet the requirements of accreditation necessary for international recognition. Benchmark: Expert participation in conferences/workshops/events providing technical information to stakeholders. Resources: RTA, short term experts and translation as appropriate. Rent of premises if appropriate.

3.5 Means/ Input from the MS Partner Administration:

3.5.1. Profile and tasks of the Project LeaderThe Project Leader (PL) from the EU MS should be a senior civil servant or equivalent staff of a MS institution who works in the field relevant to this project and has been at least three years in a

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management position within the institution.The PL will be responsible for achievement of project results, ensuring the activities for the co-operation and information exchange between EU MS side and Beneficiary side and ensuring that all the required support of the management and staff of the EU side are available. He will coordinate the Project Steering Committee (PSC) meetings on the EU MS side.The PL shall devote a minimum of three working days per month in his home administration, with an on-site visit to the Republic of Moldova at least every 3 months to participate in the PSC meetings.ProfileQualification and skills

University level education in engineering or another relevant field. Fluency in English. Command of Romanian and/or Russian would be an asset Good inter-personal skills Good management skills

General professional experience At least 10 years experience within a Quality Infrastructure Body, or related regulatory field Experience in project management Strong initiative, analytical and team working skills

Specific professional experience Specific experience in the field of Accreditation/Conformity Assessment, related to the New

Approach and other industrial sectors Knowledge of the EU “New Legislative Framework for marketing of products”, the specific

requirements applicable to Accreditation and the implementation of ISO/IEC 17011 Experience in preparation of major strategic documents

3.5.2. Profile and tasks of the RTA The RTA will be in charge of the day-to-day implementation of the Twinning project in the Republic of Moldova. S\he will coordinate the implementation of activities according to a predetermined work plan and liaise with the RTA counterpart in the Republic of Moldova. The RTA will provide significant professional input, especially at the beginning of the Twinning project.

Profile of the RTAQualification and skills University degree in engineering / chemistry or another relevant discipline Fluency in English, good command of Russian and/or Romanian would be an asset Good PC literacy (Word, Excel, PowerPoint) Good inter-personal and diplomatic skills Good management skills

General professional experience At least 3 years experience in working with EU practices concerning Accreditation and

Conformity assessment Recent experience in a senior position in a state institution/Accreditation body in an EU MS Experience in transition economies of the CIS would be an asset

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Strong initiative, analytical and team working skillsSpecific professional experience

Sound knowledge of Accreditation services Recent experience in the implementation of Accreditation activities in an EU member state Knowledge of the EU New Legislative and specific requirements applicable to accreditation Knowledge of the application of ISO/IEC 17011 Knowledge of the process of Multilateral Agreements in Accreditation Experience in preparation of major strategic documents

Duration of RTA secondment: 24 months

3.5.3. Profile and tasks of the short-term experts

A pool of short term experts is required to implement the activities as outlined above covering the following indicative subjects as identified in the indicative activities:

Legal Framework for Conformity Assessment related to technical regulation Laboratory Assessment (in key sectors) Management Systems Assessment Certification Assessment ISO/IEC 17011 implementation Peer Assessment of Accreditation Bodies to EA MLA requirements “Horizontal Harmonization issues”

Indicative General Profile of the Short Term expertsQualifications and skills: - University education the appropriate field (as indicated above)- Working knowledge of English.- Knowledge of Romanian / Russian can be considered an asset- Good inter-personal and communication skills.General professional experience:- At least 5 years of professional experience in the relevant field, 8 years experience is

considered to be an asset.

3.5.4. Profile and Tasks of the RTA AssistantThe profile and tasks of the RTA assistant will be specified by the RTA and RTA counterpart. The recruitment procedure will follow the provisions of the EC manual section 5.9. RTA assistant.

4. Institutional FrameworkThe Moldovan Centre of Accreditation in the Field of Products Conformity Assessment (CAECP) is a State Enterprise directed by Ministry of Economy. It was established under Government Decree no 1646 of 31/12/2003 on the “Creation of the Accreditation System of Moldova” under which it is the sole Accreditation Body on the territory of the Republic of Moldova. It is entrusted to provide accreditation for CABs in both regulated and non-regulated fields covering testing and calibration of laboratories, products certification bodies, services certification bodies and quality management system certification bodies. Its statute requires that it operates in line with the established principles

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of Accreditation which include public interest; inclusivity; non-discriminatory access to accreditation; competence, impartiality and independence, transparency, credibility, and confidentiality.A new law substantially based on the provisions for accreditation with EU Regulation 765/2008/EC is currently within the Moldovan legal process.The Accreditation Centre activities are coordinated by the Accreditation Council chaired by a Deputy Minister of the Ministry of Economy. The Centre is managed by a director proposed by the Accreditation Council appointed by the Government of the Republic of Moldova who has executive responsible for the management of the centre.It is structured into functional departments related to its technical functions, with separate departments responsible for finance and international relations with European and international Accreditation Bodies. The centre has a structure of technical committees reflecting the activities with which it is associated.

5. BudgetEUR 1.100.000 The Beneficiary will provide in-kind contribution in the form foreseen in the Twinning Manual.

6. Implementation Arrangements6.1. The Implementing AgencyThe Implementing Agency responsible for tendering, contracting and accounting is the Delegation of the European Union to the Republic of Moldova.

Responsible person: Ms. Speranta OLARUPosition: Project Manager, Delegation of the European Union to the Republic of

Moldova

Address: 12 Kogalniceanu Street

MD-2001 Chisinau, Republic of Moldova

Tel.: + 373 22 505 210

Fax: + 373 22 272 622

E-mail: [email protected]

The Programme Administration Office (PAO) will support the Twinning project implementation process together with the Delegation of the European Union to the Republic of Moldova:

Responsible person: Ms. Oxana DRAGUTA

Position: Senior Consultant, State Chancellery of the Government of Moldova, Division for Policy, Strategic Planning and External Assistance

Address: Piata Marii Adunari Nationale, 1

MD-2033 Chisinau

Tel: +373 22 250 465

Fax: +373 22 250 259

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6.2. Main counterpart in the BCBC Project leader:

Ministry of Economy and Trade

Responsible person: Mr. Octavian CalmîcPosition: Deputy Minister

Address: Republic of Moldova

MD-2033, Chisinau,

Piata Marii Adunari Nationale, 1

Tel./Fax: +373 22 250643

e-mail: [email protected]

RTA counterpart:

Centre of Accreditation in the field of Products Conformity Assessment

Responsible person: Ms. Galina CirsteaPosition: Manager of management systems

Address: Republic of Moldova

MD 2004 Chisinau

Stefan cel Mare, 162

Tel.: +373 22 202602


6.3. Contracts

There will be one Twinning contract with a selected Member State or consortium of Member States.

6.4. Project Steering Committee

A Project Steering Committee (PSC) will be established for the control and supervision of the project activities and the mandatory results. The PSC will meet at regular intervals and will submit by the end of the meeting (as recorded in meeting minutes) an approval/non 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 the PSC meeting.

7. Implementation Schedule (indicative) 7.1 Launching of the call for proposals:

November 2010 7.2 Start of project activities:

September 2011 7.3 Project completion:

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mailto:[email protected]



December 2013 7.4 Duration of the implementation period:

24 months (+ 3 months for opening and closing)

8. Sustainability The Centre is an existing organisation and the results are directly applicable in practice. There is no risk of backsliding on achieved changes as the changes are embedded into practice through Management Systems Documentation and training resources for future staff are provided.

9. Crosscutting issues Equal Opportunity Participation will be open to both female and male personnel, regardless of their ethnic background, political affiliation or religious believes. Records of staff participating in training and other project activities will reflect this statement. The gender structure within the public authorities, entities and bodies on state and local level where are the majority of procurement purchases is well balanced. This enables fair male/female deployment in the execution of the project itself. Poverty Reduction The project supports economic development and increases the opportunity for Moldovan economic operators to do business with the European Union counterparts and beyond. Based in the notion that “raising waters lift all boats”, the project will ultimately contribute to the reduction of poverty in Moldova. Environment The project is not envisaged to have a direct impact on the environment nor is it specifically targeted to address environmental concerns. There may be some positive impacts on the environments due to better measurements by accredited laboratories. Good Governance and Human rights The project will support Good Governance by ensuring that legislation currently in force is implemented even-handed and the reliability of documents provided by mandated bodies is improved, thus leading to a higher level of trust by the citizens in the administrate system of Moldova.

10. Conditionality and sequencing No conditionalities apply.

ABREVIATIONS

ACAA Agreement on Conformity Assessment and Acceptance of Products AP Action Plan ATP Autonomous Trade Preferences BC Beneficiary Country BIPM Bureau International des Poids et Mesures CAB Conformity Assessment Body

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CAEP Centre of Accreditation in Products Conformity Assessment CEP Competitiveness Enhancement Project CB Certification Body CE European Union Conformity Marking for Products CEN European Committee for Standardization CMC Calibration and Measurement Capability CPS Country Particular Strategy DCFTA Deep and Comprehensive Free Trade Area EA European Cooperation for Accreditation EC European CommissionENP European Neighbourhood Policy ENPI European Neighbourhood and Partnership Instrument EUD European Union Delegation in Moldova EURAMET European Association of National Metrology Institutes KPI Key Performance Indicators IAF International accreditation Forum ILAC International cooperation for Laboratory Accreditation ILC Inter-laboratory Comparisons INSM National institute for Standardization and Metrology ISO International Organisation for Standardisation MEC Ministry of Economy MLA Multilateral Agreement MS Member state of the European Union MSPL Project Leaded from the Member State MSTQ Measurement, standards, testing and quality NAAU Ukraine Accreditation Body NAB National accreditation Body PCA Partnership and Cooperation Agreement PL Project Leader PT Proficiency testing RENAR Romanian Accreditation Body RTA Resident Twinning Adviser SMEs Small and Medium size Enterprises SPS Sanitary- phytosanitary agreement STE Short term expert TACIS Technical Assistance for CIS countries TBT Technical Barriers to Trade Agreement TURKAK Turkish Accreditation Body WB World Bank WTO World Trade Organisation

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ANNEXES

1. Logical framework matrix in standard format.2. Detailed implementation chart.

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LOGFRAME PLANNING MATRIX

Project name and number:Strengthening the capacity of the Accreditation Centre in the field of Conformity

Assessment of Products of the Republic of Moldova

Programme name and number: ENPI annual Programme

Total budget: EUR 1.040.000

Overall objective Objectively verifiable indicators Sources of VerificationThe overall objective of this project is to improve the trade competitiveness of the Republic of Moldova (further – Moldova) and to harmonize the quality infrastructure with international and European standards.

Increased international trade (by 10% at project end) between Moldova and third countries (including EU).Reduced delays in brining goods to market.

Trade Statistics from EU and Moldova

European Market surveillance reports

Information obtained from tradersProject purpose Objectively verifiable indicators Sources of Verification AssumptionsTo prepare Moldova’s Accreditation Centre for signing multilateral agreements with the European Co-operation for Accreditation and to establish the conditions for the future international recognition of Moldovan accredited test results, calibration certificates, inspection reports and conformity certificates.

Accreditation Centre's application to sign MLA's for testing, management and products conformity certification.

Agreements signed and published

EU standards bodies

There is a continued commitment from the Moldovan Government to integrate into the international trade system.There is sufficient funding available to ensure that the Accreditation Agency can do its work.The Agency can stand up to vested interests.

Results Objectively verifiable indicators Sources of Verification Assumptions1. The legal framework enables the

Accreditation Body to fulfil its roles with respect to ISO/IEC 17011 and the relevant provisions of EU regulation 765/2008/EC.

2. The Accreditation Centre Quality Management System, Governance framework and assessment competences allow initiation of the process of peer assessment for a

Compatible Legal framework in place

Application for Peer Assessment prepared by Accreditation Centre

Official Journal of the Republic of Moldova. CLA reports on compatibility of legislation.

Application form for peer review.

CLA assessment of the legislation takes place.

The accreditation agency actively applies for MLA status.

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Multilateral Agreement with European Co-operation for Accreditation.

3. New skills and accreditation schemes are introduced enabling the Accreditation Centre to optimise its support to key areas of Conformity Assessment

4. Accreditation use is improved through greater understanding of the obligations and opportunities of ensuring the parity of Conformity Assessment.

New Accreditation Schemes in place and promoted by Accreditation CentreNew methods of assessment appliedRegulators and CABs consider a programme of upgrading Conformity Assessment to EU compatible practiceCertificates issued by accreditation agency are accepted by peer assessment.

Accreditation scheme promotion material.

Regulatory implementation plan requires higher standards of conformity assessment.

Peer review reports.

Accreditation agency is willing to take on new areas.

Political will to improve alignment of standards continues.

Activities Means AssumptionsComponent 1: Review and recommendations of the legal framework to enable the Accreditation Body to fulfil its roles with respect to ISO/IEC 17011 and the relevant provisions of EU regulation 765/2008/EC. 1.1 Assessment of the legal framework and

recommendations for improvement10 man days STE expertiseTranslation

Legislation is available and the partners have an open dialogue about required change.

1.2 Define Memoranda of understanding with priority competent Authorities

15 man days STE expertiseTranslation

Component 2: Review of the Accreditation Centre Quality Management System, governance framework and assessment competences2.1 Review and recommendations on

CAECP organization and management system


Staff has time to participate in the review.

2.2 Enhancement of CAECP management 40 man days STE expertise There is sufficient will in the

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systems to comply with the requirements set in relevant standards, guides and community harmonized legislation.

Translation organisation to implement the recommendations.

2.3 Study Tour for Quality Management staff

2.4 Evaluation and recommendations for CAECP competence in accreditation


Staff is available for training.

2.5 Training and coaching to improve CAECP personnel’s knowledge and skills in assessment and continuing monitoring of the competence of conformity assessment bodies


EU member states can receive the study tour

2.6 Study Tour for management staff EU member states can receive the study tour

2.7 Study Tour for Technical staff EU member states can receive the study tour

2.8 Perform an audit to check that the accreditation system operated by CAECP is in line with MLA requirements.


Staff is willing and able to participate in the audit.

Component 3: Equipment of CAECP staff with new knowledge and skills related to “Horizontal Harmonization issues” techniques and definition of New Accreditation Schemes.3.1 Development of new accreditation

schemes according to priority sectors and market demand.


There is market demand for new services

3.2 Training Needs Analysis (TNA) and development of training material in the field of “Horizontal Harmonization issues” and New Accreditation Schemes


Staff are able and willing to participate in the TNA

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3.3 Develop new relevant knowledge and skills to perform based on the TNA carried out earlier. (New Accreditation Schemes).


Staff is available for training

3.4 Study Tour for New Accreditation Schemes


3.5 Develop new relevant knowledge and skills to perform based on the TNA carried out earlier. (Accreditation of multi-site CABs, Multiple Accreditation and Flexible scope Accreditation).


Staff is available for training

3.6 Study Tour for new knowledge and skills (Accreditation of multi-site CABs, Multiple Accreditation and Flexible scope Accreditation)


Component 4: Improvement of accreditation use by understanding the obligations and opportunities of ensuring the parity of conformity assessment.4.1 Support in the enhancement of CAECP

partnerships with stakeholders20 man days STE expertiseTranslation

Stakeholders are willing to be involved

4.2 Conference to promote Accreditation Practice



4.3 Seminars/Workshops for Stakeholders 20 man days STE expertiseTranslation


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ANNEX 2 – Indicative implementation plan.

Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27

Kick off meeting xSteering Committee meetings x x x x x x xMonthly meeting x x x x x x x x x x x x x x x x x x x x x xWrap up meeting xFinal Payment xComponent 1: Review and recommendations of the legal framework to enable the Accreditation Body to fulfil its roles with respect to ISO/IEC 17011 and the relevant provisions of EU regulation 765/2008/EC.

1.1Assessment of the legal framework and recommendations for improvement x

1.2Define Memoranda of understanding with priority competent Authorities x

Component 2: Review of the Accreditation Centre Quality Management System, governance framework and assessment competences

2.1Review and recommendations on CAECP organization and management system. x x

2.2

Enhancement of CAECP management systems to comply with the requirements set in relevant standards, guides and community harmonized legislation.

x x x x

2.3 Study Tours for Quality Management staff x

2.4Evaluation and recommendations for CAECP competence in accreditation x x

2.5

Training and coaching to improve CAECP personnel’s knowledge and skills in assessment and continuing monitoring of the competence of conformity assessment bodies.

x x x

2.6 Study Tours for management staff x

2.7 Study Tours for Technical staff x

2.8Perform an audit to check that the accreditation system operated by CAECP is in line with MLA requirements.

x x

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Month 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27

Component 3: Equipment of CAECP staff with new knowledge and skills related to “Horizontal Harmonization issues” techniques, and definition of New Accreditation Schemes.

3.1Development of new accreditation schemes according to priority sectors and market demand.

x x

3.2

Training Needs Analysis (TNA) and development of training material in the field of “Horizontal Harmonization issues” and New Accreditation Schemes

x x

3.3Develop new relevant knowledge and skills to perform based on the TNA carried out earlier. (New Accreditation Schemes).

x x

3.4 Study Tour for New Accreditation Schemes x

3.5

Develop new relevant knowledge and skills to perform based on the TNA carried out earlier. (Accreditation of multi-site CABs, Multiple Accreditation and Flexible scope Accreditation).

x x

3.6

Study Tours for new knowledge and skills (Accreditation of multi-site CABs, Multiple Accreditation and Flexible scope Accreditation)

x

Component 4: Improvement of accreditation use by understanding the obligations and opportunities of ensuring the parity of conformity assessment.

4.1Support in the enhancement of CAECP partnerships with stakeholders x x

4.2 Conference to promote Accreditation Practice x x

4.3 Seminars/Workshops for Stakeholders x x x x

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