1.2. Title: Capacity Building at the Malta Standards Authority. To have an efficient data management system in place in MSA.

Transcription

1 STANDARD SUMMARY PROJECT FICHE 1. BASIC INFORMATION 1.1. Désirée number: MT Title: Capacity Building at the Malta Standards Authority 1.3. Sector: Standardisation, Conformity Assessment, Market Surveillance 1.4. Location: Malta 2. OBJECTIVES 2.1. Global Objective To establish MSA as the focal point for quality issues in Malta and to establish the quality infrastructure required by the transposition of the new and global approach in the areas of standardisation, accreditation and metrology Immediate Objectives To have an efficient data management system in place in MSA. To create and operate a notification point within MSA as per directive 98/34/EC as modified. MSA through its directorates on Consumer and Industrial Goods and on Foodstuff, Chemicals and Cosmetics should be able to provide the necessary legal and technical advice to the government and to the economic operators. Standardisation: to set up the organisational structure of the directorate so as to establish an operational base that would be capable of executing all the functions of a national standardisation body, in particular to carry out standardisation activities in conformity with the WTO agreement and the requirements of CEN and CENELEC. Accreditation: to set up the organisation structure of the directorate so as to establish an operational base that would be capable of supporting all the functions of a national accreditation body, in particular to carry out accreditation activities adequate to the needs of the Maltese economy and in conformity with the requirements of the European co-operation for Accreditation (EA) Metrology: to set up the organisation structure of the directorate so as to establish an operational base that would be capable of supporting all the functions of a Project Fiche - National Pre-Accession Programme Malta 1

2 national metrology service, in particular a metrology infrastructure catering for the major needs of the Maltese economy and government and operated according to European practices Accession Partnership and NPAA priority Accession Partnership 3.1 Short-term priorities / Internal Market / Free movement of goods: align civil and consumer policy legislation with the product liability directive by providing rules on the manufacturer liability. 3.2 Medium term priorities / Internal Market / Free movement of goods: ensure sufficient independence of standardisation, certification, accreditation and metrology bodies and finalise overall institutional arrangements DRAFT NPAA Short Term Priorities (2000) Internal market - Free Movement of Goods, Par. III Pag Enforce framework legislation, continue with transposition of New Approach directives and alignment of technical legislation, carry out awareness campaigns in the areas of consumer and industrial goods falling under the New Approach and food hygiene, publish and adopt various CEN/CENELEC European Standards. Reorganise MSA, to ensure proper implementing structures. Medium Term Priorities (2002) Internal market - Free Movement of Goods, Par. III Pag Complete the adoption of sector legislation and the alignment of EN standards, ensure proper implementing structures for all sectors, establish a market surveillance system. 3. DESCRIPTION 3.1. Background and Justification General The Malta Standards Authority (MSA) was set up in 1996 by an Act of Parliament (Cap. 187) so as to co-ordinate standardisation and other related activities in Malta. Since the MSA s mandate - besides being the national standards body entrusted to adopt, publish and disseminate voluntary standards - was very much broader and included related standardisation activities such as technical advise, notification of standards and regulations (the 98/34/EC notification point) and coordinating testing, certification, accreditation, market surveillance and metrology activities in Malta, the founding Cap 187 was repealed by the new Malta Standards Project Fiche - National Pre-Accession Programme Malta 2

3 Authority Act (Act XIX of 2000) approved by Parliament on 18 July As indicated in the Operations Review conducted within the Ministry for Economic Services (MES), through a system of Directorates, namely Certification, Metrology, and Accreditation (to be established later on during 2001) and through the three already established Directorates namely Standardisation, Consumer and Industrial Goods and that covering Foodstuffs, Chemicals and Cosmetics, the MSA is ensuring the functional separation of the various roles in the sense that the various arms of the Authority will be independent of each other as regards the decisions they take as well as financially. Co-ordination is assured through the link of each arm with the central organisation (Council through CEO) but each division will remain technically and financially independent. Currently, active consideration is being given towards the effective resourcing of the Authority and the unfolding of its mandate. In this respect, the MSA has embarked on a result-oriented project, consisting of several components, which are considered to be the cornerstone of the Free Movement of Goods principle. MSA organigramme as a result of the ongoing re-organisation: Malta Standards Authority Chairman Central Administration Directorates Management Committee 98/34/EC Notification System Management Committee Accreditation Services (Legal) Metrology (Accredited to EN 45000) Standardisation Consumer and Industrial Goods Foodstuffs, Chemicals & Cosmetics Technical Committees Technical Committees Project Fiche - National Pre-Accession Programme Malta 3

4 Organigramme showing pictorially the separation of roles (Risk Assessment MSA, Risk Management Consumer and Competition Division and System Audit Market Surveillance Directorate within the Economic Policy Division): Ministry for Economic Services Economic Policy Division Consumer and Competition Division Consumer and Industrial Goods Directorate Malta Standards Authority (RISK ASSESSMENT) Market Surveillance Directorate (co-ordination/programming of the efforts of all surveillance authorities concerned with product control) (AUDIT) Consumer Affairs Directorate (RISK MANAGEMENT) Technical Committees ADVISORY Central Administration: ensures the corporate functions of the Authority, will need to be strengthened with a legal advisor specialised in EU legislation and a database manager. Directorates: Each directorate is legally rooted in a specific legal act. Although operating under the same umbrella, and subject to further examination, the legislation drafted or already in place seems to ensure sufficient functional independence to the various directorates. Nevertheless the draft act on accreditation has to be reviewed before it is passed to the parliament. The operation of accreditation and certification services under the same umbrella (MSA) may not satisfy the international requirements of impartiality and independence. The creation of the directorate for certification services is hence postponed. Directorate for Foodstuffs, Chemicals & Cosmetics: The directorate is the technical arm of the government for all matters related to the free movement and safety of products in its remit. In that capacity they draft the relevant pieces of legislation, advise the governmental authority (tax, finances, customs, market surveillance, consumer affairs ) and the economic operators, etc. Advisory groups (experts groups or Technical Committees) will support the directorate. The director has heavily contributed to the drafting of the Maltese legislation transposing the acquis in this sector. Directorate for Consumer and Industrial Goods: The directorate is the technical arm of the government for all matters related to the free movement and safety of products in its remit. In that capacity they draft the relevant pieces of legislation, advise the governmental authority (tax, finances, customs, market surveillance, consumer affairs ) and the economic operators, etc. Advisory groups (experts groups, or Technical Committees) will support the directorate. The director has heavily contributed to the drafting of the Maltese legislation transposing the acquis in this sector. The Product Safety Act is under discussion in Parliament and will become an umbrella legislation under which all relevant EU legal acts (new and old approach directives) can be adopted as secondary legislation. The Product liability directive is in place. NPAA short-term priorities have been largely met. Standardisation: MSA is the recognised standardisation body of the Republic of Malta as per act n XIX of MSA is member of ISO and IEC as well as ETSI. Presently affiliate member of CEN and CENELEC, they intend to become members as soon as Project Fiche - National Pre-Accession Programme Malta 4

5 possible. They are negotiating an agreement with BSI for the adoption of all European standards as national standards (MSA EN xxxx) EN standards have already been published in the official Gazette. By mid-2001 they expect to have adopted more than 80% of all European standards. Only one director manages standardisation activities. At the moment MSA is not in a condition to cope with the duties and responsibilities of full membership to CEN and CENELEC. A full functioning Standardisation directorate is needed in order for Malta to achieve the free movement of goods. Before the start of this project, in order to get acquainted with the organisation and functioning of a standardisation department, the director is likely to be attached to a similar CEN member. Staff will then be recruited and trained whilst procedures and internal rules need to be drafted and put into place. Metrology: A Metrology co-ordinator has just been appointed, and the legal act setting up the directorate is still to be adopted by the parliament. Primary task of MSA is to transpose the EU legislation related to Metrology and Pre-packaging. The scope of legal metrology has still to be defined and industrial metrology is not yet existing in Malta. Some limited measurement capacity is available within the University but there is no traceability to the SI. Before the start of this project, in order to get acquainted with the organisation and functioning of a metrology service, the director is likely to benefit from a placement to a EUROMET member through TAIEX or on own MSA funds. Staff will then be recruited and trained whilst procedures and internal rules need to be drafted and put into place. Accreditation: The law creating this directorate is not yet in place. Neither a national Accreditation scheme is designed nor a responsible person appointed. The design of the Accreditation Directorate and the drafting of the launching business plan will be done by the directors for standardisation and for metrology upon their return from their respective placements. The project is intended to cover the gaps and needs identified in these areas, so as to meet the priorities defined in the Accession Partnership and in the NPAA STRATEGY Accreditation As a first step, it is intended that the draft Legal Notice (secondary legislation) to be issued by virtue of the MSA Act (cap 419) will be reviewed by an external expert (TAIEX) and aligned with the EA requirements to National Accreditation Bodies. The new legal framework will provide for the necessary "firewalls" to ensure the independence of Accreditation towards MSA's other activities and directorates. This will happen in the first quarter of The strategy of MSA is to set up a national accreditation scheme that: a) meets the requirements for EA full membership by 2003; b) meets the needs of the (limited) local market. An assessor will be trained to become lead assessor and a quality manual will be developed (with the support of the project). In parallel MSA will rely on co-operation with EA members for provision of technical auditors in the performance of accreditation. Project Fiche - National Pre-Accession Programme Malta 5

6 In a first phase, accreditation activities will be focussed on the (mainly product testing) Maltese laboratories. Then, following the development within EA (MLAs), accreditation of service certification bodies could be envisaged, as well as EMAS certification, which are both of certain importance for the tourism sector in Malta. Accreditation of inspection bodies within the regulated area can also be aimed at, as soon as the relevant EA-MLA is in place Metrology MSA strategy is to set up national metrology services: a) to serve the immediate needs of the Maltese industry; b) to meet the requirements of the acquis (pre-packaging, coming measuring instruments directive). Legal aspect: the Act will be enacted by the Parliament by the second quarter of 2001 establishing the metrology directorate under the aegis of MSA (see draft appended to the project fiche). This act will supersede the Weight and Measures Ordinance. It will allow the minimum requirements for measuring equipment and procedures. Organisational aspect: MSA will be the only metrology institute in Malta, covering both scientific (incl. industrial) and legal metrology and replace the existing Weight and Measure Inspectorate. The Directorate will work closely with the national accreditation body, in accrediting laboratories, and inspection bodies in accordance with EN17025 criteria. The Metrology Directorate in conformity with current prevention philosophy in the field of Legal Metrology will ensure that the measuring equipment used is adequate, regularly tested, and that instrument verification is traceable always, through the use of European Regional Metrological Organisations, to the International System of Units. The Metrology Directorate will develop in line with prevailing thinking to become knowledge intensive rather than an instrument intensive metrology centre. The development of a minimum laboratory framework will give Malta the capacity to build its measurement competency knowledge base. The Metrology Directorate will ensure the availability and maintenance of the highest national standards to assist in the calibration of transfer and work standards from third party calibration laboratories, and sustain all prerequisites for the fulfilment of the Legal Metrology Directives. The Metrology Directorate intends setting up of a number of laboratories namely: mass laboratory dimensional laboratory electricity laboratory pre-packaging control/stationary volume lab temperature laboratory Project Fiche - National Pre-Accession Programme Malta 6

7 At the onset of Legal Metrology in Malta focus will be placed on the implementation of the mandatory reverification of weighing systems and the periods of reverification will be set by notification through Legal notice. Regarding Legal Metrology, MSA will remain the Maltese authority in that area and it is envisaged to subcontract the actual verification of the limited number of instruments (taximeters, fuel dispensers, exhaust gas, speedometers, etc.) to a competent (and accredited) EU organisation, as this is done in France for example Certification Certification will be developed outside MSA Activities Since this project is essentially dedicated to capacity building, the activities will aim at supporting MSA by strengthening each directorate. The activities will be listed accordingly to the organisational chart of the MSA. Due to its central role in the administration of Community technical assistance programmes in the area of standards and certification, it has been decided to use CEN expertise to co-ordinate the project Central Administration MSA is to appoint legal advice capacity to support the technical activities of the directorates and of the experts groups. MSA is to appoint a database manager to design and set up all databases required for the functioning of all directorates (i.e. standardisation and accreditation in particular). MSA is to ensure adequate IT support (HW, SW and website maintenance). The director and the database manager will visit CEN and CENELEC and a national standardisation body in order to ensure the full compatibility between the IT systems used and get acquainted with the incoming e-cen. In addition, MSA technical staff will attend relevant European events (i.e. conferences, workshops, technical committees, etc.) organised by European organisations (i.e. EOTC, EA, CEN-CENELEC-ETSI, EUROLAB, EUROMET, WELMEC, CEOC, EOQ, etc.). The participation of MSA staff to such events will allow their exposure to the functioning of European organisations and facilitate the networking Standardisation MSA is to appoint two junior technical staff to support the director. Advice will be provided with visit of experts to Malta and familiarisation visits of MSA staff to the national members of CEN-CENELEC. This will provide support in the drafting and put into place of all procedures enabling MSA to face the duties and responsibilities of a CEN-CENELEC national member like the set up of technical committees, procedures for the notification (according to the directive 98/34/EC modified Project Fiche - National Pre-Accession Programme Malta 7

8 by 98/48/EC), public enquiry, formal votes, stand-still, etc as well as a thorough review of the internal MSA s Council procedures. The expert of the national CEN-CENELEC member will assist in compiling the application dossier for the membership of MSA in such European standardisation bodies. Advice will also be provided in the marketing of standards and normative documents and awareness raising campaign targeted to the different actors in the Maltese economy (industry, chamber of commerce, governmental officials, etc.) Consumer and Industrial Goods MSA is to appoint one junior technical staff. Advice will be provided for the implementation of the directives on motor vehicles and a needs assessment study for the creation of a Maltese type approval. The project will support MSA in the organisation and realisation of awareness seminars targeted to economic operators, market surveillance authorities, customs officials, in the following areas: Toys, CPD, LVD-EMC-MD, Medical Devices, Lifts, RTTE, motor vehicles. To support MSA in its advisory role towards manufacturers, a pilot project will be organised for a Maltese company in the field of lifts to achieve the CE marking. To support MSA in its advisory role towards the government, close links should be established with an EU national authority having access to the RAPEX. Unless satisfactorily realised by the Market Surveillance project (MT ) a provision will be made for training of market surveillance inspectors and customs inspectors in some specialised areas dealt within the directorate Food, chemicals and cosmetics MSA is to appoint one junior technical staff. The project will support MSA in the organisation and realisation of awareness seminars targeted to economic operators, market surveillance authorities, and customs officials, in the areas of cosmetics and foodstuff (legislation and HACCP). Assistance will be provided in the drafting of 8 hygiene guides based on HACCP: - Catering and hospitality; - Food manufacturing (non-animal origins); - Retail and Wholesale outlets; - Mobile stalls; - Butchers; - Bakers and confectioners; - Outside caterers; - Canteens, cafeterias and self service outlets. These guides are deemed to be adopted as national standards. Training will be provided to the directorate on setting up a risk assessment structure. Project Fiche - National Pre-Accession Programme Malta 8

9 Advice will be provided to the experts groups supporting this directorate in cosmetology, more specifically on the classification of borderline products, also by establishing closer links with the relevant European organisation, COLIPA. Unless satisfactorily realised by the Market Surveillance project (MT ) a provision will be made for training of market surveillance inspectors and customs inspectors in cosmetics and foodstuff Metrology MSA is to appoint the necessary technical staff. MSA will be equipped with the basic measurement equipment in mass, length and electricity (and volume). Expert s advice will be provided to: evaluate the possibility of installing the above mentioned equipment in the existing building and specify the necessary physical and architectural refurbishment; draft the technical specification for the purchase of national standards and measurement devices; hands-on training for the use and maintenance of such equipment. Training will be provided in uncertainty calculation and in the proper realisation of measurements in the above mentioned fields. Advice will be provided in the day-to-day management of a national metrology service through expertise from a comparable national metrology institute. By the end of the project, an EA Member should accredit the calibration laboratories Accreditation After the placements of the directors for standardisation and for metrology (see above), the Directorates management committee will define the future structure of the accreditation directorate and draft the initial business plan. A quality system engineer will be appointed by MSA. Quality Auditor training will be provided in order to allow him/her to design and set up a quality system in all directorates of MSA, and especially in the accreditation directorate. In order to ensure membership of MSA in EA, short-term advice will be provided as and when required accompanying MSA along the 30 steps for setting up a national accreditation body. EA representatives have designed this route map for the same purpose in central European countries. Towards the end of the project, a joint accreditation should be envisaged. For future development, support will be provided to build capacities and competencies for accreditation in following (EA MLA) domains: EMS, Quality Systems. Project Fiche - National Pre-Accession Programme Malta 9

10 Other general activities As MSA is the Notification point according to the directive 98/34/EC as modified, advice will be provided in order to structure and monitor the information flow among the government and within MSA. To support the MSA in this regard, close links should be established with an EU national notification authority. A feasibility study will be conducted with the purpose of setting up a National Quality Award according to the EFQM model mainly oriented to services. A feasibility study will be conducted with the purpose of setting up a national certification scheme. Project Fiche - National Pre-Accession Programme Malta 10

11 Table of activities Organisational Unit Pre-project activities EU Funded Project Activities Training Technical Assistance Study Visits Equipment National Contribution Malta Standards Authority Malta to sign the WTO agreement on standards Malta to become signatory to the Meter Convention To structure and monitor the information flow among the government and MSA with regard to 98/34 EC as modified. To establish close links with an EU national notification authority. To conduct a feasibility study for setting up a national quality award To conduct a feasibility for setting up a national certification scheme Central Administration Appoint and train on the job clerical / administrative staff CEN overall coordination and management The director and the database manager visit CEN and CENELEC and a national standardisation body Appoint Legal Advisor Appoint Database manager Management of a fund for participation of the Directorates staff in European Events Project Fiche - National Pre-Accession Programme Malta 11

12 Organisational Unit Pre-project activities EU Funded Project Activities Training Technical Assistance Study Visits Equipment National Contribution Standardisation Placement of the Director in comparable CEN/CENELEC National Member or receive advice from such an organisation marketing of standards and related services raising awareness on the use of standards among economic operators and public authorities Tutoring/mentoring arrangement with a CEN/CENELEC Member to install and advise in all functions and procedures of a national standardisation body To assist in the preparation of the application for full membership in CEN and CENELEC Appoint two junior technical staff Metrology Placement of the Director in comparable EUROMET member or receive advice from such an organisation Training in uncertainty calculation Training in realising basic measurements Draft technical specifications for the purchase of equipment Draft architectural specifications for the laboratories Accreditation of the calibration laboratories through an EA Member Purchase measurement and calibration devices in mass, length, electricity (and volume) Appoint necessary technical staff Tutoring/mentoring arrangement with a EUROMET Member to install and advise in all functions and procedures of a national metrology institute To assist in the preparation of the application for full membership in EUROMET Project Fiche - National Pre-Accession Programme Malta 12

13 Organisational Unit Pre-project activities EU Funded Project Activities Training Technical Assistance Study Visits Equipment National Contribution Accreditation Directorates Management Committee to define the scope and structure of the accreditation directorate and its initial business plan Training of a quality system auditor To set up a national accreditation body (EA route Map) To install and advise in all functions and procedures of a national accreditation body Appoint a quality system engineer To assist in the preparation of the application for full membership in EA To build a repository of technical auditors Consumers and Industrial Goods MSA to set up and launch the work of seven technical committees (expert groups) To train market surveillance and customs inspectors Together with MSA, organise and perform training of economic operators, market surveillance authorities, customs officials in Toys,CPD,LVD- EMC-MD, Medical Devices, Lifts, RTTE, Motor Vehicles To advise in the transposition of Motor Vehicle Directives To assess the needs for a national type approval To support a pilot certification scheme in the field of lifts To establish working relations with a Member State authority in the RAPEX system To appoint a junior technical staff Project Fiche - National Pre-Accession Programme Malta 13

14 Organisational Unit Pre-project activities EU Funded Project Activities Training Technical Assistance Study Visits Equipment National Contribution Foodstuffs, Chemicals and Cosmetics MSA to set up and launch the work of four technical committees (expert groups) To train market surveillance and customs inspectors (foodstuffs and cosmetics) Together with MSA, organise and perform training of economic operators, market surveillance authorities, customs officials in cosmetics and foodstuffs (legislation and HACCP) To assist in setting up a risk assessment system To assist in drafting 8 hygiene guides likely to become national standards To provide advice in the classification of borderline products and cosmetology To appoint one junior technical staff Project Fiche - National Pre-Accession Programme Malta 14

15 3.4. Linked activities Initial Activities In the course of 2001 MSA will finalise the draft of the necessary legal framework (acts on, accreditation and metrology) and pass it to the Parliament. The Technical Committees (experts groups) providing technical advice to the directorates responsible for Consumer and Industrial Goods and for Foodstuffs, Chemicals and Cosmetics of MSA will be set up and their respective members appointed. It is expected that they will be operational by the beginning of the project. In order to alleviate the directors of MSA of their administrative workload, MSA has committed itself to the recruitment of adequate administrative staff. This staff will be trained and fully operational before the start of the project activities Standardisation Malta will sign the WTO Agreement on standards. In the course of 2001, before the start of the project, the Director of the Standardisation Directorate will be attached for a period of two to three weeks to the STRI, the Icelandic standardisation body. This will be financed either by TAIEX or by own funds. Prearrangements have been made during the project identification phase. Should this placement not be possible, MSA has committed itself to invite an Icelandic expert to Malta. The expected result of this placement/visit is a draft business plan for the functional organisation of standardisation activities within MSA and a detailed job description of the junior technical staff to be recruited Metrology Malta will become signatory of the Meter Convention. In the course of 2001, before the start of the project, the Metrology Co-ordinator will be attached for a period of two to three weeks to DFM, the Danish Institute for Fundamental Metrology. This will be financed either by TAIEX or by own funds. Pre-arrangements have been made during the project identification phase and the placement should take place in February-March The expected result of this placement/visit is a draft business plan for the functional organisation of metrology activities within MSA and a detailed job description of the technical staff to be recruited Accreditation During the identification mission, the draft Accreditation law has revealed not to be in conformity with EA requirements. It will be submitted for evaluation to an accreditation expert who will then be invited by MSA in order to assist them in redrafting this piece of legislation. This will be financed either by TAIEX or by own funds. Pre-arrangements have been made during the project identification phase. After the placements mentioned above, the directorates management committee will draft a business plan to set up the Accreditation directorate. Project Fiche - National Pre-Accession Programme Malta 15

16 3.5. Results MSA. At the end of the project, MSA is the recognised quality reference point of Malta. MSA will have completed membership in European standardisation bodies. Standardisation The Standardisation directorate is able to cope with the responsibilities and duties of a CEN-CENELEC-ETSI national member and It is able to promote the use of voluntary standards among the economic operators and government authorities. Consumer and Industrial Goods and for Foodstuffs, Chemicals and Cosmetics The directorates for Consumer and Industrial Goods and for Foodstuffs, Chemicals and Cosmetics have drafted the relevant legal acts transposing the Acquis in their remits They are able to provide the necessary technical advice to the government in relation to the adoption of the acquis and to the economic operators in relation to the implementation of the acquis a pilot project will be organised for a Maltese company in the field of lifts to achieve the CE marking The drafting of 8 hygiene guides in the areas identified in (based on HACCP) will be completed The directorate will have set up a risk assessment structure Awareness seminars targeted to economic operators, market surveillance authorities, and customs officials, in the areas of Consumer & Industrial Goods as well as cosmetics and foodstuff will be realised. Metrology Staff will be trained in uncertainty calculation. Staff will be trained in realising basic measurements. Accreditation of the calibration laboratories through an EA Member will be achieved. Measurement and calibration devices in mass, length, volume, electricity purchased and installed. Tutoring/mentoring arrangement with an EUROMET Member to install and advice in all functions and procedures and management of a national metrology institute. Full membership in EUROMET (funding participation in intercomparisons). Accreditation Quality system auditor trained. Project Fiche - National Pre-Accession Programme Malta 16

17 National accreditation body installed (EA route Map). Full membership in EA. A repository of technical auditors installed. 4. INSTITUTIONAL FRAMEWORK MSA (Malta Standards Authority) will be the immediate beneficiary of the project and will therefore be involved in its technical implementation. Because of the size of the country, and the related limited technical resources, MSA acts as the technical arm of the Ministry for Economic Services, that retains the policy making, and hosts the operators of the national quality infrastructure while ensuring sufficient functional independence to each directorate. Similar structure can be found in some member States. 5. BUDGET Budget year 2000 Implementation start 2001 Type of activities EU funding Malta funding* Total 1. Technical Assistance 430,000 8, , Training 420, , , Equipment 500, , , Others** 0 272, ,000 TOTAL 1,350, ,000 1,830,000 * These funds are foreseen under the 2001 budget. More funds may be committed for the project by the Maltese government in the coming years however this cannot be shown since the Maltese budgetary system commits and disburses in the same year. ** Transposition of EU Directives, Memberships, Standards Agreement and installation of software for Notification Procedures. 6. IMPLEMENTATION ARRANGEMENTS 6.1. Implementing Agency The overall implementing authority will be the Malta Standards Authority. Address of the beneficiary: MSA Evans Buildings, 2 nd floor, Merchants St., Valletta VTL 03 Tel Project Fiche - National Pre-Accession Programme Malta 17

18 6.2. Overall Management In view of CEN competencies and the assistance it delivered to Malta, it is suggested to entrust it with the overall coordination and management of the project. CEN will provide a Project Leader with the following required qualifications: At least five years of experience in an advisory capacity in the field of legal approximation and alignment of quality infrastructure, preferably gained in the EU accession countries Full familiarity with EU technical regulations (old approach, new approach) Full familiarity and working links with relevant European Organisations (CEN, CENELEC, ETSI, EA, EUROMET, EOTC, CEOC, EOTA, EUROLAB, EOQ, EFQM, etc.). Ability to draft Terms of Reference and manage short-term technical assistance missions. CEN will also provide a pool of on-call legal and technical experts available on a retainer basis Other arrangements The purchase of equipment for the metrology laboratories will be done under the supervision of a technical advisor recruited by the project co-ordinator to support the metrology directorate. The contract for services, works and supplies shall be concluded in accordance with the contract award procedures laid down in the Practical guide to EC external aid contract procedures. Implementation Schedule: Start of Tendering: June/July 2001 (issue of tenders) Start of Project Activity: October 2001 Project completion: December EQUAL OPPORTUNITY The Malta Standards Authority is an equal opportunity employer. 8. ENVIRONMENT The project in itself has no major impact on the environment, but the further development of accreditation in the field of EMS will have a positive effect on the environment. Project Fiche - National Pre-Accession Programme Malta 18

19 9. CONDITIONALITY AND SEQUENCING The legal Metrology Act must be adopted before the funds for investments in Metrology are released. The Malta Standards Authority must assume adequate staff for the completion of the activities aforementioned. Annexes I. Logframe planning matrix II. Cost breakdown III. Summary detailed time implementation chart for the project IV. Cumulative contracting and disbursement schedule of EU funding V. List of Relevant (draft) - Laws and Regulations Project Fiche - National Pre-Accession Programme Malta 19

20 Annex I LOGFRAME PLANNING MATRIX Capacity Building at the Malta Standards Authority Programme name: and number: Contracting period expires: October 1, 2003 Date of drafting: Disbursement period expires: October 1, 2004 Project Number: Total Budget : EU contribution : Wider Objectives Indicators of Achievement Source of Verification Assumptions and Risks To establish MSA as the focal point for quality issues in Malta and to establish the quality infrastructure required by the transposition of the new and global approach in the areas of standardisation, accreditation and metrology i MSA is full member in CEN MS is full member in CENELEC Minutes of the General Assembly Minutes of the General Assembly Respective web sites Malta signs the WTO Code on Standards Malta signs the WTO Code on Standards Project Fiche - National Pre-Accession Programme Malta 20

21 Immediate Objectives Indicators of Achievement Source of Verification Assumptions and Risks To have an efficient data management system in place in MSA. To create and operate a notification point within MSA as per directive 98/34/EC as modified. Draft standards are regularly notified to CEN and CENELEC Draft regulations are regularly notified to the Commission CEN and CENELEC Databases DG Enterprise Full commitment of managerial staff of ministries departments and of other authorities MSA comments on time documents submitted MSA through its directorates on Consumer and Industrial Goods and on Foodstuff is able to provide the necessary legal and technical advice to the government and to the economic operators Number of information seminars realised MSAtoopenanInfoDesk All directives mentioned in Chapter Two of the White paper are transposed. Relevant chapters are closed during negotiations Full commitment of managerial staff of ministries departments and of other authorities Standardisation: to set up the organisation structure of the directorate so as to establish an operational base that would be capable of supporting all the functions of a national standardisation body Various units within the organisational structure in place. Training and ongoing support plan operational MSA produces national standards CEN Databases Official gazette Availability of adequate resources especially human ENs transposed on time Accreditation: to set up the organisation structure of the directorate so as to establish an operational base that would be capable of supporting all the functions of a national accreditation body Various units within the organisational structure in place. Training and ongoing support plan operational Accreditations are carried out Departmental Management reports and available statistics Adequate resource (external and internal) availability. MSA is member in EA MSA is signatory to the MLA for Certification (quality systems) Minutes of the General Assembly EA Web site Project Fiche - National Pre-Accession Programme Malta 21

22 Metrology: to set up the organisation structure of the directorate so as to establish an operational base that would be capable of supporting all the functions of a national metrology institute Various units within the organisational structure in place. Training and ongoing support plan operational Calibrations are performed Departmental Management reports and available statistics Adequate resource (external and internal) availability. Ability to select and recruit appropriates experts. Verifications are carried out MSA is Member in EUROMET MSA participates in EUROMET relevant laboratory intercomparisons Minutes of the General Assembly EUROMET Web site Project Fiche - National Pre-Accession Programme Malta 22

23 Cost Breakdown in EURO Annex II To be financed by EU TECHNICAL ASSISTANCE MSA Central Administration Standards Consumer and Industrial Goods Food, Chemicals and Cosmetics 40, ,000 65, , ,500 METROLOGY Institutional building Equipment 150, ,000 ACCREDITATION 70,000 Total Amount 1,350,000 Project Fiche - National Pre-Accession Programme Malta 23

24 Annex III SUMMARY DETAILED TIME IMPLEMENTATION CHART FOR THE PROJECT Title: COMPONENT M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D Pre project activities Sign WTO code Sign Meter Convention Appoint clerical staff Appoint DB Manager Appoint Quality Engineer Appoint junior technical staff Placements MSA D D C C I I I I I I I I I X X Central Administration D D C C I I I I I I I I I I I I I I I I I I I I I x x Standards D D C C I I I I I I I I I I I I I I I I I I I I I x x Metrology D D C C I I I I I I I I I I I I I I I I I I I I I x x Accreditation D D C C I I I I I I I I I I I I I I I I I I I I I x x Consumer goods D D C C I I I I I I I I I I I I I I I I I I I I I x x Foodstuffs. Cosmetics D D C C I I I I I I I I I I I I I I I I I I I I I x x D=Design C = Contracting I = Implementation X = Closure Project Fiche - National Pre-Accession Programme Malta 24

25 Annex IV CUMULATIVE CONTRACTING AND DISBURSEMENT SCHEDULE OF EU FUNDING Title: All figures in million Euro 01/12/ /03/ /06/ /09/ /12/ /06/ /12/2003 CONTRACTED 1,350 DISBURSED ,350 Project Fiche - National Pre-Accession Programme Malta 25

26 Annex V List of Relevant (draft) Laws and Regulations 1. Malta Standards Authority Act XIX of Malta Standards Authority Act XIX of 2000; Order establishing the Foodstuffs, Chemicals and Cosmetics Directorate within the Malta Standards Authority 3. Malta Standards Authority Act XIX of 2000; Order establishing the Consumer and Industrial Goods Directorate within the Malta Standards Authority 4. Malta Standards Authority Act XIX of 2000; Order establishing the Standardisation Directorate within the Malta Standards Authority 5. Draft Accreditation Act 6. Draft General Product Safety Act 7. Draft Metrology Act Project Fiche - National Pre-Accession Programme Malta 26