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Capacity Building at Malta Standards Authority Project Fiche - National Pre-Accession Programme 2001 - Malta 1 STANDARD SUMMARY PROJECT FICHE ________________________________ 1. BASIC INFORMATION 1.1. Désirée number: MT-01-04 1.2. 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. 2.2. 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

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Page 1: STANDARD SUMMARY PROJECT FICHE · national metrology service, in particular a metrology infrastructure catering for the major needs of the Maltese economy and government and operated

Capacity Building at Malta Standards AuthorityProject Fiche - National Pre-Accession Programme 2001 - Malta 1

STANDARD SUMMARY PROJECT FICHE

________________________________

1. BASIC I NFORMATION

1.1. Désirée number: MT-01-04

1.2. 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 thequality infrastructure required by the transposition of the new and global approachin the areas of standardisation, accreditation and metrology.

2.2. 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 asmodified.

MSA through its directorates on Consumer and Industrial Goods and on Foodstuff,Chemicals and Cosmetics should be able to provide the necessary legal andtechnical advice to the government and to the economic operators.

Standardisation: to set up the organisational structure of the directorate so as toestablish an operational base that would be capable of executing all the functionsof a national standardisation body, in particular to carry out standardisationactivities in conformity with the WTO agreement and the requirements of CENand CENELEC.

Accreditation: to set up the organisation structure of the directorate so as toestablish an operational base that would be capable of supporting all the functionsof a national accreditation body, in particular to carry out accreditation activitiesadequate to the needs of the Maltese economy and in conformity with therequirements of the European co-operation for Accreditation (EA)

Metrology: to set up the organisation structure of the directorate so as to establishan operational base that would be capable of supporting all the functions of a

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national metrology service, in particular a metrology infrastructure catering for themajor needs of the Maltese economy and government and operated according toEuropean practices.

2.3. Accession Partnership and NPAA priority

2.3.1. Accession Partnership

• § 3.1 Short-term priorities / Internal Market / Free movement of goods:align civil and consumer policy legislation with the product liability directive byproviding rules on the manufacturer liability.

• § 3.2 Medium term priorities / Internal Market / Free movement of goods:ensure sufficient independence of standardisation, certification, accreditationand metrology bodies and finalise overall institutional arrangements.

2.3.2. DRAFT NPAA

Short Term Priorities (2000)Internal market - Free Movement of Goods, Par. III Pag. 45 -46

Enforce framework legislation, continue with transposition of New Approachdirectives and alignment of technical legislation,carry out awareness campaigns inthe areas of consumer and industrial goods falling under the New Approach andfood 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. 46 -48

Complete the adoption of sector legislation and the alignment of EN standards,ensure proper implementing structures for all sectors, establish a marketsurveillance 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 inMalta. Since the MSA’s mandate - besides being the national standards bodyentrusted to adopt, publish and disseminate voluntary standards - was very muchbroader and included related standardisation activities such as technical advise,notification of standards and regulations (the 98/34/EC notification point) and co-ordinating testing, certification, accreditation, market surveillance and metrologyactivities in Malta, the founding Cap 187 was repealed by the new Malta Standards

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Authority Act (Act XIX of 2000) approved by Parliament on 18 July 2000. Asindicated in the Operations Review conducted within the Ministry for EconomicServices (MES), through a system of Directorates, namely Certification,Metrology, and Accreditation (to be established later on during 2001) and throughthe three already established Directorates namely Standardisation, Consumer andIndustrial Goods and that covering Foodstuffs, Chemicals and Cosmetics, theMSA is ensuring the functional separation of the various roles in the sense that thevarious arms of the Authority will be independent of each other as regards thedecisions they take as well as financially. Co-ordination is assured through the linkof each arm with the central organisation (Council through CEO) but each divisionwill remain technically and financially independent.

Currently, active consideration is being given towards the effective resourcing ofthe Authority and the unfolding of its mandate. In this respect, the MSA hasembarked on a result-oriented project, consisting of several components, which areconsidered to be the cornerstone of the Free Movement of Goods principle.

MSA organigramme as a result of the ongoing re-organisation:

Central Administration

98/34/EC Notification SystemManagement Committee

Accreditation Services (Legal) Metrology(Accredited to EN 45000)

Standardisation

Technical Committees

Consumer and Industrial Goods

Technical Committees

Foodstuffs, Chemicals & Cosmetics

DirectoratesManagement Committee

Chairman

Malta Standards Authority

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Organigramme showing pictorially the separation of roles (Risk Assessment – MSA, RiskManagement – Consumer and Competition Division and System Audit – Market SurveillanceDirectorate within the Economic Policy Division):

Central Administration: ensures the corporate functions of the Authority, will need to bestrengthened with a legal advisor specialised in EU legislation and a database manager.

Directorates: Each directorate is legally rooted in a specific legal act. Although operatingunder the same umbrella, and subject to further examination, the legislation drafted oralready in place seems to ensure sufficient functional independence to the variousdirectorates. Nevertheless the draft act on accreditation has to be reviewed before it ispassed to the parliament. The operation of accreditation and certification services underthe same umbrella (MSA) may not satisfy the international requirements of impartialityand independence. The creation of the directorate for certification services is hencepostponed.

Directorate for Foodstuffs, Chemicals & Cosmetics:The directorate is the technicalarm of the government for all matters related to the free movement and safety of productsin its remit. In that capacity they draft the relevant pieces of legislation, advise thegovernmental authority (tax, finances, customs, market surveillance, consumer affairs…)and the economic operators, etc. Advisory groups (experts groups or TechnicalCommittees) will support the directorate. The director has heavily contributed to thedrafting of the Maltese legislation transposing the acquis in this sector.

Directorate for Consumer and Industrial Goods: The directorate is the technical arm ofthe government for all matters related to the free movement and safety of products in itsremit. In that capacity they draft the relevant pieces of legislation, advise the governmentalauthority (tax, finances, customs, market surveillance, consumer affairs…) and theeconomic operators, etc. Advisory groups (experts groups, or Technical Committees) willsupport the directorate. The director has heavily contributed to the drafting of the Malteselegislation transposing the acquis in this sector. The Product Safety Act is underdiscussion in Parliament and will become an umbrella legislation under which all relevantEU 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 largelymet.

Standardisation: MSA is the recognised standardisation body of the Republic of Malta asper act n° XIX of 2000. MSA is member of ISO and IEC as well as ETSI. Presentlyaffiliate member of CEN and CENELEC, they intend to become members as soon as

ADVISORYTechnical Committees

Consumer and Industrial Goods DirectorateMalta Standards Authority(RISK ASSESSMENT)

Market Surveillance Directorate(co-ordination/programming of the efforts of all

surveillance authorities concerned with product control)

(AUDIT)

Economic Policy Division

Consumer Affairs Directorate

(RISK MANAGEMENT)

Consumer and Competition Division

Ministry for Economic Services

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possible. They are negotiating an agreement with BSI for the adoption of all Europeanstandards as national standards (MSA EN xxxx). 5000 EN standards have already beenpublished in the official Gazette. By mid-2001 they expect to have adopted more than80% of all European standards. Only one director manages standardisation activities. Atthe moment MSA is not in a condition to cope with the duties and responsibilities of fullmembership to CEN and CENELEC. A full functioning Standardisation directorate isneeded 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 andfunctioning of a standardisation department, the director is likely to be attached to asimilar CEN member. Staff will then be recruited and trained whilst procedures andinternal rules need to be drafted and put into place.

Metrology: A Metrology co-ordinator has just been appointed, and the legal act setting upthe directorate is still to be adopted by the parliament. Primary task of MSA is totranspose the EU legislation related to Metrology and Pre-packaging. The scope of legalmetrology 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 notraceability to the SI. Before the start of this project, in order to get acquainted with theorganisation and functioning of a metrology service, the director is likely to benefit from aplacement to a EUROMET member through TAIEX or on own MSA funds. Staff willthen be recruited and trained whilst procedures and internal rules need to be drafted andput into place.

Accreditation: The law creating this directorate is not yet in place. Neither a nationalAccreditation scheme is designed nor a responsible person appointed. The design of theAccreditation Directorate and the drafting of the launching business plan will be done bythe directors for standardisation and for metrology upon their return from their respectiveplacements.

The project is intended to cover the gaps and needs identified in these areas, so as to meetthe priorities defined in the Accession Partnership and in the NPAA.

3.2. STRATEGY

3.2.1. Accreditation

As a first step, it is intended that the draft Legal Notice (secondary legislation) to be issuedby virtue of the MSA Act (cap 419) will be reviewed by an external expert (TAIEX) andaligned with the EA requirements to National Accreditation Bodies. The new legalframework will provide for the necessary "firewalls" to ensure the independence ofAccreditation towards MSA's other activities and directorates. This will happen in the firstquarter of 2001.

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 bedeveloped (with the support of the project). In parallel MSA will rely on co-operationwith EA members for provision of technical auditors in the performance of accreditation.

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In a first phase, accreditation activities will be focussed on the (mainly product testing)Maltese laboratories. Then, following the development within EA (MLAs), accreditationof service certification bodies could be envisaged, as well as EMAS certification, whichare both of certain importance for the tourism sector in Malta.

Accreditation of inspection bodies within the regulated area can also be aimed at, as soonas the relevant EA-MLA is in place.

3.2.2. 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 instrumentsdirective).

Legal aspect: the Act will be enacted by the Parliament by the second quarter of 2001establishing the metrology directorate under the aegis of MSA (see draft appended to theproject fiche). This act will supersede the Weight and Measures Ordinance. It will allowthe minimum requirements for measuring equipment and procedures.

Organisational aspect: MSA will be the only metrology institute in Malta, covering bothscientific (incl. industrial) and legal metrology and replace the existing Weight andMeasure Inspectorate. The Directorate will work closely with the national accreditationbody, in accrediting laboratories, and inspection bodies in accordance with EN17025criteria.

The Metrology Directorate in conformity with current prevention philosophy in the fieldof Legal Metrology will ensure that the measuring equipment used is adequate, regularlytested, and that instrument verification is traceable always, through the use of EuropeanRegional Metrological Organisations, to the International System of Units.

The Metrology Directorate will develop in line with prevailing thinking to becomeknowledge intensive rather than an instrument intensive metrology centre. Thedevelopment of a minimum laboratory framework will give Malta the capacity to build itsmeasurement competency knowledge base.

The Metrology Directorate will ensure the availability and maintenance of the highestnational standards to assist in the calibration of transfer and work standards from thirdparty calibration laboratories, and sustain all prerequisites for the fulfilment of the LegalMetrology Directives. The Metrology Directorate intends setting up of a number oflaboratories namely:

• mass laboratory• dimensional laboratory• electricity laboratory• pre-packaging control/stationary volume lab• temperature laboratory

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At the onset of Legal Metrology in Malta focus will be placed on the implementation ofthe mandatory reverification of weighing systems and the periods of reverification will beset by notification through Legal notice.

Regarding Legal Metrology, MSA will remain the Maltese authority in that area and it isenvisaged to subcontract the actual verification of the limited number of instruments(taximeters, fuel dispensers, exhaust gas, speedometers, etc.) to a competent (andaccredited) EU organisation, as this is done in France for example.

3.2.3. Certification

Certification will be developed outside MSA.

3.3. Activities

Since this project is essentially dedicated to capacity building, the activities will aim atsupporting MSA by strengthening each directorate. The activities will be listedaccordingly to the organisational chart of the MSA.

Due to its central role in the administration of Community technical assistanceprogrammes in the area of standards and certification, it has been decided to use CENexpertise to co-ordinate the project.

3.3.1. Central Administration

MSA is to appoint legal advice capacity to support the technical activities of thedirectorates and of the experts’ groups.

MSA is to appoint a database manager to design and set up all databases required for thefunctioning 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 nationalstandardisation body in order to ensure the full compatibility between the IT systems usedand 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 functioningof European organisations and facilitate the networking.

3.3.2. 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 MSAstaff to the national members of CEN-CENELEC. This will provide support in thedrafting and put into place of all procedures enabling MSA to face the duties andresponsibilities of a CEN-CENELEC national member like the set up of technicalcommittees, procedures for the notification (according to the directive 98/34/EC modified

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by 98/48/EC), public enquiry, formal votes, stand-still, etc…as well as a thorough reviewof the internal MSA’s Council procedures.

The expert of the national CEN-CENELEC member will assist in compiling theapplication dossier for the membership of MSA in such European standardisation bodies.Advice will also be provided in the marketing of standards and normative documents andawareness raising campaign targeted to the different actors in the Maltese economy(industry, chamber of commerce, governmental officials, etc.).

3.3.3. 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 aneeds assessment study for the creation of a Maltese type approval.

The project will support MSA in the organisation and realisation of awareness seminarstargeted to economic operators, market surveillance authorities, customs officials, in thefollowing areas: Toys, CPD, LVD-EMC-MD, Medical Devices, Lifts, RTTE, motorvehicles.

To support MSA in its advisory role towards manufacturers, a pilot project will beorganised 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 beestablished with an EU national authority having access to the RAPEX.

Unless satisfactorily realised by the Market Surveillance project (MT 0001.01) a provisionwill be made for training of market surveillance inspectors and customs inspectors insome specialised areas dealt within the directorate.

3.3.4. Food, chemicals and cosmetics

MSA is to appoint one junior technical staff.

The project will support MSA in the organisation and realisation of awareness seminarstargeted to economic operators, market surveillance authorities, and customs officials, inthe 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.

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Advice will be provided to the experts groups supporting this directorate in cosmetology,more specifically on the classification of borderline products, also by establishing closerlinks with the relevant European organisation, COLIPA.

Unless satisfactorily realised by the Market Surveillance project (MT 0001.01) a provisionwill be made for training of market surveillance inspectors and customs inspectors incosmetics and foodstuff.

3.3.5. Metrology

MSA is to appoint the necessary technical staff.

MSA will be equipped with the basic measurement equipment in mass, length andelectricity (and volume).

Expert’s advice will be provided to:

– evaluate the possibility of installing the above mentioned equipment in the existingbuilding and specify the necessary physical and architectural refurbishment;

– draft the technical specification for the purchase of national standards and measurementdevices;

– hands-on training for the use and maintenance of such equipment.

Training will be provided in uncertainty calculation and in the proper realisation ofmeasurements in the above mentioned fields.

Advice will be provided in the day-to-day management of a national metrology servicethrough expertise from a comparable national metrology institute.

By the end of the project, an EA Member should accredit the calibration laboratories.

3.3.6. Accreditation

After the placements of the directors for standardisation and for metrology (see above), theDirectorates management committee will define the future structure of the accreditationdirectorate 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 aquality 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 andwhen required accompanying MSA along the 30 steps for setting up a nationalaccreditation body. EA representatives have designed this “route map” for the samepurpose 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 foraccreditation in following (EA MLA) domains: EMS, Quality Systems.

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3.3.7. Other general activities

As MSA is the Notification point according to the directive 98/34/EC as modified, advicewill be provided in order to structure and monitor the information flow among thegovernment and within MSA. To support the MSA in this regard, close links should beestablished with an EU national notification authority. A feasibility study will beconducted with the purpose of setting up a National Quality Award according to theEFQM model mainly oriented to services.

A feasibility study will be conducted with the purpose of setting up a national certificationscheme.

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Table of activities

EU Funded Project ActivitiesOrganisational Unit Pre-project activities

Training Technical Assistance Study Visits EquipmentNational Contribution

Malta StandardsAuthority

Malta to sign the WTOagreement on standards

Malta to becomesignatory to the MeterConvention

To structure and monitorthe information flowamong the governmentand MSA with regard to98/34 EC as modified.

To establish close linkswith an EU nationalnotification authority.

To conduct a feasibilitystudy for setting up anational quality award

To conduct a feasibilityfor setting up a nationalcertification scheme

CentralAdministration

Appoint and train onthe job clerical /administrative staff

CEN overall co-ordination andmanagement

The director and thedatabase manager visitCEN and CENELECand a nationalstandardisation body

Management of a fundfor participation of theDirectorates’staff inEuropean Events

Appoint Legal Advisor

Appoint Database manager

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EU Funded Project ActivitiesOrganisational Unit Pre-project activities

Training Technical Assistance Study Visits EquipmentNational Contribution

Standardisation Placement of theDirector in comparableCEN/CENELECNational Member orreceive advice fromsuch an organisation

marketing of standardsand related services

raising awareness onthe use of standardsamong economicoperators and publicauthorities

Tutoring/mentoring arrangement with aCEN/CENELEC Member to install and advise in allfunctions and procedures of a nationalstandardisation body

To assist in the preparation of the application forfull membership in CEN and CENELEC

Appoint two junior technical staff

Draft technicalspecifications for thepurchase of equipment

Draft architecturalspecifications for thelaboratories

Accreditation of thecalibration laboratoriesthrough an EA Member

Metrology Placement of theDirector in comparableEUROMET member orreceive advice fromsuch an organisation

Training in uncertaintycalculation

Training in realisingbasic measurements

Tutoring/mentoring arrangement with a EUROMETMember to install and advise in all functions andprocedures of a national metrology institute

To assist in the preparation of the application forfull membership in EUROMET

Purchasemeasurement andcalibrationdevices in mass,length, electricity(and volume)

Appoint necessary technical staff

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EU Funded Project ActivitiesOrganisational Unit Pre-project activities

Training Technical Assistance Study Visits EquipmentNational Contribution

Accreditation DirectoratesManagementCommittee to definethe scope and structureof the accreditationdirectorate and itsinitial business plan

Training of a qualitysystem auditor

To set up a nationalaccreditation body (EAroute Map)

To install and advise inall functions andprocedures of a nationalaccreditation body

To assist in thepreparation of theapplication for fullmembership in EA

To build a repository oftechnical auditors

Appoint a quality system engineer

Consumers andIndustrial Goods

MSA to set up andlaunch the work ofseven technicalcommittees (expertgroups)

To train marketsurveillance andcustoms inspectors

Together with MSA,organise and performtraining of economicoperators, marketsurveillance authorities,customs officials inToys, CPD, LVD-EMC-MD, MedicalDevices, Lifts, RTTE,Motor Vehicles

To advise in thetransposition of MotorVehicle Directives

To assess the needs for anational type approval

To support a pilotcertification scheme inthe field of lifts

To establish workingrelations with a MemberState authority in theRAPEX system

To appoint a junior technical staff

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EU Funded Project ActivitiesOrganisational Unit Pre-project activities

Training Technical Assistance Study Visits EquipmentNational Contribution

Foodstuffs,Chemicals andCosmetics

MSA to set up andlaunch the work of fourtechnical committees(expert groups)

To train marketsurveillance andcustoms inspectors(foodstuffs andcosmetics)

Together with MSA,organise and performtraining of economicoperators, marketsurveillance authorities,customs officials incosmetics andfoodstuffs (legislationand HACCP)

To assist in setting up arisk assessment system

To assist in drafting 8hygiene guides likely tobecome nationalstandards

To provide advice in theclassification ofborderline products andcosmetology

To appoint one junior technicalstaff

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3.4. Linked activities

3.4.1. Initial Activities

In the course of 2001 MSA will finalise the draft of the necessary legal framework (actson, accreditation and metrology) and pass it to the Parliament.

The Technical Committees (experts’ groups) providing technical advice to the directoratesresponsible for Consumer and Industrial Goods and for Foodstuffs, Chemicals andCosmetics of MSA will be set up and their respective members appointed. It is expectedthat they will be operational by the beginning of the project.

In order to alleviate the directors of MSA of their administrative workload, MSA hascommitted itself to the recruitment of adequate administrative staff. This staff will betrained and fully operational before the start of the project activities.

3.4.2. Standardisation

Malta will sign the WTO Agreement on standards.

In the course of 2001, before the start of the project, the Director of the StandardisationDirectorate will be attached for a period of two to three weeks to the STRI, the Icelandicstandardisation body. This will be financed either by TAIEX or by own funds. Pre-arrangements have been made during the project identification phase. Should thisplacement not be possible, MSA has committed itself to invite an Icelandic expert toMalta. The expected result of this placement/visit is a draft business plan for thefunctional organisation of standardisation activities within MSA and a detailed jobdescription of the junior technical staff to be recruited.

3.4.3. 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 beattached for a period of two to three weeks to DFM, the Danish Institute for FundamentalMetrology. This will be financed either by TAIEX or by own funds. Pre-arrangementshave been made during the project identification phase and the placement should takeplace in February-March 2001. The expected result of this placement/visit is a draftbusiness plan for the functional organisation of metrology activities within MSA and adetailed job description of the technical staff to be recruited.

3.4.4. Accreditation

During the identification mission, the draft Accreditation law has revealed not to be inconformity with EA requirements. It will be submitted for evaluation to an accreditationexpert who will then be invited by MSA in order to assist them in redrafting this piece oflegislation. This will be financed either by TAIEX or by own funds. Pre-arrangementshave been made during the project identification phase.

After the placements mentioned above, the directorates management committee will drafta business plan to set up the Accreditation directorate.

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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 aCEN-CENELEC-ETSI national member and

– It is able to promote the use of voluntary standards among the economic operators andgovernment authorities.

Consumer and Industrial Goods and for Foodstuffs, Chemicals and Cosmetics

– The directorates for Consumer and Industrial Goods and for Foodstuffs, Chemicals andCosmetics 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 tothe adoption of the acquis and to the economic operators in relation to theimplementation of the acquis

– a pilot project will be organised for a Maltese company in the field of lifts to achievethe CE marking

– The drafting of 8 hygiene guides in the areas identified in 3.3.4 (based on HACCP) willbe 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 ascosmetics 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 purchasedand installed.

– Tutoring/mentoring arrangement with an EUROMET Member to install and advice inall functions and procedures and management of a national metrology institute.

– Full membership in EUROMET (funding participation in intercomparisons).

Accreditation

– Quality system auditor trained.

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– 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 andwill therefore be involved in its technical implementation.

Because of the size of the country, and the related limited technical resources, MSA actsas 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 sufficientfunctional independence to each directorate. Similar structure can be found in somemember States.

5. BUDGET

Budget year 2000 – Implementation start 2001

Type of activities EU funding Malta funding* Total

1. Technical Assistance 430,000 8,000 438,000

2. Training 420,000 100,000 520,000

3. Equipment 500,000 100,000 600,000

4. Others** 0 272,000 272,000

TOTAL 1,350,000 480,000 1,830,000

* These funds are foreseen under the 2001 budget. More funds may be committed for the project by the Maltese government in thecoming 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:

MSAEvans Buildings, 2nd floor, Merchants St., Valletta VTL 03Tel. +356 242420

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6.2. Overall Management

In view of CEN competencies and the assistance it delivered to Malta, it is suggested toentrust 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 legalapproximation and alignment of quality infrastructure, preferably gained in the EUaccession 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 assistancemissions.

CEN will also provide a pool of on-call legal and technical experts available on a retainerbasis.

6.3. Other arrangements

The purchase of equipment for the metrology laboratories will be done under thesupervision of a technical advisor recruited by the project co-ordinator to support themetrology directorate.

The contract for services, works and supplies shall be concluded in accordance with thecontract award procedures laid down in the “Practical guide to EC external aid contractprocedures”.

Implementation Schedule:

Start of Tendering: June/July 2001 (issue of tenders)

Start of Project Activity: October 2001

Project completion: December 2003

7. 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 developmentof accreditation in the field of EMS will have a positive effect on the environment.

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9. CONDITIONALITY AND SEQUENCING

The legal Metrology Act must be adopted before the funds for investments in Metrologyare released.

The Malta Standards Authority must assume adequate staff for the completion of theactivities aforementioned.

Annexes

I. Logframe planning matrixII. Cost breakdownIII. Summary detailedtime implementation chart for the projectIV. Cumulative contracting and disbursement schedule of EU fundingV. List of Relevant (draft) - Laws and Regulations

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Annex I

LOGFRAME PLANNING MATRIXProgramme name:

and number:

Date of drafting:

Capacity Building at the Malta Standards AuthorityContracting period expires:

October 1, 2003

Disbursement period expires:

October 1, 2004

Project Number: Total Budget 2001-2003: EU contribution 2000-2002:

Wider Objectives Indicators of Achievement Source of Verification Assumptions and Risks

To establish MSA as the focal point for qualityissues in Malta and to establish the qualityinfrastructure required by the transposition of thenew and global approach in the areas ofstandardisation, accreditation and metrology i

• MSA is full member in CEN

• MS is full member in CENELEC

• Minutes of the GeneralAssembly

• Minutes of the GeneralAssembly

• Respective web sites

• Malta signs the WTO Codeon Standards

• Malta signs the WTO Codeon Standards

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Immediate Objectives Indicators of Achievement Source of Verification Assumptions and Risks

To have an efficient data management system inplace in MSA.

To create and operate a notification point withinMSA as per directive 98/34/EC as modified.

• Draft standards are regularly notified to CENand CENELEC

• Draft regulations are regularly notified to theCommission

• MSA comments on time documents submitted

• CEN and CENELEC Databases

• DG Enterprise

• Full commitment ofmanagerial staff ofministries’ departments andof other authorities

MSA through its directorates on Consumer andIndustrial Goods and on Foodstuff is able toprovide the necessary legal and technical advice tothe government and to the economic operators

• Number of information seminars realised

• MSA to open an Info Desk

• All directives mentioned in Chapter Two of theWhite paper are transposed.

• Relevant chapters are closedduring negotiations

• Full commitment ofmanagerial staff ofministries’ departments andof other authorities

Standardisation: to set up the organisation structureof the directorate so as to establish an operationalbase that would be capable of supporting all thefunctions of a national standardisation body

• Various units within the organisationalstructure in place.

• Training and ongoing support plan operational

• MSA produces national standards

• ENs transposed on time

• CEN Databases

• Official gazette

• Availability of adequateresources especially human

Accreditation: to set up the organisation structure ofthe directorate so as to establish an operational basethat would be capable of supporting all thefunctions of a national accreditation body

• Various units within the organisationalstructure in place.

• Training and ongoing support plan operational

• Accreditations are carried out

• MSA is member in EA

• MSA is signatory to the MLA for Certification(quality systems)

• Departmental Managementreports and available statistics

• Minutes of the GeneralAssembly

• EA Web site

• Adequate resource (externaland internal) availability.

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Metrology: to set up the organisation structure ofthe directorate so as to establish an operational basethat would be capable of supporting all thefunctions of a national metrology institute

• Various units within the organisationalstructure in place.

• Training and ongoing support plan operational

• Calibrations are performed

• Verifications are carried out

• MSA is Member in EUROMET

• MSA participates in EUROMET relevantlaboratory intercomparisons

• Departmental Managementreports and available statistics

• Minutes of the GeneralAssembly

• EUROMET Web site

• Adequate resource (externaland internal) availability.

• Ability to select and recruitappropriates experts.

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Annex II

Cost Breakdown in EURO

To be financed by EU

TECHNICAL ASSISTANCE

• MSA

• Central Administration

• Standards

• Consumer and Industrial Goods

• Food, Chemicals and Cosmetics

40,000

270,000

65,500

115,000

139,500

METROLOGY

• Institutional building

• Equipment

150,000

500,000

ACCREDITATION

70,000

Total Amount 1,350,000

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Annex III

SUMMARY DETAILED TIME IMPLEMENTATION CHART FOR THE PROJECT

Title: Capacity Building at Malta Standards Authority

COMPONENT 2001 2002 2003

M J J A S O N D J F M A M J J A S O N D J F MA M J J A S O N DPre project activitiesSign WTO codeSign Meter ConventionAppoint clerical staffAppoint DB ManagerAppoint Quality EngineerAppoint junior technical staffPlacementsMSA D D C C I I I I I I I I I X XCentral 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 xStandards 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 xMetrology 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 xAccreditation 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 xConsumer… 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 xFoodstuffs…. 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 = DesignC = ContractingI = ImplementationX = Closure

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Annex IV

CUMULATIVE CONTRACTING AND DISBURSEMENT SCHEDULEOF EU FUNDING

Title: Capacity Building at Malta Standards Authority

All figures in million Euro01/12/2001 01/03/2002 01/06/2002 01/09/2002 01/12/2002 01/06/2003 31/12/2003

CONTRACTED 1,350DISBURSED 125 425 550 813 970 1,350

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Annex V

List of Relevant (draft)Laws and Regulations

1. Malta Standards Authority Act XIX of 2000

2. Malta Standards Authority Act XIX of 2000; Order establishing the Foodstuffs, Chemicalsand Cosmetics Directorate within the Malta Standards Authority

3. Malta Standards Authority Act XIX of 2000; Order establishing the Consumer andIndustrial Goods Directorate within the Malta Standards Authority

4. Malta Standards Authority Act XIX of 2000; Order establishing the StandardisationDirectorate within the Malta Standards Authority

5. Draft Accreditation Act

6. Draft General Product Safety Act

7. Draft Metrology Act