TWINNING PROJECT 1 BASIC INFORMATION 1.1 Programme: Support to the Association Agreement Programme (SAAP) 1.2 Twinning Number: EG08/AA/TR11 1.3 Title: Building the Capacity of the Egyptian Accreditation Council to deliver Accreditation Services 1.4 Sector: Economic (Market Access) 1.5 Beneficiary Country: Egypt

2 OBJECTIVES

2.1 Overall objective

The overall objective is to further develop Egypt's quality infrastructure, thus increasing the competitiveness of Egyptian products in the international market as well as enhancing accessibility to EU markets.

2.2 Project purpose

To contribute to the improvement of the Egyptian Accreditation Council’s (EGAC) role in the area of conformity assessment; paving the way for the Agreement on Conformity Assessment and Acceptance (ACAA) being negotiated between Egypt and the EU. This purpose is to be achieved through the following:

2.3 Contribution to National Development Plan/Cooperation agreement /Association Agreement/Action Plan

Comprehensive and effective accreditation services are crucial to guarantee the competence and credibility of the national conformity assessment network that encompasses laboratories, inspection and certification bodies. Acceptance of products in the national and foreign markets - in many cases - depends on the acceptance of quality compliance results of products; provided by conformity assessment organizations.

Accreditation bodies also assess organizations with responsibilities within the market surveillance area, fostering the official guarantee of safety and compliance of products on the market, thus contributing to the safety of consumers.

The Egyptian Accreditation Council (EGAC) is therefore an essential and integral element for the development of Industry and Trade. It follows that by contributing to the improvement of the technical competence and strength of Egyptian Accreditation Council (EGAC) to deliver high quality accreditation and conformity assessment services, the twinning project at hand, will undoubtedly have a significant and positive impact in

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attaining some of the main purposes established by the National Development Plan of Egypt particularly the following:

• building the capacities of national institutions with a view towards improving the quality of life and standard of living of Egyptian people and the achievement of a significant expansion in the production and export capacity of the Egyptian economic sectors.

The twinning project will also support the implementation of Article 47 of the Association Agreement between Egypt and the EU which stipulates that both Parties shall aim to trim down any major differences in standardization and conformity assessment practice. In this context, the project aims at assisting EGAC in building and upgrading its institutional capacity to undertake more comprehensive and effective conformity assessment and accreditation activities.

Furthermore, the objectives and activities of the twinning project are aligned with the objectives of the European Neighbourhood Policy (ENP) Action Plan jointly adopted by Egypt and the EU since March 2007; which introduces a comprehensive policy framework with specific and detailed mechanisms to support economic, political, and social development as well as to improve Egypt's access to the European Single Market. Specifically, this twinning project responds to two topics of the ENP:

(1) the identification of suitable areas for gradual regulatory upgrading and approximation with EU technical legislation, standards and conformity assessment procedures and;

(2) the continuation on the implementation of the Palermo Action Plan for the Free Movement of Industrial Products approved in July 2003 during the Euro-Mediterranean Conference of Trade Ministers which involves:

i. Identification of priority sectors

ii. Acquaintance with the applicable EC legislation and conducting a gap analysis on the basis of the existing legislation;

iii. Transposition of necessary framework legislation and sectoral legislation;

iv. Creation/ Reform of existing institutions;

v. Set up necessary certification and conformity assessment bodies;

vi. Identification of technical assistance needs and capitalization on existing programmes.

Additionally, by assisting EGAC (and other relevant stakeholders) in contributing to the reform of the regulatory and institutional framework as well as in raising the capacity and awareness of key players in the area of standardization, conformity assessment and accreditation; the twinning project paves the way towards the adoption of the Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) currently under negotiation between Egypt and the EU.

The ACAA requires the alignment of the partners' horizontal and sectoral 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).

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3 DESCRIPTION

3.1 Background and justification

3.1.1 Project Background

Quality infrastructure, accreditation and conformity assessment in Egypt

The Government of Egypt is strongly supporting the reform of the national quality infrastructure in line with international and European best practices. Such support includes the modernization of the Egyptian Organization for Standardization (EOS) - the national standardization body in Egypt - and the translation of almost all European and International standards related to the implementation of the ENP Action Plan.

In this context, the National Quality Program / Industrial Modernization Centre overseen by the Supreme Council for Quality has – in coordination with the Egyptian Organization for Standardization (EOS) - contributed to the incorporation of more than 6.000 European and international standards into the Egyptian standards holdings.

Additionally, the National Institute for Standards (NIS) - a national structure responsible for maintaining the major national metrology measuring standards - has been established enabling both public and private calibration laboratories to have their instruments calibrated.

It is important to note however that to date, there is no clear national plan to consolidate a market surveillance system that meets international best practice and the requirements of the ENP Action Plan. Market surveillance needs to be established in Egypt as an essential post-production activity that can assure the safety of products placed on the market. This would also enable the appropriate control of CE marking on products imported from Europe or from other parts of the world. In brief, the quality infrastructure of Egypt is progressing in line with international and European best practice, namely through:

• the modernization of the Egyptian Organization for Standardization (EOS);

• the translation of European and international standards relevant for the implementation of the ENP Action Plan as well as the harmonization of a significant set of European standards;

• the establishment of a Supreme Council for Quality responsible for overseeing the national Quality Program;

• the maintenance of the highest national metrology standards by the National Institute for Standards (NIS);

• the joint understanding between EGAC and NIS that lead to the decision of merging all laboratory accreditation activities into one national organization for accreditation, EGAC;

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• the preparation of accreditation activities focused on international trade requirements and on procedures for mutual recognition arrangements at European and international levels.

The Egyptian Accreditation Council (EGAC)

The Egyptian Accreditation Council (EGAC) was established in 1996 by Presidential Decree number 312/1996. This decree was replaced in 2006 by Presidential Decree number 248/2006 which designates EGAC as the sole national body for the assessment and accreditation of conformity assessment bodies including testing and calibration laboratories, inspection bodies as well as certification bodies for products, management systems and personnel.

This Presidential Decree presently entitles EGAC to:

• achieve international recognition of the Egyptian national infrastructure for quality,

• enhance the competitiveness of the Egyptian industry,

• improve the national and international image of Egyptian products.

EGAC is operating under the direction of the Minister of Trade and Industry and is managed by a General Director appointed by the Minister and administered by a board of 14 members, representing stakeholders and concerned bodies. EGAC obtains its financial resources from the allocated government budget, revenues from the delivered services as well as donations.

A recent Memorandum of Understanding has been signed between the Ministry of Trade and Industry and the Ministry of State for Scientific Research resulting in the integration of the National Laboratory Accreditation Bureau (NLAB)1 into EGAC, effectively enabling EGAC to be the sole accreditation body for all the accreditation scopes. Necessary measures are currently being undertaken to ensure that the merger between EGAC and NLAB maintains the status of both organizations within IAF and ILAC.

EGAC is presently operating in a large range of sectors and is complying with the international standard ISO/IEC 17011 required for mutual international recognition purposes.

The number of conformity assessment bodies operating under accreditation by EGAC and/or other recognized international accreditation body is growing. Presently, there are around 30 accredited certification bodies2 and about 104 accredited laboratories operating in Egypt. The number of accredited inspection bodies is still relatively low; however it is important to note that EGAC is exerting great efforts to boost accreditation within this sector. EGAC is also planning to expand its current activities, in the near future by providing accreditation of certification bodies for products which is an essential activity to comply with the European Conformity Assessment (ACAA) requirements.

EGAC's fast development was largely sustained by the recurring exchange of knowledge with European and international organizations through the organization of training 1 Prior to the MoU, NLAB was acting independently from EGAC as a laboratory accreditation body 2 Special emphasis is being placed by EGAC on the accreditation of certification bodies for management systems, such as those for quality and environment systems, as well as of those certification bodies operating for the medical and for the auto-motor sectors.

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programmes and study tours. Such activities were mostly financed by the local National Quality Program (NQP), one of the programmes managed by the Industrial Modernization Centre established in 2000 with the support of the European Union and the Egyptian Government.

This National Quality Program supported inter alia the following measures that concerned EGAC’s activities:

• elaboration of the accreditation scheme and the revision of legislation, consequently supporting the preparation of the above mentioned Presidential Decree number 248/2006 that allowed the merging between EGAC and the National Laboratory Accreditation Bureau (NLAB) into a national Accreditation Body;

• EGAC’s capacity building including the training of EGAC’s personnel and affiliated assessors,

• the implementation of EGAC’s quality system complying with the International Standard ISO 17011,

• the assessment by the American Association for Laboratory Accreditation (A2LA) of EGAC’s compliance with international standards and good practices and the assistance to EGAC’s application to ILAC and IAF;

• technical assistance for the application of the International Standard ISO 17025 to around 300 public and private laboratories and provision of equipment, leading some of those organisations into accreditation;

• the organization of awareness campaigns on quality issues, that did not address the European Union’s regulations and CE marking.

Additionally, EGAC's executive personnel have undertaken training provided by EUROMET on European notification procedures.

The EU Legislative background

Since the beginning of the 1980’s, the European Union has been reforming its legal requirements in a way that brought about the strengthening of the European standardisation system and conformity assessment activities. At the present time, the European Commission encourages further; the reinforcement of national conformity assessment systems by assigning to the national accreditation bodies a clearer and stronger role in dealing with the enforcement of national regulations.

Moreover, within the European Union, the establishment of close and trustful cooperation arrangements between national regulatory agencies and the national accreditation body along with the stringent application of legal requirements are prerequisites for the successful implementation of national quality schemes.

3.1.2 Project justification

Legislative Reform The placement of a country in 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.

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In other words, without verified compliance with both management standards (such as those for quality and environmental management) and product performance standards, access to the markets of industrialized countries including the EU region is becoming increasingly difficult.

As a matter of fact, European legislation, such as the New Approach Directives require testing, certification and inspection of certain products by credible organizations to ensure their compliance with health and safety regulations. Besides, several proposals of European Regulations and Decisions are presently put forward emphasizing the role of accreditation. It follows that the increased access to the EU internal market needs from Egypt an adequate infrastructure of standardization, accreditation, conformity assessment and metrology.

The EU-Egypt ENP Action Plan envisages the introduction of principles underlying the New and Global Approaches in Egypt along with the adoption of specifically chosen EC directives. Such measures which entail the reform of the regulatory framework governing conformity assessment bodies are aimed at increasing trade between Egypt and the European Union.

This twinning project will thus be carried out with the aim of fostering EGAC image as a competent and reliable accreditation body thus increasing the confidence in conformity assessment organizations operating in Egypt. This in turn will facilitate exports of Egyptian products and will simultaneously ensure that Egyptian consumers have access to a wide range of safer and higher quality locally manufactured and imported products. For this effect, the project includes a gap analysis comparing conformity assessment regulations in force in Egypt with existing and anticipated EU legislation and providing recommendations for the most appropriate strategy to increase the competitiveness of Egyptian products in the EU and other international market. The project will also assist the Egyptian competent authorities in drafting national regulations for conformity assessment and accreditation that are in line with EU and international best practices.

Capacity building of EGAC

In the context of the Palermo Action Plan and the ACAA negotiations, the following sectors have been selected by the Government of Egypt for approximation with relevant EU legislation (New Approach EU Directives):

(1) Pressure Equipment Directive (97/57 EC),

(2) Low voltage Equipment Directive (73/23/EEC, as amended by 93/68 EEC),

(3) Electromagnetic Compatibility Directive (Directive 2004/108/EC repealing 89/336/EEC)

(4) Construction products Directive (89/106/EEC, as amended by 93/98 EEC),

(5) Medical Devices Directive (93/42EEC, as amended by 98/79EC)

(6) Reclassification of breast implants (2003/12/EC)

(7) 2003/32/EC: On introducing detailed specification to Directive 93/42/EEC with respect to MD manufactured utilising tissues of animal origin;

(8) 2005/50/EC: Reclassification of hip, knee and shoulder joint replacements in framework of Directive 93/42/EEC.

(9) Gas appliances Directive (90/396, as amended by 93/68 EEC).

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The implementation of the ACAA also entails the approximation of Egyptian regulations to the following priority EU horizontal Directives.

(1) the General Product Safety Directive (2001/95EC);

(2) the Directive on Product Liability (87/247).

It is important to note that approximation of Egyptian legislation to the abovementioned horizontal Directives will set the correct framework for the application of the first five technical regulations selected in the framework of the ACAA as well as for others to come; based in the New and Global Approach principles.

The twinning project will therefore support EGAC by providing the knowledge, experience and competence to assist EGAC in building its administrative and technical capacities. In particular, the project will contribute to the establishment of criteria, procedures and mechanisms for the operation of accreditation within the five prioritized areas mentioned above. In addition, the project will support EGAC in developing its accreditation capacity in existing and new areas especially those related to the application of the EU New and Global Approach principles, which include the accreditation of:

• Testing and calibration laboratories • Inspection • Certification of quality management systems • Certification of personnel • Certification of products

The following areas will also be tackled since they are of special importance for the EU - Egypt trade relations:

• Medicare including medical laboratories

• Food and agriculture

It is worth pointing out that EGAC is already seeking full 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 of Egyptian products.

Given the important role of EGAC in the implementation of the New and Global Approach principles in Egypt, EGAC needs also to build up relations with the European co-operation for Accreditation (EA); which is currently sorting out measures to establish a closer relationship with ENP countries, particularly by opening its membership to ENP countries.

The twinning project will therefore facilitate the route of EGAC towards a closer participation and collaboration with EA by assisting EGAC’s readiness to receive peer evaluations from EA, an essential step to join the EA multilateral arrangements (MLA). It is important to note that EA’s MLA enables its members to recognize the equivalence of each others technical competences thus facilitating access to the EU market. Being a party of the MLA also improves access to the international markets through the on-going co-operation between EA, ILAC and IAF.

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External Communication and Awareness building

The positive impact on society and industry of developing a sound quality infrastructure including its accreditation component is not yet entirely obvious in Egypt. Therefore, general awareness to quality related issues must be raised among all stakeholders (e.g. industry and trade, consumer organizations, governmental authorities etc.) to secure the needed for public and private investment and to expand the clients base for the services provided.

Successful experiences in other countries have shown that it is very important to raise and maintain a high level of transparency and awareness about the benefits from an efficient quality infrastructure aimed mainly at the higher management and executive levels, particularly high ranking civil servants and decision makers in the private sector.

Consequently, the project will assist EGAC in developing an effective and sustainable external communication plan. This plan will extend its activities continuously throughout the institutional life of EGAC and will include awareness activities through the media, visibility conferences, technical seminars, web information and technical and administrative reports.

The communication plan should complement similar activities being implemented by other organizations and should address a variety of subjects such as accreditation, certification, inspection, testing laboratories, technical regulations, standardization and standards, metrology, market surveillance, CE marking, the principles of mutual recognition and WTO issues etc. As stated above, the general purpose of this communication plan is to alert stakeholders of the quality infrastructure to its benefits and to motivate their commitment.

3.2 Linked activities

Within the framework of the European Union-Egypt ENP Action Plan the present project should particularly link with the following projects:

The twinning project on organization and modernization of the occupational, health and safety management system, being initiated with the Ministry of Manpower with the aim of contributing to the improvement of the effective implementation and quality of the Occupational Health and Safety policies, procedures and services, hence reducing the number of work-related accidents and incidents in Egypt. This will be achieved through undertaking the relevant legislative and institutional reforms as regards to Occupational Health and Safety services to ensure an effective implementation of its mandate promoting and ensuring labour safety, health and welfare of employees, as well as safeguarding the public from being exposed to work activities entailed risks. Under this purpose the project will endeavour to improve the national labour policy framework, through:

• improving procedures for the enforcement and implementation of secondary

occupational health and safety laws;

• strengthening the institutional capacity of the Occupational Health and Safety Agency (OSH) on the central (national) level;

• strengthening the institutional capacity of the Occupational Health and Safety Agency (OSH) on both the central (national) and the executive (governorate) levels.

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• strengthening the institutional capacity on the central and executive levels will include, but not limited to, structure, process, communication flow, monitoring internal control, human resources development, performance measures, inspection process reengineering and awareness raising as well as infrastructure upgrading.

The EC-Euromed Quality Programme which is targeted at the countries of MEDA (Algeria, Cyprus, Egypt, Israel, Jordan, Lebanon, Malta, Morocco, Palestinian Authority, Tunisia, Turkey and Syria), aims at establishing a stable environment that will help MEDA enterprises to develop and place quality products on the market as well as be able to compete in the export markets. This project is being implemented by the European Standardization Body, CEN, officially started on 14 January 2004 and is expected to last until 2008.

Its activities include training and awareness for different aspects, namely, accreditation, conformity assessment, legislation, market surveillance, metrology and standardization.

The program already implemented a number of activities including training on ISO/IEC 17011 on general requirements for bodies providing assessment and accreditation of conformity assessment bodies.

During 2007, EC-Euromed Quality Programme includes a number of activities namely a seminar on ACAA in the MEDA region (4 days), 7 inter-laboratory comparisons, a study of the implementation of 3 New Approach Directives, an Annual Conference (2 days), 2 seminars on New Approach in the EU (3 days) and 48 training visits (1 week).

3.3 Results

This project will lead to the following three main results:

Component I: Legislative Reform

A proposal for structured and integrated reforms of the regulatory and legislative framework governing quality infrastructure in Egypt that is line with EU best practice is presented to competent ministries and authorities focusing on: (1) conformity assessment reform; (2) approximation of relevant EU directives.

Component II. Institutional Capacity Building (1) EGAC's institutional and technical capacity, with particular emphasis on strategic

planning, accreditation and conformity assessment activities (focusing on areas selected within the context of ACAA) is developed.

(2) International recognition for formal Multilateral Agreements by ILAC and IAF is obtained and maintained. In addition, relations are established with EA.

Component III: External Communication (1) An external communication plan, paving the way to the institutionalization of a

sustainable communication mechanism within EGAC is prepared and implemented. Among other aspects, the plan will include raising the awareness of interested parties on matters related to the EU Internal market and conformity assessment requirements.

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(2) Establishment of EGAC’s image as a client friendly organization.

3.4 Activities

C1 Component I: Legislative Reform

C1.1. Conducting a gap analysis between Egyptian and EU legislation on conformity assessment and accreditation.

C1.2. Proposing a plan for the implementation of necessary reforms to the legislative framework for conformity assessment (including secondary legislation) - in line with EU best practices.

C1.3. Organizing a Conference on "the impact of the EU Internal Market policy on Egyptian trade and industry".

Target Audience: high ranking Egyptian officials from national authorities. Objectives: increase awareness of Egyptian stakeholders of the impact of the internal market policy with a view towards undertaking the necessary legislative reforms. Focus Areas: Conformity assessment procedures required by EU Regulations and directives such as Horizontal directives on Product Safety and Product Liability and EU policy on market surveillance as well as the consequences of the application or non application of CE marking.

C1.4. Reviewing existing legislation, proposing reforms (to competent stakeholders) and drafting legislation governing conformity assessment.

C2 Component II: Institutional Capacity Building

C2.1. Assisting in reforming EGAC the organizational structure and developing strategic directions

• Analyzing EGAC’s organizational structure and management practices in line with EU best practices and assisting in the introduction of necessary changes to the existing structure.

• Supporting EGAC in developing a long term strategy and action plan (including the adoption of Balance Score Card approach) taking into account national and international developments.

• Assisting EGAC in formulating and implementing a Human Resources Development plan.

• Assisting EGAC in improving the Quality Management and Information System:

- Assessing and improving EGAC’s management system and introducing relevant Management Information Systems (MIS) applications.

- Developing EGAC’s capacity to facilitate exchange of information and data with stakeholders (including clients) in the accreditation process. This includes but is not limited to developing an on-line Newsletter.

- Assisting in the development of a Manual for EGAC’s personnel covering organizational structure, activities, information on quality system, rules and procedures and other relevant information about the organization.

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• Supporting EGAC in obtaining international recognition (ILAC, IAF and EA) by providing assistance during the assessment process and the conclusion of formal Multi Lateral Agreements (MLA).

• Supporting the participation of EGAC experts in meetings and working groups of European and international organizations such as EA, IAF and ILAC, on prioritized sectors, in order to align its technical development with regional and international practices.

C2.2. Assisting EGAC in approximating regulations with EU directives

• Introducing institutional change, supporting the elaboration of information material about the EU legal requirements, quality management procedures and work practices as well as conducting training for lead and technical assessors of EGAC on the five New Approach directives (Priority Directives within the context of the ENP Action Plan particularly the ACAA Agreement), namely:

o construction products (89/106/EEC, as amended by 93/98), o pressure equipment (97/57 EC), o low voltage (73/23/EEC, as amended by 93/68 EEC), o Electromagnetic Compatibility Directive (Directive 2004/108/EC

repealing 89/336/EEC)

o medical devices (93/42EEC, as amended by 98/79EC), and o Reclassification of breast implants (2003/12/EC)

o 2003/32/EC: On introducing detailed specification to Directive 93/42/EEC with respect to MD manufactured utilising tissues of animal origin;

o 2005/50/EC: Reclassification of hip, knee and shoulder joint replacements in framework of Directive 93/42/EEC.

o gas appliances (90/396, as amended by 93/68 EEC).

The training will focus on assessment techniques and fundamental principles of management and procedures for accreditation in the priority sectors.

• Organizing study visit(s) for EGAC personnel and experts to MS accreditation

body(s), covering the following issues:

o the implementation of accreditation activities within the framework of the New Approach Directives,

o European procedures and methods for assessment/accreditation of conformity assessment bodies, as well as,

o observation of the assessment process of bodies seeking notification.

• Organizing a conference on the New Approach Directives and the ACAA agreement being negotiated between Egypt and the EU.

Target Audience: National authorities, conformity assessment bodies and other interested parties.

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Objectives: increase awareness of Egyptian stakeholders of the impact of the European technical legislation, namely, of the role of accreditation within trade relations EU/Egypt. Focus Areas: Conformity assessment procedures required by EU Regulations and directives, accreditation role and impact of the CE marking

• Assisting EGAC in acquiring and translating documents such as interpretation Guides developed by EA, ILAC and IAF that need to be adopted and made available in Arabic to technical experts and assessors.

C2.3. Assisting EGAC in developing its Inspection Unit

• Assisting EGAC in harmonizing auditing procedures.

• Conducting training for assessors and experts in the objectives of ISO/IEC 17020 and how the accreditation assessments and reassessment of certification bodies should be carried out according to the standards and guidelines applicable in EA – ILAC/IAF). The training should be supported by on-site audits.

• Organizing study visit(s) to national accreditation bodies in EU countries aimed at providing relevant employees from EGAC with the possibility to take part in the assessment of inspection bodies.

• Performing joint accreditation by EGAC and a MS national accreditation body.

• Organizing a seminar on the importance of inspection activities under the regulatory and non regulatory sectors.

Target Audience: Relevant Egyptian institutions with inspection responsibilities. Objectives: outline the importance of inspection activities at the European regulatory technical area and voluntary inspection activities. Focus Areas: the role of inspection bodies under the Global Approach principles and on inspection activities namely on periodic inspections of regulator authorities.

C2.4. Assisting EGAC in Establishing a Unit for Certification of Personnel

• Introducing institutional change and supporting the elaboration of quality management procedures and work practices for personnel certification focused on industrial vocational training.

• Training assessors and experts in Egypt on ISO/IEC 17024, and on the development of normative documents for personnel (ISO/IEC Guide 7).

• Organizing study visits to national accreditation bodies in EU country(s) for Lead assessors from EGAC aimed at the assessment in the MS of certification bodies for personnel.

• Organizing a seminar for relevant Egyptian institutions on the role of certification bodies for personnel. Target Audience: EGAC’s MoU partners for industrial vocational training, the EOS, the Industrial Training Council (ITC), the Technical and Vocational Education and Training (TVET) and the National Quality Council, and other interested parties in personnel certification Objectives: to promote the new activity of personnel accreditation by EGAC

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Focus Areas: vocational training sector.

C2.5. Assisting EGAC in the Establishment of a Unit for Certification of Products

• Assisting EGAC in introducing institutional changes and providing support for elaboration of quality management procedures and work practices for product certification.

• Conducting training for assessors for product certification and marks of conformity, taking into account ISO/IEC Guide 65, ISO/IEC Guide 67, ISO/IEC Guide 28, ISO/IEC Guide 53, ISO/IEC Guide 67 and ISO/IEC 17030, including establishment of normative documents (ISO/IEC Guide 7).

• Organizing study visits for lead assessors from EGAC to national accreditation body in EU country(s) aimed at the participation in the assessment in of an MS certification body for products.

• Conducting a joint assessment/accreditation by EGAC and the MS partner in Egypt

C2.5.1 Food and agriculture

• Assisting relevant employees from EGAC in the assessment of conformity assessment bodies for foodstuff and agriculture.

• Organising study visits to national accreditation bodies in EU country(s).

• Accompanying EGAC employees attending EA meetings and ILAC / IAF committees responsible for food testing and certification.

• Organizing a seminar about the mandatory and voluntary conformity assessment schemes in the food and agricultural sectors.

Target Audience: Egyptian interested parties in the food and agriculture sectors, including ministries, authorities and experts. Objectives: raise the awareness about the importance of accreditation for laboratories, inspection and certification bodies within the food and agriculture national and trade policies. Focus Areas: enhance available instruments for safety and quality in this sector such as standard ISO/IEC 17022 and risk assessment principles and tools, the role and responsibilities of enforcement authorities, accreditation and certification bodies.

C2.6. Assist EGAC in developing its Medicare Quality Management Accreditation Unit

• Organizing a training course/ workshop for EGAC specialists on the new guide CEN TS 15 224 Health services – Quality management – Guide for the use of ISO 9001:2000 and its applications. The training should be supported by on-site audits.

• Accompanying EGAC experts attending EA and ILAC/IAF meetings related to activities in the Medicare area.

C2.7. Building EGAC’s capacity to conduct laboratory and inspection accreditation activities

C2.7.1 International comparisons and proficiency testing (PT)

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• Supporting EGAC in establishing a PT provider’s accreditation Unit and assisting in the development of four national or international schemes for proficiency testing in main areas based on the identified needs. This includes the selection of schemes and PT providers.

• Conducting training for EGAC assessors and experts on accreditation of PT providers according to ISO Guide 43-1:1997 and EA – Guide 2: 2005

• Introducing institutional changes and providing support in the elaboration of quality management procedures and work practices. The training should be supported by on-job activities (on-site audits).

• Organizing a study visit for EGAC assessors aimed at the technical assessments of accreditation for PT providers undertaken by a MS national accreditation body.

C2.7.2 Uncertainty calculation Conducting training on calculation of uncertainty within laboratory accreditation.

C2.7.3 Textiles testing

• Conducting training in technical assessment for laboratories in the textile area for EGAC assessors and experts. Training should be supported by on-site audit.

• Organizing a study visit to a MS accreditation body active in the field. The visit should involve a joint assessment of an accredited laboratory in the sector.

C2.7.4 Medical laboratories

• Organizing a training course for EGAC specialists in accreditation of medical laboratories according to 17025 and ISO 15189 as well as the OECD Good Laboratory Practice (GLP) for testing of some pharmaceutical and chemical products.

• Organizing study visits to national accreditation bodies in EU country(s) covering technical assessment of medical laboratories.

• Conducting a joint assessment/accreditation, of a medical laboratory by EGAC and a MS national accreditation body.

• Organizing a seminar for the Egyptian Medicare sector that includes speakers from MS accredited laboratories, certification bodies, medical authorities and MS national accreditation body.

Target Audience: Specialists from the national Egyptian medical authorities, EGAC, the pharmaceutical industry and other Egyptian stakeholders in the medical health area. Objectives: Inform what EU accreditation bodies and authorities have achieved in this sector, and support a joint effort in Egypt to build up a national quality policy for medicare where accredited entities will have a relevant role. Focus Areas: accreditation policy for the medicare sector, laboratory accreditation and GLP – Good Laboratory Practices, application of ISO 9001:2000 and roles, principles and communication mechanisms in this sector.

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C2.7.5 Food and Agriculture

• Conducting a joint assessment/accreditation of laboratories for foodstuff and agriculture products.

• Organizing study visits to national accreditation bodies in EU country(s) with laboratory and inspection activities.

C3 Component III: External Communication

C3.1. Assisting EGAC in establishing a Unit for External Relations • Providing assistance to EGAC in the establishment of a Unit for External

Relations and in the development and implementation of an external communication plan

C3.2. Assist EGAC in developing and implementing an awareness campaign

• Organizing an “Open Day” with the aim of exchanging information and obtaining clients’ feedback regarding EGAC’s services as well as communicating to clients information about European and international forums. This activity will help EGAC in building a closer relationship with clients and establish a positive image of the organization.

• Dissemination of information on accreditation and conformity assessment procedures related to the EU Internal Market policy, including information on the impact of the adoption of CE marking on Egyptian products, the role of the quality infrastructure and technical requirements for trade.

3.4.1 Means/Inputs from the Member State Partner Administration

3.4.2 Profile and tasks of the Project Leader (PL)

The PL will be expected to devote a minimum of 3 days per month to the project in his home administration. In addition, he will coordinate, from the Member State side, the Project Steering Committee (PSC), which will meet in Egypt at least every three months.

Tasks

The main tasks of the Member State (MS) Project Leader are to ensure: • The overall coordination of the Project;

• The achievement of the mandatory results.

Profile • Long-term officer from a Member State with 10 years experience in the fields of

accreditation or relevant conformity assessment activities.

• Have education and experience in the field of project management, institutional issues and organisation of national quality infrastructure to the European requirements.

3.4.3 Profile and tasks of the Resident Twinning Advisor (RTA)

The Resident Twinning Adviser (RTA) will provide 24 months input on site.

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Tasks • Manage the day-to-day coordination and progress of the activities in Egypt (office

accommodation in EGAC premises)

• Liaise with the Beneficiary Country (BC) Project Leader and RTA counterpart

• Report to the MS Project Leader

• Liaise with other relevant EGAC and other Egyptian institutions

Profile • Senior officer from the Member State with extensive experience in accreditation and

conformity assessment.

• Previous experience in project management (preferably also managing a team composed of EU and local Experts)

• Excellent command of written and spoken English. A spoken capability in Arabic would be an asset.

3.4.4 Profile and tasks of the Short-term experts

The RTA will be assisted by short-term experts so as to cover the full range of expertise required. These will be suitably qualified and capable to provide the necessary skills according to the activities mentioned above.

SHORT-TERM EXPERTS: TYPE; TASKS; PROFILE; QUANTITY

TYPE ACTIVITY PROFILE

Component I: Legislative Reforms (170 man days) Legal experts C1.1 Gap analysis of Egyptian/EU

legislation C1.2 Proposal for Egyptian framework legislation C1.4 Support to the elaboration of Egyptian legislation transposing EU directives and give accreditation a privileged position

Legal knowledge on EU framework legislation and approximation of directives in the conformity assessment field

General experts on the European internal market for goods and the conformity assessment rules

C1.3 Conference to increase awareness and to clarify the role of the European conformity assessment system

Wide experience on the EU internal market policy for conformity assessment

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Component II. Institutional Capacity Building (683 man days)

Expert(s) on strategic planning and information

Support EGAC to evaluate structure, management practices and HR and training needs

Long term strategy and a Balance Score Card for EGAC

Experiences of strategic planning for accreditation

EGAC to become member of ILAC, IAF and EA MLAs

Lead Assessor recognized by IAF, ILAC or EA

Expert(s) with experience in the referred EU directives

Training, elaboration of internal procedures and elaboration of training Manuals and of information material about the EU legal requirements for the 5 directives: Pressure Equipment Directive (97/57 EC), Low voltage Equipment Directive (73/23/EEC), Construction products Directive (89/106/EEC), Medical Devices Directive (93/42EEC), and Gas appliances Directive (90/396).

Conference on the New Approach Directives and the ACAA agreement EU/Egypt

Training experts with wide experience in the five New approach directives. High technical competence.

Communication expert(s)

Elaboration of a EGAC “Welcome Manual”

Business communication expert

Expert(s) on accreditation of inspection bodies

Support for the establishment of an Accreditation Unit for inspection bodies. Elaboration of quality procedures for inspection activities.

Training for EGAC staff and assessors in ISO/IEC 17020

Seminar on accreditation of inspection bodies

Wide experience of accreditation of inspection in the harmonised, non harmonised and voluntary areas in the different categories A, B and C, of the standard

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Expert(s) on accreditation of personnel certification

Support for the establishment of an Accreditation Unit for personnel certification bodies. Elaboration of quality procedures for accreditation of personnel certification

Training for assessors and experts in Egypt on ISO/IEC 17024, including for establishment of normative documents for personnel

Seminar on accreditation of personnel certification bodies

Wide experience of writing procedures and for accreditation of certification bodies for personnel particularly for vocational training activities.

Expert(s) on product certification

Support for the establishment of an accreditation Unit for product certification bodies. Elaboration of quality procedures for accreditation of product certification activities.

Training of relevant stakeholders and EGAC staff and assessors in product certification to ISO Guide 65

Wide experience of writing procedures and of accreditation of Product certification bodies including the establishment of normative documents.

Expert(s) on foodstuff

Joint assessment/accreditation to be performed by EGAC and MS for foodstuff certification bodies

Wide experience on accreditation of product certification bodies for foodstuff

Expert(s) on quality management systems

Training for CEN TS 15224and ISO 9001:2000 Attendance of meetings of ILAC and IAF or EA. 1 person/meeting, 1meeting/year in each of two organizations, duration for each meeting 4days, for two years

Wide knowledge and experience in training for quality management systems in the medical sector sectors

Food and agriculture experts

Seminar for conformity assessment schemes for food and agriculture

Technical experience in Food or Agriculture. Long experience of Food/Agriculture accreditation of laboratories/inspection and certification bodies

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PT Schemes expert(s)

Support establishment of an Accreditation Unit for PT providers and elaboration of quality procedures

Wide experience in accreditation of PT providers

Selection of PT providers and annual technical support for management of PT schemes

Experience in operation of PT schemes

Training for ISO Guide 43 and EA Guide

Wide experience in training for ISO Guide 43

Expert(s) on uncertainty calculation

General training for EGAC staff and interested parties on calculation of uncertainty within laboratory accreditation

Wide knowledge on training for uncertainty calculation

Textiles testing expert(s)

Training in technical assessment for laboratories in the textile area

Joint assessment/accreditation 2EEx12

Experience of accreditation of textile laboratories

Medical Laboratory expert(s)

Training for ISO 17025 Training for ISO 15189 and OCDE GLP

Joint assessment in Egypt

Conference for Egyptian Medical authorities, labs/ certification bodies & other health stakeholders

Wide experience of accreditation of medical laboratories (ISO 17025 and ISO 15189)

Specialists on internal quality management, information systems and auditing procedures of accreditation bodies

Assessment of existing IT supported quality system and proposal for upgrading of IT system

Experts with wide knowledge and experiences in IT

Harmonization of EGAC’s auditing procedures on 4 new sectors

Audit Experts in selected sectors

Component III: External Communication (80 man days)

Marketing and communications expert(s)

C3.1 Support the establishment of an External Communications Unit and development and implementation of an external communication plan

Experience in developing communication plans

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Expert(s) on the European Conformity assessment system

C3.2 Organization of one “Open Day” event per year

Knowledge of information activities in the conformity assessment field.

Joint awareness campaign EGAC and Industry and Trade associations on the EU Internal Market policy on accreditation and the conformity assessment procedures established by the European Union

Qualified experts with general knowledge on the EU internal Market and the organisation of the European conformity assessment system an its role in the quality assurance policy

Working Groups

The establishment of Working Groups should be considered. These groups should meet regularly to review progress, schedule activities and address any issues or constraints that may have arisen.

The membership of the different Working Groups should be proposed in consultation with the Beneficiary Institutions and should be agreed with the Contracting Authority during the Inception Phase.

4 INSTITUTIONAL FRAMEWORK

The direct beneficiary institution is the Egyptian Accreditation Council (EGAC) with headquarters in Cairo.

EGAC, established as an accreditation body since 1996, was in 2006 designated as the sole accreditation body at national level to perform accreditation of laboratories and conformity assessment bodies.

EGAC is headed by the Minister of Trade and Industry, governed by a board of 14 representatives of stakeholders and concerned bodies and has financial resources originating from the government budget, from revenues of services provided as well as from donations.

This project will, namely, support EGAC to establish standardized rules of procedure for accreditation of conformity assessment bodies, allowing services generated by these organizations to be recognized and accepted with confidence by Egypt’s trade partners.

5 BUDGET

The maximum estimated budget allocated for this Twinning project is € 1,300,000

6 IMPLEMENTATION ARRANGEMENTS

6.1 Implementing Agency responsible for tendering, contracting and accounting

The Programme Administration Office (PAO), Ministry of International Cooperation, is the contracting authority in charge of all the activities and administrative management of the programme managing several projects, where this project is under the same umbrella. The PAO will be the responsible institution for the management of this twinning project.

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It will manage the tenders, contracts and payments and this, in accordance with the provisions of ex-ante control under decentralized management defined in the Practical Guide to contract procedures financed from the General Budget of the EC in the context of external actions.

Contact person at the PAO:

Name: Zeinab A. Awad Title: Projects Manager Support to the EU - Egypt Association Agreement (SAAP) Ministry of International Cooperation 9, Abd El Kadar Hamza Str. Garden City, apt. 401 CAIRO – EGYPT Tel: +202 792 34 38 Fax: +202 792 05 83 Email: zeinab.awad@ee-aa.net Egyptian Project Leader

The Egyptian Project Leader (PL) will act as the counterpart of the Member State PL. In close cooperation with him/her, the Egyptian PL ensures the overall steering and co-ordination of the project, the operational dialogue and the backing at political level. The PL's seniority will ensure his ability to mobilise the necessary staff in support of the efficient implementation of the project. He will also coordinate the Project Steering Committee (PAC) from the Egyptian side.

RTA Counterpart

The RTA Counterpart will work with the RTA on a daily basis to ensure proper coordination and implementation of all the activities of the project and achieve an efficient transfer of knowledge. He will be responsible, together with the RTA, of finalising the reports to be submitted to the PLs for the Project Steering Committee. His profile should be as follows:

• At least 7 years of relevant experience in the area of their expertise

• Good management and administration capabilities

• University degree in a relevant field

• Fluency in English and have experience in similar international projects

Senior management of EGAC will ensure that appropriate staff is made available to work with the Member State partner. They will also make sure that the Member State partner is provided with legislation and other documents necessary for the implementation of the project. EGAC will ensure adequate support and basic equipment for the work of the full team of experts. This includes office space, phone and fax, access to Internet and translation (when necessary).

Indicators of Achievement

When drafting the work plan for this project, the partners (EGAC and the selected Member State) will develop a set of measurable performance indicators/benchmarks, on the basis of those given in the logical framework (see annex 1) and the commonly agreed activities and outputs. In order to meet the specific objectives, the partners may propose

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alternative or complementary activities and outputs to those identified in the previous sections.

6.2 Main counterpart in the Beneficiary Country

The main counterpart in Egypt will be the Egyptian Accreditation Council (EGAC) Contact Person - Focal Point Name: Mamhoud A. Eltaib Egyptian Accreditation Council (EGAC) Borg Riad El-Maadi (1), Korneish El-Nil MAADI – CAIRO EGYPT Tel: (202) 5275220 Fax: (202) 5275226 E- mail: egac2000@idsc.net.eg

6.3 Contracts

Equipment and software is required for EGAC’ internal management of processes, for interface with clients, to support the new staff joining EGAC to comply with the organization requirements in new areas of activity, for training needs for internal and external purposes (assessors and experts for all areas of EGAC activities).

For this purpose it is foreseen that an additional supplies contract with an estimated value of 55000 Euros will be tendered for and procured by the PAO as complimentary assistance to the twinning project.

7 IMPLEMENTATION SCHEDULE (INDICATIVE)

7.1 Launching of the call for proposals: January 2008

7.2 Start of project activities: September 2008

7.3 Project completion: August 2010

7.4 Duration of the implementation period: 24 months

8 SUSTAINABILITY

Considering the key factors for the continuation of benefits produced by this project after the external support, the following can be associated to EGAC:

• Ownership by beneficiaries: EGAC was directly involved in the preparation of this project fiche and is thus committed to its objectives and targets.

• Policy support/consistency: EGAC is an organization headed by the Minister of Trade and Industry, has recently changed its legal status and is now the sole accreditation body in Egypt, governed by a board that represent its stakeholders and other interested parties, thus complying with the international requirements.

• As the sole accreditation body in Egypt, EGAC has the national market opened to its accreditation services, namely for laboratories, inspection and certification bodies in all sectors of activity. Besides, the usual national activities, this project will support EGAC to start on working for specific export purposes, attending

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especially to the technical requirements of the EU directives and the EC marking that Egyptian economic agents need to engage in.

• Appropriate technology: This project will assist EGAC to improve its knowledge base and to further align its management system and activities with European accreditation organizations and by the international standards adopted by any accreditation body.

Institutional management capacity and economic and financial viability:

• Presently, EGAC has a sound leadership and technically competent staff that has in a relatively short period managed to accredit more than 140 entities.

• To keep and develop its capacity and viability, EGAC’s performance should be monitored; its top management accounted for EGAC’s results and kept off political pressures. In view of future enlargement of its scope of activities, EGAC’s staff will need to be increased and trained to deal with new sectors and activities. Development of EGAC´s information system also supported by this project relate to the transparency of its performance and activities which are of the utmost importance for accreditation organizations.

• EGAC reveals good financial stability, secured from the allotted government budget, its own revenues and from donations.

9 CROSSCUTTING ISSUES

Good governance concerns are built into this twinning project as this project assists EGAC in developing a transparent and accountable organization; for this purpose the project will enable EGAC to carry out a communication plan and to improve its information system. The project will also assist EGAC in setting up its own performance monitoring system. Moreover, as any accreditation body, the compliance of EGAC’s management operations with the applicable international standards will be periodically evaluated by its international peers; this project will provide the needed resources for this intent.

Then again, an accreditation body inherently exerts a good governance function as it provides independent monitoring and evaluation against international standards to the whole set of accredited conformity assessment bodies and is empowered to discontinue the activities of those non-compliant bodies.

As an accreditation body for environmental management systems and environmental testing laboratories, EGAC is one of the many players for the protection of a clean and sustainable environment. Also, being EGAC a governmental organisation, it necessarily respects the national policies aimed at gender equality.

10 CONDITIONALITY AND SEQUENCING

10.1 Conditionality There are no apparent conditionality for a successful implementation of this project, as:

• EGAC is working according to an updated legal status, has financial stability and has staff capable of acquiring new competence and knowledge through training;

• There is a strong political commitment in Egypt that can lead to necessary legislative reforms according to international rules;

• International forums are opened to members such as EGAC to sign international recognition agreements.

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10.2 Sequencing

• First activities to take place within this project are related to legislative reform as prioritized by the ACAA and identified as necessary for EGAC to support and improve its activities within a credible framework.

• The development of the structure, organization and administrative capacity of EGAC follows as a basis for the increase and improvement of EGAC’s technical capacities.

• The development of new Units and new sectors within EGAC should follow in order to answer to specific needs expressed by signed MoU (vocational training) or by clients’ requests.

• A sustainable communication system and an organized information campaign will be developed and implemented during the entire project as a support for all EGAC’s activities.

The duration of this twinning project is 24 months, whereas the full implementation of the ACAA agreement is planned to be achieved by 2015-2018.

ANNEXES TO PROJECT FICHE Annex 1: Logical Framework Matrix

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ANNEX 1 LOGICAL FRAMEWORK MATRIX FOR TWINNING PROJECT

Title: Improve the Capacity of the Egyptian Accreditation Council to Deliver Accreditation Services”

PROJECT DESCRIPTION OBJECTIVELY VERIFIABLE INDICATORS

SOURCES OF VERIFICATION ASSUMPTIONS

Overall objective To further develop Egypt's quality infrastructure, in order to increase the competitiveness of Egyptian products in the international market as well as enhance accessibility to EU markets.

Increased trade between Egypt and EU.

EU and Egyptian trade statistics

Project Purpose To contribute to the improvement of the Egyptian Accreditation Council’s (EGAC) role in the area of conformity assessment; paving the way for the Agreement on Conformity Assessment and Acceptance (ACAA) being negotiated between Egypt and the EU.

EGAC working in the areas established for the implementation of the EU-Egypt AA and prioritised by the ENP Action Plan. International recognition of EGAC by ILAC and IAF. Extension of EGAC’s activities into new areas. EGAC's institutional capacity developed

Follow up mechanisms of EU-Egypt AA and ENP Action Plan ILAC’s and IAF’s MLA Annual report of EGAC EGAC's annual report

Political commitment in Egypt to continue to introduce the European principles for conformity assessment activities, under accreditation. The concept of accreditation and one stop testing and certification is fully understood in Egypt.

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PROJECT DESCRIPTION OBJECTIVELY VERIFIABLE INDICATORS AT THE END OF PROJECT

SOURCES OF VERIFICATION ASSUMPTIONS

RESULTS

C.1 Component I: Legislative Reform A proposal for structured and integrated reforms of the regulatory and legislative framework governing quality infrastructure in Egypt that is line with EU best practice is presented to competent ministries and authorities focusing on: (1) conformity assessment

reform; (2) approximation of relevant

EU directives.

EGAC activities strengthened through legislation.

Necessary regulations drafted in line with EU best practices.

Reformed Legislation Sustained political commitment to support external trade and protect consumers. Government and relevant authorities committed to enhance and use accreditation.

C.2 Component II. Institutional Capacity Building (1) EGAC's institutional and

technical capacity, with particular emphasis on strategic planning, accreditation and conformity assessment activities (focusing on areas selected within the context of ACAA) is developed.

(2) International recognition for formal Multilateral Agreements by ILAC and

National market penetration of accreditation (% increase of present/potential accreditations in Egypt in each sector).

MLA signed with ILAC/IAF

Number of assessment/ accreditations in process or carried out in each category Accreditations in the following sectors: 5 personnel certification bodies

EGAC reformed organizational structure balance score card Assessment reports of ILAC and IAF teams

Minutes of ILAC and IAF General Assemblies

Assessment reports EGAC’s list of accredited entities

Annual report of EGAC

Government and relevant authorities commitment for quality and for the application of accreditation in the specific sectors. Legal reform is in implementation or accomplished. Regulatory bodies opened to changes. Easy access to information on legislation. ILAC and IAF have capacity to assess during the project time

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IAF is obtained and maintained. In addition, relations are established with EA.

4 product certification bodies 10 proficiency testing providers 40 laboratories 5 medicare entities

5 food and agricultural entities

Number of auditors and experts trained and working on the project sectors increased

Pool of auditors and experts

schedule.

C3 Component III: External Communication

(1) An external communication plan, paving the way to the institutionalization of a sustainable communication mechanism within EGAC is prepared and implemented. Among other aspects, the plan will include raising the awareness of interested parties on matters related to the EU Internal market and conformity assessment requirements.

(2) Establishment of EGAC’s image as a client friendly organization.

External communication unit established and operational by Month 12 External communication plan prepared and approved by EGAC by Month 8 External communication plan implemented by Month 21 Results of communication activities evaluated and changes to the plan incorporated by Month 23 Improved stake holder's awareness of conformity assessment related issues Intensification of communication between EGAC and stakeholders

External Communication Unit Organogram Job descriptions Communications plan Survey of stakeholders understanding of conformity assessment issues and opinion on the quality of services provided by EGAC Information available on EGAC web site

Extensive coverage and use of broadband internet network

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Activities Means Assumptions

• C.1 Component I: Legislative Reform C.1 Total Man Days: 170

C1.1. Conducting a gap analysis between Egyptian and EU legislation on conformity assessment and accreditation.

C1.2. Proposing a plan for the implementation of necessary reforms to the legislative framework for conformity assessment (including secondary legislation) - in line with EU best practice.

C1.3. Organizing a Conference on "the impact of the EU Internal Market policy on Egyptian trade and industry".

Reviewing existing legislatC1.4. and drafting legislation governing conformity assessment.

ion, proposing reforms (to competent stakeholders)

Legal Expert - 30 man days Legal Expert - 30 man days Experts on European Internal Market – 10 man days Legal Experts – 100 man days

Easy access to information on legislation.

Regulatory bodies opened to changes. Political commitment. Implementation follows the agreed timetable.

C.2 Component II. Institutional Capacity Building C.2 Total Man Days: 683 C2.1.

strategic directions

Analyzing E

Assisting EGAC in reforming the organizational structure and developing

• GAC’s organizational structure and management practices in line with

•

• plementing a Human Resources development

• GAC in improving the Quality Management and Information System

•

• EGAC experts in meetings and working groups of

Strategic Planning and ent

Strategic Planning and ent

Capacity for recruitment of

ILAC/IAF have capacity to

EA opened to participation.

EU best practices and proposing necessary changes to the existing structure.

Supporting EGAC in developing a long term strategy and action plan (including the adoption of Balance Score Card approach) taking into account national and international developments.

Assisting EGAC in developing and implan.

Assisting E

Supporting EGAC in obtaining international recognition (ILAC, IAF and EA) by providing assistance during the assessment process and the conclusion of formal Multi Lateral Agreements (MLA).

Supporting the participating of

C.2.1 Total Man Days: 126

Organizational ManagemExpert(s) - 30 man days

Organizational managemExpert(s) - 40 man days Strategic Organizational Management and Information Systems Expert(s) - 30 man days Expert in Lead Assessment – 10 man days

Rules of best practices applied by EGAC personnel

proposed HR

assess during the project time schedule Financial resources available for equipment and software

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Activities Means Assumptions European and international organizations such as EA, IAF and ILAC, on prioritized sectors, in order to align its technical development with regional and international practices.

Accreditation Expert 16 man days

C2.2 Assisting EGAC in approximating regulations with EU directives

• Introducing institutional change, supporting the elaboration of information material about the EU legal requirements, quality management procedures and work practices as well as conducting training for lead and technical assessors of EGAC on the five New Approach directives (Priority Directives within the context of the ENP Action Plan particularly the ACAA Agreement)

• Organizing study visit(s) for EGAC personnel and experts to MS accreditation body(s)

• Organizing a conference on the New Approach Directives and the ACAA agreement being negotiated between Egypt and the EU.

• Assisting EGAC in acquiring and translating documents such as interpretation Guides developed by EA, ILAC and IAF that need to be adopted and made available in Arabic to technical experts and assessors.

C2.2 Total Man days: 150 Experts with experience in EU directives governing the 5 sectors specified in the ACAA – 100 man days Communications Expert – 20 man days Accreditation Expert – 5 Man days Expert on EU directives (ACAA Sectors) - 5 Man days Accreditation Expert(s) 20 man days

Legal reform is in implementation or accomplished The priorities established are maintained Existing technical translators for Arabic language available in the necessary sectors Good understanding of the Welcome Manual by users Government and relevant authorities recognize the use of inspection in the mandatory field

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Activities Means Assumptions C2.3 Assist EGAC in developing its Inspection Unit

• Assisting EGAC in harmonizing auditing procedures.

• Conducting training for assessors and experts in the objectives of ISO/IEC 17020 and how the accreditation assessments and reassessment of certification bodies should be carried out according to the standards and guidelines applicable in EA – ILAC/IAF). The training should be supported by on-site audits.

• Organizing study visit(s) to national accreditation bodies in EU countries aimed at providing relevant employees from EGAC with the possibility to take part in the assessment of inspection bodies.

• Performing joint accreditation by EGAC and a MS national accreditation body.

• Organizing a seminar on the importance of inspection activities under the regulatory and non regulatory sectors.

C2.3 Total Man days: 60 Expert on Accreditation of Inspection Bodies – 40 Man days Expert on Accreditation of Inspection Bodies – 5 Man days Expert on Accreditation of Inspection Bodies – 10 Man days Expert on Accreditation of Inspection Bodies – 5 Man days

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Activities Means Assumptions C2.4 Assist in the implementation of a Unit in EGAC for Certification of Personnel • Introduce institutional change and support elaboration of quality management

procedures and work practices for personnel certification focused on industrial vocational training

• Training assessors and experts in Egypt on ISO/IEC 17024, and on the development of normative documents for personnel (ISO/IEC Guide 7).

• Organizing study visits to national accreditation bodies in EU country(s) for Lead assessors from EGAC aimed at the assessment in the MS of certification bodies for personnel.

• Organizing a seminar for relevant Egyptian institutions on the role of certification bodies for personnel.

C2.4 Total Man days: 50 Expert on the Accreditation of Personnel – 30 Man days Training Expert on the accreditation of Personnel – 10 Man days Expert on Accreditation of Personnel – 5 Man days Expert on Accreditation of Personnel – 5 Man days

MoU between EGAC and EOS, ITC, TVET and the National Quality Council is in progress

C.2.5 Assist in the implementation of a Unit in EGAC for Certification of Products • Assisting EGAC in introducing institutional changes and providing support for

elaboration of quality management procedures and work practices for product certification.

• Conducting training for assessors for product certification and marks of conformity, taking into account ISO/IEC Guide 65, ISO/IEC Guide 67, ISO/IEC Guide 28, ISO/IEC Guide 53, ISO/IEC Guide 67 and ISO/IEC 17030, including establishment of normative documents (ISO/IEC Guide 7).

• Organizing study visits for lead assessors from EGAC to national accreditation body in EU country(s) aimed at the participation in the assessment in of an MS certification body for products.

• Conducting a joint assessment/accreditation by EGAC and the MS partner in Egypt

C2.5 Total Man days: 115 Product Certification Expert – 30 man days Product Certification Expert – 40 man days Product Certification Expert – 5 man days Product Certification Expert – 10 man days

Market interest in product certification Government or relevant authorities commitment for quality in the food and agriculture sectors Political commitment and market interest

C2.5.1 Food and agriculture • Assisting relevant employees from EGAC in the assessment of conformity

Experts on Food Stuff Certification - 30 man days)

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Activities Means Assumptions assessment bodies for foodstuff and agriculture.

• Organising study visits to national accreditation bodies in EU country(s).

• Accompanying EGAC employees attending EA meetings and ILAC / IAF committees responsible for food testing and certification.

• Organizing a seminar about the mandatory and voluntary conformity assessment schemes in the food and agricultural sectors.

C.2.6 Assist EGAC in developing its Medicare Quality Management Accreditation Unit

C2.6 Total Man days: 20

• Organizing a training course/ workshop for EGAC specialists on the new guide CEN TS 15 224 Health services – Quality management – Guide for the use of ISO 9001:2000 and its applications. The training should be supported by on-site audits.

• Accompanying EGAC experts attending EA and ILAC/IAF meetings related to activities in the Medicare area.

Quality Management Expert – 10 man days Quality Management Expert – 10 man days

C2.7 Building EGAC’s capacity to conduct laboratory and inspection accreditation activities

C2.7.1 International comparisons and proficiency testing (PT)

• Supporting EGAC in establishing a PT provider’s accreditation Unit and assisting in the development of four national or international schemes for proficiency testing in main areas based on the identified needs. This includes the selection of schemes and PT providers.

• Conducting training for EGAC assessors and experts on accreditation of PT providers according to ISO Guide 43-1:1997 and EA – Guide 2: 2005 The training should be supported by on-job activities (on-site audits).

• Introducing institutional changes and providing support in the elaboration of quality management procedures and work practices.

• Organizing a study visit for EGAC assessors aimed at the technical assessments of accreditation for PT providers undertaken by a MS national accreditation body.

C2.7 Total Man days: 162 PT Schemes expert - 30 man days PT Schemes expert - 10 man days PT Schemes expert - 30 man days PT Schemes expert - 5 man days

The previewed PT schemes take place as foreseen, namely international schemes under the responsibility of an international PT provider

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Activities Means Assumptions

C2.7.2 Uncertainty calculation

• Conducting training on calculation of uncertainty within laboratory accreditation.

Uncertainty testing Expert - 10 Man days

C2.7.3 Textiles testing

• Conducting training in technical assessment for laboratories in the textile area for EGAC assessors and experts. Training should be supported by on-site audit.

• Organizing a study visit to a MS accreditation body active in the field. The visit should involve a joint assessment of an accredited laboratory in the sector.

C2.7.4 Medical laboratories

• Organizing a training course for EGAC specialists in accreditation of medical laboratories according to 17025 and ISO 15189 as well as the OECD Good Laboratory Practice (GLP) for testing of some pharmaceutical and chemical products.

• Organizing study visits to national accreditation bodies in EU country(s) covering technical assessment of medical laboratories.

• Conducting a joint assessment/accreditation, of a medical laboratory by EGAC and a MS national accreditation body.

• Organizing a seminar for the Egyptian Medicare sector that includes speakers from MS accredited laboratories, certification bodies, medical authorities and MS national accreditation body.

Textile testing training expert – 10 man days Textile testing expert – 5 man days

Medical Laboratory Expert – 20 man days

Medical Laboratory Expert – 5 man days Medical Laboratory Expert – 12 man days

Medical Laboratory Expert(s) – 10 man days

Government or relevant authorities commitment for quality in the medicare sector and the accreditation of medical laboratories

C2.7.5 Food and Agriculture

• Conducting a joint assessment/accreditation of laboratories for foodstuff and agriculture products.

• Organizing study visits to national accreditation bodies in EU country(s) with laboratory and inspection activities.

Food Stuff Expert – 10 man days

Food Stuff Expert – 5 man days

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Activities Means Assumptions

C3 Component III: External Communication C3 Total Man days: 80

C3.1 Assisting EGAC in establishing a Unit for External Relations

• Providing assistance to EGAC in the establishment of a Unit for External Relations and in the development and implementation of an external communication plan

C3.2 Assist EGAC in developing and implementing an awareness campaign

• Organizing an “Open Day” with the aim of exchanging information and obtaining clients’ feedback regarding EGAC’s services as well as communicating to clients information about European and international forums. This activity will help EGAC in building a closer relationship with clients and establish a positive image of the organization.

• Dissemination of information on accreditation and conformity assessment procedures related to the EU Internal Market policy, including information on the impact of the adoption of CE marking on Egyptian products, the role of the quality infrastructure and technical requirements for trade.

Marketing and Communications Expert - 20 man days

EU Conformity Assessment Systems Expert – 5 man days Communications Expert - 55 man days

Extensive coverage and use of broadband internet network

(**) 1 person/meeting, 1meeting/year in each of two organizations, duration for each meeting 4days, for two years