DOCUMENTS Country Report Expertise Centre COUNTRY REPORT 2006 - 2007

6 Key organisations of the quality infrastructure

6.1        Turkish Standards Institute (standardisation only)

6.1.1    Legislation

6.1.2    Process of standardisation 

6.1.2.1 Mirror technical committees (MTCs)

6.1.2.2 Strategic Policy Committee

6.1.2.3 Editorial Committees

6.1.3    New organisation of standardisation in TSE

6.1.4    Transparency of information towards the users

6.1.4.1     Business Plan

6.1.4.2 Quality manual

6.2        Conformity Assessment Bodies

6.2.1    The open system and its benefits

6.2.2    Conformity assessment bodies

6.2.2.1    TSE

6.2.2.1.1    General on TSE

6.2.2.1.2    TSE Products and Materials Testing

6.2.2.1.3    TSE Products and Materials Testing, Ankara and Gebze laboratories

6.2.2.1.4    TSE Product Certification

6.2.2.1.5    TSE Management Systems Certification

6.2.2.1.6    TSE Certification of persons

6.2.2.1.7    TSE Calibration

6.2.2.1.8    TSE in the import control

6.2.2.1.9    TSE as a Notified Body

6.2.2.2    Public conformity assessment bodies

6.2.2.3    Private conformity assessment bodies

6.2.3    Notified bodies

6.2.4    Associations of Conformity Assessment Bodies

6.2.4.1    UDDer

6.2.4.2    TURKLAB

6.3        TÜRKAK – Turkish National Accreditation Agency

6.3.1    Present organisation

6.3.2    International acceptance

6.3.3    Statistics

6.3.4    Role in the notification process 

6.4        Key institutions in metrology

6.4.1    UME, key institution for scientific and industrial metrology

6.4.2    MIT, the key institution in legal metrology

6.1        Turkish Standards Institute (standardisation only)

The Turkish standards institute (TSE) was founded in 1954 for the purpose of drawing up standards for all kinds of products and services. TSE is an independent, non-governmental, public organisation but, according to law 132, promulgated in 1960, only those standards adopted by TSE shall be called “Turkish standards”. Furthermore, the authorities have entrusted TSE with representing Turkey within the regional and international organisations dealing with standardisation. TSE was very active at the national level but also at the international level (ISO and IEC). In 2002 there were 18 129 Turkish standards in the TSE catalogue.

In 2002, an assessment of TSE showed that TSE’s organisation was efficient and adapted to national and centralised standardisation. Three pillars supported it:

• a network of “interested parties” who were consulted at certain key stages of the process (registration in the programme and enquiry prior to approval by the Technical Board);
• small groups of “professional experts”, centralised in Ankara, who had a highly sustained working rhythm and were interested in completing work rapidly thanks to fees;
• a TSE, which was independent of the interested parties and financially self-supporting, which enabled it to make rapid decisions without external pressure.

However, there were major weak points, which were as follows:

• absence of some economic stakeholders in the decision-making process;
• too few experts coming from private businesses;
• lack of visibility of the link between voluntary and mandatory standards;
• excessive dependence of standards on derived products (certification, laboratories);
• location and frequency of meetings (in Ankara only);
• Statute 132, promulgated in 1960.

This organisation did not correspond to the European standardisation organisations which were more open and more transparent. Therefore it was recommended that TSE proceed to both structural and methodological changes.

Further to the 1^st Country Report, TSE decided that the main objective would be to have a national system in line with European systems and, as a result, to seek CEN and CENELEC membership for TSE.

Consequently, a Meda Project “support to standardisation” was allocated to the AFNOR/AENOR/DIN/ÖN consortium. It was divided into 7 components: standardisation, legislation, working procedures including QMS, structure of TSE including TCs, business plan, CEN/CENELEC membership, implementation of the 98/34 directive and training of instructors. This project started on January 29, 2005 and should end by July 29, 2007.

Numerous changes were proposed and implemented within TSE, in particular over the course of the last two years, with a view to increasing the transparency of its organisation, to facilitating access of the system to Turkish economic actors, and thus to harmonising its practice with that of the European organisations.

6.1.1    Legislation

It is recalled that several provisions of the current legislation (i.e. Statute no. 132 for the establishment of the Turkish Standards Institution (1960)) are in contradiction to EU practice and that, as long as the current legislation remains in force, this would block TSE's application for full membership of CEN and CENELEC.

Therefore it was recommended in previous reports that Statute no. 132 be revised, or a new legislation on standardisation promulgated which inter alia:

• made no references to mandatory standards or to the ability of Ministries to confer mandatory status to Turkish Standards;
• included a clause which expressly encouraged voluntary standards implementation.
• made no references to TSE making payments to members of its Technical Committees for their participation;
• made reference to TSE’s status as the officially recognised body in Turkey for standards in all areas, particularly those covered by CEN and CENELEC, and authorised TSE to represent Turkey in European and international standardisation fora;
• made reference to the copyright of Turkish Standards belonging to TSE.

Amendments to Statute no. 132 for the establishment of TSE have been prepared by TSE and the Ministry of Industry and Trade and have to be sent to the Prime Minister for formal ratification, prior to being submitted to Parliament.

It is understood that the amendments of the legislation addressed the above recommendations. However, although TSE has confirmed that it intends to terminate its current practice of paying fees to the experts who participate in its Technical Committee work, an ambiguous clause could remain in the legislation. If such a clause remains, it could impede TSE's application for full CEN and CENELEC membership.

6.1.2    Process of standardisation 

Until 2004, the process was organised around small groups, initially called Standard Preparatory Groups (SPGs) then Technical Committees (TCs), where experts were very few (2 to 4) and appointed and paid by TSE. In order to open up its technical structures to all the Turkish economic stakeholders, TSE has completely restructured its standardisation process. The latter now relies on technical structures or so-called “mirror technical committees” (MTCs) which are the core of the system. The MTCs are open to all interested parties and are entrusted with defining national positions and approving standards. They also rely on the “upstream” side on a “Strategic policy committee” (SPC) and an “Arbitration committee” (AC).

6.1.2.1 Mirror technical committees (MTCs)

These committees are the core of the standardisation process and are the basic tool of this process. They are in charge of defining the national positions on European and international draft standards and of approving Turkish standards. They are open to all interested parties, whether public or private, without limitation of the number of experts who, in addition are appointed by the parties concerned, and are therefore official representatives of the latter. These experts are not paid any fees for their participation.

TSE Board of Directors on April 2004 approved the MTC Directive which determines the terms of reference of MTCs and the working rules and procedures to be applied. The first announcement emphasizing TSE’s decision for setting up mirror technical committees and inviting the public to participate in the work of technical committees as mirror committee members and contribute to the development of standards was made on June 10, 2004 to the private firms and sectoral unions and associations. This announcement was made on a sectoral basis with a list of technical committees chosen sectorwise.

Moreover, a publicly accessible link where one could access the list of technical committees, the guidelines for MTC work and the criteria for membership was created on TSE website in October 2004. 

On October 8, 2004, a second announcement was made to universities, chambers of commerce and industry, commodity exchanges, export unions, consumer associations and all Ministries. A meeting introducing mirror technical committees was held in Ankara on December 15, 2004.

As of November 2006, there are 86 mirror technical committees, which follow 185 international and European technical working bodies within ISO and IEC and within CEN and CENELEC.

The participation is as follows:

The average participation is about 10 people, however participation varies depending on the sector: only 3 experts in MTC « Furniture » and 39 experts in MTC « Fire safety in buildings »! Generaly speaking, private sector and main technical ministries (For example Industry and Trade, Public Works, Health, etc…) are well represented, but there are very few representatives of consumers’ organisations.

TSE is continuing its efforts to ensure the balanced representation of all stakeholders in the mirror technical committees and active participation at European and international levels by using various communication channels such as conferences, workshops, briefings, internet, newsletter, etc. TSE’s objective is to double the number of experts on MTCs within 2 years: 1500 experts in 2008.

Note: Concerning the merger of mirror technical committees (MTCs) and national technical committees (NTCs), the work is in progress and it is planned to be finalised by 2007. To achieve this goal, the number of national technical committee members was reduced from 197 to 117, during the last four years, and the number of national technical committees was reduced from 37 to 24.

6.1.2.2 Strategic Policy Committee

The “Strategic Policy Committee” is entrusted with drafting TSE’s standardisation programme and policy. It is composed of 12 to 15 members appointed by the Board of directors, one half representing the public authorities (among which the ministries) and the other half originating from the private sector (professional organisations, universities, consumer organisations). It holds meetings twice a year.

6.1.2.3 Editorial Committees

The “Editorial committees” are set up as need be in order to check the quality of the versions of the standards in Turkish and their consistency with the rest of the national collection. They can be compared with the “editing committees” at CEN or ISO.

6.1.3    New organisation of standardisation in TSE

All technical activities which, until 2003, were distributed between 2 departments are now regrouped in the Standards Preparation Center (SPC) and the Directorate of National Technical Committees is responsible for all activities related with the preparation of Turkish Standards, starting from the inclusion of new work items in the work programme up to the publication of the standard. Moreover, two new divisions, the Directorate of Library and the Directorate of Document Selling and Information, have been included in SPC, excluded from the IT Department and connected to the Standards Preparation Centre.

Now all activities relating to standardisation are therefore regrouped within one single entity, SPC, and well separated from the other TSE activities (such as certification, testing, calibration)( see Annex 6). This unit has been given its own internal budget, and its resources and charges are well identified. In order to face the increase in standardisation activities, including the development of MTCs, it is planned in SPC Business Plan (2007-2011) that the budget will be increased by 10 % each year over the future three years.

6.1.4    Transparency of information towards the users

In order to improve the transparency of its standardisation activities, TSE has decided to better inform its users on what its actions are, how they are performed, and what they will be tomorrow. To achieve this goal, it will rely on the following three tools:

• a Business Plan
• a Quality Manual
• its Website

6.1.4.1     Business Plan

A Business Plan has been prepared by TSE with the support of the Meda Project “Support to standardisation ». This Business Plan covers the period 2007-2011 and includes the main following data:

• role of standardisation and functioning of TSE with its new organisation (with respect to MTCs in particular);
• development policy for the standardisation activity, on both qualitative and quantitative planes; For example:

§         to increase the number of mirror committees and their members during the period of this business plan( 1500 experts in 2008 !)

§         to held international and European technical committee meetings in Turkey : to host at least 10 international and European technical committee/sub committee/working group meeting in Turkey during the BP period.

§         to encourage active participation in international and European level: it is planned to hold secretariat duties of ISO, IEC, CEN and CENELEC technical committees.

§         training for standards developers will be organized

• diffusion policy for standards and related documents;
• financial aspects.

As soon as it is adopted by the Board of Directors, this document will be used as a communication tool towards all stakeholders to improve their understanding of TSE functioning and objectives. This will make it easier for them to get involved in the work of interest to them.

6.1.4.2 Quality manual

One of the objectives of the Meda Project “support to standardisation » was to prepare a specific Quality Management System (QMS) for standardisation in TSE. First priority was the elaboration of a QM (Quality Manual). The Quality Management System is now established and the Quality Manual is available. All the quality documentation has been reviewed and modified, including the terms of reference, the working rules and procedures of MTC. This document or extracts form the document, will be circulated, not only to existing experts, but also to new experts to inform them of SPC’s rules of functioning, but also of their rights and duties.

TSE decided that more regular updating was necessary, and that additional information had to be supplied on the decisions made by European and international organisations. More specific information on new work items will also be given.

Concerning MTCs, the site will give the following information: list of the committees, correspondence with European and international TCs, working procedures and procedures for becoming an expert.

For two years TSE has been accelerating the reform of its internal and external practices in order to be organised in the same manner as the large European standards institutes. In 2006, a new organisation was implemented (see Annex 6) with a clear separation between standardisation activities and other activities (certification, testing, inspection and calibration). The standardisation activities (standards drafting, dissemination of information, sales of standards) are regrouped within one unit, being well defined and having its own budget. The standardisation process has been completely restructured. It now relies on MTCs which are open to experts appointed by the interested parties. The standardisation policy and the rules of operation are made available to all economic stakeholders and will soon be widely published. Amendments to the existing legislation have been suggested to the Ministry so as to align it completely with the European Union. A more transparent and more open TSE is now working along rules in accordance with those of the European organisations. It should now be able to be accepted as a CEN and CENELEC member provided the amendments to the current legislation are accepted by the authorities.

6.2        Conformity Assessment Bodies

6.2.1    The open system and its benefits

The principle of free movement of goods is one of the cornerstones of EU’s internal market. For products that have been the subject of harmonisation, member states are forbidden to maintain barriers to trade, all aiming at easier circulation of goods on the market. The New Approach and European standardisation have contributed significantly to the development.

The New Approach is based on the following principles.

Ø Harmonisation is limited to essential requirements as expressed in the directives.

Ø Only products fulfilling the essential requirements may be placed on the market and put into service.

Ø Harmonised standards published in the Official Journal and transposed into national standards, are presumed to conform to the corresponding essential requirements.

Ø Application of harmonised standards remains voluntary and manufacturers are free to choose any technical solution that provides compliance with the essential requirements.

Ø Manufacturers may choose between different conformity assessment procedures provided for in the applicable directive. Manufacturers or importers are responsible for their products.

Ø Qualified conformity assessment bodies may be appointed as notified bodies, are considered as equals and can freely compete on the common market.

Ø Consequently there is no need of specific appointed key organisations in conformity assessment. Actors on the conformity assessment market are only due to qualification requirements, but free to act in free competition on the market.

6.2.2    Conformity assessment bodies

6.2.2.1    TSE

6.2.2.1.1    General on TSE

TSE was founded in 1954 and still based on Law 132 from 1960 giving TSE the status as a separate legal entity, a public agency. The duty of TSE is to perform all activities for encouraging high quality production in conformity with the standards and issuing related certificates thereto. TSE is in principle an independent non-governmental organisation. TSE is active in calibration, product testing, product certification, inspection, management system certification, certification of persons and training. TSE’s head quarters are in Ankara, while calibration, product testing, management system certification and product certification services also are offered from regional branch offices. TSE has technical facilities in 12 provinces and representatives in 27 cities. Apart from this TSE has a representation in further 4 Turkic countries. TSE has been a conformity assessment body for 52 years and has deep relations both at a national and an international level.

While TSE over the last years already continuously has made organisational changes to meet its new role in conformity assessment a draft law will introduce a number of changes in the TSE structure giving TSE freedom to act freely on a market under competition. TSE’s main clients come from the following sectors: electrotechnical, construction, machinery, automotive, chemical and food. The private area dominates these sectors.

6.2.2.1.2    TSE Products and Materials Testing

TSE applied for TÜRKAK accreditation in testing in 2001 and received their accreditation in 2003. Their total accredited scope can be found on the TÜRKAK website: www.turkak.org.tr.

The TSE statistics on the total number of test reports presents a gradual decrease over the last years as a result of the removal of mandatory standards. The distribution of TSE test reports between product categories over the last years is shown in Annex 10 together with further statistics on testing activities in the TSE Ankara and Gebze laboratories.

6.2.2.1.3    TSE Products and Materials Testing, Ankara and Gebze laboratories

Statistics on test reports from the major TSE laboratories in Ankara and Gebze have been analysed and demonstrated in Annex 10.

Ø      The numbers of reports in electrical, electronics and mechanical testing have gradually decreased over the last two years. These product areas were dominated by test on imported goods and the declining statistics fully reflects an increase in tests on imported goods. The Ankara Mechanical laboratory was closed from July 2006.

Ø      The number of reports in construction materials testing has rapidly decreased during 2006. This most probably reflects manufacturers waiting that the CPD, Construction products directive, becomes mandatory in January 2007. The implementation of a new mandatory certification mark, the G-mark, for construction materials may influence future testing.

Ø      The number of reports in chemical testing has as well rapidly decreased during 2006, reflecting removal of mandatory standards under the Turkish Import regime.

6.2.2.1.4    TSE Product Certification

TSE Product Certification Center is developing its product certification in a European direction. In addition TSE is studying how to expand its business both inside Turkey and abroad, including both in EU and Middle Eastern countries. The new law on TSE will open up the possibilities. However, TSE considers that the investment needed prevents from entering into vehicle testing.

TSE Product certification has been re-organised to meet the new situation with two subdivisions, one each for voluntary and mandatory certification activities. TSE is not yet accredited by TÜRKAK as a product certification body. Their product certification schemes cover more than 2000 products.

Since 2003 TSE is the Turkish recognizing body in the Common Criteria Recognition Arrangement for IT certification. TSE will use TUBITAK laboratories for evaluations to the Common Criteria (ISO 15408).

TSE still offers a variety of product certifications, both the voluntary and regulated fields, as listed in Annex 11. 

The number of TSE certificates has developed as follows:

6.2.2.1.5    TSE Management Systems Certification

TSE has been accredited from TÜRKAK for system certification since 2001. TSE issued 65 of the first 100 management system certificates to big companies in Turkey and have since then developed to offering certification to a variety of standards with a development as follows.

Annex 12 illustrates further details on TSE management system certification.

6.2.2.1.6    TSE Certification of persons

TSE was the very first organisation in Turkey accredited to grant certificates to persons.

TSE is the Turkish member of EOQ, European organisation for Quality and has applied for membership in EFNDT, European Foundation for Non Destructive Testing.

TSE maintains and develop a leading role in the personnel certification field in Turkey, has in September 2006 renewed its accreditation by TÜRKAK to TS ISO/IEC 17024, replacing EN 45013, and covers the following areas:

Ø Quality Categories (Auditor, Manager, Professional)………. also recognised by EOQ

Ø Environmental Categories (Auditor, Manager) ……………… also recognised by EOQ

Ø OHSAS (Auditor, Manager)……………………………………. also recognised by EOQ

Ø Welders 

Ø Non-destructive testing, NDT 

Ø Safety Data Sheet Preparing Personnel 

Ø Occupational Standards (Police, Secretary, Drivers of Refuse collection vehicle)

Notable new areas in certification of persons started by TSE in the last year are:

Ø Food Safety (HACCP) personnel (Manager, Auditor), 40 certificates issued

Ø Auditors in good agriculture practise, 75 certificates issued

Ø NDT, visual testing, > 20 certificates issued

Ø Automatic welding operators, 10 certificates issued

Ø Copper welders, so far no certificates issued

Further areas in certification of persons planned by TSE are:

Ø Information Security Management System personnel (Auditor)

Ø Quality management System Personnel in Healthcare (Manager, Technician)

Ø Safety Advisor for the transportation of Dangerous goods

Ø A number of occupational standards

The numbers of certifications granted by TSE up to the end of November 2006 are demonstrating the rapid growth rate:

TSE also offers a large number of training courses and seminars. These cover, among others, the following topics.

Ø Training in the accreditation standards

Ø EU legislation in general

Ø Specific EC directives

Ø Technical standards under the directives.

6.2.2.1.7    TSE Calibration

TSE has become more competitive, free to set its prices, that has resulted in more calibrations. TSE still has problems with its biomedical calibrations and tests, despite that this is a rapidly growing field, now the biggest for TSE metrology.

In particular the TSE subsidiary calibration company SOJUZTEST offers very competitive calibrations and tests but accredited by a Russian accreditation body without any relation to EA. TSE has declared that when TÜRKAK has become a signatory to the EA-MLA, the accreditation of SOJUZTEST will be transferred to TÜRKAK.

TSE calibration services are offered from the Ankara, Gebze and Bursa offices and seem to be developing very satisfactory.

TSE mainly takes traceability from UME with whom it has a very good relation, but in a few cases, foreign laboratories are used, when offering the same service at significantly lower price.

Uncertainties and Inter laboratory comparisons are fully implemented in TSE Metrology.

See further statistics on TSE calibration activities in Annex 15.

6.2.2.1.8    TSE in the import control

TSE’s obligations for the inspection and testing of imported goods as required by the regulations (under Law No 1703:1930) from the Undersecretariat for Foreign Trade, DTM, are dealt with by TSE Certification of Imported Goods Department.

6.2.2.1.9    TSE as a Notified Body

TSE has a broad area of competence that relates to several new approach directives. So far TSE has applied to respective ministry for 12 EU directives. After evaluation by TÜRKAK 8 applications have been forwarded by DTM to the EU Commission. Six of these directives are under the Ministry of Industry and Trade, MIT, the Toys directive under the Ministry of Health, MoH, and the Construction Products directive under the Ministry of Public Works and Settlements, MPWS.

Annex 16 illustrates the TSE progress towards being a Notified Body. The EU Commission has accepted TSE as NB for the Lifts directive, its NB nr being 1783. TSE’s applications to further 3 directives have been approved, but not yet listed by the EU Commission, CEC.

6.2.2.2    Public conformity assessment bodies

There are around 1 200 public service laboratories in Turkey, all areas included. Some organisations have very advanced laboratories, like Istanbul University. Ministries most often have their own inspectorates in the 81 provinces around Turkey.

Ministry of Industry and Trade, MIT, identified in 2002 around 1 200 conformity assessment bodies in their field of responsibility. MIT considers that these cover the needs of the Turkish market, except for testing of explosives for civil use, verification of energy labelling and testing of hot water boilers.

The Ministry of Health, MoH, has 81 provincial Public Health laboratories. The Public Health Laboratories perform air pollution, food and biological tests as well as some medical tests (pregnancy test, etc.). Detergents, cosmetics and pharmaceutical products are tested by the Ministry’s own laboratories, the Refik Saydam Hygiene Center in Ankara and seven regional laboratories in Istanbul, Samsun, Izmir, Adana, Erzurum, Diyarbakir and Antalya.

The Telecommunications Authority has its own laboratories for radio communication and PSTN (Public Switch Telephone Network) testing, mainly used for market surveillance purposes. A new laboratory also mainly meant for market surveillance activities were equipped for SAR, Special Absorbing Rate, EMC, OATS, Open Area Test Site, PSTN, Public Switch Telephone Network, testing as well as Low Voltage Directive, LVD, tests for R&TTE products.

Testing of products to the R&TTE Directive is also offered by the following public organisations:

Ø TÜBITAK-UEKAE, that has an EMC laboratory used for R&TTE testing.

Ø TÜBITAK-UME, with competence in EMC and radio communication testing.

Ø TSE Gebze labs, with facilities for EMC and Public Switch Telephone Network testing.

Ø YıldızCell, a part of Yıldız Technical University, active in GSM technology and research.

Some examples on further public organizations offering conformity assessment services:

Ø KOSGEB’s laboratories do mechanical testing and materials analysis, incl. spectral analysis. KOSGEB also offers help to companies in developing their Quality Management Systems.

Ø TÜBITAK-ÜSAM has three laboratories: Electronic Cards Maintenance and Repair Laboratory, Textile Testing and Quality Control Laboratory and Design and Rapid Prototyping Laboratory.

Ø The TAMTEST laboratories have three main departments: Agricultural Power Resources Department, Farm Mechanization Department, Plant Protection Machinery Department.

Ø TÜBITAK-MRC’s Material and Chemical Technologies Research Institute, MCTRI, has since its start served industry in research projects and testing, including regular materials testing.

Ø EGE University Research Centres try to focus on areas of interest to industry and exporters.

Ø METU - Middle East Technical University has some of its laboratories already offering services to the outside market and so does its Petroleum Research Centre (PRC).

6.2.2.3    Private conformity assessment bodies

A lot of testing laboratories exist in the private sector and big exporting manufacturing companies often have their own laboratories.

Some examples on private conformity assessment bodies:

Ø 24 private laboratories are authorised by TARIM for food testing on demand from TARIM’s 81 provincial inspectorates, but also offering testing directly to manufacturers, farmers, etc.

Ø SimKal, earlier SIMKO, was originally set up 1989 as in-house calibration laboratory within Siemens in both electrotechnical and mechanical second level calibrations.

Ø Türk Loydu has a laboratory of its own to support its inspection services. 

Ø ESIM offer testing services to manufacturers of electric and electronic products, but is also active in certification of quality systems and third party inspection.

Ø Meyer has the capability to test products under the Medical Device, the Active Implantable Medical Devices and the In Vitro Diagnostic Medical Devices directives.

Ø Kalite Sistem Laboratuar Grubu, KSG, in Istanbul does food safety test for TARIM and performs analyses for TSE as the bases for TSE certificates of conformity.

Ø TUV Teknik Kontrol Belgelendirme in Istanbul is a management system certification body working to the standards ISO/IEC 9001, QS 9000, ISO 14001, OSHAS, and ISO 16949.

Ø Classification and quality services, Gözetim, in Istanbul is a classification company being part of the Lloyd’s Register group and has been active on the Turkish market since 1951.

Ø Centro Laboratories in Istanbul is offering a broad range of medical testing and analysis.

Ø DÜZEN Laboratories in Ankara is a clinical biochemistry laboratory doing tests for private persons and for hospitals. They have both in vivo and in vitro analyses.

Ø Çevre Group of Laboratories in Istanbul has textiles, industrial and food laboratories of has a broad range of accreditations, authorizations and certifications.

Ø KTU Mechanical Engineering Department laboratories also sell testing services to industry.

Ø Bureau Veritas in Istanbul offers textile testing, analytical chemistry and inspection.

Ø Turkish Cement Manufacturers’ Association, TCMB, laboratories do testing and research on cement and similar materials for its member companies.

Ø The Aflatoxin and food Analysis Laboratory under the Commodity Exchange determines the quality of products offered on the market as a service to both producers and exporters.

Ø EGE Calibration Laboratory and Metrology Training Center, founded in 1997, is owned by the Chamber of Mechanical Engineers and Chamber of Electrical Engineers Izmir Branches.

Ø DAF is an inspection body of type C that performs inspections according to EU Council Directive 96/96/EC, roadworthiness tests for motor vehicles and their trailers.

Ø Environmental Counselling Centre does wastewater and pollution tests.

Some examples on industry with in house conformity assessment services:

Ø Gürsoy, producer of hazel nut products, has in-house laboratories for most of its needs, including an aflatoxin laboratory that is authorised by TARIM.

Ø ÖZCAY KOOP, tea producer, established its own laboratory for in house analyses in 1991.

Ø Zümrüt Food Industry has its own laboratory to perform test on raw materials, process control tests as well as tests of finished products.

Ø Super Film Packaging Industry has its own laboratories for Research and Development and in-house measurements, but some tests are done by KOSGEB and also at Universities.

Ø Başer Ambalaj has its own in-house laboratory for its production control, but some materials testing needs to be done at external laboratories.

Ø KAMBETON, concrete manufacturer, has its own in-house laboratory for its production control. Raw material is tested throughout the production process.

Ø The Vicat Group has its own laboratories at both of its Turkish cement factories. The Konya laboratory has testing facilities both for cement and concrete. It will be organised as a separate company to offer tests on a commercial basis also to external clients.

Ø EGEMET has its own calibration laboratory also marketing its services.

Ø The Turkish Renault factory has an internal quality control and an evaluation system for parts and products from external sources.

Ø The Izmit water treatment plant has a in-house laboratory that makes analyses, including microbiological, of the water quality in different stages of the process.

6.2.3    Notified bodies

Annex 13 lists the Turkish potential Notified Bodies as indicated by the Undersecretariat for Foreign Trade, DTM, and the Ministry of Industry and Trade, MIT, respectively.

The DTM list cover 12 organisations competent to be notified as in total 31 NBs to 14 directives.

The MIT list cover 11 organisations competent to be notified as in total 39 NBs to 12 directives.

The lists from DTM and MIT result together in that totally 16 organisations, besides universities, are listed as competent to be in total 50 NBs to 17 directives.

Annex 16 illustrates the TSE progress towards being a Notified Body, as a first step potentially to 8 directives.

6.2.4    Associations of Conformity Assessment Bodies

6.2.4.1    UDDer

The Conformity Assessment Board was established in 2003 and served as an advisory board to all stakeholders in conformity assessment: public authorities, private sector, consumer federations and CABs. DTM was responsible for the chairmanship of the Board and enhanced its initiatives. DTM further took the initiative to establish an association in order to increase the functioning of the Conformity Assessment Board while replacing it. A draft regulation for an Association of Conformity Assessment, UDDer, was accepted by the members of the Conformity Assessment Board and UDDer was established in June 2006. UDDer is set up as an association to set policy and vision on the overall quality infrastructure. UDDer had its first Steering Committee on 23 November and its first General Assembly on 15 December 2006. UDDer is established as a NGO and still chaired by DTM. It will represent and serve all stakeholders in the Turkish quality infrastructure, both the private and public sectors.

6.2.4.2    TURKLAB

The first country report 2002-2003 proposed that a Laboratory Association (TURKLAB) should be set up similar to the national members of EUROLAB in the EU countries. Such an association could establish the forum for exchange of experience between laboratories, act as the voice of the laboratories as a group and form the Turkish member of EUROLAB.

The second country report 2003-2004 could inform that 7 companies (4 testing laboratories and 3 calibration laboratories) as founding members were in process to establish TURKLAB as an association of laboratories in Turkey.

The third country report 2004-2005 could inform that TURKLAB as the Turkish organisation of laboratories, both accredited and non-accredited, had 34 members all of which were private enterprise laboratories. Furthermore, EUROLAB National Members’ Meeting on 2004-10-26 approved TURKLAB as a EUROLAB International Affiliate Member.

The fourth country report 2005-2006 could inform that TURKLAB had reached 48 members out of which 30 % were calibration laboratories and 70 % testing and analysis laboratories. Two of the members were non-private: TSE and a cement testing laboratory.

In this final report TURKLAB can be reported as a vital organisation with 51 members, one third accredited, 49 private and 2 public, 36 testing and 15 calibration laboratories. See Annex 7.

Annex 8 shows an extract of the Articles of Association of TURKLAB. TURKLAB is an association of calibration and testing laboratories with the membership policy to accept both accredited and non-accredited laboratories, private as well as public and independent of their size of business. During last years both big and public laboratories has show interest in membership, with TSE as an example on both and being a strong supporter of TURKLAB, holding a position in its Board. Further membership applications are expected in the near future from public laboratories as their new regulations so permit.

The Board of TURKLAB has seven members who meet monthly. TURKLAB has no permanent office and is entirely dependent on the board members and the contributions from their companies. TURKLAB’s ability to promote its activities and arrange seminars and other events could improve with an own office, but the membership fees could yet not finance such a step. TÜRKAK apply a flat fee of around 200 Euro per member independent of size of organisation.

TURKLAB’s website www.turklab.org supplies open information on TURKLAB and technical matters as well as information exclusive to members. The English version of the page is under construction. TURKLAB is developing a database of laboratories that aims to cover members as well as non-members.

TURKLAB has last year established specialised subgroups in the following areas: environmental, food, textiles and cement testing laboratories, health labs expected to be next.

TURKLAB arranges workshops to help member laboratories in their accreditation process.

TURKLAB has discussed the competition between the private and Governmental laboratories in the three authorisation schemes and sent a recommendation to the ministries to require quality systems and perform proper audits before granting authorizations.

Ø Food testing under the Ministry of Agriculture and Rural Affairs, TARIM

Ø Medical testing under the Ministry of Health

Ø Cement and concrete testing under the Ministry of Public Works and Settlement

TURKLAB has worked in close co-operation with the EU MEDA Program Expertise Center. Several technical training programs have been performed during 2006 with TURKLAB as the beneficiary body, and the laboratory community of Turkey as the target group:

After the end of support from the EU MEDA project TURKLAB needs to finance corresponding training programs with fees from the participants.

TURKLAB has also been very active in participating in meetings during 2006:

Besides being member in EUROLAB, TURKLAB would benefit from membership in the “stakeholder members” group within EA and ILAC. However, time would not allow the active Board members to cover also this.

6.3        TÜRKAK – Turkish National Accreditation Agency

6.3.1    Present organisation

In its present organisation TÜRKAK has 33 employees. It has moved to new offices with an infrastructure that supports the needs of the organisation properly. The organisational structureremains still the same as forseen in the law on TÜRKAK. However, the decision making process revelant to accreditation status of assessed bodies has been modified after the peer-evaluation of TÜRKAK by EA. At present, accreditation decisions are taken by an authorized committee composed of the General Secretary and two deputies who are more competent in evaluating accreditation operations than the Board of Management.

TÜRKAK has 4 sector committees.

-          Certification Sector Committee

-          Inspection Sector Committee

-          Calibration Sector Committee

-          Food Sector Committee

TÜRKAK has developed its cooperation with stakeholders. For example, TÜRKAK cooperates with TÜRKLAB in its training courses. However, there are also issues for which TÜRKAK is being criticised by its stakeholders. One of these is the fee structure in which, apart from the direct costs for surveillance, the conformity assessment bodies have to pay a 1% turn-over fee. This fee structure is imposed by the TÜRKAK law and will hopefully change with the amendment which is in the pipeline. The other aspect of costs is the fact that TÜRKAK still needs to employ foreign assessors in many fields. The fees of the foreign assessors are substantially higher than those of the national assessors. This direct cost is passed on to the clients and causes dissatisfaction among the clients of TÜRKAK.

Traceability is a very important issue in conformity assessment work. TÜRKAK has a protocol with the Turkish National Metrology Institute, UME, covering many aspects of the cooperation b etween the two organisations. UME provides traceability for the accredited calibration laboratories, technical assessors, interlaboratory comparisons and proficiency testing. This protocol is going to be revised very soon to update it to the needs of the present market and the present status of the two organisations. TÜRKAK and UME are also cooperating on the subject of traceability in the medical sector. UME, the Ministry of Health, TSE and TÜRKAK are planning to have a meeting on traceability in the medical sector and accreditation in the medical area.

UME is both a client and a cooperation partner of TÜRKAK. UME is accredited by TÜRKAK for its top level calibration facilities. The technical assessors used were experts from other National Metrology Institutes. UME has also been assessed as a notified body for the Non-automatic Weighing Instruments directive.

6.3.2    International acceptance

The development and present status of TÜRKAK is the biggest success story of the present project. Many of the development projects proposed by the experts for TÜRKAK were taken on board immediately by TÜRKAK management and solved with its own efforts and in some cases with support from Germany. In this respect the TÜRKAK management has shown great capability to take action in its own capacity. The support provided to TÜRKAK during the project has therefore been of a more advanced nature than what was envisaged from the beginning. For this purpose, EA has led a cooperation project with TÜRKAK to help TÜRKAK reach the ultimate goal to sign the EA MLA and cobsequently the ILAC and IAF MRA arrangements.

Since April 2006 TÜRKAK is a signatory to the EA MLA for testing, calibration, inspection, QMS certification. TÜRKAK has also applied to be evaluated for product certification, EMS and certification of persons. The evaluation is expected to take place during 2007.

Since May 2006, TÜRKAK is also a signatory to the ILAC MRA for testing and calibration. In June 2006, TÜRKAK has applie for membership of IAF

Being in a region with neighbours in two continents, TÜRKAK has had the advantage of being able to cooperate with both east and west. TÜRKAK has training activities in countries like Azerbaijan, Uzbekistan, Kazakhstan, Kyrgyzstan, Tatarstan, Mongolia, Moldova. It has also been asked to arrange training courses in Saudi Arabia. TÜRKAK has also training activities for the countries in the Middle East and South Western Asia. Thus TÜRKAK contributes to the dissemination of the international European accreditation practices in a developing region.

TÜRKAK has participated in a number of projects since 2000, in order to reach its present status. Some of these are listed here.

• PTB Project: This is the technical support project of Germany in order to build an accreditation system in Turkey. It started in 2000 and was completed at the end of 2005.
• MEDA Project: In 2006, within the DELTUR/MEDTQ/040-04 project TÜRKAK experts have made study visits to EA member accreditation bodies such as SWEDAC (Sweden), NA (Norway), UKAS (United Kingdom) and RvA (The Netherlands).
• GLP ‘Good Laboratory Practice’: Twinning Project between Slovakian Standards, Metrology and Testing Institution and Refik Saydam Hygiene Center is commenced. The duration of the project is 21 Month. Interministerial consensus was reached for the national GLP Monitoring Authority to be established within the Turkish Accreditation Agency (TÜRKAK)
• EU-MEDA Proficiency Testing and Interlaboratory Comparisons:Identification, Support and Evaluation: The long term technical support project is commenced on December 2005 and the duration of the project is 19 months. TÜRKAK supports the project by giving a working office, located in TÜRKAK premises, to the national/international experts. TÜRKAK also supports the project by giving permission to use TÜRKAK’s training and meeting rooms free of charge.
• Accreditation Awareness Raising Project: Total duration of the project commenced on September 2006 is 9. The project team is supported by TÜRKAK Training and Public Relations Department.

In the meanwhile TÜRKAK continues its cooperation project with EA in order to strengthen its quality infrastructure.

In summary, TÜRKAK has achieved international acceptance by,

• Taking on board without delay all proposed improvements and developments
• Using its resources in the best way to achieve its goals
• Using the foreign resources provided to it in the best manner to achieve its goals
• Signing the EA MLA and the ILAC MRA
• Using its acceptance among its eastern neighbours to disseminate European and international accreditation practices.

6.3.3    Statistics

For 2007 TÜRKAK expects 30 applications from inspection bodies, 3-4 applications from product certification bodies, 20applications from QMS cetification bodies and 2-3 applications from person certification bodies.

The table above shows statistics on the training programmes provided by TÜRKAK. This also shows that TÜRKAK has trained a total of almost 500 assessors.