TURKISH ACCREDITATION AGENCY. Laboratory Accreditation Department

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1 TURKISH ACCREDITATION AGENCY Laboratory Accreditation Department

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3 Laboratory Accreditation Accreditation, is the evaluation, competence approval and regular assessment of Laboratories and Inspection Certification and Proficiency Testing Provider Bodies according to Nationally and Internationally Accepted Technical Criteria

4 As of 2008, TURKAK has signed a mutual recognition agreement with European Co-operation for Accreditation in all areas of accreditation subject to mutual recognition agreements. Our agency is a full member of European Co-operation for Accreditation (EA), International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC). Accreditation Standards Accreditation activities are carried out by TÜRKAK based on international standards. These standards are as follows; For Bodies Providing Laboratory Services: TS EN ISO/IEC For the Accreditation of Medical Laboratories: TS EN ISO For the Accreditation of Proficiency Testing Provider Bodies: TS EN ISO/IEC For Inspection Bodies: TS EN ISO/IEC For Personnel Certification Bodies: TS EN ISO/IEC For Management System Certification Bodies: TS EN ISO/IEC For Product Certification Bodies: TS EN ISO/IEC 17065

5 Accreditation activities are carried out by TURKAK based on international standards. When the national accreditation system is observed, it is noticed that laboratory sector is among the important fields of service. In this sector; there are testing-calibration laboratories and medical laboratories. A measurement infrastructure which ensures the accuracy of the works conducted in these laboratories requires measurement reliability and traceability of the measurements conducted by laboratories and compatibility of measurement works. The basic document used by TURKAK for the accreditation of testing and calibration laboratories is TS EN ISO/IEC standard. And the basic document used by TURKAK for the accreditation of medical laboratories is TS EN ISO standard. The basic document used by TURKAK for the accreditation of testing and calibration laboratories is TS EN ISO/ IEC standard. And the basic document used by TURKAK for the accreditation of medical laboratories is TS EN ISO standard. In our country, accreditation of laboratories relies on a voluntary basis (regulatory bodies may make accreditation obligatory), a laboratory becomes ready for accreditation by ensuring conformity with the relevant standard. However, in addition to this standard, documents containing additional criteria on the working fields of laboratories can also be used when necessary. TS EN ISO/ IEC and TS EN ISO Standards only provide general principles, general approaches, policies and the measures required for technical competence. Additional criteria for certain implementations are prepared separately according to the working field of laboratories by European Co-operation for Accreditation (EA), International Laboratory Accreditation Cooperation (ILAC), European Network for Forensic Science Institutes (ENFSI), Legal Authorities and similar bodies. Guide documents have been prepared by relevant authorities on how to apply the standards and the additional criteria set by relevant authorities in laboratories and made available for the use of involved parties. It is recommended that the parties interested in laboratory accreditation benefit from these during the preparation for accreditation process.

6 Advantages of Being an Accredited Laboratory Laboratory accreditation represents national and international respectability as a reliable indicator of technical competence. By providing formal recognition of the laboratory competence, laboratory accreditation presents an easy way to customers for determining and selecting reliable testing, analysis and calibration services. There are significant differences in terms of respectability and reliability between the testing reports and certificates provided by any laboratory before and after it is accredited. Customers of accredited laboratories can be the bodies and businesses, inspection bodies and product certification bodies which demand testing reports and calibration certificates as well as industrial organizations and laboratories which are in the position of requesting the calibration of their measurement devices. World Trade Organization (WTO) demands that, in its member countries, conformity assessment processes are secured and technical competences and transparencies are ensured. The main instrument to secure the conformity assessment processes is accreditation. The main instrument to secure the conformity assessment processes is accreditation.

7 TS EN ISO/IEC Standard is concerned with the testing-calibration laboratories and TS EN ISO Standard is concerned with the medical laboratories general conditions for competence as well as laboratories ability to produce technically accurate and reliable results and their technical competence. By means of using only one standard on the international level as the indicator for laboratory competence, the aim is to ensure that all testing-calibration and medical laboratories around the world compete at the same level. Therefore, any testing report or calibration certificate issued by a laboratory which operate in conformity with these standards can have recognition abroad. The fact that the need for being subject to re-testing in the countries where the products were exported is decreased or eliminated becomes quite beneficial for the producer in terms of decreased time and costs. Since the reports prepared by a laboratory accredited according to TS EN ISO/IEC or TS EN ISO standard have international validity, it provides a wider market, in other words, a wider customer base for the laboratory. Since the reports prepared by a laboratory accredited according to TS EN ISO/IEC or TS EN ISO standard have international validity, it provides a wider market, in other words, a wider customer base for the laboratory.

8 Significance of Proficiency Testings and Comparison Measurements in Laboratory Accreditation As specified in TS EN ISO/IEC 17025, TS EN ISO Standards and relevant ILAC and EA guides, proficiency testings and comparison measurements are among the most important elements to be considered in ensuring the quality of the works conducted by the laboratory. In this context, participation in proficiency testings is considered as an important performance criterion for the evaluation of the technical competence of the laboratory. Therefore, before the laboratories which apply for accreditation are accredited in general fields within the accreditation scope of their demand, they must participate and succeed in at least one proficiency testing and/or inter-laboratory comparison scheme acceptable to TURKAK. In addition, in order for the accreditation to be sustained throughout the four-year period, accredited laboratories must divide the accreditation scopes into sub-fields and prepare and implement participation schemes for each divided sub-field. In the fields where proficiency testing or inter-laboratory comparison schemes are possible, accredited laboratories must participate in the relevant cycle. Laboratories must prepare their works related to proficiency testings by taking into account the procedure which contains TURKAK policies and keep relevant records accordingly. TURKAK s relevant policies on proficiency testings and comparison measurements are given in detail in P 704 Procedure on Proficiency Testings and Inter-laboratory Comparison Schemes.

9 Accreditation Process of Laboratories Provided that the documents which applicant testing-calibration laboratories and medical laboratories are required to submit before the accreditation assessment are complete, works for accreditation assessment shall be initiated. After the documents sent to TURKAK by the laboratory are examined by the assessment team, the assessment team goes to the laboratory for on-site assessment and following the completion of the assessment, the report prepared by the assessment team is submitted to TURKAK. When the corrective actions carried out by the laboratory for eliminating the non-conformities determined during the assessment are examined and deemed appropriate by the assessment team, the file is examined and concluded at the Accreditation Decision Board. R10.04 Guidance on Accreditation of Conformity Assessment Bodies which describes how to file an application for accreditation and which stages are involved is available on website. R10.04 Guidance on Accreditation of Conformity Assessment Bodies which describes how to file an application for accreditation and which stages are involved is available on website.

10 How to Identify Accredited Laboratories? Accreditation agency authorizes the accredited bodies to use the accreditation mark under the terms of accreditation contract. Laboratory shall use the accreditation mark in the testing, analysis, calibration and measurement reports it issues within the scopes in which it was accredited. In addition, accreditation agency prepares and publishes a list containing the names, addresses and accreditation scopes of the laboratories it has accredited. List of the bodies accredited by TURKAK is published on webpage. For Laboratory Accreditation Application: Turkish Accreditation Agency (TURKAK) Laboratory Accreditation Department (LAD) Mustafa Kemal Mahallesi Sokak No:1 Çankaya/ANKARA Tel : Fax :

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12 LAB-1_EN_04/2016 Rev.0 Turkish Accreditation Agency Mustafa Kemal Mahallesi Sokak No: 1 Çankaya/ANKARA Tel: (0312) Faks: (0312)