Pestisit kalıntı analizlerinde kalite sistemleri: ISO 17025 ve OECD-GLP

Ulusal tüketim ve uluslar arası ticaret ile ilgili olarak kalıntı analiz verilerinin kalitesi çok önemlidir. Bu anlamda ISO 17025 gereklilikleri ve İyi Laboratuvar Pratikleri (Good Laboratory Practices, GLPs) düzenlemelerinin her ikisi de veri kalitesini sağlamak için tasarlanmışlardır. Verilerin güvenirliği nin ISO 17025 akreditasyonu ve E konomik İşbirliği ve Kalkınma Organizasyonu – İyi Laboratuvar Pratikleri (OECD - GLP) gibi üniversal kalite sistemleri tarafından o naylanmaları gereği vardır. Laboratuvar aktiviteleri ISO 17025 akreditasyonu veya OECD - GLP sistemlerinin gerekliliklerine uygun olmalıdır. Bu iki sistem çok kolay ve karşılaştırılabilir özelliktedirler. Her iki sistemde kimyasal, analitik ve mikrobiyolojik testler gerçekleştirilir. Farklılıkları ise iki dökümanın hedefleri ve ele alınma zamanlarının farklı olmasından kaynaklanmakta dır. Bu durum her iki sistem için geçerli olan yönlerinin avantajlarını kullanarak tek bir sistem olarak birleştirilmesiyle iyileştir i lebilir. Bu makalede her iki kalite sisteminin benzerlikleri, farklılıkları, örtüşen konularını ortaya konulması amaçlanmı ştır. Aynı zamanda Türkiye‟de kalıntı laboratuvarları için ISO 17025 akreditasyonu ve OECD - GLP prensipleri ile ilgili son durumları özetlenmiştir.

Quality systems for pestıcide residue analyses: ISO 17025 and OECD-GLP

Quality of residue analytical data has a great importance with regarded to national food consumption and international trade. In this respect ISO 17025 requirements and Good Laboratory Practices (GLPs) regulations are both designed to assure data quality. Reliability of data should be approved by universally accepted quality systems such as ISO 17025 accreditation and the Organization for Economic Cooperation and Development g ood laboratory practice (OECD - GLP). Laboratory operations should meet the requirements of a recognized accreditation scheme, complying with ISO 17025 or Good Laboratory Practice (GLP). The requirements of ISO 17025 and OECD - GLP principles are very similar and compatible. Both systems perform chemical, analytical and microbiological tests. The differences are mainly due to scope of two documents and the difference in time scale of their elaboration. They could be integrated into one overall system taking adv antage of the aspects common to both. This article deals with similarity, differences and overlapping issues of two quality systems. Also latest status of ISO/IEC 17025 accreditation and implementation of OECD - GLP principles for pesticide residue laborator ies in Turkey will briefly be summarized.

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  • Güzeldemir, M.E. Kalite Yönetimi. 13. Ulusal Yoğun Bakım Kongresi 3-7 Mayıs, Antalya 2006.
  • ISO 8402:1994, Quality management and quality assurance. iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csn umber=20115 http://www.iso.org/ iso/ Toplam Kalite Yönetimi, TKY http://www.bumatek.boun.edu.tr/orgnizasyon/download/
  • TKY_ www.bumatek.boun.edu.tr.pdf. 2012.
  • Tiryaki, O. “Pestisit Kalıntı Analizlerinde Kalite Kontrol (QC) ve Kalite Güvencesi (QA)”. Nobel Yayın Nu: 1635,
  • Fen Bilimleri:116, Nobel Bilim ve Araştırma Merkezi yayın No:73, ISBN 978-605-395-446-0. Erciyes Üniversitesi Yayın No: 182; Erciyes Üniversitesi Seyrani Ziraat Fakültesi Yayın No: 2; Şubat, 2011. http://www.nobelyayin.com/detay.asp?u=3230
  • CITAC/EURACHEM Guide. Guide to Quality in Analytical Chemistry. An aid to Accreditation. Edition, http://www.eurachem.org/guides/CITAC%20EURACHE M %20GUIDE .pdf. 2002.
  • Şenyuva, H.Z. Analitik Kalite Güvence: Minimum gereksinimler, 16–17 Ekim, Bursa TUBİTAK-ATAL, Maestroni, B. Explanation of ISO/IEC standard 17025.
  • FAO/IAEA Training Workshop on Introduction to QC/QA in Pesticide Analytical Laboratories, Training and Reference Center for Food and Pesticide Control, Seibersdorf, Vienna, Austria, 12 Sept- 7 Oct 2005.
  • Visi, E. Quality Assurance/Quality Control in pesticide residue laboratories. Possibilities of controlling the various analytical steps. FAO/IAEA Training and Reference Centre for Food and Pesticide Control Training workshop on Introduction to QC/ QA measures in Pesticide Residue Analytical Lab. 17 June-26 July IAEA‟s Laboratories Seibersdorf; Austria, 2002. International Organization For Standartization,
  • ISO/IEC 17025: 2005. General requirements for the competence of testing and calibration laboratories, Geneva, 2005.
  • Bakır, F., Laleli, Y. TS EN ISO/IEC 17025
  • Kapsamında Akreditasyona Teknik Hazırlık. Türk Biyokimya Dergisi [Turkish Journal of Biochemistry - Turk J Biochem]; 31 (2); 96–101. 2006.
  • Tiryaki, O., Baysoyu, D. The Use of Radiotracer Techniques for QA/QC Principles in Pesticide Residue Analysis. Ankara Universitesi Ziraat Fakültesi, Tarım Bilimleri Dergisi [Journal of Agricultural Sciences] 13 (2):108-113, 2007.
  • OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, No. 1-15, OECD Environmental http://www.oecd-library.org/environment /oecd-series- on-principles-of-good-laboratory-practice-and- compliance-monitoring_2077785x 01.1012). Paris (1998). (Erişim:
  • Engelhard, T., Feller, E., Nizri, Z. A comparison of the complimentary and different issues in ISO/IEC 17025 and OECD GLP. Accred Qual Assur 8:208–212. 2003. Fox, A. GLP Regulations
  • Requirements:How do they differ? Accred Qual Assur. : 303, 2003. vs. ISO
  • Feller E. Implementation of the OECD principles in test facilities complying with a quality system accredited to the ISO/IEC 17025. OECD Event, Villa
  • Tuscolana, Frascati (Roma),Italy, April 10-11 2008, http://www.oecd.org/dataoecd/4/4/40568497.pdf (Erişim: 10.01.2012).
  • Tiryaki, O., Temur, C. Quality Systems for Pesticide Residue Analysis: ISO 17025 and OECD-GLP 7th
  • MGPR International Symposium “Paolo Cabras” Pesticides in Food and the Environment in Mediterranean ,Thessaloniki, Greece. Program and Abstacts. p: 65. November 11, Grunert G. K. Food quality and safety: consumer perception and demand. European Review of Agricultural Economics, 32, 3, 369–391. 2005.
  • Tiryaki, O. “İyi Laboratuvar Uygulamaları (OECD Good Laboratory Practices – GLPs),” 05.03.2008,
  • SEMİNER, TAEK/SANAEM Uygulama Bölümü, Tarım Birimi, Saray, Ankara. 2008.
  • Feller E. Implementation of the OECD principles of good laboratory practice in test facilities complying with a quality system accredited to the ISO/IEC 17025 standart.
  • Ann Ist Super Sanità , 44, 4, 344-347. 2008.
  • Deney ve Kalibrasyon Lâboratuvarlarının Yeterliliği İçin Genel Şartlar, TS EN ISO/IEC17025. 2005.
  • Jiang, W. Good Laboratory Practice in Analytical Laboratory. The Journal of American Science;1(2):93-94. Immel B.K. 25 Years of Good Laboratory Practice, Biopharm International. Duluth:18:58-9. 2005. Organisation for Economic
  • Development. OECD principles on good laboratory practice (as revised in 1997). Paris: OECD; 1998. (OECD
  • Series on Principles of GLP and Compliance Monitoring, No. http://www.olis.oecd.org/ mc-chem(98)17. Co-operation and , ENV/MC/CHEM(98)17). Available from: olis/1998doc.nsf/LinkTo/env
  • ISO 17025 and GLP, Total Manual Consulting, http://www.tqmc.pl/quality/iso_17025_and_ glp_good_laboratory_practice. 2012d.
  • Hembeck, H.W. GLP and other Quality Assurance Systems –A comparison.Accred Qual Assur, 7:266–268. OECD Series on principles of good laboratory practice and compliance monitoring. Number 8 (revised) GLP Consensus Document The role and responsibilities of the study http://www.oecdilibrary.org/docserver/download/fulltext/9 e.pdf?expires=1326368949&id=id&accname
  • =guest&checksum=F840682FBDDDE78079D08498A849 (Erişim: 16.01.2012) GLP studies.
  • OECD Series on Principles of GLP and Compliance Monitoring Number 4 (Revised) Consensus Document Quality Assurance and GLP, 2012. http://www.oecd- ilibrary.org/docserver/download/fulltext/9760041e.pdf? expires=1326372485&id=id&accname=guest&checksum =CD019839A6F963BF390DF52969CF3636. 01.2012) (Erişim:
  • OECD Series on prıncıples of Good Laboratory PRACTICE and Complıance Monıtorıng Number 15 Advisory Document of the Working Group on Good Laboratory Practice Establishment and Control of Archives that Operate in Compliance with the Principles of docserver/download/fulltext/9760151e.pdf?expires=13263 =B659977B705851EDA8B511AA917C1E5D(Erişim: 01.2012). Türk Akreditasyon Kurumu, TURKAK. (Erişim: http://www.turkak.org.tr/index.php/home 01.2012).