Dobecki Marek, Wziątek Agata
Instytut Medycyny Pracy im. prof. J. Nofera / Nofer Institute of Occupational Medicine, Łódź, Poland (Biuro Zapewnienia Jakości / Quality Assurance Bureau).
Instytut Medycyny Pracy im. prof. J. Nofera / Nofer Institute of Occupational Medicine, Łódź, Poland (Zakład Bezpieczeństwa Chemicznego / Department of Chemical Safety).
Med Pr. 2016;67(2):267-83. doi: 10.13075/mp.5893.00361.
This publication presents the principles of organization, implementation, assessment and exploitation of proficiency testing results in the work environmental laboratory based on basic requirements included in standard PN-EN ISO/IEC 17043 and ISO 13528. The basis for the proper functioning of the laboratory is to use and observe the basic requirements for the competence to carry out the tests and the guidelines on ensuring reliable and accurate results, specified e.g., according to the guidelines described in the standard PN-EN ISO/IEC 17043. The confirmation of the laboratory competence is the obtained accreditation. To obtain this certificate several conditions, including proficiency testing (PT) should be met. The main aspects of this paper is to show the role of proficiency testing in the process of assuring a properly functioning quality system in the laboratory. The accreditation requirements, the types of proficiency testing schemes, methods of statistical analysis and interpretation of results are also discussed by the authors. Med Pr 2016;67(2):267-283.
本出版物基于标准PN-EN ISO/IEC 17043和ISO 13528中包含的基本要求,介绍了工作环境实验室中能力验证结果的组织、实施、评估和利用原则。实验室正常运作的基础是使用并遵守进行测试的能力的基本要求以及确保结果可靠准确的指南,例如根据标准PN-EN ISO/IEC 17043中所述的指南。实验室能力的确认是获得认可。要获得此证书,应满足包括能力验证(PT)在内的若干条件。本文的主要方面是展示能力验证在确保实验室质量体系正常运行过程中的作用。作者还讨论了认可要求、能力验证方案的类型、统计分析方法和结果解释。《医学实践》2016年;67(2):267 - 283。