ISO15189在多医疗区实验室管理的应用

Application of ISO15189 in laboratory management in multi-medical area

ISO15189即《医学实验室——质量和能力的专用要求》,是国际标准化组织临床实验室起草的,用于指导医学实验室建立自己的检测质量及技术管理体系并指导其运作的标准。实验室的管理具有多样性、复杂性、管理难度大等特点,多医疗区实验室的管理则更加考验管理者的能力。本文参照国内外医学实验室广泛认可的ISO15189质量管理体系对多医疗区实验室的统一管理模式进行探讨,以期建立适合多医疗区实验室的质量管理体系。

ISO15189,"Medical Laboratories—Special Requirements for Quality and Capability",was drafted by the International Standardization Organization Clinical Laboratory,to guide medical laboratories to establish their own testing quality and technical management systems and guide their operation standards.The management of laboratories has the characteristics of diversity,complexity,and difficulty in management.The management of laboratories in multi-medical areas further tests the ability of managers.This article discusses the unified management model of laboratories in multiple medical areas with reference to the ISO15189 quality management system widely recognized by domestic and foreign medical laboratories,with a view to establishing a quality management system suitable for laboratories in multiple medical areas.