【关键词】 医学实验室 ISO 质量体系

【摘 要】为实验室如何满足ISO 15189:2003 医学实验室能力和质量特殊要求提供了指南。本指南描述了在医学实验室内建立质量体系逐步过程的基本原理。本指南可应用于新建和已存在实验室。它包括了ISO 15189:2003 管理和技术要求。

【Key words】 Medical laboratory, ISO ( International Standardization for Organization), Quality system

【Abstract】 This article provides guidance to laboratories on how to meet the requirements for competence and quality that are particular to medical laboratories

contained in ISO 15189:2003. This guide describes the basic principles of a step by step process to build a quality system within a medical laboratory. The guide is

equally applicable to newly established and existing laboratories. It encompasses both the management and technical requirements of ISO 15189: 2003.

全文请见附件.