Centers for Disease Control and Prevention, Atlanta, Georgia, USA
City of Milwaukee Health Department Laboratory, Milwaukee, Wisconsin, USA.
Clin Microbiol Rev. 2018 May 2;31(3). doi: 10.1128/CMR.00062-17. Print 2018 Jul.
This document outlines a comprehensive practical approach to a laboratory quality management system (QMS) by describing how to operationalize the management and technical requirements described in the ISO 15189 international standard. It provides a crosswalk of the ISO requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the Clinical and Laboratory Standards Institute. The quality principles are organized under three main categories: quality infrastructure, laboratory operations, and quality assurance and continual improvement. The roles and responsibilities to establish and sustain a QMS are outlined for microbiology laboratory staff, laboratory management personnel, and the institution's leadership. Examples and forms are included to assist in the real-world implementation of this system and to allow the adaptation of the system for each laboratory's unique environment. Errors and nonconforming events are acknowledged and embraced as an opportunity to improve the quality of the laboratory, a culture shift from blaming individuals. An effective QMS encourages "systems thinking" by providing a process to think globally of the effects of any type of change. Ultimately, a successful QMS is achieved when its principles are adopted as part of daily practice throughout the total testing process continuum.
本文件通过描述如何实施 ISO 15189 国际标准中描述的管理和技术要求，概述了实验室质量管理体系 (QMS) 的全面实用方法。它将国际标准化组织 (ISO) 对医学实验室的质量和能力要求与临床和实验室标准协会 (CLSI) 规定的 12 个质量体系要素进行了对比。质量原则分为三大类组织：质量基础设施、实验室操作和质量保证及持续改进。为微生物学实验室工作人员、实验室管理人员和机构领导层概述了建立和维持 QMS 的角色和职责。提供了示例和表格，以协助在实际中实施该系统，并允许根据每个实验室的独特环境对系统进行调整。承认并接受错误和不符合事件，将其视为改进实验室质量的机会，这是一种从归咎于个人转变为文化。有效的 QMS 通过提供一种全局思考任何类型变更影响的过程来鼓励“系统思维”。最终，当其原则被整个测试过程连续体中的日常实践所采用时，成功的 QMS 就得以实现。
