ISO13485标准导读完整文本

YY/T0287—2003idtISO13485:2003《医疗器械质量管理体系用于法规的要求》标准导读北京国医械华光认证有限公司（原中国医疗器械质量认证中心）2003年10月主编：郝和平编审：陈志刚、李慧民、郑一菡编写：陈志刚、李慧民、秦树华、孟庆增、武俊华校对：赵兴文-1-前言国际标准化组织（ISO）于2003年7月15日发布ISO13485：2003《医疗器械质量管理体系用于法规的要求》标准，这一标准将替代ISO13485：1996《质量体系医疗器械ISO9001应用的专用要求》和ISO13488：1996《质量体系医疗器械ISO9002应用的专用要求》两个标准。ISO13485：2003标准是专门用于医疗器械产业的一个完全独立的标准，该标准的发布贯彻和实施对于医疗器械产业的质量管理有着重大和深远的意义。ISO13485：2003标准是以ISO9001：2000《质量管理体系要求》标准为基础，采用了ISO9000：2000标准的质量管理理念，引用了ISO9001：2000标准的结构、条款和格式，包含了ISO9001：2000标准的大部分质量管理体系的通用要求，以能确保医疗器械生产企业建立保持的质量管理体系具有持续稳定生产符合规定要求产品的能力。ISO13485：2003标准是以医疗器械法规为主线，强调实施医疗器械法规的重要性，提出相关的医疗器械法规要求，通过满足医疗器械法规的要求，来确保医疗器械的安全有效。2003版13485标准的这一主要调整变化，是近年来GHTF在各国政府间协调的重大突破，体现了医疗器械生产企业质量管理体系建设必须围绕安全、有效这一本质来展开的原则，这一原则的很多要求都是以政府法律、法规来体现的，订入了政府的法律法规中。建设医疗器械生产企业质量管理体系，必须同时执行相关法规，这就是推行医疗器械质量管理体系认证与其他行业的根本差别。ISO13485：2003标准是以促进全世界医疗器械法规协调为目标，促进世界各国各自多种多样的医疗器械行政法规、技术法规的协调一致，为医疗器械法规要求的一致性作出贡献，为世界各国医疗器械质量管理体系的互认作出贡献，顺应经济全球化的趋势，促进国际医疗器械贸易的发展和进步。1996版YY/T0278—ISO13485《质量体系医疗器械ISO9001应用的专-2-用要求》和1996版YY/T0288—ISO13488《质量体系医疗器械ISO9002应用的专用要求》标准对于提高我国医疗器械生产企业的管理水平，确保产品质量符合规定要求，降低成本，提升产品的竞争能力，为产品进入国际市场发挥了历史性的作用。2003版ISO13485标准的发布为推动我国医疗器械生产质量管理的水平提供了一个重要的前提和难得的机会。自1998年国家药品监督管理局成立以来，由于有计划、有步骤地在制药工业推行GMP的贯彻，药品生产企业的质量管理水平的提高十分明显，此项工作并得到了国务院领导的肯定。借鉴美国FDA的经验，国家食品药品监督管理局将制订中长期规划，在我国医疗器械产业全面推动医疗器械GMP的工作。依据美国和欧洲一些国家的作法，现代医疗器械的GMP就是针对具体国情、具体产品类别的以政府的质量管理法规与ISO13485标准有机结合制订的企业生产质量规范。我国推动医疗器械生产质量管理规范的工作随着2003版ISO13485的发布已经正式起动。2003版ISO13485的推行必将有利于我国医疗器械生产企业管理水平和产品实物质量上一个新的台阶，有利于确保医疗器械的安全有效，有利于医疗器械监督管理的深化，有利于医疗器械质量认证事业的发展，有利于我国医疗器械行业的健康快速发展。ISO于2003年7月发布ISO13485：2003标准后，国家食品药品监督管理局按等同采用的原则于2003年9月17日转化为行业标准YY/T0287—2003《医疗器械质量管理体系用于法规的要求》标准，医疗器械生产企业、经营企业、医疗器械监管部门、医疗器械认证机构、检测机构、医疗器械使用部门和相关单位都需要学习贯彻ISO13485：2003标准，切实提高我国医疗器械产业的整体水平。为满足医疗器械生产企业学习ISO13485：2003标准的需要，在国家食品药品监督管理局的指导下，北京国医械华光认证有限公司（以下简称CMD）在短时间内编写“YY/T0287—2003《医疗器械质量管理体系用于法规的要求》行业标准导读”以有助于医疗器械生产企业建立实施保持质量管理体系，也有助于第三方认证机构规范实施医疗器械质量认证。本书第一章由陈志刚同志负-3-责起草，第二章由李慧民同志负责起草，第三章由李慧民同志、秦树华同志、孟庆增同志负责起草，第四章由武俊华同志负责起草，全书由CMD审定。对教材中存有的问题欢迎批评指正，今后将根据生产企业贯标实施和质量认证中遇到问题予以完善。2003年10月-1-目录第一章ISO13485：2003标准概述·························································1第一节ISO13485标准的产生和发展······························································1第二节ISO13485：2003标准的基本思想和特点··········································4一、ISO13485：2003标准的基本思想·················································4二、ISO13485：2003标准的主要特点·················································7第三节ISO/TC210和我国SAC/TC221······················································9一、ISO/TC210·······················································································9二、SAC/TC221····················································································10第四节ISO13485标准在中国······································································12第五节ISO13485和ISO9000族标准的关系············································13第二章GB/T19000族标准简介···························································16第一节ISO9000族标准简介··········································································16一、ISO9000族标准的内容和作用·····················································16二、ISO9000族标准的产生和发展·····················································18第二节质量管理体系基础·············································································26一、八项质量管理原则·········································································26二、质量管理体系基础·········································································31三、质量管理原则，质量管理体系基础与GB/T19000族标准的关系······37第三节质量管理体系的基本术语和定义·····················································39一、概述·································································································39二、基本术语介绍·················································································40第三章YY/T0287—2003标准的理解···············································48第一节概述·····································································································48一、2003版ISO13485标准的名称和用途·········································48-2-二、2003版ISO13485标准的结构和内容·········································50三、2003版ISO13485的特点······························································53第二节引言范围规范性引用文件·······················································60一、ISO引言··························································································60二、标准的应用范围·············································································65三、规范性引用文件·············································································68第三节术语和定义·······················································································69一、医疗器械·························································································70二、有源医疗器械·················································································71三、有源植入性医疗器械·····································································72四、植入性医疗器械·············································································73五、无菌医疗器械·················································································73六、标记··