下载后可任意编辑ISO13485 医疗器械质量管理体系标准12024 年 5 月 29 日下载后可任意编辑目 录前 言........................................................30引言.........................................................40.1总则.....................................................40.2过程方法.................................................40.3与其它标准的关系.........................................40.4与其它管理体系的相容性...................................51范 围........................................................51.1总则.....................................................51.2应用.....................................................52引用标准.....................................................63术语和定义...................................................64质量管理体系.................................................74.1总要求...................................................74.2文件要求.................................................85管理职责.....................................................95.1管理承诺.................................................95.2 以顾客为关注焦点........................................95.3 质量方针................................................95.4 策划...................................................105.5职责、权限和沟通........................................105.6管理评审................................................106资源管理....................................................116.1资源提供................................................116.2人力资源................................................116.3 基础设施..............................................126.4 工作环境..............................................1222024 年 5 月 29 日下载后可任意编辑7产品实现....................................................127.1产品实现的策划..........................................127.2与顾客有关的过程........................................137.3 设计和开发............................................137.4采购.....
