第1页共42页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第1页共42页YY/T0287-2003质量体系-医疗器械GB/T19001-ISO9001应用的专用要求第2页共42页第1页共42页编号：时间：2021年x月x日书山有路勤为径，学海无涯苦作舟页码：第2页共42页目录前言...............................................................................................................................................................30引言................................................................................................................................................................40.1总则.......................................................................................................................................................40.2过程方法................................................................................................................................................40.3与其他标准的关系................................................................................................................................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......................................................................................
