ISO-13485质量手册VIP专享VIP免费

1质量手册[依据：ISO9001:2008ISO13485:2016]编制/日期：审核/日期：批准/日期：受控状态：□受控□非受控持有者：2016年xx月xx日发布2016年xx月xx日实施苏州思维医疗科技有限公司目录01.版本修改记录_____________________________________________________________________________2编号：SW-QM-A-2016版本：A0发放号：2016第1号2102.质量手册颁布令___________________________________________________________________________303.管理者代表任命书_________________________________________________________________________404.公司简介_________________________________________________________________________________505.质量方针、质量目标_______________________________________________________________________606.质量管理体系组织机构图___________________________________________________________________707.质量管理体系职能分配表___________________________________________________________________81.范围______________________________________________________________________________________91.1总则_________________________________________________________________________________91.2应用_________________________________________________________________________________92.引用标准_________________________________________________________________________________103.术语及定义_______________________________________________________________________________104.质量管理体系_____________________________________________________________________________114.1总要求______________________________________________________________________________114.2文件要求____________________________________________________________________________125.管理职责_________________________________________________________________________________145.1管理承诺____________________________________________________________________________145.2以顾客为关注焦点____________________________________________________________________145.3质量方针____________________________________________________________________________155.4策划________________________________________________________________________________155.5职责、权限与沟通____________________________________________________________________155.6管理评审____________________________________________________________________________166.资源管理_________________________________________________________________________________176.1资源提供____________________________________________________________________________176.2人力资源____________________________________________________________________________176.3基础设施____________________________________________________________________________186.4工作环境和污染控制__________________________________________________________________187.产品实现_________________________________________________________________________________197.1产品实现的策划______________________________________________________________________197.2与顾客有关的过程____________________________________________________________________207.3设计和开发__________________________________________________________________________217.4采购________________________________________________________________________________237.5产品和服务提供______________________________________________________________________247.6监视和测量设备的控制________________________________________________________________268.测量、分析和改进______________...