【ISO13485认证程序文件】某医疗器械行业标准程序文件大全 中鸿认证咨询
[ISO13485] a certification program files of medical device industry standard program file Daquan hung Certification Advisory
一、文件控制程序
A, document control procedure
二、质量记录控制程序
Two, quality record control procedure
三、管理评审控制程序
Three, management review control procedure
四、人力资源控制程序
Four, human resource control procedure
五、基础设施控制程序
Five, infrastructure control procedure
六、工作环境控制程序
Six, work environment control procedure
七、与顾客有关过程控制程序
Seven, and customer related process control program
八、设计和开发控制程序
Eight, control program design and development
九、设计更改控制程序
Nine, the design change control procedure
十、评价供方的控制程序
The control procedure ten, evaluation of supplier
十一、采购控制程序
Eleven, procurement control procedures
十二、生产和服务提供控制程序
Twelve, control of production and service provision program
十三、服务控制程序
Thirteen, the service control program
十四、标识和可追溯性控制程序
Fourteen, identification and traceability control procedures
十五、产品防护控制程序
Fifteen, product protection procedure
十六、监测和测量装置控制程序
Sixteen, monitoring and measuring device control program
十七、顾客满意度测量控制程序
Seventeen, the customer satisfaction measurement control procedure
十八、内部审核控制程序
Eighteen, the internal audit control program
十九、产品监测和测量控制程序
Nineteen, product monitoring and measurement control procedure
二十、不合格品控制程序
Twenty, nonconforming product control procedure
二十一、数据分析控制程序
Twenty-one, the analysis of data control procedures
二十二、纠正和预防改进措施控制程序
Twenty-two, corrective and preventive measures of improvement control procedure
二十三、忠告性通知和事故报告
Twenty-three, advice and accident report
二十四、CE标志产品分类控制程序
Twenty-four, the CE logo products classification control program
二十五、风险管理程序
Twenty-five, risk management procedures
二十六、标签和语言控制程序
Twenty-six, label and language control program
二十七、临床资料汇编程序
Twenty-seven, the clinical data of assembler
二十八、售后监督程序
Twenty-eight, customer service and supervision procedures
二十九、警戒系统控制程序
Program control twenty-nine, warning system
三十、与公告机构联系控制程序
Thirty, and the notified body contact control program
三十一、符合性声明控制程序
Thirty-one, declaration of conformity control procedures
【ISO13485认证程序文件】某医疗器械行业标准程序文件大全 中鸿认证咨询
[ISO13485] a certification program files of medical device industry standard program file Daquan hung Certification Advisory