医疗器械质量管理管理体系审核人天表及收费标准.doc

医疗器械质量管理管理体系审核人天表及收费标准 Audit man/day form and charging standards of medical equipment quality control management system 医疗器械质量管理体系认证价格 Certificate price of medical equipment quality control management system 人数 The number of people 初评价 Initial audit 监审费/年 Surveillance review fee/ year 65人以下 Below 65 1.2万元 Twelve thousand 6000元 Six thousand 66-125人Between 66-125 1.8万元 Eighteen thousand 7000元 Seven thousand 126-275人Between 126-275 2.1万元 Twenty-one thousand 8000元 Eight thousand 276-625人 Between 276-625 2.8万元 Twenty-eight thousand 10000元 Ten thousand 626-1175人 Between 626-1175 3.2万元 Thirty-two thousand 12000元 Twelve thousand 1176-1550人Between 1176-1550 3.6万元 Thirty-six thousand 13000元 Thirteen thousand 1551-2000人 Between 1551-2000 4.0万元 Forty thousand 15000元 Fifteen thousand 核算依据： Calculating basis: 序号NO 收费项目 Charging item 收费标准 Charging standards 备注 Note 1 申请费Applying fee 1000元 One thousand yuan 2 注册费（含证书费） Registration fee(including certificate fee) 2000 元 如需加印证书，每张证书另收费50元 Two thousand yuan If it is needed to additionally print certificate, each certificate should charge additional 50 yuan. 3 注册审核费3000元×人天数× man/day 人天数见表1 4 监督审核费3000元×人天数× man/day 人天数见表1 5 年金（含标志使用费）Annual fee (including the using fee of logo) 2000 元 每年交纳一次 医疗器械质量管理体系认证审核人天核算：management system certificate 雇员的有效数量包括审核时将在现场的非长期(季节性、临时、和分包的)雇员，非长期雇员的折算方法如下： 非长期雇员的可计人数 ( 非长期雇员 ( 工作时间（月）( 12 The valid number of the employees include the non-regular employees (seasonal, temporary and sub-contracting) on the site during the audit. The conversion method is as follows: the valid number of the non-regular employees ( the non-regular employees ( working duration (month) ( 12 一个审核人日通常指完整的8小时正常工作日，开始策划时，不可用增加每天的工作时间来减少要使用的审核人天数； An auditor days usually refers to the full 8 hours of normal weekday, began planning, increase the working hours every day may not be used to reduce to use audit days; 临时场所指一度发生在认证文件界定场所以外的被认证活动的场所和（或）地点。这些场所也许是重要的项目管理场所，也