新版GB/T 42061：2022医疗器械质量管理体系内审员培训报名通知

2022-11-28 作者：NBAMDI 浏览量：378

各医疗器械企业：

2022年10月12日，国家标准化管理委员会批准公布了GB/T 42061- 2022 idt ISO 13485:2016《医疗器械质量管理体系用于法规的要求》标准，并将于2023年11月1日正式实施。该标准为原行业标准YY/T 0287-2017升级为国家标准，为帮助企业内审员充分理解标准，使企业质量管理体系不断完善，宁波市医疗器械行业协会将于12月13日至12月16日举办新版GB/T 42061-2022 /ISO13485:2016和GB/T 19001-2016 /ISO9001:2015标准内审员培训班。现开展培训预报名工作。

一、培训对象

管理者代表、各部门负责人、产品注册人员、体系专员、工艺工程师、检验员以及医疗器械行业监管人员等。

二、培训内容

1、新版GB/T42061-2022/ISO 13485:2016 标准详解；

2、新旧版标准的区别与变化；

3、GB/T 19001-2016 /ISO9001:2015标准详解；

4、质量管理体系建立及文件的编写；

5、内审程序、方法、技巧及练习；

三、培训时间及地点

1、培训时间：12月13日至12月16日（共四天）

每天8:30开始签到，9:00-17:00上课

2、培训地点：地点：宁波沧海开元名庭酒店三楼会议室（宁波市鄞州区中河街道沧海路3388号沧海广场3号楼，嵩江东路地铁站A口旁。）

3、注意：培训期间请自备口罩等防疫用品，进入会场需扫描出示场所码，提供72小时内核酸阴性证明。建议绿色出行，合理安排时间，准时参加培训。

四、培训教师及证书

本培训班由浙江药科职业大学教授授课，培训结束经考试合格后，发放合格证书。

五、费用

1、2200元/人（会员）、2600元/人(非会员)（包括培训费、教材费、证书费及中餐。其它费用自理。）

2、付款方式：培训费请通过公司账户汇款至协会帐户，备注“内审员培训”，报名最终以付款为准。

户名：宁波市医疗器械行业协会账号：33030122000051924

开户行：宁波银行华光城支行

六、报名流程

1、填写《培训报名回执表》(见附件)，回传至邮箱torningz@163.com

2、联系人：张老师 0574-27720689、15824524090（微信同号）

宁波市医疗器械行业协会

2022年11月28日

2022年新版医疗器械内审员培训报名通知(2).pdf

欧盟批准L-(+)-乳酸作为现有活性物质用于产品类型6的生物... 宁波市医疗器械行业协会携手浙药大医疗器械学院调研宁波老年康复...

基本文件流程错误 SQL 调试

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