ISO13485: 2016 医疗器械行业质量管理内审员
ISO13485: 2016 Medical Device Industry Quality Management Internal Auditor
ISO13485中文叫“医疗器械 质量管理体系 用于法规的要求” 由于关系到人类本身的健康和安全,医疗器械是救死扶伤、防病治病的特殊产品,全球对医疗器械行业都有严格的要求。在欧洲市场上,医疗器械生产厂商早已被强制要求通过认证机构的CE认证。
市场的压力使国内医疗器械企业深入了解这方面的要求成为迫切的需要,ISO组织颁布了ISO13485:1996版标准(YY/T0287 和YY/T0288),ISO13485 内容包含安全上的基本要求、法规要求、风险分析/评估,临床评估/调查、标示、其它技术标准,以及讯息回馈系统、上市后的监督、客户抱怨调查、警戒系统、建议性通告(召回)等,对医疗器械生产企业的质量管理体系提出了专用要求,为医疗器械的质量达到安全有效起到了很好的促进作用。
德国TUV莱茵,一直致力于提供与人类相关的环境、健康、安全的服务,2016版ISO13485医疗器械行业质量管理标准发布后,专家团队依据标准要求、立足企业实际需求,研发设计本教程。
Chinese name of ISO13485 is called “Medical Device Quality Management System for Regulatory Requirements.” Because it is related to the health and safety of human beings, medical devices are special products for life-saving, disease prevention and treatment. The global medical device industry has strict requirements. In the European market, medical device manufacturers have long been forced to pass the CE certification of the certification body.
The pressure of the market has made it urgent for domestic medical device companies to understand this requirement. The ISO organization has issued ISO13485:1996 version standards (YY/T0287 AND YY/T0288). This ISO13485 content contains basic requirements for safety and regulatory requirements. Risk analysis/assessment, clinical assessment/survey, labeling, other technical standards, as well as information feedback systems, post-marketing surveillance, customer complaint investigations, alert systems, advisory notices (recalls), etc., quality management systems for medical device manufacturers special requirements have been put forward, which has played a very good role in promoting the safety and effectiveness of medical devices.
TUV Rheinland of Germany has been committed to providing environmental, health and safety services related to human beings. After the release of the 2016 ISO13485 medical device industry quality management standard, the expert team developed and designed this tutorial based on the standard requirements and based on the actual needs of the enterprise.
本课程将:
- 透彻的讲解医疗器械行业认证要求
- 详细讲解医疗器械行业质量管理的过程方法,包括基于风险的思维
- 如何计划审核、实施审核、报告审核以及关闭审核发现
- 使您全面掌握有关ISO 13485:2016的相关要求,有效的进行体系应审核迎审工作
This course will:
- Explain medical device industry's certification requirements
- Explain in detail the process approach to quality management in the medical device industry, including risk-based thinking
- How to plan for review, implementation review, report review and turn off audit discovery
- Provide a comprehensive understanding of the relevant requirements of ISO13485: 2016, and show how effective implementation of the system should be reviewed
参加对象:
- 医疗器械行业生产、技术、质量管理、法规注册人员
- 医疗器械制造行业从事医用电气设备研发、生产、检测技术等医疗器械监管人员
- 其他需要了解人员
Target Audience:
- Medical device industry production, technology, quality management, regulatory registration personnel
- Medical device manufacturing industry engaged in medical eletrical equipment research and development, production, testing technology and other medical device supervisors
- Other Staff who would like to learn
课程大纲:
- ISO9001: 2015术语和定义
- ISO9001:2015过程介绍 & 案例分析
- 医疗器械术语和定义(新旧版术语的差异)
- EN ISO13485: 2016与医疗器械指令的关系
- ISO13485:2016 & ISO13485:2003主要差异
- ISO13485:2016在具体企业应用中的特点
- 文件要求
- 过程控制
- 内部审核工作的策划
- 内部审核技巧
- 案例分析 & 分组讨论
- 内审员考试
Course Outline:
- ISO9001: 2015 Terms and Definition
- ISO9001:2015 Process Introduction and Case Analysis
- Terms and Definition of Medical Devices (Difference of new and previous one)
- Relationship between EN ISO13485: 2016 and Medical Devices Diretives
- Main Distinction between ISO13485:2016 & ISO13485:2003
- Application Charateristics of ISO13485:2016 in Enterprises
- Documentary Requirements
- Process Control
- Working Plan of Internal Audit
- Internal Audit Skills
- Case Analysis and Discussion in groups
- Examination
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直播特色
在线直播:零接触,全互动
小班教学:每班不超过30人,保证学习质量
听课方式:讲课+讨论+练习+答疑+考试
有趣互动:幸运大转盘抽奖、现金红包领取
资料齐全:教材提前一周邮件,方便预习
培训证书:与线下课程一致,发放TÜV莱茵学院注册培训证书