3月15-19日 广州
课程介绍
本课程专为医疗器械行业人员而设。学员将全面理解ISO 13485：2003质量管理体系的要求并了解ISO 14971：2007标准——”风险管理在医疗器械的应用”的相关概念。通过小组活动、审核演练、互动讨论和教练式课程等方式深入理解审核原则和如何应用ISO19011：2002标准来执行有效的内审。
Course Brief
The course is designed for those with knowledge of medical device manufacturing. Students gain a broad understanding of the ISO 13485:2003 quality management system requirements. In addition, the concepts of ISO 14971:2007, “Application of Risk Management to Medical Devices,” are introduced. Through small group activities, audit roleplays, lively discussions, and instructor-led lectures, students gain a thorough understanding of the principles of auditing. Students also learn how to apply the guidance of ISO 19011:2002 to implement effective internal audit programs。
参加对象
- 质量部经理
- 法规部经理
- 医疗器械工厂审核员（内审和外审）
- 执行该标准的相关部门组员
Who should attend
- Quality managers
- RA managers
- Auditors of medical device manufacturing firms (internal and external)
- Cross functional team members implementing the standard
内容大纲
- 理解质量管理原则
- ISO13485：2003条文分析解说
- PD CEN ISO/TR 14969:2005应用原则和ISO 14971:2007
- ISO 19011:2002在审核过程中的应用原则
- 计划、执行和报告有效的ISO13485：2003内审
- 理解注册过程
Course Outline
Understand quality management definitions, concepts, and guidelines
- Understand the quality management principles
- Interpret all clauses of ISO 13485
- Apply Principles of PD CEN ISO/TR 14969:2005 and ISO 14971:2007
- Apply principles of ISO 19011:2002 to the auditing process
- Plan, Conduct, and Report Effective Internal Audits to ISO 13485:2003
- Understand the registration process
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