医疗器械质量管理体系(ISO 13485)内审员

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

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 14971：2009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。

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 14971:2009
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 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。
Who should attend
Quality managers
RA managers
Auditors of medical device manufacturing firms (internal and external)
Cross functional team members implementing the standard
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