本项培训课程讲解的是《ISO 13485标准（2016年版）》这项“质量管理体系”标准的要求部分，讨论了各项主要原则、以及这项标准与《ISO 9001(2015年版)》之间的互动关系；此外，这项标准还可以加快全球各种“医疗器械”质量管理体系之间的一致性。
如果您需要了解《ISO 13485标准(2016年版)》这项质量管理体系标准的各项要求，并且对不需要接受讲师引导式培训具有足够的信心，那么，这项线上的、自定进度的课程将为您提供完全的灵活性。
This training course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015 and also it serves to facilitate global alignment for Medical Device quality management systems.
If you need to understand the requirements of this ISO 13485:2016 quality management system standard and are confident enough not to need tutor-led training, this online, self-paced course offers you complete flexibility.
课程收益 How will I benefit?
- 迈出ISO 13485:2016认证的第一步
- 了解你如何能更好地满足监管要求，从而提高病人的安全性
- 找到通过质量管理提高效率和节约成本的方法
- 监测供应链以实现持续改进
- 开发安全和有效的医疗设备
- 通过CPD激励员工
- Take the first steps towards ISO 13485:2016 certification
- Understand how you can better meet regulatory requirements leading to increased patient safety
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
- Develop safe and effective medical devices
- Motivate employees through CPD
目标对象Who should attend?
- 高级管理层、质量经理、监管事务经理、内部和外部审计师、顾问以及任何参与标准实施的人。
- Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
课程亮点What's included?
你可以在适合自己的时间学习，从任何支持互联网的设备上24/7访问该课程。
You can study in your own time when it suits you, and you can access the course from any internet-enabled device 24/7.
