This two-day course provides an in-depth understanding of ISO 13485:2016. It’s designed specifically for those who are looking to further their knowledge of the management system.
Training will be delivered either live and online or in-person in a classroom setting. You will learn how to explain the scope and structure of ISO 13485:2016 and interpret what’s required for your own organization. You will finish this stage of your learning journey with deeper knowledge and confidence and have a clear pathway for putting ISO 13485:2016 certification into place for any organization
How will I benefit?
This course will help you:
- Full understanding of ISO 13485:2016 requirements
- Able to explain and interpret requirements, relevant to your organization
- Learn how a quality management system provides a framework for safer medical devices
- Comprehensive training notes and 14 CPD points on completion
Who should attend?
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
What will I learn?
On completion, you should gain the knowledge and skills to:
- Explain the scope and the structure of ISO 13485:2016
- Describe the requirements of ISO 13485:2016
- Explain how to interpret the requirements of the standard within your organization
- Develop your knowledge of how the requirements of ISO 13485:2016 are established and maintained in an organization
Identify the systems that are required to implement an ISO 13485:2016 QMS in order to gain or maintain certification to ISO 13485:2016
What's included?
- Detailed course notes and lunch provided
- Loan copy of the standard (to be returned after the course)
- On completion, you'll be awarded an internationally recognized BSI Training Academy certificate
Contact us
If you have any enquiries, let us know how can we help you.
Call: +91 80815 80815
Email us: info.in@bsigroup.com
