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?
- 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?
- Regulatory, quality, research, design, development, and manufacturing personnel who will be involved in working with ISO 13485:2016 and need to have a greater understanding of the management system
- Organizations preparing to put ISO 13485:2016 in place
- Personnel who have joined an organization who have ISO 13485:2016 and require in depth knowledge
- Delegates attending the Lead Auditor to ISO 13485:2016 course who do not already have a good knowledge of the standard
What will I learn?
- 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?
You will gain:
- 14 CPD points on completing the course
- Training course notes
