ISO 13485:2016 Medical Devices Quality Management Implementation Training Course
Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.
This two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016. The course introduces the concepts needed to understand, develop, and implement a quality management system.
Who should attend?
“While quality has always been our number one priority, we now have a more systematic approach to the way it is managed.”
- Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
- Management representatives
- Implementation team members
What will I learn?
On completion of this training, participants will be able to:
- Define a ISO 13485:2016 QMS
- Identify the steps for defining, planning, organizing and scheduling necessary activities
- Implement an effective quality management system
- Conduct a base line review of an organization’s current position with regard to ISO 13485:2016.
How will I benefit?
- Understand how to implement a QMS as required by medical device directives
- Plan the implementation of ISO13485:2016 within your organization
- Take the first steps towards ISO 13485:2016 certification
- Identify how you can better meet regulatory requirements
- Find ways to increase efficiency and add value through quality management
- Monitor supply chains to achieve continuous improvement.
- Training course notes for delegates
- Lunch & Refreshments
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate
- Loan copy of the standard (to be returned after the course)