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.
You’ll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 certification.
How will I benefit?
This course will help you:
- Plan the implementation of ISO 13485 within your organization
- Take the first steps towards ISO 13485 certification
- Understand how you can better meet customer and regulatory requirements
- Find ways to increase efficiency and adding value through quality management
- Monitor supply chains to achieve continuous improvement
Who should attend?
Anyone involved in defining, planning, or implementing an ISO 13485:2016 QMS, as well as management representatives and implementation team members.
What will I learn?
On completion, you should gain the knowledge and skills to:
- Define a quality management system
- 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
What is included?
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
