This two-days 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 13485:2003 certification. The course introduces the concepts needed to understand, develop, and implement a quality management system.
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.
Who should attend?
- Anyone involved in defining, planning, or implementing an ISO 13485:2016 based quality management system
- Management representatives
- Implementation team members
What will I learn?
Upon completion of this training, delegates will be able to:
- Describe the fundamentals of quality management systems
- Explain the purpose, structure and requirements of ISO 13485
- Apply a process of implementing a quality management system that meets the requirements of ISO 13485
- Prepare for ISO 13485 certification
What is included?
- You will gain 16 CPD points on completing the course
- Certificate
- Training course notes
- Lunch and refreshments