Implementing ISO 13485 Medical Devices Training Course
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 13485:2003. The course introduces the concepts needed to understand, develop, and implement a quality management system.
Who should attend?
- Anyone involved in defining, planning, or implementing an ISO 13485 based quality management system
- Management representatives
- Implementation team members
What will I learn?
On completion of this training, participants 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 are the benefits?
- Take the first steps towards ISO 13485 certification
- Understand how you can better meet customer and regulatory requirements
- Find ways to increase efficiency and cost savings through quality management
- Monitor supply chains to achieve continuous improvement
What is included?
- Training course notes
- Certificate of attendance