Highlight's of the Course:
Who should Attend?
Our ISO 13485 one day foundation course gives a thorough introduction to Medical Device Quality Management System (QMS), together with the requirements for a MS-QMS implementation. It is also highly beneficial for those needing to fully understand or implement MS-QMS within their organization. It can be used as a foundation for those wishing to go on to complete certified quality.
- To provide an understanding of what a Medical Devise Quality Management System is and how it can help a business
- The business benefits of improved performance as a result of a medical devise quality management system
- To help you understand the tools required to meet the requirements
- The structure and content of ISO 13485 and its relationship with other standards
- Learn to interpret and apply the key concepts and principles of the standard to existing processes within your organization.
- To understand the implementation of a ISO 13485 in accordance with other related standards.
- Introduction to the ISO 13485 & its family
- Introduction to management systems and the process approach
- Fundamental principles
- Implementation phases & framework
- Continual improvement of Quality
- Process and Conducting of ISO 13485 certification audit
- Certification Exam