Learn how to design and implement an effective Quality Management System (QMS) based on ISO 13485:2016.
Applicable for those preparing for ISO 13485 certification or those looking to improve the effectiveness of their current management system.
Who should attend?
- Individuals responsible for their organisation's ISO 13485 based Quality Management System
- System managers who may in the future be involved in managing an ISO 13485 based Quality Management System.
What will you learn?
- To implement a QMS based on ISO 13485:2016
- To develop a quality policy and objectives
- The need for documenting systems, processes and typical methods
- Key features of risk assessment
- Importance and relevance of legislation
- Design requirements
- The significance of process and environmental controls (e.g. clean rooms, sterilisation, personnel controls)
- Plan and manage your internal quality auditing activities
- Eliminate the causes of problems through effective corrective action
- Develop an appropriate management review process and implement processes for improving the effectiveness of the system.
What do you need to prepare?
Knowledge of QMS fundamentals.
- 2.25 CPD hours
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.