This introductory course provides an overview of ISO 13485:2016 and gives delegates an understanding of the intent and the requirements for ISO 13485:2016 quality management systems (QMS) for manufacturers of medical devices.
Who should attend?
- Individuals, of any level, involved with an ISO 13485:2016 management system who needs an overview of the intent and requirements of the standard
- Those involved with ISO 13485:2016 who need to create a single Quality Management System.
What will you learn?
- Scope and application of the new standard
- The differences between ISO 13485:2003 and ISO 13485:2016
- Essential definitions and terminology
- Key requirements of ISO 13485:2016 and how they relate to each other to form a robust, effective system
- The relationship between the standard and the risk management standard ISO 14971.
What do you need to prepare?
No previous training or knowledge is required to attend this course.
- 7 CPD hours
- Training course materials
- Lunch and refreshments for public attendees only
- Certificate of attendance.