AWARENESS TRAINING COURSE
This course is designed for, all levels of management and those whose responsibility it is to implement new systems or maintain existing systems, for all those involved in advising and auditing quality management systems.
WHO THE COURSE IS FOR
- Familiarity with the structure and requirements of ISO 9001:2008 is desired.
- Knowledge in Medical Device Directives (MDD’s) is desirable but not mandatory.
By attending this program, participants will have:
- An understanding of the key requirements of ISO 13485: 2016
- An understanding of the philosophy behind the standard, and the approaches to quality management
- An understanding of the basic ISO 13485: 2016 concepts
- Understanding of the potential benefits of implementation of ISO 13485: 2016 in the Medical Device industry