The Implementation of ISO 13485 MasterClass is dedicated to the basic principles of a quality management system.
The Implementation of ISO 13485 MasterClass covers topics such as:
- Understanding the basic principles of a quality management system
- Gaining an understanding of the relationship between standards and quality management systems
- Identifying the critical elements of a quality system
- Incorporating the Plan-Do-Check-Act approach
- Assessing and applying risk throughout the quality system
- Creating a documentation structure that is consistent with the system requirements
- Understanding the differences between ISO 9001, ISO 13485: 2003 and ISO 13485: 2016
- Comparing the requirements of ISO 13485 to the FDA QSR
- Establishing a plan for implementing the revised requirements of ISO 13485: 2016
- Understanding the QMS requirements of the proposed EU Medical Device Regulation that are not in ISO 13485: 2016
The Implementation of ISO 13485 MasterClass brings together:
- Quality managers
- Quality associates
- Project Managers
- Document Control coordinators
- Middle management in regulated industries
- Regulatory Affairs professionals
- Independent service organizations