Course Content:
- Introduction & Course Objectives
- The history of Quality Assurance
- The process approach
- System requirements of IS EN ISO 9001:2015 or ISO 13485:2016
- Other standards based on ISO 9001:2015
- Permissable exclusions
- Certification process & costs
- Quality Management System Documents
- Process Mapping & Metrics
- Introduction to Quality Management System Auditing
- Audit checklists
- Q&A
- Conclude & Follow Up Process