Before starting this course, students are expected to have the following prior knowledge:
MANAGEMENT SYSTEMS:
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
QUALITY MANAGEMENT:
- The fundamental concepts and the seven quality management principles (see ISO 9000):
- Customer focus
- Leadership
- Engagement of people
- Process approach
- Improvement
- Evidence-based decision making
- Relationship management
ISO 13485:2016 STANDARD:
- Knowledge of the requirements of ISO 13485, and the focus on meeting applicable regulatory requirements, using a risk based approach.
- Preferable experience in performing internal audits against ISO 13485
Learners will need to demonstrate acceptable performance and be fully involved in the interactive workshops in order to complete the course successfully.