QI : Course duration is 3 days (4 hours per day).
2. The aim of the course (Exab apprentice knowledge and knowledge) as follows:
How to prepare a quality policy for a medical establishment.
How to prepare a quality manual for a medical facility.
How to prepare the required work procedures in accordance with ISO 13485: 2016.
How to prepare the operating instructions for the medical facility.
How to prepare flow charts.
How to prepare an assessment of risks and opportunities.
How to set up documents.
3. Summary of the course includes:
Day 1: The historical development of the quality management system of the medical establishment.
Quality Management System Requirements for the Medical & Domain Facility.
Standard Reference & Terms & Definitions.
The context of the organization includes {understanding of the organization and its context / understanding of the needs and expectations of the stakeholders / identification of the scope / quality management system of the medical facility and its operations}.
the second day:
Leadership.
Planning.
Support includes {resources / efficiency / awareness / communication / documented information}.
the third day:
Processes.
Analysis, evaluation and performance measurement.
continuous improvement
