The goal of this training is to clarify the requirements of the ISO 14971 standard and sharing information regarding to how these requirements should be met. The training will be done through sample documents and records.
What is risk management process?
Explaining the terms and descriptions in ISO 14971 standard
What is the purpose of the product that the risk analysis will be done for?
What are the responsibilities of the top managers for the risk management process?
What are the qualities that the people in risk management team should have?
How should the risk management be planned?
What does the risk management file include? How should it be prepared?
How should the risk be evaluated and analyzed?
What is risk/benefit analysis?
How should the risk management report be composed?
How should the before and after production data be acquired and evaluated and how should the risks be analyzed?
Employees who work in quality, top management, production, design and development departments
ISO 13485 Standard internal audit candidates
Each attendant will receive an “ISO 14971 Standard Informational Training Participation Certificate”.