As per the requirements of the ISO 13485 certification, all involved personnel must have the requisite training, skills and competency required to perform their duties. For achieving the certification as per the Saudi Food and Drug Authority (SFDA) regulations, consultants specify the following requirements:

• The entire training process should be systematically documented.
• All associated records must be maintained along with employee files.
• The efficacy of the training program should be periodically assessed and duly recorded.
• Individuals involved in the quality process should be aware of their respective roles.
• A risk based training program should be developed.

For ISO 13485 Certification, ISO 13485 Consultancy, ISO 13485 Consultants, ISO 13485 SFDA requirements, in Riyadh, Jeddah, Dammam, Jubail, Yanbu, Hofuf drop an email to [email protected].