Course: ISO 13485: 2016 Internal Auditor Training

Description: 

This course is designed to teach your internal audit team how to plan and perform internal audits to the ISO 13485:2016 Quality Management Systems – Requirements for Regulatory Purposes Standard.   The course begins with detailed review of ISO 13485:2016 to raise the students’ knowledge and understanding of the requirements of the medical device standard. Auditing techniques and tools including how to plan and perform “process-based” internal audits will be reviewed. The lecture will be reinforced with hands-on workshops including performing a “mock-audit” to the ISO 13485 Standard, to enhance the students understanding and experience.