ISO 13485:2016 Internal Auditor Training Slides (PDF)
ISO 13485:2016 Internal Auditor Training Slides (PDF)
Our ISO 13485:2016 Internal Auditor Training (PDF) is ideal for the cost-sensitive Do-It-Yourselfer. Slides have been converted from PPT to PDF allowing for a seamless slide show that is classroom ready. PDF slides can be used as an electronic presentation or printed out to create your own hardcopy student handbooks.
Modules include:
Introduction, gathering of expectations & initial self-assessment
The importance of systems
Overview of the ISO 13485:2016 standard (part I)
Overview of the ISO 13485:2016 standard (part II)
FDA requirements & online resources
Must-have tools for medical device operations
ISO 13485:2016 clause 1-4
ISO 13485:2016 clause 5-6
ISO 13485:2016 clause 7 (part I)
ISO 13485:2016 clause 7 (part II)
ISO 13485:2016 clause 8
ISO 13485:2016 clause 9-10
Creating a world-class auditing program
Audit preparation for optimal results
Process audit breakout
Reporting results & evaluating improvement activities
Closing & improving the audit cycle
Resources for personal development & organizational improvement
Final self-assessment
