ISO 13485:2016 Internal Auditor Training Slides (PPT)
ISO 13485:2016 Internal Auditor Training Slides (PPT)
Our ISO 13485:2016 Internal Auditor Training (PPT) is ideal for the cost-sensitive Do-It-Yourselfer that would like to make modifications to the native PowerPoint slides. Slides have been created by industry experts & certification body auditors for actual use within online, onsite & open enrollment courses that we provide.
Over 200 slides with exercises, audit scenarios & dozens of links to online resources and other media.
PowerPoint (ppt) file format allows you to edit the material and make it your own. Use the slide master feature to incorporate your company brand or add company-specific policies & examples for a better learning experience. The presentation can also be saved as a PPS (slideshow) format for display only to prevent changes outside of your control. Material can also be 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
