ISO 13485:2016 Internal Auditor Training Slides (PDF)

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ISO 13485:2016 Internal Auditor Training Slides (PDF)

$19,995.00

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.

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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

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