ISO 13485 Internal Auditor Training


This three-day program is designed for quality professionals with a knowledge of medical device manufacturing.  The objective of the course is to teach, through lectures, workshops and exercises, how to plan, conduct and report internal audits that are compliant for the medical device industry. In so doing participants will review the new 2003 standard from an auditor’s perspective, highlighting the changes from the former version. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be introduced.


Program Content: 

This course includes all ISO 9001:2000 information from our standard internal auditor course, with the additional benefit of showing how the audit process fits with regulatory issues.

  • Introduction to ISO 13485
  • Selecting a sample
  • Review of the standard (and comparing it to former version) from an auditor’s viewpoint
  • Learning to process audit and audit for effectiveness
  • A look at ISO 14971 – Medical Device Risk Management Standard
  • Following audit trails
  • Apply principles of ISO 19011:2002 in the auditing process
  • Understanding when to write non-conformances and how to grade them
  • Planning, preparation, scheduling audits
  • Preparing audit reports and communicating results
  • Effective audit techniques
  • Following through with corrective and preventive actions

Program Benefits:

  • The knowledge, confidence and practical skills to conduct internal audits within your organization.
  • Provides a company’s management with the opportunity to develop, nurture and grow its own personnel resources and maintain its QMS.


Who Should Attend:

  • Management designated personnel who will be required to conduct internal ISO 9000 audits.


Program Duration:   Three-day program, 9:00 a.m. to 5:00 p.m. $1,095

Course Locations: Atlanta, GA, Tampa, FL or at your facility (on-site)


Call us to get started: 1-800-355-3876


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