Understanding ISO 13485:2016

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This course is designed for experienced auditors who will be performing internal and/or supplier audits to ISO 13485:2016 requirements in the future. Designed to help adapt your auditing technique to accommodate the new and amended requirements of ISO 13485:2016, this course will discuss the differences between ISO 13485:2003 and ISO 13485:2016 requirements from an internal and supplier auditor’s perspective. Special attention will be given to concepts that are difficult to audit.

By the end of the course, participants will be able to:

  • Identify the differences between the current standard and new standard and how this will impact your approach to performing audits
  • Adapt your auditing technique to accommodate the new and amended requirements in the ISO 13485:2016 standard
  • Conduct effective audits against the requirements of ISO 13485:2016
  • Update your knowledge of audit principles, practices and terminology
  • Understand the alignment between the new Quality Management System requirements in ISO 13485:22016 and related regulatory requirements

Who Should Attend:
People who are currently performing internal and/or supplier audits against the ISO 13485:2003 standard and will be auditing to ISO 13485:2016 in the future. Managers, Quality Engineers, Process Owners, and Audit Program Managers will also benefit from this training

Experience performing first or second party (internal or supplier) audits against the ISO 13485:2003 standard.

Cost: 1-day class

Location: Location and driving directions will be emailed separately upon registration.


March 6, 2018
8:30 am - 5:00 pm
$375.00 – $475.00
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Julie Black


Portland State Business Accelerator – Mt. Hood Room
2828 S. Corbett Ave.
Portland, OR 97201 United States
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