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ISO 13485:2016 Internal Auditor Upgrade Training

Course Details:

1 Day, 6.5 Instructional Hours
6.5 Engineering Professional Development Hours (PDHs)

Course Description:
Refresh your auditing skills and gain an understanding of how to audit to the new requirements of the standard.

Prerequisites: Registrant must be an ISO 13485:2003 Internal Auditor.

Learning Objectives:
This course is designed for existing ISO 13485:2003 Quality Management System Internal Auditors. Our experienced instructor, will discuss the new requirements, facilitate hands-on exercises, and provide guidance on how to audit to the new ISO 13485:2016 requirements. By attending this one-day course you will be capable of:

  • Explain the background for the changes to ISO 13485:2016
  • Explain the requirements, and purpose of ISO 13485:2016
  • Identifying and understanding the key changes between ISO 13485:2003 and ISO 13485:2016
  • Explain how regulatory requirements have been imbedded into ISO 13485:2016
  • Understanding how the key changes will impact existing approaches to auditing
  • Understanding how to audit to the new requirements of the standard
  • Planning an audit program and process-specific audits
  • Preparing for the audit by developing effective process diagrams and checklists
  • Performing the audits to gather objective evidence through observation, interviewing and sampling of documents and records
  • Reporting audit findings accurately to help your organization improve
  • Providing exceptional audit documentation

Each participant will receive a training manual and a copy of the ISO 13485:2016 standard.

Who Should Attend:
This course is designed for existing ISO 13485:2003 Internal Auditors.

Course Info


For location details and single session sign-ups:



Claire Pickrell

Upcoming Dates

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On-Site Availability

Any of our open enrollment classes can be brought on-site. Please Contact Us for more information.