ISO 13485:2016 Internal Auditor Training – Online

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Training Dates: August 9 and August 11 from 8:30 a.m. – 5:00 p.m.

To successfully implement and maintain a quality management system a company must have an Internal Audit process and use trained auditors to perform the audits. Internal auditors are also a key element in quality system improvement. This course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process.

By the end of the course, participants will understand how to:

  • Describe the goals of an internal audit
  • State the benefits of internal auditing
  • Determine the requirements of an internal audit
  • Explain how ISO 13485:2016 differs from ISO 9001 and the areas of focus for Medical Devices.
  • Plan an internal audit, and develop a guide list
  • Perform an internal audit
  • Identify nonconformity to requirements during an audit
  • Report on an audit and follow up on corrective actions taken in response to audit findings
  • Describe the actions necessary for maintaining a successful audit program

Who Should Attend:
People tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System.

There are no prerequisites to attend this training course but a basic understanding of the ISO 13485:2016 Quality Management System standard would be beneficial.

Cost: 2-day class (delivered in 2 full-day live online modules)

Location: Oregon Bio Virtual Classroom.


August 9, 2022
8:30 am - 5:00 pm
$625.00 – $775.00
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Oregon Bio Virtual Classroom
OR United States