ISO 13485:2016 Internal Auditor Training - 2016 Standard
Training dates: Dec. 15-16, 2025 and Jan. 5-6, 2026 | 8a - 12:30p
Virtual class link will be sent to registrants prior to first class.
Event Details
Overview:
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 new course teaches auditing to the ISO 13485:2016 standard and places a strong emphasis on promoting employee participation in the improvement process.
On completion of this training program, participants will be able 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
This course takes place over four half-day sessions. Training dates: December 15 and 16, 2025 and January 5 and 6, 2026 online in Oregon Life Sciences Virtual Classroom from 8:00am-12:30pm.
Who Should Attend:
People tasked with conducting Internal Audits of their organization’s ISO 13485:2016 Quality Management System.
Prerequisites:
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.
Location: Oregon Life Sciences Virtual Classroom.
Registration:
Oregon Life Sciences Members - $ 625
Non-Members - $ 775
Questions? - please contact Julie Black at 503-953-3145