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Program Description

ISO 13485 specifies requirements for an ISO-certified quality management system for manufacturers of medical devices and related services.

Designed for new and current internal auditors, this course provides an understanding of ISO 13485 and the skills needed to evaluate the effectiveness of the quality management system at your organization. You will be guided through the internal audit process, from planning an audit to reporting on audit results and following up on corrective actions.

Other Important Information

A written exam that covers ISO 13485 content and the application of audit principles and practices based on ISO 13485 will be administered during class.

Program Cost

Visit the Corporate College website for pricing.

Financial aid eligibility

This program is not Federal Financial Aid/Pell Eligible.

Scholarships, payment plans, and other financial aid options may be available.  For more information, call 216-987-6000, option 1.

Upon completion students receive

Certificate of Completion

Related Programs/Training

Register and learn more about Plexus: ISO 13485:2016 – Medical Devices Understanding and Internal Auditing.