ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
Designed for new and current internal auditors, this course will provide an understanding of ISO 13485 and the skills 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 the content of ISO 13485 and the application of audit principles and practices based on ISO 13485 will be administered during class.
Visit the Corporate College website here 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 216-987-3075, option #1..
Upon completion students receive
Certificate of Completion
- ISO Standards and Certified Training (Professional Development Programs)
- Lean/Lean Six Sigma
- Business Management
- Business Management (Human Resources Management)
- Business Management (International Business)
- Business Management (Small Business Management)
- Manufacturing Industrial Engineering Technology
To Register for and Learn more about Plexus: ISO 13485:2016 – Medical Devices Understanding and Internal Auditing