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Certified Lead Auditor Training Course
Updated to reflect the revised ISO 19011:2018 (issued July 2018), the standard for auditing quality management systems
Learn how to conduct effective audits of quality management systems for medical devices. Expert instruction, engaging class discussions, and workshops use ISO 13485:2016 as the primary audit criteria. Workshops reinforce key topics with hands-on practice opportunities. Our course teaches the audit discipline according to ISO 19011:2018 while providing a sector-focused learning experience for professionals in the medical device industry.
Over 5 rigorous days, you will go through every phase of an audit, so you will be able to lead audits against the ISO 13485 standard efficiently and effectively.
Note: All attendees must study the current published version of ISO 13485 before attending class. Evening study recommended. A 2-hour final exam is required.