ISO 13485 Lead Auditor Training Course
Our #1 best selling class! Ready to become a LEAD auditor? Over several rigorous days, you will go through every phase of an audit, giving you the skills and confidence to lead audits against the ISO 13485 standard. While other classes may bore you with an endless series of PowerPoint slides, this class includes numerous hands-on workshops and exercises so you understand how to apply what you just learned in real-world situations. Our course teaches the audit discipline according to ISO 19011:2018. We also offer an ISO 13485 internal auditing class. Both courses are Exemplar Global RTP certified and include an online exam.
- Class Overview
- Upcoming Classes
- Course Overview
- What You Will Learn
- Who Should Attend
- Related Courses & Services
Brief Overview of This ISO 13485 Lead Auditor Course
SkillsLab Class ?
Class Content
In-Depth
Class Duration
9 Half-Days*
Teaching Format
Live, Instructor-Led
Delivery Options
Virtual or In Person**
Certification of Completion
Yes
Continuing Education Units (CEUs)
4.4
* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 5 consecutive days.
** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!
Upcoming ISO 13485:2016 Lead Auditing Classes

Course Code | Location | Class Begins | Class Ends | Daily Schedule | Course Delivery | Class Agenda | Registration |
---|---|---|---|---|---|---|---|
LAF | VIRTUAL DELIVERY (Eastern Time) | 18 Aug 2025 | 28 Aug 2025 | 1:00PM – 5:00PM daily (last day starts at 11:30AM) Eastern US Time | Virtual | REGISTER | |
LAF | VIRTUAL DELIVERY (Eastern Time) | 01 Sep 2025 | 11 Sep 2025 | 1:00PM – 5:00PM daily (last day starts at 11:30AM) Eastern US Time | Virtual – Spanish Delivery | REGISTER | |
LAF | Boston, MA | 08 Sep 2025 | 12 Sep 2025 | 8:00AM – 5:00PM Eastern US Time | In-Person | REGISTER | |
LAF | VIRTUAL DELIVERY (Eastern Time) | 29 Sep 2025 | 09 Oct 2025 | 1:00PM – 5:00PM daily (last day starts at 11:30AM) Eastern US Time | Virtual | REGISTER | |
LAF | San Francisco Area, CA | 17 Nov 2025 | 21 Nov 2025 | 8:00AM – 5:00PM Pacific US Time | In-Person | REGISTER | |
LAF | San Jose, Costa Rica | 17 Nov 2025 | 21 Nov 2025 | 8:00AM – 5:00PM CR | In-Person | REGISTER | |
LAF | VIRTUAL DELIVERY (Eastern Time) | 01 Dec 2025 | 11 Dec 2025 | 1:00PM – 5:00PM daily (last day starts at 11:30AM) Eastern US Time | Virtual | REGISTER |