ISO 13485:2016 Certified Lead Auditor Training
Prepare yourself for real-life ISO 13485:2016 auditing situations and learn how to manage the complete audit process.
This course is Exemplar Global-certified.
Develop the skills you need to lead a successful medical device audit in this ISO 13485 lead auditor training course. Specifically designed to meet the needs of the medical device industry, this four-day class prepares medical device lead auditors for real-life situations via hands-on workshops.
Participants will learn how to lead the audit process and to complete reporting.
Three competency exams are included that can be submitted to Exemplar Global as part of your application for ISO 13485 Lead Auditor certification.
Competency Units:
• Foundations (MD)
• Certified Internal Auditor – Management Systems Auditing (AU)
• Certified Lead Auditor – Leading Management Systems Audit Teams (TL)
Note: For the exam portion of the course, each attendee is required to have a computer with a webcam (smart phone can be used if computer webcam is not functional). Paper exams available with prior notice for onsite virtual courses only.
ASQ virtual courses provide electronic access to course materials for 365 days beginning five days before the first day of your course. Extensions and/or refunds cannot be issued if course materials have been accessed. Chrome and Edge browsers are recommended – Internet Explorer is not supported.
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Course Data
- CEU Hours: 0
- Length: 36 Hours
- ASQ RU: 3.6
- Audience: Practitioner, Professional
Learning Objectives:
- Fully understand and interpret the requirements of ISO 13485
- Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
- Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
- Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
- Understand how to apply the requirements of ISO 9001 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
- Understand the terminology of the ISO 9001 and ISO 13485 and how these apply in a Medical Device Environment
- Learn how to develop an ISO 9001 / ISO 13485 auditing system based on the ISO 19011 auditing requirements
- Learn how to ask audit questions that get results
- Learn how to conduct opening and closing meetings that have impact
- Learn how to construct effective audit checklists
- Learn how to generate effective corrective actions
Prerequisites:
All attendees are required to have their own copy of the ISO 13485:2016: Medical devices - Quality Management Systems - Requirements for regulatory purposes. Click to purchase Standards
Who Should Attend:
Those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry- Course Introduction
- Terminology and Definitions
- Background, History and Rationale of Quality Management
- Introduction to Documents and Resources
- Analysis of the Requirements of the Standard
- Audits and Audit Findings
- Exemplar Global & ANAB
- Auditor Qualifications
- Roles and Responsibilities During Audits
- The Audit Checklist
- Documentation in the Management System
- Planning and Conducting Audits
- Application of the Audit Cycle
Format
An Internet-based, instructor led course utilizing web and teleconferencing technologies to allow students to interact without traveling. Virtual courses offer interaction with instructor and students via phone and Internet capabilities. Students have access to interaction both with the instructor and other students in an Internet-based learning environment (white board, Q&A tools, application sharing, and breakout rooms). Virtual courses are classroom-like experiences offered using the latest Internet tools.Registration Email
After course registration, you will receive an email with access instructions. If you do not, please check your email junk, spam, or clutter folders. If the email is not there, please contact ASQ. For virtual WebEx courses, you will receive another email 24 hours prior to the start of class containing additional access information.
Technical Requirements (impacts all ASQ-owned eLearning)
Hardware
- PC, Mac, or mobile device
- Audio speakers or headset
- High-speed internet connection
Browsers for ASQ Courses
You can view courses on any devices that support these browsers. This includes mobile devices such as iPhones, iPads, and Android-enabled phones and tablets.
- Windows: Internet Explorer 11, Microsoft Edge (latest version), Google Chrome (latest version), Firefox (latest version)
- Mac: Safari (latest version), Google Chrome (latest version), Firefox (latest version)
- Mobile: Safari in Apple iOS 10 or later, Google Chrome in Apple iOS 10 or later, Google Chrome in Android OS 4.4 or later
Required Browser Settings for Viewing Courses
- JavaScript must be enabled for published courses to work.
- Font downloads must be enabled to see the correct fonts and characters.
- When using Internet Explorer, turn off Compatibility View for sites where courses are hosted.
WebEx – Virtual Course: Advance Preparation and Student Information
Join a Test Session
We strongly suggest that you join a WebEx test session in advance of your scheduled virtual training, using your preferred web browser. This can help prevent problems launching content the day your training begins.
If you do not have administrative privileges on the SAME computer you will be using the day of your training (i.e., your workstation within your organization) you may need the assistance of your local IT/IS help desk staff for the platform to engage correctly.
To join a test session (meeting), click here and enter your name and email address to join. If successful, you will see a screen that says "Congratulations! Your system is now set up properly ..."
Deactivate Pop-up Blockers
You should deactivate any pop-up blockers, spam filters, and company firewalls that could prevent the WebEx client platform or web-based course from working properly. Third-party toolbars such as Bing, Yahoo, and Google should also be disabled due to their own pop-up blocking capabilities.
If you need to cancel, we will refund your paid registration fee as noted below.
- Requests for cancellations or transfers to another course offering received at least 30 calendar days before the start of the course can receive a full refund or transfer.
- There are no refunds within 30 calendar days before the start of the course.
- Requests to transfer to another course offering received between 29 and 10 calendar days of the course starting incur a $150 processing fee.
- There are no transfers within 9 calendar days before the start of the course.
- There are no refunds if the content has been accessed.
- Enrolled students who fail to attend their registered course without advance notice are liable for the entire course fee.
- IMPORTANT: Some courses are delivered by ASQ’s partners and have separate cancellation policies. Please refer to the product page for exact information or contact Customer Care at [email protected].
Enrollment Details

A web-based, live, classroom-like instructor led experience allowing attendees to interact without traveling. Some courses include an electronic book or online access to materials for a limited time and up to three hard copy prints. – see course description for details.
July 14, 2025 - July 17, 2025 08:00 AM - 06:00 PM CST Show Class Schedule | VIR1309 | DEKRA | English | Early Bird Ends June 14, 2025 List: $1575 Member: $1475 Regular List: $1905 Member: $1735 | |||
Attendance to all virtual sessions is required to earn a certificate of completion and for the course to be listed as completed on your ASQ transcript.
Schedule: 4-days Monday, July 14 – Thursday, July 17, 2025 Time: 8:00 AM- 6:00 PM (Central Time Zone). (Virtual sessions are NOT recorded) |
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October 06, 2025 - October 08, 2025 08:00 AM - 06:00 PM CST Show Class Schedule | VIR1330 | DEKRA | English | Early Bird Ends September 06, 2025 List: $1575 Member: $1475 Regular List: $1905 Member: $1735 | |||
Attendance to all virtual sessions is required to earn a certificate of completion and for the course to be listed as completed on your ASQ transcript.
Schedule: 3-days Monday, November 6 – Wednesday, November 8, 2025 Time: 8:00 AM – 6:00 PM (Central Time Zone). (Virtual sessions are NOT recorded) |
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December 08, 2025 - December 11, 2025 08:00 AM - 06:00 PM CST Show Class Schedule | VIR1350 | TBD | English | Early Bird Ends November 08, 2025 List: $1575 Member: $1475 Regular List: $1905 Member: $1735 | |||
Attendance to all virtual sessions is required to earn a certificate of completion and for the course to be listed as completed on your ASQ transcript.
Schedule: 4-days Monday, December 8– Thursday, December 11, 2025 Time: 8:00 AM – 6:00 PM (Central Time Zone). (Virtual sessions are NOT recorded) |

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