ISO 13485:2016 Certified Internal Auditor Training
Prepare yourself for real-life ISO 13485:2016 auditing situations and learn how to audit using the process approach.
This course is Exemplar Global-certified.
Learn to plan and schedule an internal audit program for medical device quality management systems.
Develop the skills you need to conduct a successful audit in this course devoted to the ISO 13485:2016 Medical Device Quality Management System standard. This three-day class begins with foundational knowledge of the ISO 13485 standard and builds upon it to prepare you for real-life auditing situations—including managing the audit process and completing reporting—via hands-on workshops and two competency exams (MD & AU).
Competency Units:
• Foundations (MD)
• Certified Internal Auditor – Management Systems Auditing (AU)
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: 24 Hours
- ASQ RU: 2.4
- Audience: Professional, Practitioner
Learning Objectives:
- Fully understand and successfully interpret the ISO 13485:2016 requirements
- Understand how to audit using the process approach
- Ask audit questions that get results
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
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.
June 16, 2025 - June 18, 2025 08:00 AM - 06:00 PM CST Show Class Schedule | VIR1303 | DEKRA | English | Early Bird Ends May 17, 2025 List: $1095 Member: $995 Regular List: $1325 Member: $1205 | |||
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) Dates: Monday, June 16 - June 18, 2025 *Times: 8:00 AM - 6:00 PM (Central Time Zone). Includes approximately 1-hour for Lunch and Breaks throughout the day. (Virtual sessions are NOT recorded) |

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