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ISO 13485 Internal Auditing— Online & Self-Paced

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Become the ISO 13485 Internal Auditor Your QMS Needs, at Your Own Pace

Plan, conduct and report internal audits of a medical device quality management system. You’ll finish with a completed audit checklist, a real internal audit report and a certificate of completion for your auditor qualification records.

30-day money-back guarantee. If the course isn’t right for you, we’ll refund you.

What You'll Be Able to Do

  • Read ISO 13485:2016 the way an auditor does, and know where it differs from ISO 9001
  • Turn your own procedures into audit questions for a desk audit and an interview audit
  • Plan audits by scope, objective and risk, and stay objective while auditing colleagues
  • Gather evidence, write clear findings and follow up on corrective action
  • Run an internal audit program that feeds management review

How the Course Works

  • 11 video lessons, about 6 hours, in three modules (see the curriculum below)
  • Two practical assignments: build your audit checklist, then submit an internal audit report. Both are reviewed for satisfactory completion.
  • Certificate of completion issued when your assignments are approved. It documents 16 hours of formal internal auditor training for your qualification records.
  • Downloadable templates and checklists you can use on the job

Your Instructor

Diana Lynn, President of Management Systems International (MSI), has 28 years of ISO experience. She audits medical device manufacturers, contract manufacturers and design houses. MSI has helped 80+ organizations reach certification with a 100% first-time success rate and has trained 600+ professionals.

Who It's For

Quality, regulatory and operations professionals who will audit or take part in ISO 13485 internal audits, including new auditors and ISO 9001 auditors moving into medical devices. No prior ISO 13485 knowledge is required.

FAQs

Do I need prior ISO 13485 knowledge? No. Module 2 covers the requirements before you start auditing.

Will this qualify me to audit? Your organization decides auditor qualification. This course gives you the documented training and a completed audit report to support it.

How long do I have? Lifetime access to the current edition. Assignments are due within 20 days of finishing the videos.

Do I need the standard? We recommend a copy of ISO 13485:2016. Your company may already have one.

Can my team take this together? Yes. Ask about team pricing, or we can deliver it privately online or on-site.

Ready to Start?

Enroll today and start with Module 1. Questions? Call (888) 914-9141 or email info@msi-international.com.

Learning Objectives

  • Audit planning
  • Audit checksheet development
  • Opening and closing meetings
  • Audit program management
  • ISO 13485 requirements
  • Interviewing strategies
  • Nonconformity and report writing

Course Curriculum

Module 1: Internal Auditing for Medical Devices: The Big Picture
Start here. See how ISO 13485 internal audits work from planning to reporting, and the tools you'll use throughout the course.

Module 2: Auditing the ISO 13485 Requirements, Clause by Clause
Build your audit checklist from your own procedures, then work through Sections 4 to 8 of ISO 13485: what to look for, which records to sample and how to confirm each requirement is met.

Module 3: Running the Internal Audit Program
Set up an internal audit program that registrars trust: scope, schedule, auditor objectivity, interviews, evidence, findings and corrective action follow-up. Then complete your internal audit report.

Earn a certificate

Add this certificate to your resume to demonstrate your skills & increase your chances of getting noticed.

selected template
Purchase  $379   Purchase  $1,137  
  • Level
    Intermediate
  • Duration
    16 hours
  • Last Updated
    October 18, 2026
  • Certificate
    Certificate of completion

A course by

Diana Lynn

Material Includes

  • Access to 11 recorded video lessons (approximately 6 hours)
  • Downloadable medical device audit templates and checklists
  • Two practical assignments: an audit checklist and an internal audit report, each reviewed for satisfactory completion
  • ISO 13485 internal auditor certificate of completion for your auditor qualification records
  • Lifetime access to the current edition

Requirements

  • No prior ISO 13485 knowledge required
  • All assignments must be satisfactorily completed to receive the Certificate
  • Assignments must be completed within 20 days of finishing the video lessons
  • We recommend having a copy of the ISO 13485:2016 standard for reference — your company may already hold one

Tags

Target Audience

  • Current internal auditors
  • Managers responsible for the audit program
  • Newly assigned internal auditors
  • Quality and regulatory professionals moving into ISO 13485 auditing
  • ISO 9001 auditors transitioning to medical device QMS

This training is available for corporate teams, multi‑site organizations, and consulting firms and can be delivered online, privately, or on‑site with auditor qualification documentation aligned to expectations. 
See our developing Learning Paths

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