Skip to content

Become an ISO 13485:2016 Internal Auditor

Build internal audit competence for medical device quality systems with QMII’s Exemplar Global-recognized ISO 13485 Internal Auditor training: Online or in-classroom, built for real impact.

Receive post-course support and join a thriving alumni network of systems thinkers and lead auditors with QMII’s industry leading “Alumni for Life” program.

Register Now!

Why This Course Matters

QMII’s ISO 13485:2016 Internal Auditor Training is a 3-day, instructor-led program designed for organizations operating in the medical device and FDA-regulated industries. This course focuses on how management systems conforming to ISO 13485 apply to real-world medical device environments and how internal audits can be used to maintain compliance, manage risk, and drive continual improvement.

Learning Objectives

Participants will be able to:

  1. Interpret and apply ISO 13485 requirements and their relationship to 21 CFR 820.
  2. Lead first and second party audits of medical device organizations and suppliers. 
  3. Apply process-based and risk-based auditing to evaluate quality-critical activities.
  4. Assess effectiveness of  documentation and operational controls.
  5. Identify and report nonconformities, root causes, and opportunities for improvement.
  6. Manage audit teams effectively, ensuring audit objectives are achieved professionally.
  7. Integrate regulatory and customer requirements into audit planning and evaluation.

Who Needs This Course

For Leaders in Medical Device Organizations

  • Quality Managers and Leads within medical device organizations.
  • Auditors seeking Exemplar Global ISO 13485 Auditor qualification.
  • Professionals from FDA regulated industries
  •  Systems professionals or people who want to understand how management systems work
  • Buyers in FDA regulated industries
  • Leaders/managers/professionals in the Medical Device industry

Whether you audit internally, oversee suppliers, or prepare for certification, this course enables you to verify quality, consistency, and conformity throughout the system.

Skills You’ll Acquire

Audit Excellence:

  • Plan, perform, and lead audits per ISO 19011 and ISO 13485.
  • Evaluate the system ability to meet customer and regulatory requirements.
  • Conduct process-based audits that focus on system outcomes, not paperwork.

Quality Focus:

  • Audit controls for effectiveness of implementation.
  • Assess effectiveness of corrective and preventive maintenance procedures.
  • Link audit results directly to product safety and quality and customer satisfaction.

Duration and Coverage

1
Day 1
  • Lecture: Intro to Management Systems
  • Lecture: ISO 13485
  • Test: ISO 13485 Self Study
  • Lecture: Internal Audit
  • Lecture: Internal Audit Planning and Preparation
  • Workshop: ISO 13485 – Review System Docs and Prep Audit Schedule
2
Day 2
  • Workshop: ISO 13485 – Reviewing Processes and Prep Checklists
  • Lecture: Performing the Internal Audit Investigation
  • Workshop: ISO 13485 – Determining Nonconformities
  • Lecture: Concluding the Audit
3
Day 3
  • Workshop: ISO 13485 – Interviewing Auditees
  • Workshop: Writing Nonconformity Statements
  • Lecture: Corrective Action and Follow-up

Course Format & Agenda

  • 3-day instructor-led program, available virtually or onsite.
  • Includes lectures, interactive workshops, audit simulations, and case studies from real industry environments.
  • Concurrent modular tests throughout the course.
  • May be run in conjunction with an ISO 13485 Lead Auditor course.

Certification & Recognition

Students successfully completing QMII’s 3-day ISO 13485 Internal Auditor training and the examinations provided in conjunction with this course, receive a Certificate of Attainment for the following QMII training units:

13485 – Medical Devices Management Systems
AUDITOR – Management Systems Auditing

This course is recognized by Exemplar Global as meeting the training requirements for 13485 – Medical Devices Management Systems Internal Auditor personnel certification.

Successful course candidates can use these certifications as earned credit towards other certifications such as ISO 9001, ISO 14001 Auditor and other similar standards.

Register Now!
Download Brochure

Frequently Asked Questions

Quality managers, auditors, regulatory affairs professionals, and anyone involved in the design, manufacture, or distribution of medical devices.

Course length varies — typically 2 days for overview, 3 days for internal auditor, and 5 days for lead auditor training.

Yes. The Certificate of Attainment is recognized by Exemplar Global.

While the focus is ISO 13485, QMII’s instructors draw connections to FDA Quality System Regulation requirements where relevant.

Yes. QMII offers customized onsite delivery for medical device QMS training globally.