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ISO 13485:2016 Internal Auditor Training

Course Certified by Exemplar Global

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).

Course Details

  • Length: 3 days
  • CTUs: 2.4
  • Competency Units: MD, AU
  • Audience: Anyone responsible for planning and scheduling an internal audit program for ISO 13485:2016, including quality assurance managers, ISO project managers, ISO project team members, compliance managers, and regulatory personnel

More ISO 13485 Training Options

Highlighted Topics

  • Requirements of the ISO 13485:2016 standard

  • Terminology for medical device quality management systems

  • Principles, processes, and methods of auditing

  • The Plan-Do-Check-Act (PDCA) methodology

  • Fully understand and successfully interpret the ISO 13485 requirements
  • Identify medical device QMS terms
  • Understand how to audit using the process approach
  • Ask audit questions that get results
  • Describe the relationship between ISO 13485:2016 and applicable regulatory requirements

All attendees are required to bring their own copy of the standard ISO 13485:2016 Quality Management System – Requirements For Regulatory Purposes. Copies will not be provided for you.

This is a three-day, instructor-led course available online or in-person. There are written tests on each of the competency units on days 2 and 3. Days 1 and 2 will cover ISO 13485:2016 along with a corresponding competency exam (MD). Day 3 will cover management systems auditing (AU) along with a corresponding competency exam.

The Instructor was able to simplify the standards and challenged our understanding of them through real-world examples.

Course feedback from a student, 2021


Industry-leading accreditation and unparalleled experience

Exemplar Global-certified Internal Auditor Course

DEKRA Training (formerly AQS) offers a full range of training in support of organizational improvement and implementation of international management system standards.

This Exemplar Global-certified course for ISO 13485:2016 meets the training requirements for Exemplar Global Quality Management Systems Auditors and Provisional Auditors.

Have questions? Contact us

DEKRA Training

8990 Springbrook Dr. NW

Suite 210

Minneapolis , MN 55443

+1 800-633-2588