ISO 13485:2016 Internal Auditor Course

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2 -days (16 hrs)

9 AM to 5: 00 PM


$1,095.00 USD / CAD per participant 

Discounts Offered

  • 10% Early Bird discount when registered 90 days prior to the class
  • 10% Group Rate 3+
  • 15% Combination Early Bird/Group Rate 3+


Participants will receive the below certificates at the conclusion of the course. All certificates are issued by TUV USA.

Certificate of Attendance to the attendant who participates in the entire course.

Certificate of Successful Completion to the attendee who passes the examination.

Course Objectives

The aim of this 2-day course is to provide information and knowledge about the internal auditing of the standard ISO 13485:2016. This course is intended for the management and active teams, internal auditors and persons of interests in ISO 13485. This course will also provide understanding to first, second and third party auditors learn the ISO 13485:2016 auditing process.


Learning Outcomes: What can the participants expect to learn in the course?

  • Understanding of ISO 13485:2016 Auditing Principles
  • Knowing Auditor responsibilities and competence requirements
  • Understanding Internal audit planning process and execution
  • Documentation and reporting of non-conformities Reporting Internal audit
  • Internal audit corrective actions verification and closure


  • ISO 13485:2016 – Understanding the Requirements

Course Agenda


Introduction and welcome

Introduction of objective/goals of the training.

Development of the Internal Audit Program

  1. Overview of the ISO13485 Internal Audit Requirements
  2. Review of Internal Audit Procedure(s)
  3. Development and Maintenance of the Audit Schedule


The Internal Audit Process Management System Audit Planning and Preparation

  1. Audit Planning and Preparation
    • Desktop Review
    • Importance of selecting the appropriate criteria, scope, objectives, and methods
    • Breakout Exercise No. 1

    • Selection of Auditors and Subject Matter Experts 
    • Agenda Development and Issuance
      • Breakout Exercise No. 2 

Day 2

Recap of Day One/Questions

The Internal Audit Process Continued

4.Opening Meeting

5. Conduct the Audit

  • Audit Techniques, skills and audit trials 
  • Process auditing, risk based approach and data analysis, sampling and questioning
  • Break out Exercise 3

6. Writing clear nonconformity statements

  • Break out Exercise 4
    1. Writing, Review and Issuance of Audit Results
  • Closing Meeting

Break out Exercise 5 Part I

Break out Exercise 5 Part II

  • Completing the Audit Report

2. Follow up Activities and Closure

  • Response to non-conformance
  • Verification of Corrective Actions

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