ISO 13485:2016 Internal Auditor Training Course


Course Overview Who is this course for?

The focus of the ISO 13485:2016 Internal Auditor Training Course is on assisting and verifying the competencies & capabilities of the Learner to be able to effectively audit a process, activity or department/function of a QMS based on ISO 13485 requirements with specific emphasis of 1st Party auditing [Internal Audits].

During the delivery, the Learner will complete a Consultant facilitated audit of a process within an QMS, covering the full audit life cycle as defined by ISO 19011 & the Learner will have to demonstrate and be assessed on the effective application of audit tools and techniques, auditor skills and behaviors.



Key Course Learning Outcome Why this course is unique?

Provide Internal Auditors with both the confidence and ability to apply the audit assurance tools and techniques, methodology and desired behaviors to assess the organization’s QMS Medical Device processes and process controls to consistently provide safe & effective medical evice products and services that meet customer and applicable statutory and regulatory requirements.



Course Basics What is essential to know about this course?

  • This is a 2-day (16hr) learning event.
  • Start/Finish Times: 08:00am – 18:00pm (each day)
  • Prior Learning Requirement: Learners are required to be familiar with ISO 13485 Requirements or have received ISO 13485 Fundamentals training in advance of attending this course.


Upcoming Dates and Locations Where can I register?

We are sorry but there are currently no public training dates available for this course at the moment! If you would like to send us your details, we will contact you when a course becomes available near you. If you have any questions about this course, call (312) 496 6607.

Where are you looking to attend this training?

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Course Learning Topics What does the course cover?
    • Introduction to Internal Auditing
    • The role of Internal Audits and the Audit Life Cycle
    • Audit Terminology and Principles
    • Audit Types and Objectives
    • Understanding the PDCA Cycle and Process Approach and their significance for Internal Auditors**
    • Internal Auditor Competence, Roles & Responsibilities
    • Behaviors & Performance Evaluation**
    • Business Process Management**
    • Audit Planning (Process & Risk-based)**
    • Initiating & Preparing for the on-site activities**
    • Developing an Audit Plan/Scope Audit Protocol (Checklist/Process Documentation)**
    • Audit Protocol (Checklist/Process Documentation)**
    • Opening Meeting (Real Life Scenario)**
    • Evidence, Methods & Procedure for Gathering Evidence (Wider Audit Methods)**
    • Interviewing and Writing Audit Findings
    • Auditing Reporting (In more depth)**
    • Audit Findings, Terminology, Classification and Elements
    • Writing Audit Findings & the Audit Report
    • Completing the Audit
    • Audit Follow-Up Strategies (In-depth)**
    • Corrective and Preventative Action including Audit Finding Closure (Robust Evaluation)**
    • Audit Follow Up
    • Closing/Exit Meeting (Real Life Scenario)**

**not found on most standard/competitor courses

Course Certification Kelmac Group® Certified Course

This course has been designed by leading experts to provide high quality training to professionals seeking to internally audit Quality Management Systems based on ISO 13485.

Additional Important Course Information

Who Should Attend?
  • Quality Managers
  • Quality Professionals/Technicians
  • Quality Engineers
  • Procurement Personnel
  • Financial Personnel
  • Document Controllers 
  • Internal Auditors 
  • Owner Managers 
  • Implementation Members 
Course Pre-Requisites
  • Prior to attending this training, Learners should be familiar with the requirements of ISO 13485:2016 or have completed recognised ISO 13485:2016 requirements (understanding) training.
Course Assessment

Each Learner is assessed based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course.

Please note, full attendance is required during the training course.

Our Course vs. Our Competitors Why is our course the best?

Assessment of Process Effectiveness Why is this important?

To have a high performing QMS [MD] that directly and indirectly impacts business performance requires a QMS [MD] that is integrated with the organizations business processes.

Our course focuses on providing Learners with skills to provide real value and underpin Process Owner and other Stakeholder confidence – this leads to better improvements, more insightful audits, better quality information and therefore, better informed decisions.

Wider Coverage of Audit Methods Why is this important?

What sets the Kelmac Group® course apart from both the IRCA course specification and competitor courses is we develop the Learner’s competency using a wide variety of audit methods, namely interview, document review and analysis of process and product data and information and operational records.

By comparison, competitor courses only focus on one audit method, interview and this does not expose the QMS [MD] Auditor to the real-life audit situation – the Kelmac Group course does.

Ready to stand out from the crowd?