ISO 13485:2016 Fundamentals Training Course

Course Overview Who is this course for?

The focus of the ISO 13485:2016 Fundamentals Training Course is to comprehensively introduce Learners to Quality Management Systems and provide them with a highly insightful introduction to the purpose, intent and requirements of ISO 13485:2016 plus the business case for adopting ISO 13485:2016



Key Learning Outcome Why this course is unique?

Our training demonstrates to the Learner the benefits of adopting the unique Kelmac Group® One System Model for enhancing organizational compliance, effectiveness and efficiency based on utilizing Business Process Management to enhance ISO.



Course Basics What is essential to know?

  • This is a 1-day (8hr) learning event.
  • Start/Finish Times: 08:00am – 17:30pm
  • Ideal for those looking to get started and understand the requirements of Quality Management Systems and ISO 13485:2016 


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?
  • Course Introduction

    • The Business Case for ISO 13485 :2016 and the Relationship with Product Safety and Effectiveness
    • Key ISO 13485:2016 Terms*
    • The Relationship with the Medical Device Life Cycle and Regulatory Framework*
    • The Family of Medical Device Standards including Software*
    • Overview of various Medical Device Statutory and Regulatory Requirements*

    ISO 13485 – General Requirements for a Quality Management System

    • The Scope of the QMS
    • The PDCA Cycle and the Process-based Quality Management System Model for ISO 13485:2016*
    • The Organization Business Model, Alignment with the Medical Device Product Life Cycle and Benefits*
    • Medical Device Documented QMS Requirements
    • Audit Evidence and Sources*
  • ISO 13485 – Management Responsibility

    • The New and Enhanced Requirements for Leadership
    • The Seven Principles of Quality Management
    • Quality Policy
    • Quality Objectives and Plans to Achieve Them
    • Management of Change
    • Responsibility
    • Authority and Communication
    • Management Review
    • Audit Evidence and Sources*

    ISO 13485 – Resources

    • The Requirements for Resources to Support the Development, Implementation and Maintenance of the Medical Device 
    • Quality Management System
    • Human Resources, Infra-structure and Work Environment
    • Audit Evidence and Sources*
  • ISO 13485 – Product Realization

    • The Requirements for the Medical Device Life Cycle
    • Planning including Risk Management [ISO 14971]
    • Customer Requirements
    • Design Controls, Purchasing, Production, Installation & Servicing
    • Monitoring and Measuring Devices.

    ISO 13485 – Measurement, Analysis and Improvement

    • The requirements for Monitoring and Measurement
    • Control of Non-Conforming Product
    • Analysis of Data and Improvement
    • Audit Evidence and Sources*
    • Certification and Accreditation*

*Kelmac Group cover this topic in more depth compared to our competitors.

Course Certification Kelmac Group Certified Training Course

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

Additional Course Information

Who Should Attend?
  • Quality managers
  • RA managers
  • Auditors of medical device manufacturing firms (internal and external)
  • Those individuals working in an ISO 13485 complaint environment or in the Medical Devices Industry
  • Cross functional team members implementing the standard
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?

Working with a Case Study: Almost Full Documented QMS [Medical Devices] Why is this important?

Each Learner will audit the almost full documented QMS [Medical Devices] from the unique Kelmac Group® assurance perspective. The Kelmac Group® assurance perspective is unique as we audit like many professional financial audit practices where the focus is on providing top management with the quality of insight to make decisions and actions aimed at improving performance of the organization. 

We boast the most comprehensive documented QMS [MD] Case Study available including a ISO 13485 Quality Manual; 13 SIPOC processes [Value chain, Support and Management]; 19 procedures; the organization’s statutory and regulatory and other legal obligations register, and the organization’s risk register, and related documented Quality templates and records.

One System Model Why is this important?

The one system model is based on utilizing Business Process Management to enhance ISO based Management Systems.

Our course is unlike our competitors as we will outline a methodology for developing and implementing an Quality Management System based upon the requirements of ISO 13485:2016 where the QMS is integrated with the organization’s business model. 

Others train followers, we train leaders™

More Topics Covered In More Depth Why is this important?

In this course, we cover 9 topics in more depth than any of our competitors.

If you look at other courses, they are largely focused on knowledge based learning which does not cover all requirements of ISO 13485:2016

Ready to stand out from the crowd?