Medical Devices Quality Management Systems
ISO 13485:2016 Foundation Course (Self-Paced Online)
Level
Foundation
Certification
Exemplar Global
Delivery
Self-Paced Online
Duration
8 hours
Content
Video Lessons
Access
Lifetime
What you will learn
- The purpose and structure of ISO 13485:2016 as a quality management system for regulatory purposes
- The clause 4 to 8 layout and why it is not the Annex SL structure used by ISO 9001
- The regulatory role concept: manufacturer, authorized representative, importer, distributor
- Risk management and its link to ISO 14971 across the device life cycle
- The medical device file, design controls, sterile and implantable device requirements, and traceability
- The feedback, complaint handling, and regulatory reporting chain
- How ISO certification works and how organisations achieve and maintain it
Who is this for?
Open to everyone. Ideal for quality and regulatory staff, engineers, production and design team members in medical device organisations, and anyone new to ISO 13485. No prior knowledge required.
- Course Overview
- Introduction to ISO 13485:2016
- Clause 4: Quality Management System
- Clause 5: Management Responsibility
- Clause 6: Resource Management
- Clause 7: Product Realization
- Clause 8: Measurement, Analysis and Improvement
- What is ISO Certification and how does it work?
An understanding of ISO 13485:2016 is valuable across every part of a medical device organisation. This foundation course enables you to:
- Understand ISO 13485:2016 and speak the language of medical device quality management with confidence
- Contribute to your organisation's quality management system and its certification readiness
- Understand how regulatory requirements shape the QMS, from design through to postmarket surveillance
- Build a solid foundation before progressing to Internal Auditor training
- Earn a globally recognised foundation credential
Why learning online works for you
- Learn anytime, anywhere. Study on demand, on site or off site, whenever it suits you
- Self paced. Move at your own speed and spend more time on the areas you want to master
- Cost effective. No travel, accommodation, or time away from the office to fund
- Lifetime access. Return to the materials whenever you need them
- Built to stick. Interactive, multi format lessons keep you engaged and improve retention
A quick look inside
By the end of this course you will be able to:
- Explain the purpose of a medical device quality management system and how ISO 13485:2016 differs from ISO 9001
- Describe the structure of ISO 13485:2016 and how its clause 4 to 8 requirements fit together
- Explain the regulatory role concept and how role drives applicable regulatory requirements
- Describe the risk based approach and its link to ISO 14971, and the meaning of maintaining effectiveness rather than continual improvement
- Explain key elements such as the medical device file, design controls, sterile and implantable device requirements, and traceability
- Describe the feedback, complaint handling, and regulatory reporting chain
- Explain what ISO certification is and how organisations achieve and maintain it
As a bonus, this course explains how ISO certification works. You will learn what it means for an organisation to be certified, the role of accredited certification bodies and accreditation, and how organisations achieve and maintain certification.
This course is designed for anyone who wants a working understanding of the standard, including:
- Anyone new to ISO 13485 or medical device quality management
- Quality, regulatory, design, and production staff who work within or contribute to the QMS
- Managers, engineers, and consultants who need a working understanding of the standard
- Suppliers and distributors to the medical device industry
- Anyone preparing to progress to Internal Auditor training
- Those supporting their organisation towards ISO 13485 certification
There are no prerequisites for this course. It is suitable for complete beginners.
Some of our courses share the same lessons. If you have already done those lessons in another course with us, you will not have to watch them again. You just do what is new in this course. This happens automatically when you enrol.
This is not the formal Recognition of Prior Learning that exempts you from a qualification, and it does not mean there is nothing left to do. It saves you time, while the units that make up your course remain mandatory to complete.
You will need a computer, laptop, or tablet with a reliable internet connection. The course works in any modern web browser, such as Google Chrome, Microsoft Edge, Mozilla Firefox, or Apple Safari. For the best experience, keep your browser updated to the latest version.
What standard is relevant to this course?
Do I need any prior knowledge or experience?
Is ISO 13485 the same as ISO 9001?
Does this course have assessment requirements?
How long does the course take to complete?
What is the difference between this course and the Internal Auditor course?
Is this course accredited, and what do I receive on completion?
What if I need assistance to complete the course (literacy, numeracy, physical, vision, or hearing support)?
Can this course help my career?
Exemplar Global Certified Training
A certification that opens doors worldwide
This course carries Exemplar Global recognition and digital badge. Your enrolment unlocks:
- Access to Exemplar Global Community
- An globally recognised qualification
- Digital badges and a certificate
What learners say
Words from Audit Workshop graduates
Lonnie C.
ISO 9001:2026 Transition
United States · Oct 2026
Straightforward. Great course
Susan J.
ISO 9001:2026 Foundation
Cyprus · Oct 2026
Very easy to follow. Clear and concise
Jaco W.
ISO 9001:2026 Internal Auditor
Australia · Oct 2026
Really well-structured course and a great platform. I appreciated how evenly paced the modules were, with consistent completion times across each section. The system runs smoothly, making the whole learning experience seamless. Great work!
VEACESLAV A.
ISO 9001:2026 Internal Auditor
Germany · Oct 2026
Speaking from my own subjective perspective: I found lectures of this type easy to follow back when I was at university, but now—as an adult who has taken various other courses—I believe that interactive content is better absorbed and remembered than a dry lecture. Nevertheless, the speaker was interesting to listen to, and the fact that I passed the test on the first attempt is the best possible measure of the lecture's quality.
Christine K.
ISO 9001:2026 Foundation
United States · Oct 2026
Easy to follow and understand
Wojciech S.
ISO 13485:2016 Internal Auditor
United Kingdom · Oct 2026
I found the Audit Workshop very interesting, but also quite challenging, with a lot of knowledge and information to take in. For me, some of the material was a little easier to relate to because I work for a company that is already ISO 13485 certified, and I have my own copy of the standard that I can refer to. I am also audited every year by BSI and several times by our customers, so I already have some experience with the audit process from the other side. However, the workshop gave me a much better understanding of the auditor’s perspective and helped me put my existing experience into a broader context. I really enjoyed the course and found it very useful.
Paul K.
Integrated Management Systems Lead Auditor
Australia · Oct 2026
The course I just completed was a really good experience. Everything was clear , professional and very well organised. I was very happy with it overall , looking forward to taking my next step with this training organisation.
Julie H.
ISO 9001:2026 Lead Auditor
United Kingdom · Oct 2026
Self -paced, clear explanations and materials
Teresa S.
ISO 14001:2026 Lead Auditor
United States · Oct 2026
It was good class. I would have liked a little more time on the standard and less on auditing. Otherwise the speaker was engaging and the content good. If I would have been a new auditor; it would have provided me with lots of insights! As an experienced auditor it did a great job of reviewing the basics!
Laura-Mioara L.
ISO 19011:2026 Transition
Romania · Oct 2026
I liked the way the lecturer presented the changes to the standard and I feel that I learnt a lot. I also liked the materials I received, as they were clear, useful, and easy to follow. Thank you for this informative and enjoyable training!
Michael L.
ISO 19011:2026 Lead Auditor
United States · Sept 2026
Self Paced and informative
Mike M.
ISO 19011:2026 Lead Auditor
United States · Sept 2026
Instructor was great
Leandro A.
ISO 14001:2026 Lead Auditor
Australia · Sept 2026
Great value, very practical, super fast response, everything works as expected. Highly recommended.
Lonnie C.
ISO 14001:2026 Transition
United States · Aug 2026
The information was to the point and easy to understand. The presenter was very professional and well prepared. Excellent course.
Ittira C.
ISO/IEC 27001:2022 Lead Auditor
Oman · Aug 2026
The ISO 27001:2022 LA course by Audit Workshop is a well thought out course running through an actual case study. The content is good and the support from the Audit Workshop is excellent.
Muhammad H.
ISO/IEC 42001:2023 Lead Auditor
Australia · Aug 2026
Great course... I learned alot... Very responsive team
Michael N.
ISO/IEC 42001:2023 Lead Auditor
Australia · Aug 2026
Third course in, great platform - easy to navigate and excellent resources.
Asif K.
ISO 45001:2018 Lead Auditor
Australia · Aug 2026
Presentation, knowledge shared and topics explanations from Mr. Dilawar.
Michael S.
ISO 14001:2026 Lead Auditor
United States · July 2026
Excellent course with clear explanations, practical examples, and strong case-study assignments. The quizzes and templates reinforced how to plan, conduct, report, and follow up on an ISO 14001 audit in a realistic way. I especially appreciated the focus on objective evidence, clause interpretation, grading nonconformities, and making defensible certification recommendations. The course was well structured, challenging, and highly relevant to real-world lead auditing.
Michael S.
ISO 45001:2018 Lead Auditor
United States · July 2026
The ISO 45001 Lead Auditor course was clear, practical, and very well structured. The case studies, audit planning exercises, NCR writing, and final audit report assignment helped connect the standard’s requirements to real-world auditing. I especially valued the focus on objective evidence, clause alignment, audit conclusions, and the difference between making a certification recommendation and the final certification decision. The templates and examples were also very useful and made the course easy to follow. Overall, it was a highly valuable course that strengthened both my ISO 45001 knowledge and my confidence as an auditor.
Maria H.
ISO 45001:2018 Lead Auditor
Australia · July 2026
I found the practicsl case studies and non conformity exercises especially helpful as they improved my ability to write corrective actions. Highly recommend this course
Obed A.
ISO 45001:2018 Lead Auditor
Ghana · July 2026
Case studies and real world examples
Questions?
Have a look at our common questions.
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