ISO 13485 Internal auditor - Practitioner training
- Blended course: online course + 2 live virtual classroom sessions
- EU and US requirements
- Beginner - advanced
- Last updated - Jan 2026
Fully grasp ISO 13485 requirements. Gain practical confidence to conduct internal and supply chain audits according to ISO 13485 and ISO 19011 — with an online course plus two live virtual classroom sessions to apply it practically and solidify understanding.
- Develop both theoretical and hands-on skills to run internal and supply chain audits.
- Learn to interpret ISO 13485 requirements in realistic audit scenarios.
- Gain the ability to plan, conduct, and report audits end-to-end, and produce clear, defensible reports.
- Use remote auditing methods in line with ISO TS 17012.
- Receive a course certificate/training record documenting practical competence, along with downloadable templates to support your audit work.
2 Live classroom sessions
+ Templates
| Course length | approx. 24-53 hours (40 CPD points) |
| Next classroom sessions | 14-15 Oct, 2026 1PM-4:30PM CET |
Select your course plan
ONLINE
€ 499
Average completion time 17-46 hours
Total video duration 9.1 hours
CPD points 33
Number of quizzes 68
Final exam
Course certificate
Ask the instructor
6 months access to the course and instructor
Digital course companion
ONLINE LIFETIME
€ 599
Average completion time 17-46 hours
Total video duration 9.1 hours
CPD points 33
Number of quizzes 68
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
BLENDED
YOU ARE HERE
€ 1149
Average completion time 24-53 hours
Total video duration 9.1 hours
CPD points 40
Number of quizzes 68
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
Classroom sessions (2 * 3.5 hours)
Templates
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Course overview
This course consists of two parts:
1. The ISO 13485 Internal Auditor Training online course
2. Two half day live virtual classroom sessions facilitated by an industry expert
First, you complete the popular ISO 13485 Internal Auditor Training online course where you’ll learn the theory of how to conduct audits. You’ll also learn how to determine if a requirement has been met or not according to ISO 13485.
You can start the online course immediately after enrolment and you must successfully complete the final exam prior to the classroom sessions. If you have already completed the online course, you can register for the classroom sessions only.
During the live virtual classroom sessions, you get to apply the theory you have learnt via case studies, workshops, and discussions. There is plenty of time for Q&As, and with a maximum of 8 people per classroom session, all participants have the opportunity to learn firsthand from an industry expert.
A downloadable pdf with text and slides, and time-saving templates are included in the blended course.
This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
The course is relevant not only for current or aspiring auditors but also for anyone who might be on the receiving end of an audit. Plus, you’ll gain a thorough understanding of interpreting the ISO 13485 standard, making this course beneficial even if becoming an auditor isn’t your main focus.
- This course is CPD-accredited. You will receive a certificate awarding you CPD points following completion of the training.
- Medical Device HQ is a member of the Swedish standardisation committee TK355 developing standards such as ISO 13485, ISO 14971 and IEC 62366-1. Peter Sebelius has partaken in authoring all of the above standards at an international level.
Want to know more about our blended courses? Watch the video below.
Our blended learning courses combine the best of both worlds: online training and two half-day live virtual classroom sessions afterwards.
The online training allows for the flexibility in the way you learn, so that you can learn in a way which suits you best. You can access it whenever and wherever you want, and you can stop, start, and repeat the lessons and quizzes as often as you would like. To help maximise your learning, you can check your knowledge and understanding every step of the way by taking the assessment test beforehand, as well as the checkpoint quizzes that are found throughout the course. Ultimately, you will take a final exam at the end of the course.
The classroom sessions are highly interactive and focus on applying the theory you have learnt during the online course with the guidance of the expert instructor. There are real life case scenarios to work through and plenty of time for discussions and questions.
Course structure
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
He has vast ‘hands on’ experience, having developed, amongst other things, a mechanical chest compression device and an ex vivo perfusion machine for lungs. He has received numerous awards including the Great Design Award and the title “This year’s specialist” by Veckans affärer.
Pontus Gedda is a dedicated medical device specialist that has worked both in the industry, as a design engineer and project manager, and in the notified body world as a medical device lead auditor and manager.
He has deep practical experience in auditing and quality management systems according to ISO 13485 and MDR requirements, including leading audit teams and supporting organisations in meeting compliance expectations.
Reviews
Vision RT
Medical Devices
Wertefest GmbH
Benefits for you
Learn practical auditing skills
Build audit-ready capability for internal and supply-chain audits. Start with requirements and approach online; then apply them in two live virtual classrooms through case studies and workshops.
By the end, you’ll confidently plan, execute, and report audits according to ISO 13485 and ISO 19011.
Direct access to standards authors
Gain exclusive up-to-date insights by learning directly from those involved in writing the standards.Our courses are developed by committee members at national and international levels — including Peter Sebelius, contributor to the latest version of ISO 13485 and ISO 19011 — giving you in-depth understanding of the standards, plus the opportunity to ask questions during the training.
Interactive instructor engagement
Our instructors are passionate about what they do, bringing their expertise and love for the subject into the learning experience.
Participate in active learning by asking questions directly to the instructor, taking part in group workshops and discussions. This allows you to seek clarification, share insights, apply and transfer knowledge.
Course modules
- Welcome
- What you need to know
- Set your course completion date
- Pre-course assessment
- What is auditing and why it is important
- What is a QMS
- Process, procedure and policy
- Understanding auditing terminology
- Different types of audits
- The standards – ISO 13485 and others
- The audit process
- Audit principles
- The auditor’s competence
- The risk-based approach
- The audit plan and inputs from the audit programme (part 1)
- The audit plan and inputs from the audit programme (part 2)
- Remote auditing methods
- Communicate with the auditee
- Determine the feasibility
- Create the audit checklist
- Review the documented information
- Sampling
- Create the audit schedule and confirm the plan
- The opening meeting
- Collecting audit evidence
- Evaluating against audit criteria
- Conformities and nonconformities
- Categorising audit findings
- NC or not?
- Document the audit evidence
- Determine audit conclusion and closing meeting
- Writing and sending the audit report
- Follow-up on nonconformities
- Welcome to the ISO 13485 part of the course
- Introduction to ISO 13485
- Shall, should and appropriate
- Documenting and maintaining the QMS
- Determining and managing QMS processes
- Ensuring the effectiveness of QMS processes
- Managing and controlling changes to QMS processes
- Documenting and validating QMS software applications
- General documentation requirements
- The quality manual
- Control of documents (part 1)
- Control of documents (part 2)
- Control of records
- Management commitment and quality
- Responsibility, authority and role
- Management review
- Resources and training
- Infrastructure and work environment
- Planning of product realization
- Customer-related processes
- Design and development planning (part 1)
- Design and development planning (part 2)
- Design and development inputs
- Complete and unambiguous
- Design and development review
- Design verification and validation
- Design outputs and design transfer
- Control of design changes
- Documentation files
- Purchasing
- Verification of purchased product
- Control of production and service provision
- Process validation
- Cleanliness and sterile medical devices
- Identification and traceability
- Installation and service
- Customer property and preservation of product
- Control of monitoring and measuring equipment
- Feedback
- Complaint handling
- Reporting to regulatory authorities
- Internal audit
- Monitoring of process and product
- Control of nonconforming product
- Analysis of data
- CAPA
- Pre-final exam
- Final exam
- Course evaluation
Classroom sessions
You will attend these two half-day live virtual instructor-led classroom sessions via Zoom. The focus is on practicing the new skills, knowledge, and understanding learnt during the online course, in a relaxed environment, with the guidance of an expert instructor. There are real–life case scenarios to work through, and plenty of time for discussions and questions.
The maximum number of people in a classroom session is 8.
You will also get a downloadable course companion, workshop solutions, and the following time-saving templates:
Frequently asked questions
The practitioner training course consists of two parts: the online course, and two half day live virtual classroom sessions.
The online course is made up of carefully scripted pre-recorded videos in order to maximise your learning. The classroom sessions are live virtual sessions, where you will be interacting with the instructor and the other course participants via Zoom. You are required to be visible on video when taking the classroom sessions.
Yes, you can.
The time spent on the course varies greatly. If you are a beginner or have very high ambitions, you will typically spend more time on it. If you are already experienced in the field, you will probably finish it more quickly. The online course takes 17-46 hours to finish for most participants.
You do not have to watch the whole course at once. In fact, you can pause, resume, and replay as often as you like.
The two half-day live virtual classroom sessions, take approximately 7 hours in total.
You will be receiving a course certificate after completing the final exam. The course certificate is available when you log in to your account. Go to “My Courses”, and scroll down. You will find it under “Your Course Certificates”.
After successfully completing the classroom session, you will receive a course certificate covering both the online course and the classroom session by email.
If you wish to buy 3 or more seats, we invite you to reach out using the contact form to discuss discount options.
Please note, if there are more than 5 people from your organisation wising to take the course, consider arranging an in-house course. The price per participant will be lower, and the course can be customised to your needs.
If you complete the final exam within 6 months of enrolment, you will have life-time access to the online course (conditions apply). If you do not, your course access will expire after 6 months.
Yes, you can download a course companion within the online course. It contains a selection of key slides from the course and is in PDF format.
The maximum number of participants for the live virtual classroom session is 8.
There is no pass/fail score on the exam as such, but you are required to achieve 85% or more on the final exam to be allowed to attend the classroom session. The check-point quiz questions that are available during the online course will be a good model of what you will get on the final exam.
If you do not achieve 85%, the final exam can be reset for an administrative fee of 50 EUR, and you can take it again.
If you have already completed the online course and taken the final exam more than 3 weeks prior to the classroom sessions, and regardless of whether you have achieved >85%, we will reset the final exam for you for free.
You will need to retake the final exam by 3pm CET the day before the first classroom session. This is because we insist all participants have the information fresh in their mind in order to maximise the learning experience in the live virtual classroom sessions.
There are no pre-requisites for this course.
The instructor has conducted training in the field for many years and continuously participates in authoring standards such as the ISO 13485 and ISO 19011. This ensures the instructor has access to leading-edge knowledge and information, which is the highest qualification available for teaching the course.
We offer a number of payment methods including credit card, GooglePay, ApplePay, PayPal, wire transfer/invoice depending on the country you are buying from. If you cannot find your country on the list at checkout or you are not given wire transfer as a payment method, you can submit your order via our invoice order form.
Medical Device HQ is proud to be an accredited CPD provider, demonstrating our commitment to your continued professional development with high-quality training courses.
A CPD record showcases your professional growth, boosts confidence in your abilities, and can be presented to management for better career opportunities.
As a participant of a CPD certified course, you will receive a certificate awarding you CPD points following completion of the training.
Upon completion of this blended course, you are awarded 40 CPD points.
Your course certificate will display the exact number of CPD points. Read more.