ISO 13485 Internal Auditor Training
- Online course
- EU and US requirements
- Beginner - intermediate
- Last updated - March 2025
Learn how to conduct internal and supply chain audits according to ISO 13485 and ISO 19011 during this self-paced, interactive online course.
- Develop skills necessary to conduct internal and supply chain audits.
- Learn to interpret every requirement of the ISO 13485.
- Understand the audit process, including audit planning, conducting audit activities, and preparing and distributing the audit report.
- Learn to use remote auditing methods according to ISO TS 17012.
- Receive a course certificate/training record to demonstrate you are competent to perform audits.
Select your course plan
ONLINE
YOU ARE HERE
€ 499
Average completion time 17-46 hours
Total video duration 9.1 hours
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
Number of quizzes 68
Final exam
Course certificate
Ask the instructor
Lifetime access to the course and instructor
Digital course companion
IN-HOUSE TRAINING
CONTACT US
Tailored training to meet your company's needs
Course overview
This online course is specifically designed to prepare you to conduct internal and supply chain audits (1st and 2nd party audits) following an audit process based on ISO 19011 and using ISO 13485 as audit criteria.
The course is made up of two parts:
– Part 1. Learning how to conduct audits.
– Part 2. A detailed and interactive walkthrough of the requirements of ISO 13485 that will teach you how to determine if a requirement has been met or not.
The first part of the course includes topics such as audit terminology, audit principles, the audit process, risk-based approach, remote auditing methods, auditing virtual locations, preparing audit checklists, conducting opening meetings, collecting audit evidence, evaluating audit findings, conducting closing meeting, and preparing the audit report.
The second part of the course is focused on ISO 13485 and will include: requirements on the quality management system, management responsibility, resource management, product realization, measurement, analysis, and improvement. For full details, see the outline below.
The online course is made up of pre-recorded videos, quizzes, and a final exam. You will receive a course certificate upon successful completion of the course.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access (conditions apply).
- 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.
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
Benefits for you
Direct access to standards authors
Our courses are developed by members of the standardization committees involved at both national and international levels, ensuring you receive first-hand knowledge and insights.
You can ask our instructors questions during the online course thereby gaining exclusive up-to-the-minute information.
Self-paced and bite-sized learning
Our interactive online courses offer the flexibility to learn at your own pace. The high-quality videos are designed in bite-sized segments, making it easier to grasp and retain information.
This format provides a convenient alternative to traditional classroom courses accommodating different learning styles and preferences.
Training effectiveness and record-keeping
Participants’ knowledge is assessed through pre-training quizzes and a final exam, enabling a true measure of the training’s effectiveness.
Furthermore, we provide records, including the final exam score and course certificate, to satisfy ISO 13485 requirements, ensuring compliance and accountability.
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 has authored the latest versions of 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.
Frequently asked questions
The course is not a webinar. This online course is made up of carefully scripted pre-recorded videos to maximize your learning. You can watch it as many times as you like, whenever and wherever you want. You can not download the course though, thus you will need to have an internet connection to take the course.
All in all, the average time to complete the course is 17-46 hours, but you can complete it in less time if you don’t repeat any of the lessons and have just one attempt at the quizzes. Please note, you don’t have to watch the whole course at once. In fact you can pause, resume and replay as often as you like. The only limitation is the final exam, where you will only have one shot.
If you purchase the ‘Online’ course plan you will have access to the course for 6 months from enrolment. If you purchase the ‘Online lifetime’ course plan you will have lifetime access to the course if you complete the final exam within 6 months of enrolment (conditions apply).
You need to have contact with our servers for your results to register on the final exam. If your computer for some reason has a problem and does not allow you to send the result of the final exam to our servers, we recommend that you take a photo or a “print screen” of the screen with your results. E-mail this image to us and we will investigate if you have successfully completed the exam and therefore should receive a course certificate even though the result has not been registered, or if you have to do the final exam again.
There is no pass/fail on the final exam (as long as you complete it within the time frame). Your result will be printed on the course certificate which means you can be really proud of your result if you get between 90% and 100% of the answers correct!
The course certificate is available for download after completing the final exam. All you need to do is log in to your account, go to My Courses and scroll down. You will find it under Your Course Certificates.
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.
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.
Yes, you can. The course is in HTML5 format which will play on any new iOS, Android or Windows devices.
If you purchase five seats for the same online course at the same time, we will give you one extra seat for free on that same course (e.g. buy 5 get 6, buy 10 get 12, etc). The free seat is assigned manually after the order has been received.
The course is personal, that means you buy a license for one person. It is also really inexpensive compared to any traditional course with the same scope. If you have more than one person needing the course, please purchase another seat on the 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 14971. This ensures the instructor has access to leading-edge knowledge and information, which is the highest qualification available for teaching the course.
There are no pre-requisites for this course.
Upon completing the course, you can claim 33 CPD hours (33 CPD points) for the online course.
Your course certificate will display the earned CPD hours.
Reviews
Group purchase
If you wish to purchase two or more seats on the same online course, click the ‘Buy multiple seats’ button below which will take you to the product page where you can simply enter the number of seats you require.
If you purchase three seats or more on the same online course at the same time, you will be added to the Professional Plan for free. This means a group account will be created for you that you can manage. You will be able to track the participant’s course progress from your group account and view quiz results.
It is the person that places the order who will be our single-point-of-contact and group leader for the group account. If you wish to change this to someone else later on, you can email us at support@medicaldevicehq.com.