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ISO 13485 Foundations Course
In this online course, you’ll learn everything you need to know about ISO 13485, including all the requirements and best practices for compliance. The course is made for beginners in quality management and ISO standards, and no prior knowledge is needed to take this course.
After passing the exam, you will receive a certificate proving that you have a working knowledge of all ISO 13485 requirements.
The course is organized into 5 modules, where each module has several video lectures and quizzes that will help you learn more quickly, as well as a recap quiz that will prepare you for the certification exam – please see below for the content of each module. All the video lectures are pre-recorded, so you can take the course from anywhere, at any time for your convenience.
- The total course duration, including the reading of required materials, is approximately 8 hours.
- Materials provided in the course (video lectures, articles, and practice exams) are everything you need to successfully pass the certification exam.
- There is no time limit for taking the course, but it is recommended that you finish it within one week’s time.
- Access to this course and the quizzes is completely free; the fee for the certification exam is US$ 349 – after you pass the exam we’ll send you your certificate in a matter of days.
- After you purchase the exam, you will receive a bonus PDF containing scripts from all of the video lectures and quizzes, links to additional reading, and access to the practice exams.
- Course instructor: Kristina Zvonar Brkic
- Course language: English
The instructor for this course is Kristina Zvonar Brkic, who has broad experience in ISO 13485, ISO 9001, ISO 22716, MDD, and MDR. She is the author of numerous articles in the leading ISO 13485 blog, and also of the ISO 13485 & MDR Integrated Toolkit.
Course Curriculum
| Introduction | |||
| Introduction to the course | 00:00:00 | ||
| Module 1 - Introduction to ISO 13485 | |||
| Introduction & suggested reading | 00:00:00 | ||
| What is ISO 13485:2016? | 00:00:00 | ||
| What is the QMS? | 00:00:00 | ||
| Why is ISO 13485:2016 important? | 00:00:00 | ||
| What is the structure of ISO 13485? | 00:00:00 | ||
| Key principles of quality management | 00:00:00 | ||
| Key interested parties in ISO 13485 | 00:00:00 | ||
| Implementing ISO 13485 using The Plan Do Check Act Process | 00:00:00 | ||
| The ISO 13485 Project | 00:00:00 | ||
| Certification FAQs | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 2 - Management and Supporting Processes | |||
| Introduction & suggested reading | 00:00:00 | ||
| What is a process? | 00:00:00 | ||
| Top management commitment (clauses 5.1 and 5.2) | 00:00:00 | ||
| Quality Policy and objectives (clauses 5.3 and 5.4) | 00:00:00 | ||
| Roles and responsibilities (clause 5.5) | 00:00:00 | ||
| Management review (clause 5.6) | 00:00:00 | ||
| Documentation process (clauses 4.1 and 4.2) | 00:00:00 | ||
| Quality Manual (clause 4.2.2) | 00:00:00 | ||
| Medical Device File (clause 4.2.3) | 00:00:00 | ||
| Handling the QMS documentation (clause 4.2.4) | 00:00:00 | ||
| Records for the QMS (clause 4.2.5) | 00:00:00 | ||
| Importance of Resources management process (clause 6.1) | 00:00:00 | ||
| Managing human resources (clause 6.2) | 00:00:00 | ||
| Managing infrastructure resources (clause 6.3) | 00:00:00 | ||
| Managing work environment (clause 6.4.1) | 00:00:00 | ||
| Managing contamination (clause 6.4.2) | 00:00:00 | ||
| Managing monitoring and measuring equipment (clause 7.6) | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 3 - Product Realization Planning, Contract Review, and Design & Development | |||
| Introduction & suggested reading | 00:00:00 | ||
| Planning of Product Realization (clause 7.1) | 00:00:00 | ||
| Example of planning Product Realization | 00:00:00 | ||
| Overview of Customer-Related processes (clause 7.2.1) | 00:00:00 | ||
| Review of a contract or customer purchase order (clause 7.2.2) | 00:00:00 | ||
| Communication methods for the Customer-Related processes (clause 7.2.3) | 00:00:00 | ||
| Design and development overview (clause 7.3.1) | 00:00:00 | ||
| Planning for design and development (clause 7.3.2) | 00:00:00 | ||
| Design and development inputs (clause 7.3.3) | 00:00:00 | ||
| Design and development outputs (clause 7.3.4 and 7.3.5) | 00:00:00 | ||
| Design and development verification and validation (clause 7.3.6 and 7.3.7) | 00:00:00 | ||
| Design and development transfer to production (clause 7.3.8) | 00:00:00 | ||
| Control of design and development changes (clauses 7.3.9, 7.3.10) | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 4 - Purchasing, Production, and Service Provision | |||
| Introduction & suggested reading | 00:00:00 | ||
| Purchasing overview (clause 7.4) | 00:00:00 | ||
| Vendor Evaluation and performance (clause 7.4.1) | 00:00:00 | ||
| Purchasing information and verification of product (clauses 7.4.2 and 7.4.3) | 00:00:00 | ||
| Production and service provision overview (clause 7.5.1) | 00:00:00 | ||
| Qualification of your infrastructure (clauses 7.5.3 and 7.5.6) | 00:00:00 | ||
| Validation of processes (clauses 7.5.6 and 7.5.7) | 00:00:00 | ||
| Labeling and packaging (clause 7.5.11) | 00:00:00 | ||
| Cleanliness of product (clauses 7.5.2 and 7.5.5) | 00:00:00 | ||
| Identification and traceability (clauses 7.5.8 and 7.5.9) | 00:00:00 | ||
| Customer property and preservation (clauses 7.5.10 and 7.5.11) | 00:00:00 | ||
| Post-delivery processes (clauses 7.5.3 and 7.5.4) | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 5 - Measurement, Analysis, and Improvement | |||
| Introduction & suggested reading | 00:00:00 | ||
| Monitoring and measuring overview (clause 8.1) | 00:00:00 | ||
| Monitoring and measurement of products (clause 8.2.6) | 00:00:00 | ||
| Monitoring and measurement of processes (clause 8.2.5) | 00:00:00 | ||
| Feedback (clause 8.2.1) | 00:00:00 | ||
| Complaint handling (clause 8.2.2) | 00:00:00 | ||
| Reporting to regulatory authorities (clause 8.2.3) | 00:00:00 | ||
| Internal audits (clause 8.2.4) | 00:00:00 | ||
| Control of non-conforming product (clause 8.3) | 00:00:00 | ||
| Analysis of data (clause 8.4) | 00:00:00 | ||
| Improvement (clause 8.5.1) | 00:00:00 | ||
| Corrective actions (clause 8.5.2) | 00:00:00 | ||
| Preventive actions (clause 8.5.3) | 00:00:00 | ||
| Related documentation | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Instructions for taking the exam and obtaining the certificate | 00:00:00 | ||
- With the purchase you get:
- Certificate approved by ASIC
- Access to course script
- Free exam retake
- Access To Practice Exam
Leading international authority in certification of training providers
Benefits of getting the certificate
Certificate of competence proves that you attended the eTraining course, and that you passed the exam certified by ASIC. This ensures that you understand and can apply the knowledge you gained in each of the course's modules.
How to get certified?
It's simple:
1) Watch complete videos of all lectures, and answer all practice exams.
2) Pass the online certification exam.
Bonuses with the certificate
Once you purchase the certificate, you will receive the following bonuses:
Course Script (PDF)
If you decide to purchase the exam you will get the PDF script from the course completely free. The script includes everything said in the videos and all quizzes.
This way, you can access course materials any time you like, making it much easier to practice and prepare for the exam.
Free exam retake
Once you purchase the exam, you will be able to retake it.
This means, if you do not pass the exam on your first attempt, you can retake it one time, free of charge.
There is no mandatory waiting period between the two attempts.
Practice Exam
You can use these exams to test your knowledge and familiarize yourself with the exam environment.
The result from practice exam does not have any effect on the results from the final exam.
Course Reviews
Frequently Asked Questions
The course materials (video lectures, quizzes, reading materials, practice exams, and other resources), are all you need to successfully pass the certification exam and receive your certificate.
With your purchase of the certification exam, you will gain access to a bonus PDF of all the scripts from the video lectures, all of the course questions, readings, and access to the practice exams.
All you need to access the course is your PC, Mac, or mobile device, any major browser (Chrome, Firefox, Internet Explorer, Safari, etc.), and a broadband Internet connection. And, of course, plenty of available time to devote to the course.
After watching all of the video lectures, you may take the certification exam. If you earn a passing score, you will be issued the certificate. Please note that during the exam, an online proctoring service will verify your identity and ensure that you take the exam without assistance. Click here to learn more about our online proctoring service.
The certification exam may be taken online, from anywhere. To make this possible, we employ an online proctoring service. Click here to learn more.
We have to pay for all of our great resources somehow :). Our video lectures are freely available, but there is a fee required to take the certification exam and receive the certificate – but, this fee is highly discounted compared to what you would pay to attend a comparable course in a classroom. In addition, when you pay for the exam, we will send you a download link to a PDF containing scripts from all of the video lectures, plus practice quizzes, practice tests, and links to extra reading materials. Having access to all of the content from the video lectures will make it much easier to prepare for your certification exam.
You don’t need any prior knowledge or experience in the implementation – this course was designed so that a beginner to these topics will understand it.
You may access the video lectures at any time. Because the lectures section is a made up of pre-recorded video lectures and freely available practice quizzes, reading, and other resources, you may access them whenever it is convenient.
There is no time limit, so you can take as long as you need to watch the video lectures. We do, however, recommend that you watch them all within 3–4 weeks so that you get the most benefit from them.
- With the purchase you get:
- Certificate approved by ASIC
- Access to course script
- Free exam retake
- Access To Practice Exam
Leading international authority in certification of training providers
