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ISO 13485 Lead Implementer Course
Take our online course to learn all you need to know about ISO 13485, as well as how you can become an independent consultant for the implementation of Medical Devices Management Systems using ISO 20700. Our course was created for beginners in medical devices quality management and consulting, so no prior knowledge is needed to take this course. The course includes a certificate, approved by ASIC, which proves your expertise in the standard and enhances your consulting practice, as most organizations seek out certified consultants.
The certificate received upon successfully completing the course exam is proof of your qualifications as an ISO 13485 practitioner or consultant. Recognized globally, this certification will enhance your career prospects, given that most organizations actively search for professionals with formal certification.
The ISO 13485 Lead Implementer Course is divided into three sections: a video lecture library, an interactive workshop, and an online examination. Each of these will provide you with additional knowledge and get you one step closer to your certification as an ISO 13485 Lead Implementer.
Kristina Zvonar Brkic & Garry Cornell
Course language: English
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 | ||
| Module 6 - Getting the project approved | |||
| Introduction & suggested reading | 00:00:00 | ||
| What is your situation? | 00:00:00 | ||
| For consultants: Get more sales meetings with prospects | 00:00:00 | ||
| How to get the interest of top management in your project? | 00:00:00 | ||
| How to present the project | 00:00:00 | ||
| Other techniques for presenting the project | 00:00:00 | ||
| For consultants: Writing a great proposal | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 7 - Prepare for the implementation | |||
| Introduction & suggested reading | 00:00:00 | ||
| Define the scope of the project | 00:00:00 | ||
| Key stages of the project | 00:00:00 | ||
| Tips for project management | 00:00:00 | ||
| Estimating the project | 00:00:00 | ||
| Communication | 00:00:00 | ||
| Use of tools | 00:00:00 | ||
| Define roles and responsibilities | 00:00:00 | ||
| Project manager beware | 00:00:00 | ||
| Project documentation | 00:00:00 | ||
| Write a Project Plan | 00:00:00 | ||
| Kick-off meeting | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 8 - Implementation of a management system | |||
| Introduction & suggested reading | 00:00:00 | ||
| Executing the project work | 00:00:00 | ||
| Work assignment | 00:00:00 | ||
| Managing work assignments and resources | 00:00:00 | ||
| Enabling smooth project execution | 00:00:00 | ||
| Gathering information and recommending changes | 00:00:00 | ||
| Introducing documentation and changes in day-to-day use | 00:00:00 | ||
| Overcoming the resistance to change | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 9 - Monitor, control and completing the project | |||
| Introduction & suggested reading | 00:00:00 | ||
| Verifying and issuing a status report | 00:00:00 | ||
| Communication about the project status | 00:00:00 | ||
| Monitor and control meeting | 00:00:00 | ||
| Internal audit | 00:00:00 | ||
| Management review purpose | 00:00:00 | ||
| Management review preparation and execution | 00:00:00 | ||
| Acceptance and implementation closure | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 10 - Taking the organization for the certification | |||
| Introduction & suggested reading | 00:00:00 | ||
| Go for certification or not? | 00:00:00 | ||
| Choose a certification body | 00:00:00 | ||
| Certification process | 00:00:00 | ||
| Stage 1 and Stage 2 audits | 00:00:00 | ||
| Prepare the certification audit | 00:00:00 | ||
| Logistics of the certification audit | 00:00:00 | ||
| Preparing your people for the certification audit | 00:00:00 | ||
| What to expect from the certification auditors | 00:00:00 | ||
| After the certification audit | 00:00:00 | ||
| Recap quiz | 00:00:00 | ||
| Module 11 - Maintaining the certification | |||
| Introduction & suggested reading | 00:00:00 | ||
| Keeping the certification | 00:00:00 | ||
| Improving the management system | 00:00:00 | ||
| Top management leadership and example | 00:00:00 | ||
| Keep the management system updated | 00:00:00 | ||
| Until the next surveillance audit | 00:00:00 | ||
| What is the surveillance audit | 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:
- 1-Day online workshop
- Certificate approved by ASIC
- Access to course script
- Free exam retake
- Access to practice exam
- Price US$ 1797
Leading international authority in certification of training providers
The access to video lectures section of the course is free, so you can obtain all this knowledge at zero cost. The videos are organized into 11 separate modules, with each containing several videos and quizzes to aid your learning, plus a recap quiz that will give you an idea of the types of questions you may see on the certification exam. You may view a list of the module contents in the curriculum above. The video lectures have all been recorded, allowing you to watch them at your convenience, anywhere you like.
This course was created by Jeanine Wilmot, who has extensive experience in consulting and business in senior management and executive positions. Over the past few years, she has trained, transitioned and consulted with various clients in the ISO 9001, ISO 13485 and AS9100D standards and helped improve their quality and manufacturing systems.
There are two instructors for this course. Garry Cornell has global experience as a senior manager certification auditor, and consultant helping a wide range of businesses in their implementations of various ISO standards. Kristina Zvonar Brkic, who has reach broad experience in ISO 13485, ISO 9001, and ISO 22716, MDD, and MDR. She is the author of numerous articles in the leading ISO 13485blog, and also of the ISO 13485 & MDR Integrated Toolkit.
Type: Online video lectures
Course language: English
Because we believe that the skills for implementing ISO 13485 cannot be learned solely through video lectures, we also prepared a workshop. This one-day workshop is delivered online via webinar. During the workshop, you will learn how to use your knowledge in real life through various case studies, role play, etc., and you will learn soft skills that will additionally prepare you for the certification exam as well as for the role of consultant.
Take a look at the times of the online workshops and pick the one that suits you the most. You can participate from anywhere.
Duration: 1-day workshop
Type: Online webinar
Once you have watched all of the video lectures, completed the quizzes, and attended the interactive workshop, you may access the certification exam. This is the final step in your certification journey, and because it is online, you may take it at a time and place convenient to you.
Upon successful completion of the examination, you will be presented with a certificate that formally states your competence as an ISO 13485 consultant.
The ISO 13485 Lead Implementer exam fee is already included in the price of the workshop, so you’ll have instant access once your workshop is booked and paid for.
Number of question: 55
Type: Online proctored exam
Benefits of getting the certificate
A 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 implementation 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) Attend the workshop.
3) Pass the online 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), along with the skills you learn from the workshop, are all you need to successfully pass the certification exam and receive your certificate.
With your purchase of the certification exam, in addition to having access to the workshop, you will also 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.
After watching all of the video lectures and completing the workshop, 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.
Completion of all of the video lectures is the only prerequisite.
To participate in the online workshop, we will send you a special link to connect to the Zoom. All you need is a computer with microphone and speakers.
We have to pay for all of our great resources somehow :). Our video lectures are freely available, but there is a fee required to attend the workshop, 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 workshop, 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 workshop and certification exam.
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.
The certification exam may be taken online, from anywhere. To make this possible, we employ an online proctoring service. Click here to learn more.
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:
- 1-Day online workshop
- Certificate approved by ASIC
- Access to course script
- Free exam retake
- Access to practice exam
- Price US$ 1797
Leading international authority in certification of training providers
