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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 certificate received upon successfully completing the course exam is proof of your competence 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.

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
STEP 1: Watch video lectures

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.

ISO 13485 Lead Implementer Course

Type: Online video lectures

Course language: English

STEP 2: Interactive workshop

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.

ISO 13485 Lead Implementer Course

Duration: 1-day workshop

Type: Online webinar

STEP 3: Online certification exam

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 ISO13485 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.

ISO 13485 Lead Implementer Course

Number of question: 40

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 certification exam. 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

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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 GoToWebinar. 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.

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