ISO 13485 Lead Implementer Course
-
Language
English
-
Duration
30 hours
-
CPE
36
-
Course type
Online self-paced + live online workshop
-
This free ISO 13485 Lead Implementer course will teach you how to become an independent consultant or practitioner for the implementation of a medical device QMS using the ISO 13485 standard, and how to build your consultant business.
After passing the exam, you will receive a certificate, accredited by ASIC, which proves your expertise as an ISO 13485 Implementer and enhances your consulting practice, as most organizations seek out certified consultants.
This ISO 13485 Lead Implementer training is divided into three parts:
- A video library: includes lessons and practical information about the standard and how to implement ISO 13485 in your company or at your client
- An interactive workshop: helps you practice the concepts necessary for implementing ISO 13485 guided by our top experts
- Certification exam: upon successful completion of the ISO 13485 Lead Implementer exam, you will get a certificate and a badge for your LinkedIn profile to highlight your qualifications
Who should attend:
- Project and quality managers involved in ISO 13485 implementation
- Novice consultants seeking to learn new expertise
- Experienced consultants needing proof of their competence in ISO 13485 implementation
Prerequisites:
- There are no prerequisites to attend this course.
-
Introduction
Introduction to the course
Module 1 - Introduction to ISO 13485
Introduction & suggested reading
What is ISO 13485:2016?
What is the QMS?
Why is ISO 13485:2016 important?
What is the structure of ISO 13485?
Key principles of quality management
Key interested parties in ISO 13485
Implementing ISO 13485 using The Plan Do Check Act Process
The ISO 13485 Project
Certification FAQs
Recap quiz
Module 2 - Management and Supporting Processes
Introduction & suggested reading
What is a process?
Top management commitment (clauses 5.1 and 5.2)
Quality Policy and objectives (clauses 5.3 and 5.4)
Roles and responsibilities (clause 5.5)
Management review (clause 5.6)
Documentation process (clauses 4.1 and 4.2)
Quality Manual (clause 4.2.2)
Medical Device File (clause 4.2.3)
Handling the QMS documentation (clause 4.2.4)
Records for the QMS (clause 4.2.5)
Importance of Resources management process (clause 6.1)
Managing human resources (clause 6.2)
Managing infrastructure resources (clause 6.3)
Managing work environment (clause 6.4.1)
Managing contamination (clause 6.4.2)
Managing monitoring and measuring equipment (clause 7.6)
Related documentation
Recap quiz
Module 3 - Product Realization Planning, Contract Review, and Design & Development
Introduction & suggested reading
Planning of Product Realization (clause 7.1)
Example of planning Product Realization
Overview of Customer-Related processes (clause 7.2.1)
Review of a contract or customer purchase order (clause 7.2.2)
Communication methods for the Customer-Related processes (clause 7.2.3)
Design and development overview (clause 7.3.1)
Planning for design and development (clause 7.3.2)
Design and development inputs (clause 7.3.3)
Design and development outputs (clause 7.3.4 and 7.3.5)
Design and development verification and validation (clause 7.3.6 and 7.3.7)
Design and development transfer to production (clause 7.3.8)
Control of design and development changes (clauses 7.3.9, 7.3.10)
Related documentation
Recap quiz
Module 4 - Purchasing, Production, and Service Provision
Introduction & suggested reading
Purchasing overview (clause 7.4)
Vendor Evaluation and performance (clause 7.4.1)
Purchasing information and verification of product (clauses 7.4.2 and 7.4.3)
Production and service provision overview (clause 7.5.1)
Qualification of your infrastructure (clauses 7.5.3 and 7.5.6)
Validation of processes (clauses 7.5.6 and 7.5.7)
Labeling and packaging (clause 7.5.11)
Cleanliness of product (clauses 7.5.2 and 7.5.5)
Identification and traceability (clauses 7.5.8 and 7.5.9)
Customer property and preservation (clauses 7.5.10 and 7.5.11)
Post-delivery processes (clauses 7.5.3 and 7.5.4)
Related documentation
Recap quiz
Module 5 - Measurement, Analysis, and Improvement
Introduction & suggested reading
Monitoring and measuring overview (clause 8.1)
Monitoring and measurement of products (clause 8.2.6)
Monitoring and measurement of processes (clause 8.2.5)
Feedback (clause 8.2.1)
Complaint handling (clause 8.2.2)
Reporting to regulatory authorities (clause 8.2.3)
Internal audits (clause 8.2.4)
Control of non-conforming product (clause 8.3)
Analysis of data (clause 8.4)
Improvement (clause 8.5.1)
Corrective actions (clause 8.5.2)
Preventive actions (clause 8.5.3)
Related documentation
Recap quiz
Module 6 - Getting the Project Approved
Introduction & suggested reading
What is your situation?
For consultants: Get more sales meetings with prospects
How to get the interest of top management in your project?
How to present the project
Other techniques for presenting the project
For consultants: Writing a great proposal
Recap quiz
Module 7 - Prepare for the Implementation
Introduction & suggested reading
Define the scope of the project
Key stages of the project
Tips for project management
Estimating the project
Communication
Use of tools
Define roles and responsibilities
Project manager beware
Project documentation
Write a Project Plan
Kick-off meeting
Recap quiz
Module 8 - Implementation of a Management System
Introduction & suggested reading
Executing the project work
Work assignment
Managing work assignments and resources
Enabling smooth project execution
Gathering information and recommending changes
Introducing documentation and changes in day-to-day use
Overcoming the resistance to change
Recap quiz
Module 9 - Monitor, Control and Completing the Project
Introduction & suggested reading
Verifying and issuing a status report
Communication about the project status
Monitor and control meeting
Internal audit
Management review purpose
Management review preparation and execution
Acceptance and implementation closure
Recap quiz
Module 10 - Taking the Organization for the Certification
Introduction & suggested reading
Go for certification or not?
Choose a certification body
Certification process
Stage 1 and Stage 2 audits
Prepare the certification audit
Logistics of the certification audit
Preparing your people for the certification audit
What to expect from the certification auditors
After the certification audit
Recap quiz
Module 11 - Maintaining the Certification
Introduction & suggested reading
Keeping the certification
Improving the management system
Top management leadership and example
Keep the management system updated
Until the next surveillance audit
What is the surveillance audit
Recap quiz
Instructions for taking the exam and obtaining the certificate
-
Advisera’s courses are accredited by ASIC
ASIC is one of the world's largest international accreditation agencies for schools, colleges, universities, and online learning providers. Based in the UK, this government-approved quality assurance body is recognized globally, with more than 400 providers accredited in over 65 countries.
Why Advisera chose ASIC
Advisera chose ASIC accreditation because it is focused primarily on leading universities and online training organizations. When compared to other accreditation bodies, it has the largest portfolio of higher education organizations, as well as distance education providers.
-
About the ISO 13485 Lead Implementer online training
How do I purchase exams for several people?
We have prepared a discount if you purchase certificates for more than one student at once. Do not hesitate to contact us at sales@advisera.com to find out the prices.
Are the ISO 13485 Lead Implementer course and certificate accredited?
Yes, both the course and the certificate are accredited by ASIC, an internationally renowned quality standard for schools, colleges, universities, and online learning providers. This accreditation provides additional credibility for the quality of Advisera’s courses and ensures that the certificate is globally recognized.
What is the deadline for attending the video lectures?
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 three to four weeks so that you get the most benefit from them.
What is needed to access the ISO 13485 Lead Implementer online course?
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, enough available time to devote to the course.
What do I need to know before attending the course?
You don’t need any prior knowledge or experience in the implementation of ISO 13485 – this course was designed so that a beginner to these topics will understand it.
How do I participate in the workshop?
To participate in the online workshop, we will send you a special link to connect to Zoom. All you need is a computer with a microphone, speakers, and web camera. We recommend that you have the web camera on during the workshop for an enhanced learning experience.
Are there prerequisites for attending the workshop?
Completion of all of the video lessons is the only prerequisite.
How do I get certified as ISO 13485 Lead Implementer?
It's simple:
- Watch complete videos of all of the lessons, and answer all of the practice exams.
- Attend the workshop.
- Pass the online exam.
When will I receive the certificate for the ISO 13485 Lead Implementer course?
After watching all of the video lessons and completing the workshop, you may take the ISO 13485 Lead Implementer 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.
About the ISO 13485 Lead Implementer examWhat does it take to pass the exam and earn the certificate?
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 ISO 13485 Lead Implementer certificate.
How many questions are on the exam?
There are a total of 55 questions on the exam; some of them are True/False questions, while the others are multiple-choice questions, and all correctly answered questions are worth 1 mark.
How much time is allowed for the exam?
The time allowed to answer all the questions on the exam is 90 minutes. However, please reserve an additional 15 minutes of your time for a system check up before you start the exam session.
In which language is the ISO 13485 Lead Implementer exam?
The exam is in English.
Where will I take the examination?
The certification exam can be taken online, from anywhere. To make this possible, we employ an online proctoring service. Click here to learn more.
Online course
Workshop and certificate
- 1-day online workshop
- Accredited course
- Course script
- Access to practice exam
- Exam retake
Exam submitted
Exam failed
Exam passed
Exam failed
Please expect an email from exams@proctorexam.com titled "Please register for your exam." This email will usually arrive within one business day of purchase.
Your time slot for the exam will be open right after your complete the system check. You will be able to enter the session the moment you click on the link from the email titled "You are now ready to take your exam" as seen here.
Please contact us at support@advisera.com if you need our help.
Select the date
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
-
US $1797
Course Instructors

Kristina Zvonar Brkic
Kristina Zvonar Brkic is an experienced consultant, auditor, assessor, and trainer for ISO 13485 and EU MDR. She runs a thriving ISO 13485 consulting practice and helps companies and consultants to build their businesses. In her career, she also worked as an ISO 9001 and ISO 22716 consultant and lead auditor, and auditor and assessor for MDD.

Garry Cornell
Garry Cornell has more than 25 years of global experience as a senior manager, certification auditor, and consultant, helping a wide range of businesses in their implementations of ISO 14001, ISO 45001, and ISO 50001. He has developed various courses and is the author of several books on auditing techniques and ISO 14001. He is a member of the Institute of Environmental Management and Assessment.
Why Advisera ISO 13485 Lead Implementer Course?
Free unlimited access to the entire course
Globally recognized accreditation by ASIC
Expert support from Advisera's top experts
400 students have attended this course already
Related Trainings
ISO 13485 Lead Auditor
This course teaches you the core principles you need to become an auditor for the ISO 13485 standard and offers accredited certification from ASIC.
ISO 9001 Lead Implementer
Learn how to become an independent consultant for Quality Management Systems and more based on the ISO 9001 standard.
ISO 9001 Internal Auditor
Advance your career by becoming an internal auditor for ISO 9001.
Get in Touch
Need some help? Contact us now. We respond quickly.