In this Introduction to ISO 13485:2016 eLearning course is designed to provide learners with an introduction to the ISO 13485:2016 standard, its principles, and its application in the medical device industry.

ISO 13485:2016 is an internationally recognized quality management system standard specifically tailored for medical devices, ensuring compliance with regulatory requirements and maintaining the highest standards of product safety and efficacy.Throughout this course, participants will gain a solid foundation in understanding the key principles, requirements, and benefits of ISO 13485:2016. The course is structured to provide a clear and structured approach to learning, ensuring participants can easily grasp and apply the concepts covered.

Participants can progress through the course at their own convenience, enabling them to balance their professional commitments alongside their learning objectives.

Who should take this course?

This course is ideal for professionals working in the medical device industry, including manufacturers, regulatory affairs personnel, quality assurance managers, and auditors.

1. Understand the scope of ISO 13485:2016.  
2. Learn about the content of ISO 13485:2016.
3. Grasp the purpose and importance of ISO 13485.
4. Recognize its role in the medical device industry.
5. Understand the components and purpose of the “Introduction” section.
6. Comprehend the concept and benefits of the “Process Approach.
7. Explore terms in Clause 3 and their implications.
8. Understand general requirements in Clause 4.

The following topics will be covered in this course:

In-dept look at the Introduction section of ISO 13485:2016

The “Process Approach” to quality management.

Each clause of ISO 13485:2016 will be addressed.

Clause 1: Scope.
Clause 2: Normative Reference.
Clause 3: Terms and Definitions.
Clause 4: General Requirements.
Clause 5: Management Responsibility.
Clause 6: Resource Management.
Clause 7: Product Realization.
Clause 8: Measurement, Analysis and Improvement. 

There will be an inept look at the following sections of the standard::

Introduction Section of the Standard

Clause 1 Scope

Clause 3 Terms and Definitions

Clause 4 General Requirements

The concept of the “process approach” to quality management will be reviewed.

Assessment:

There will be an end of course quiz consisting of 20 questions.

Supplemental Material:

Participants will have access to additional resources, such as downloadable course materials, reference documents, and supplementary reading materials.

Upon completing the course and when you obtain a passing grade on your final quiz (80% or over), you will receive a PDF certificate to show that you have completed all the course content. 

 Dr. Fiona Masterson 

Fiona is the founder of The Learning Reservoir. She has 25+ years of parallel paths in quality management, operations management and education. She has broad technical expertise encompassing quality systems compliance, quality standards implementation, regulatory affairs and operations management. She has worked in start-ups and high‐tech, fast paced manufacturing environments. She lectures part-time in technical universities on subjects related to her industrial expertise.

Fiona has Bachelor and Masters of Science degrees, and a Doctorate in Mechanical Engineering. Her Doctorate focused on innovative drug/device combinations products. Fiona is a certified lead auditor. Fiona has published in peer reviewed journals on topics such as medical device and pharmaceutical regulatory affairs, on-the job training and innovative training technologies and strategies.

She writes many of The Learning Reservoir’s blog posts and invites you to connect with her on LinkedIn. 

We appreciate your interest in the “Introduction to ISO 13485:2016 Online Training Course.” We would like to inform you that the course does not include a copy of the ISO 13485:2016 standard itself. 

Why We Don’t Include a Copy of ISO 13485:2016:
Please note that the cost of the ISO 13485:2016 standard can be significant, and including it in the course materials would increase the overall course cost. However, we’ve designed this course to be comprehensive and cost-effective by providing you with focused extracts from the standard that are directly relevant to the sections we discuss. You’ll have access to the essential content needed to grasp the concepts we cover.

Extracts and In-Depth Content:
Rest assured, throughout the course, we will provide you with extracts from the ISO 13485:2016 standard that are pertinent to the specific topics and sections we delve into. This way, you’ll have a clear understanding of the requirements and concepts without the need to purchase the entire standard.

Purchasing the Full Standard:
If you wish to have access to the complete ISO 13485:2016 standard for your reference, you can purchase it separately through this link. Owning a copy of the standard can be valuable, especially if you’re part of a medical device company that needs it for in-house processes. By taking this course, you’re equipped with the key information you need without the added cost of the full standard.