Course aim

Gain an insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device organizations. 

Course description

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001 and also it serves to facilitate global alignment for Medical Device quality management systems.    

E-Learning - training that’s even more flexible 

If you need to understand the requirements of this ISO 13485:2016 quality management system standard and are confident enough not to need tutor-led training, this online, self-paced course offers you complete flexibility.  

You can study in your own time when it suits you, and you can access the course from any internet-enabled device 24/7. 

How will I benefit?

This course will help you: 

• Take the first steps towards ISO 13485:2016 certification 

• Understand how you can better meet regulatory requirements leading to increased patient safety 

• Find ways to increase efficiency and cost savings through quality management  

• Monitor supply chains to achieve continuous improvement 

• Develop safe and effective medical devices  

• Motivate employees through CPD 

What will I learn?

You will learn about: 

• Gain an appreciation for the origins of ISO13485 

• Understand the use of ISO13485 as the basis for a Quality Management System for Medical Device organisations  

• Awareness of the key differences to the ISO9001 standard 

• Appreciate the process approach concept of the standard and the Plan-Do-Check-Act (PDCA) framework 

• knowledge of the overall structure of ISO 13485:2016  

• Recognize the key clauses of the ISO 13485:2016 standard 

Who should attend?

Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard. 

How will I learn?

This is an online, interactive eLearning course. Learning is self-study and you can progress at your own pace. You will have access to the course for 12 months. 

What will I gain?

On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.  

Prerequisites

There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course. 

Further information

This eLearning course is ideal if you cannot attend one of our tutor-led classroom or virtual training courses. 

To benefit from the expertise of a tutor, and interaction with other delegates, choose the virtual online or classroom version of this course. 

 

Modules

• BSI ISO 13485:2016 Introduction
• BSI ISO 13485:2016 The Process Approach and PDCA Framework
• BSI ISO 13485:2016 Requirements: Clause 4
• BSI ISO 13485:2016 Requirements: Clause 5: Management Responsibility
• BSI ISO 13485:2016 Requirements: Clause 6 Resource Management
• BSI ISO 134852016 Requirements Clause 7 Product Realization
• BSI ISO 13485:2016 Requirements: Clause 8 Measurement, Analysis and Improvement