This training course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, and also how it serves to facilitate global alignment for Medical Device quality management systems.
From consultants to senior managers, this course is suitable for anyone who needs to implement the standard. You’ll learn to use ISO 13485:2016 as the basis for regulatory requirements worldwide and recognize the key clauses.
eLearning - 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. You will be able to access the training for 12 months.
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
Who should attend?
Senior management, quality managers, regulatory affairs managers, internal and external auditors, consultants and anyone involved with the implementation of the standard.
There are no formal prerequisites, however it will be useful for delegates to read the standard before attending the course
What will I learn?
You'll learn about:
- Gain an appreciation for the origins of ISO 13485
- Understand the use of ISO 13485 as the basis for a Quality Management System for Medical Device organisations
- Awareness of the key differences to the ISO 9001:2015 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
What's included?
- This is an online, interactive eLearning course.
- You’ll have access to the course for 12 months.
BSI's Qualifications
Auditor Qualifications
This course forms part of our auditor qualification programme. Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application.
Medical Devices Regulation (MDR) Qualifications
This course forms part of our MDR Practitioner Qualification. This qualification will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner status by successfully completing courses, exams and demonstrating practical application.
I'm interested, please send me more information about the course.
