Introduction to ISO 13485:2016
ISO 13485 is the standard specific to quality management systems to ensure regulatory compliance for medical devices.
This practical and interactive 1-day course can help you to understand the key requirements of ISO 13485, what an effective Quality Management System should look like and how this can be applied to your organisation.
Early Bird Price £250 + VAT
- How to cut through the ‘ISO speak’ to give you a practical understanding of ISO 13485:2016.
- Destroying the myths of system documentation — what you actually need to run your system.
- Key System Elements: How to implement ISO 13485 into your business, not your business into ISO 13485.
- The links between ISO 13485 and the Medical Device Directive and CE Marking.
This course is for anyone who wishes to gain an insight in to how ISO 13485 and quality management systems can be applied to medical device manufacture. It may be that you are considering the application of ISO 13485, have been given responsibility for quality management or just need to have an understanding of the system to do your job. The course is also recommended for delegates who are about to attend one of our medical device auditor courses.
This course will give you a good practical understanding of quality management systems and ISO 13485:2016. Completion of the course will help you and your organisation to identify gaps in your quality management system as a basis for improvement, helping you to maintain your regulatory compliance and system effectiveness. Our experienced trainers will also guide you through ISO 13485:2016 so that you have a clear understanding what it is your certification body is looking for the next time they audit.
Learning becomes easier and more effective if you, as a delegate, feel more involved and participate! We lead the training experience but also encourage thought, analysis and involvement to ensure you gain greater insight and understanding.
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Read what our delegates say:
I found the course very helpful to understanding more about ISO 13485 and how to carry out internal audits. Alistair was very helpful on any questions I had and very good at explaining different areas....
Found this course to be very helpful & it gives you a better understanding on how to audit properly & what you are looking for...
Good course which I can relate to my place of work..
Great experience, great trainer, I enjoyed the course very much and I would use QCS again in the future....
Great course very well presented. Active learning through practical exercises is a great way to deliver the course...
The training was very excellent, well informed and tutor knowledge of auditing was tremendous. It will really help me to conduct future audits....