Introduction to ISO 13485:2003

ISO 13485 can ensure regulatory compliance and drive your operational improvement.

This practical and interactive 1 day course will help you to understand the key requirements of ISO 13485, what an effective Quality Management System should look like, and how this applies to your organisation.

You will learn:

• How to cut through the ‘ISO speak’ to give you a practical understanding of ISO 13485:2003.
• 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. 
   

Should you attend?
This course is for anyone who wishes to gain a better understanding of Quality Management Systems for Medical Devices. The course is also useful for someone who is about to attend our Medical Device Internal QMS Auditor Course or Auditor/Lead Auditor Course.

What are the benefits to you?
This course will give you a good practical understanding of Quality Management Systems and ISO 13485:2003. This will help you and your organisation to identify gaps in your quality management system as a basis for improvement - helping you to increase your regulatory compliance and system effectiveness. Our experienced trainers will also guide you through ISO 13485:2003 so that you have a good understanding of what your notified body is looking for the next time they audit you.

Hands On - Practical Training…
We have developed our training courses to make them hands on and interactive. Simply put, it is our belief that if we keep you involved in learning, you will learn more and be able to use more back at work.

Peace of mind that your qualification is valid…
As an IRCA approved training organisation, our company and our trainers undergo an intensive inspection and assessment every year with the International Register of Certificated Auditors (IRCA) to give you the peace of mind that the training you receive is always to the highest possible standard.

How to book…
Our course calendar can be viewed below or just go to BOOK NOW if you know the course date you require.   Not too sure about which course to book? Just call us on 01236 734447 to discuss your training needs further.