Medical Device QMS Internal Auditor
(IRCA Approved 18203)
QCS International was the first training organisation in UK/Europe to hold IRCA approval for our internal and lead auditor courses within the medical device sector. With the new ISO 13485:2016 standard we continue to be the leader in preparing IRCA-registered auditor courses. This internal auditor course will give you the very latest training on how to audit medical device quality management systems in addition to giving you an internationally recognized qualification that your certification body and your customers will recognise.
Early Bird Price £695 + VAT
Two for less £1200 + VAT
- How to get maximum benefits from your internal audits.
- A basic understanding of a process based quality/medical device management system.
- Steps to ensuring you become an value-added internal auditor.
- The key steps you should follow to plan, prepare and perform an effective audit.
- How to effectively perform the audit by knowing the right questions to ask.
- How you can write a nonconformity that will deliver and effective corrective action every time.
- How you can write a non conformity that will deliver an effective corrective action every time.
- Relationship between quality management, production service conformity, regulatory requirements and customer satisfaction.
This course is for anyone who wishes to conduct effective internal audits on their medical device quality management system.
To attend this course, please see IRCA Pre Course Knowledge Requirements. If you are not sure if you have the pre-course knowledge our Introduction to ISO 13485 Training Course – available at the discounted cost of only £250, this will give you a good one day introduction in preparation for this audit training course.
This course will give you a thorough understanding of how to perform value added internal audits on your organisation’s processes. This will help you and your organisation to identify gaps in your medical device quality management system as a basis for improvement of regulatory compliance and system effectiveness. It allows you to demonstrate to your certificate body that your internal auditors have been trained to a recognised standard.
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.
As an IRCA approved training partner, this course, our company and our trainers undergo an intensive inspection and assessment every year with the International Register of Certificated Auditors (IRCA). This gives you the peace of mind that your qualification is valid and will be recognised by your customers and certification body.
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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....