Medical Device QMS Auditor/Lead Auditor
(ISO 13485:2003 with ISO 9001:2008) (IRCA Registered A17037)

This IRCA registered course will give you the very latest training in how to audit medical device quality quality systems in addition to giving you an internationally recognised qualification that your notified body and your customers will recognise. 

This five day course is recognised by regulatory agencies as the qualification for auditors and quality managers and gives you the same qualification as your notified body assessor. This course is delivered by expert auditors with wide experience of the medical device industry and will give you the skills required to perform internal, supplier or notified body audits.

You will learn...

• How to get maximum benefits from your audits.
• 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.
• The secrets of becoming a process based auditor.
• How you can write a non‐conformity that will deliver an effective corrective action every time.
• How to ‘calibrate’ yourself and your non‐conformities with your notified body.
• Move beyond compliance: Use your audit system to genuinely improve the effectiveness of your organisation.
• Key systems elements including; Links to ISO 9001, risk management, validation and post market surveillance systems.

Should you attend?
This course is for anyone who wishes to conduct, and potentially lead, quality audits using ISO 13485: 2003 and ISO 9001:2008. The course is also useful for someone who would like to have an in depth working and practical knowledge of ISO 13485, and how to manage a quality system. This will include senior managers, operations managers, quality managers and anyone else who needs to use and audit ISO 13485 directly.

To attend you will need to have a working knowledge of quality management systems including ISO 13485. Not too sure? Why not take a look at our Introduction to ISO 13485 Training Course - available for only £99, this will give you a good one day introduction in preparation for this Lead Audit Course.

What are the benefits to you?
This course will give you a good understanding of how to perform a quality audits in your organisation and at your suppliers. The course also gives you the same level of training as your ISO 13485 and ISO 9001 certification body assessor. This will help you and your organisation to identify gaps in your quality management system as a basis for improvement of regulatory compliance and system effectiveness.

Our experienced lead auditors will also guide you through ISO 13485:2003 and give you a clear, practical and in depth understanding of the quality standard so that you have a good understanding of what your certification body is looking for the next time they audit you.

Hands On - Practical Training…
We have invested heavily in our 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 course, this course, our company and our trainers undergo an intensive inspection and assessment every year with the International Register of Certificated Auditors to give you the peace of mind that your qualification is valid and will be recognised by your customers and certification body.

How to book…
Our course calendar can be viewed below or just go to our BOOK NOW page 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.