(IRCA Registered A17037)

ISO 13485: 2003 Auditor / Lead Auditor

This is the only IRCA registered course in Europe. 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.