Categories: Auditing ,  IRCA Approved Lead Auditor & Conversion Courses ,  ISO 13485 and Medical Devices

ISO 13485 Auditor / Lead Auditor Course

As the first IRCA registered course in the UK, this course is recognised by regulatory agencies as a principle means to train auditors and demonstrate auditor competence. The course is delivered by qualified lead auditors with wide experience of the medical device industry and delivers the skills required to perform internal, supplier or certification body audits to ISO 13485:2003.

CPD: 40 hours

5 day course includes:

• Quality management systems
• Principle requirements & regulatory links
• Structure & format of ISO 13485
• Links to ISO 9001
• Risk management & ISO 14971
• Overview to process validation
• Audit planning & preparation
• Evaluation & reporting results