Categories: Auditing ,  ISO 13485 and Medical Devices

ISO 13485 Internal Auditor Course

Auditing is essential to ensure your system is implemented, maintained and effective. Internal auditing is also a key regulatory requirement. This course will enable delegates to undertake internal audits to ISO 13485 as well as giving an overview to ISO 9001. Based on ISO 19011 (Guidelines for Quality Auditing) this course is recognised by certification bodies and regulatory agencies as a key qualification for auditors.

CPD: 14 hours

2 day course includes:

• Structure & content of ISO 13485
• ISO 9001 Overview
• Auditing to ISO 13485
• Audit planning, preparation & effective system sampling
• Process based audits to ensure system effectiveness
• Audit reporting & follow up
• Links to regulatory compliance