Internal Auditor Training for ISO 13485

Understand how to prepare, conduct, and follow up on internal audits for ISO 9001 and ISO 13485.

• Introduction to Internal Quality Systems Assessment: An introduction to the elements comprising a quality system, interpretation of the requirements of ISO 9001 and ISO 13485, and a discussion of what third-party assessment agencies look for.
• The Three Audit Phases: Planning, execution, and follow-up are examined closely using concepts detailed in ISO 19011.
• Planning and Auditing: How to prepare for an audit and manage your resources effectively.
• Conducting the Audit: How to collect objective evidence and document observations, including techniques for effective questioning and listening.
• Follow-Up Activities: How to verify effectiveness and adequacy of corrective action, close out an audit, and conduct follow-up surveillances.

• Analysis and interpretation of ISO 13485
• The quality system
• The quality audit cycle
• Preaudit activities
• Internal audit case study
• On-site audit activities
• Report writing, nonconformity reports
• Corrective action (case study)
• Final examination (1 hour)