ISO 13485:2003 Internal Auditor Training (RABQSA Certified)
 

1. The Internal Quality System and ISO 13485
1. Overview of the elements comprising a sound quality system, requirements of the governing documents, and the relationship of quality policy, the quality manual, procedures, and instructions. Included is a discussion of the audit evidence necessary to comply with ISO 13485.
2. The Audit Cycle
1. Using ISO 19011 as a guide, pre audit activities, conducting the audit, and post-audit and follow-up activities are reviewed.
3. Planning and Conducting the Audit
1. How to prepare for an audit and effectively manage your resources
2. How to collect audit evidence and document observations, including techniques for effective questioning and listening.
4. Follow-Up Activities
1. How to verify effectiveness of corrective action, close out an audit, and conduct follow-up surveillances
5. Case Studies and Simulations
1. Hands-on workshops reinforce the methods and techniques discussed.

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