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ISO 13485 Internal Auditor training ISO 13485 Internal Auditor training Objectives ISO 13485 Internal Auditor training suitable for those wishing to conduct internal audits to ISO 13485. This 3-day ISO 13485 Internal Auditor training enables delegates to interpret the requirements of the ISO 13485 medical devices standard from an auditing perspective, conduct effective audits and produce audit findings. Delegates completing the ISO 13485 internal auditing training will be able to audit their quality management system for conformity to ISO 13485, the effectiveness of their business processes, and to identify opportunities for improvement. Improving Medical Devices-QMS performance and continual improvement are key elements of this ISO 13485 Internal Auditor training. ISO 13485 Internal Auditor training will help you understand the underlying philosophy, principles, concepts, and requirements of the ISO 13485 Standard, the application of this International Standard within your organization and the skills necessary to conduct an ISO 13485 management system audit. ISO 13485 Internal Auditor training Course Content Outline Audit Fundamentals Definitions, purpose, types Quality Management Systems (Medical Devices) In-depth discussion on ISO 13485:2003 Standard requirements GMP background and FDA requirements