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ISO 13485 Lead Auditor Certification
This certification provides an in-depth understanding of ISO 13485, covering the requirements for establishing and maintaining a quality management system for medical devices. It explores essential areas such as quality management system structure, audit processes, corrective and preventive actions, and risk management. Delegates will gain practical knowledge to apply these standards effectively in the medical device industry through various exercises and real-world examples.
What You Will Learn?
ISO 13485 Lead Auditor Certification offers several benefits, including enhanced career opportunities in the medical device industry by demonstrating expertise in quality management systems. Certified auditors are equipped to conduct thorough assessments, ensure compliance, and drive continuous improvement within organizations. The certification also provides a competitive edge, boosting credibility and recognition as a skilled professional in regulatory and quality management processes.
• Introduction to ISO 13485:2016
• Conducting an ISO 13485 Certification Audit
• ISO 13485 and Quality Management Systems
• Lead Auditor Responsibilities
• Medical Devices, Quality, and Auditing Terminology
• Planning, Preparation, and Management of Audits
• Preventative Action
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