Episode Synopsis "206 - Quality Management Systems"

A Quality Management System (QMS) is a structured framework organizations use to manage and improve the quality of their products, services, and processes, ensuring customer satisfaction, continuous improvement, and regulatory compliance. Key elements encompass policies, procedures, risk-based approaches, documentation, resource management, monitoring, measurement, and continuous improvement. ISO 9001 and ISO 13485 are prominent QMS standards, with ISO 9001 focusing on overall organizational processes and customer satisfaction, while ISO 13485 tailors requirements for the medical device industry. ANSI/AAMI EQ56:2020 provides guidance for comprehensive medical equipment management plans, aligning with quality principles and regulatory standards, enhancing patient safety, and meeting ISO 9001 compliance requirements.

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