#324 Management Responsibility: The most important part of a QMS
Sara Adams, a Lead Auditor and Quality Engineer at Greenlight Guru, explains the critical role of management responsibility in a medical device Quality Management System (QMS). She details how top management must establish a meaningful quality policy, provide adequate resources, and conduct rigorous management reviews to ensure regulatory compliance and a culture of quality. Adams emphasizes that without active executive buy-in and cross-functional engagement, even well-documented systems fail to protect patients or satisfy auditors.