Executive Development Programme in ISO 13485: Leading Change
-- ViewingNowThe Executive Development Programme in ISO 13485: Leading Change is a certificate course designed to empower professionals in the medical device industry. This program emphasizes the importance of ISO 13485, the international standard for quality management systems in this sector.
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⢠Understanding ISO 13485: An overview of the international standard for medical device quality management systems, including its purpose, benefits, and requirements.
⢠Change Management Best Practices: A deep dive into the principles and strategies for effective change management, including risk assessment, communication, and implementation.
⢠Driving Change in ISO 13485: Specific guidance on how to lead change within the context of ISO 13485, including the role of leadership, the importance of a quality culture, and the use of process approaches.
⢠ISO 13485 Audits and Assessments: A review of the audit and assessment process for ISO 13485, including the purpose, scope, and criteria for evaluating compliance with the standard.
⢠Continuous Improvement and ISO 13485: An exploration of the role of continuous improvement in ISO 13485, including the use of performance metrics, corrective and preventive action, and internal audits.
⢠ISO 13485 and Regulatory Compliance: A discussion of the relationship between ISO 13485 and regulatory compliance, including the implications for medical device manufacturers and the role of the quality management system in ensuring compliance.
⢠Innovation and ISO 13485: An examination of the intersection between innovation and ISO 13485, including the importance of fostering a culture of innovation within the organization, and the role of the quality management system in supporting innovation.
⢠ISO 13485 in a Global Context: A consideration of the challenges and opportunities associated with implementing ISO 13485 in a global context, including the impact of cultural differences, geographic location, and international regulations.
⢠Case Studies in ISO 13485 Implementation: Real-world examples of successful ISO 13485 implementation, including the strategies employed, the challenges faced, and the lessons learned.
⢠Best Practices for ISO 13485 Leadership: A summary of the key leadership practices that support successful ISO 13485 implementation, including the role of communication, collaboration, and continuous learning.
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