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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โข Understanding ISO 13485: An overview of the international standard for medical device quality management systems, including its purpose, benefits, and requirements.
โข Change Management Best Practices: A deep dive into the principles and strategies for effective change management, including risk assessment, communication, and implementation.
โข 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.
โข 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.
โข 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.
โข 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.
โข 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.
โข 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.
โข 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.
โข 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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