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9781637424407 Academic Inspection Copy

Transforming Quality Organizations

A Practical Guide
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Is your Quality organization holding your business back? Is regulatory compliance seen as more important than product or service quality? Do you feel the needs of your customers are lost in a sea of regulations?Transforming Quality Organizations: A Practical Guide questions whether the current approach to managing quality is fit for purpose and, using the latest organizational thinking provides fresh, practical ways to balance a quality system to: Manage risk for better patient, customer, regulator, and stockholder outcomes. Achieve balance between ensuring compliance and supporting innovation. Transform your Quality organization through a roadmap of change. Applicable to all businesses where quality is paramount, the content is based on practical experience of executing transformational change in the healthcare sector resulting in: Product recall rates cut by 50%. Product development cycle-times cut by 50%. Significant cost savings in quality system execution. This book is invaluable for business leaders who want to transform their Quality organization and increase the value it delivers for their business.
Matthew P. Wictome, PhD, is Managing Director and founder of Datod Consulting. Datod specializes in building better and more effective Quality organizations. He holds a PhD in Biochemistry and an executive Masters in Strategy, Change and Leadership with the University of Bristol. He is passionate in designing and implementing quality systems that are effective, efficient and outcome driven. Ian Wells, PhD, is Vice President of QARA for Trinity Biotech. Ian holds a PhD in analytical chemistry and chemometrics and has over thirty years' experience of R&D, Operations and Quality/Regulatory in the healthcare sector. Through experience, he has developed a methodology of strategic quality change based on the transformation map concept.
The book describes the integration of quality theory to practical application in a refreshing way, that's an excellent reference book for those driving operational transformation in their business.--Ian Elliott, Retired Chief Operations Officer, Medical Devices This book offers a unique perspective on managing your quality system, with both strategic and practical advice for leaders who are looking to maximize their business impact.--Jennifer Paine, Senior VP, Global Regulatory Affairs, Medical Devices This is the first quality management systems book I have read that focuses more on solving problems and achieving opportunities and provides frameworks and methodologies to achieve these goals.--Thomas Stevenson, Chief Operating Officer, Ocutec
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