Higher education, tertiary education

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The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices.

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Process Improvement Simplified is written for leaders and managers of organizations or enterprises who:Are struggling with their organization s successAre not satisfied with the current stateAre striving to be number oneHave heard about the negatives or positives of process improvement (PI) but have never implemented itBut PI is not a panacea; it takes leadership commitment and involvement, plus organizational behavior modification so that PI becomes a disciplined way of life.

The last decade has seen wide changes in how quality standards are applied in industry.

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The recognition that all well-managed companies are interested in preventing or at least minimizing risk in their operations is the concept of risk management analysis.

This book is the culmination of inter-firm comparisons done by the author of more than 4,000 companies in over 100 different industries.

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This primer was written to promote the application of basic and sound supply chain management principles.

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This book is for those in healthcare practices whose customers/payers may be encouraging or requiring them to use Lean Six Sigma in the workplace, or to simply improve the way healthcare is being provided.

In order to stay competitive, organizations need to continuously improve their processes.

Perfect for anyone charged with implementing a quality audit program or those performing the audit, this book is an ideal reference on the established techniques of quality auditing.

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This book is written for the Six Sigma Black Belt who needs an understanding of many statistical methods but does not use all of these methods every day.

Many organizations have realized bona fide reward payoffs using a systematic continuous approach to quality and quality improvement.

This book explains how an organization can use a management system to both control and improve its environmental performance.

This primer was written to promote the application of basic and sound supply chain management principles.

Little in the current world is simple.

This groundbreaking resource book is the place where readers will find all that is required to implement a successful accelerated reliability program.

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Corporate sustainability planning has risen in prominence over the past few years among leading organizations as a tool to achieve strategic dominance within the global marketplace.

Business growth depends on more than asking a single question.

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This book is written for the Six Sigma Black Belt who needs an understanding of many statistical methods but does not use all of these methods every day.

You may wonder, "e;Why do we need ISO 50001 EnMS when we have already implemented ISO 14001 Environmental Management (EMS)?

Internal quality audits can provide an unbiased view of the processes that directly impact the products and services of an organization.

The last decade has seen wide changes in how quality standards are applied in industry.

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Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine.

This book is designed to walk the reader through the ASQ Certified Six Sigma Black Belt (CSSBB) Body of Knowledge (BoK) at a medium level of detail.

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine.

This book follows the ASQ Certified Six Sigma Black Belt (CSSBB) Body of Knowledge exactly and is designed to walk the reader through at a medium-level of detail.

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Innovation--developing new and better products and services--is the key to surviving in today's competitive business landscape.

Authors Pirasteh and Fox know what causes various improvement approaches to fail, and in response provide a new model that combines theory of constraints (TOC), lean, and Six Sigma into a unique program called TLS.

This handbook was developed to help small and medium-sized organizations better understand ISO 9001:2015.

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The uncertainty of measurement results is drawing attention of managers, metrologists and customers.

Change can be hard.

You've been trained and tested and you've been successful.

If a business expects to be a player in their market segment, their product(s) must have the quality expected by their customers.

This book was written to aid quality technicians and engineers.

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