Excellence Beyond Compliance

Establishing a Medical Device Quality System

Business & Finance, Industries & Professions, Quality Control, Management & Leadership, Production & Operations Management
Cover of the book Excellence Beyond Compliance by William I. White, Taylor and Francis
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: William I. White ISBN: 9781351032568
Publisher: Taylor and Francis Publication: May 16, 2018
Imprint: Productivity Press Language: English
Author: William I. White
ISBN: 9781351032568
Publisher: Taylor and Francis
Publication: May 16, 2018
Imprint: Productivity Press
Language: English

Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.

This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.

After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help.

This book offers:

  • Advice that will lead to an effective and efficient QMS.
  • Detailed guidance on the key decisions to be made regarding the quality system being established.
  • Detailed ideas on how to execute those decisions.
  • Up-to-date information on compliance to current regulations and standards and guidance on staying up to date.
  • Specific examples of procedures.
  • Information regarding requirements for combination products, such as a drug + device combination.
  • Advice on incorporating risk management in the QMS.
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation.

This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful.

After a review of the challenges that any medical device company faces in the world of today—the multiple sources of QMS requirements—the book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help.

This book offers:

More books from Taylor and Francis

Cover of the book The Psychology of Grandparenthood by William I. White
Cover of the book Self and Identity by William I. White
Cover of the book Dilemmas of Care in the Nordic Welfare State by William I. White
Cover of the book A History of Management Accounting by William I. White
Cover of the book Human Factors and Aerospace Safety: An International Journal: v.1: No.1 by William I. White
Cover of the book Ancient Christianity in the Caucasus by William I. White
Cover of the book Gender and Power in Britain 1640-1990 by William I. White
Cover of the book From Clement to Origen by William I. White
Cover of the book Managing Green Teams by William I. White
Cover of the book The Many Faces of Relativism by William I. White
Cover of the book Planning and Housing in the Rapidly Urbanising World by William I. White
Cover of the book Global Cities, Governance and Diplomacy by William I. White
Cover of the book History of Art by William I. White
Cover of the book Co-Dependency by William I. White
Cover of the book Revising Oral Theory by William I. White
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy