Excellence beyond compliance : establishing a medical device quality system / William I. White.

Format:

Book

Author/Creator:

White, William I., author.

Language:

English

Subjects (All):

Medical instruments and apparatus--Quality control.

Medical instruments and apparatus--Standards.

Physical Description:

1 online resource (212 pages)

Edition:

1st edition

Place of Publication:

Boca Raton : Taylor & Francis, 2018.

System Details:

text file

Summary:

"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 todaythe multiple sources of QMS requirementsthe 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."--Provided by publisher.

Contents:

chapter 1 The Challenge / William I. White

chapter 2 The Path / William I. White

chapter 3 Key Decisions / William I. White

chapter 4 A Quality Plan / William I. White

chapter 5 Documentation, the Big Picture / William I. White

chapter 6 Level 1 Documentation / William I. White

chapter 7 Level 2 Documentation / William I. White

chapter 8 Level 3 Documentation / William I. White

chapter 9 Level 4 Documentation / William I. White

chapter 10 Fully Incorporating Risk Management / William I. White

chapter 11 Implementation / William I. White

chapter 12 Maintenance (and Improvement) / William I. White.

Notes:

Description based on print version record.

"A Productivity Press book."

Includes bibliographical references and index.

ISBN:

9781351032575

1351032577

9781351032582

1351032585

9781351032568

1351032569

OCLC:

1027770072