Proactive supplier management in the medical device industry / James B. Shore and John A. Freije.

Format:

Book

Author/Creator:

Shore, James B., 1965- author.

Freije, John A., 1964- author.

Language:

English

Subjects (All):

Production control.

Medical instruments and apparatus industry--Management.

Medical instruments and apparatus industry.

Physical Description:

1 online resource (144 pages) : illustrations

Place of Publication:

Milwaukee, Wisconsin : ASQ Quality Press, [2016]

Summary:

In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business aspect.The intent of this book is to show readers a process of effectively selecting, evaluating, and implementing applicable controls based on the evaluation and ongoing proactive management of suppliers, consultants, and contractors in a state of compliance. These processes can be applied to all suppliers, consultants, and contractors.In writing this book, the authors made sure that readers could immediately apply its content. They provide best practices based on a combined 50+ years of quality and engineering experience, having worked with some of the best medical device companies and contract manufacturers in the world.Four icons use throughout the book help readers navigate and understand the content. The FDA and toolbox icons assist in determining whether it's a requirement or a tool to help achieve compliance. The Lessons from the Road" icon indicates real-life stories and what the authors have learned throughout their careers. Lastly, the check mark icon is used to highlight key thoughts, what they feel are unique takeaways or deserve a special focus.

Notes:

Includes bibliographical references (page 115) and index.

Description based on print version record.

ISBN:

9781953079657

1953079652