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ISO 9001 : 2008 Explained

ISO 9001 : 2008 Explained

          
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About the Book

This book explains the meaning and intent of the requirements of ISO 9001:2008 and discusses the requirement as they relate to each product category. Where appropriate, it elaborates on why the requirements are important. It includes a list of typical audit-type questions that an organization may use to appraise compliance with the requirements.

New in this third edition are recommendations for implementation. While some implementation guidance was provided in earlier editions, they had focused on achieving understanding of the requirements. Each clause now has a section on tips for implementation. There is also a completely new chapter devoted to the implementation of a quality management system, as well as new chapters on auditing the process-based quality management system and sector applications.

Written by authors with a combined 100 years of experience in quality management systems deployment in a wide variety of manufacturing and service environments, both for profit and nonprofit, this book addresses the needs of the following:

  • Organizations seeking a general understanding of the contents of ISO 9001:2008
  • Organizations desiring guidance to ensure that their ISO 9001:2000 quality management system also meets the new version
  • Organizations considering the use of ISO 9001:2008 as a foundation for the development of a comprehensive quality management system
  • Educators who require a textbook to accompany a training class or course on ISO 9001:2008
  • Auditors who desire to increase their level of auditing competence
You need no other resource for ISO 9001:2008, as this book contains the exact text of the standard and also the exact definitions of ISO 9000:2005!

About the Author
Charles A. Cianfrani is a U.S. expert representative to ISO/TC 176/SC2WG 18, the Working Group that wrote ISO 9001:2008 and the revision of ISO 9004:2000, which will be released in 2009. He is the vice president and managing director of the quality consulting group at ResCare, Inc. in Media, PA, and has led implementation of ISO 9001-compliant processes on six continents. He is an ASQ Fellow, holds BS, MS, and MBA degrees, and is an ASQ CQE, CRE, and CQA, as well as an RAB Certified Auditor.

Joseph J. Tsiakals is the vice chairman of the U.S. Technical Advisory Group for ISO/TC 176, the ISO committee responsible for the ISO 9000 family of standards. He is currently a member of the task group responsible for developing the next revision to ISO 9001. He was the medical device technical expert on the ISO/TC 176 writing team for ISO 9001:2000 and previously served as the lead U.S. technical expert for the development of ISO 9001:1994. Tsiakals is one of the founding members of the ISO Medical Device Quality Committee. His career has been in FDA regulated industries. He is the senior vice president, quality and regulatory, for Baxa Corporation.

John E. (Jack) West is immediate past chairman of the U.S. Technical Advisory Group for ISO/TC 176 and a delegate for the United States to the ISO committee responsible for the ISO 9000 family of quality management standards. He is a business advisor who helps organizations to improve their growth and profitability. West has more than thirty years of experience in various industries around the world.

Table of Contents
  • Introduction
  • Quality Management System and General Documentation
  • Management Responsibility
  • Human and Other Resources
  • Planning of Product Realization and Customer-Related Processes
  • Design and Development
  • Purchasing
  • Production and Service Provision
  • Measurement
  • Control of Nonconforming Product
  • Analysis of Data
  • Improvement
  • Implementation of a Quality Management System Conforming to ISO 9001:2008
  • Auditing the Process-Based Quality Management System
  • Use of ISO 9001 and Sector Applications


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Product Details
  • ISBN-13: 9788122431018
  • Publisher: New Age International (P) Ltd
  • Publisher Imprint: New Age International (p) Ltd
  • Language: English
  • ISBN-10: 8122431011
  • Publisher Date: 2011
  • Binding: Hardcover

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