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Each chapter stands alone, and the chapters may be read in any order. Some material reaching beyond the content of the BOK has been added. Supplemental reading suggestions are provided.

This book addresses the needs of:

• Users and organizations seeking a general understanding of the contents of ISO 9001:2015
• Users and organizations desiring guidance to ensure their ISO 9001:2015 QMS meets the new version requirements
• Users and organizations considering the use of ISO 9001:2015 as a foundation for the development of a comprehensive QMS
• Educators who require a textbook to accompany a training class or course on ISO 9001:2015
• Auditors who desire to increase their level of auditing competence

Authors Cianfrani and West, members of the expert group that developed ISO 9001:2015, strive to provide a context for all requirements to enable you to develop and deploy processes that will strengthen your QMS. Getting or retaining a certificate is not the real objective. Satisfied customers and organizational sustainability should be primary objectives for the organization.

The book has 43 chapters covering a range of issues organizations are fraught with in the current dynamic environment.Almost all of these are real, live cases describing situations middle to senior executives have dealt with, with a given amount of success.

Understanding and improving the CAPA system as a whole is the focal point of this book, the first of its kind dealing exclusively with this critical system within this highly regulated industry. By helping those in this industry improve their CAPA systems, it will be a crucial aid in their mission of producing safe and effective products.

This fourth edition now includes information on the quality cost systems involved with the education, service, banking, and software development industries. You’ll also find new material on ISO 9001, cost systems in small businesses, and activity based costing. Additional information on team-based problem-solving, customer satisfaction, and the costs involved with the defense industry are also offered.

For details please mail at info@kojopress.com

The CD accompanying the print book and at the end of the e-book versions includes a practice problem set covering each part of the book and a simulated examination that has problems distributed among parts according to the scheme published in the Body of Knowledge.

An entire chapter is devoted to measurement errors. The book goes in-depth into explaining national and international measurement systems and standards, and includes a complete chapter on calibration and measurement trace ability. Measurement Uncertainty will show how to evaluate various uncertainties in measurements using several approaches including international consensus. Calibration laboratories can look specifically at the chapter on that profession to guide them in their measurement improvements. Kimothi also looks at specific industries and their measurement capabilities and includes examples of R&R studies.

The CD-ROM has been expanded into two disks, and a layout diagram is available in Appendix R. Given that this is an electronic format, you are encouraged to search the files for any number of forms, examples, templates, videos, and other useful tidbits that can help in running projects and preparing for the exam.