The Process Approach of ISO 9001
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UPDATED for ISO 9001:2015 (Fourth edition, Jan. 2016) Two enormous challenges confront the quality management community--and these challenges affect quality consultants, organizational management and quality auditors. There is an urgent need to abolish a mindset pervading the community for decades, one that has reduced quality to its current confused state. Conversely, it is necessary to promote a new mindset that will bring glory to quality management, Deming and Shewhart, and ISO 9001. Until those in the quality community unequivocally accept and promote the process approach the value of ISO 9001 will continue to evade organizations hoping to find value in their ISO 9001-certified quality management systems. For those customer-focused quality professionals who understand and promote the process approach, the future is bright. Although the process approach isn't new, it's the future of quality management. The focus of this book is the process approach. Though it references the most current version of the developing standard, the message is about the process approach itself, which underlies ISO 9000, 9001, and 9004. The process approach (in some form) will underlie all future revisions of ISO 9001.
T. D. ("Dan") Nelson has been closely involved with ISO 9000 since 1994 as a technical writer, quality manager, management representative, consultant, author, and CB auditor. Holding an MA in Business Administration from the University of Iowa, he also has 12 years of experience as an IRCA-certified QMS Lead or Principal Auditor. Dan has conducted registration audits and surveillance audits, and has trained Lead Auditor candidates in accredited courses as well as hundreds of top-notch internal auditors. Using a process approach, Dan has taken scores of clients of various shapes and sizes through registration to ISO 9001:1994/2000/2008 and related standards (e.g. QS 9000, AS9100, ISO 13485, and ISO 17025). Dan's numerous articles about the process approach have been published by Quality Digest, Inside Quality, ASQ Quality Management Division, Quality Progress (ASQ), Certified Enterprise Risk Management (CERM), the Society for Manufacturing Engineers (SME), ISO 9000 Academy, The Auditor, and the South African Quality Institute (SAQI).
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