Endnotes

[1] Many companies prefer to use other terms such as champion rather than steward. Terms such as process champion and subprocess champion are used. The thought is equivalent—we must have clearly established and committed leadership.

[2] The assignment of specific elements to the ISO management representative during QMS creation does not relieve the representative of the overall responsibility to coordinate the entire QMS creative process. It is meant to level out the writing and editing load.

[3] See, for example: Defeo, Joseph A., "The Tip of the Iceberg," Quality Progress, ASQ, May 2001, p. 29.

[4] See, for example, Neuscheler-Fritsch, Debbie, and Robert Norris, "Capturing Financial Benefits from Six Sigma," Quality Progress, ASQ, May 2001, p. 39.

[5] Based on the work of Dr. Anthony F. Costonis, president and founder of Corporate Development Services, Inc., of Lynnfield, MA, at http://www.corpdevelopment.com.

[6] "ISO 9000 Consultants Guide," Quality Digest, May 2001, p. 69, at http://www.qualitydigest.com.

[7] See, for example: Hiebler, Robert D., Thomas B. Kelly, and Charles Ketteman, Best Practices: Building Your Business with Customer-Focused Solutions, New York: Simon & Schuster, 1998, and Camp, Robert C., Business Process Benchmarking: Finding and Implementing Best Practices, Milwaukee, WI: ASQ Quality Press, 1995.

[8] See, for example: Hendricks, Kevin B., and Vinod R. Singhai, "Don't Count TQM Out," Quality Progress, April 1999, p. 35, and Tai, Lawrence S., and Zbigniew H. Przasnyski, "Baldrige Award Winners Beat the S&P 500," Quality Progress, April 1999, p. 45.

[9] The selection of third-party assessors is integral to the selection of a registrar. For a complete exposition on this topic, refer to Weightman, R.T., "How to Select a Registrar," Quality Systems Update, August 1996. Mr. Weightman is the president of Qualified Specialists, Inc., Houston, TX. Also see, Russell, J.P., The Quality Audit Handbook, Second Edition, Milwaukee, WI: ASQ Quality Press, 2000.

[10] See, for example: Russell, J.P., "Auditing ISO 9001:2000," Quality Progress, July 2001, p. 147, at http://www.asq.org.

[11] The shoulds of the QS-9000 quality system requirements are to be treated the same as the SHALLS of ISO 9001. Should, in this case, indicates a preferred approach. It is not to be confused with the notes of ISO 9001 that are not mandatory, but are used as an interpretive aid.

[12] Schlickman, Jay J., ISO 9000 Quality Management System Design: Optimal Design Rules for Documentation, Implementation, and System Effectiveness, Milwaukee, WI: ASQ Quality Press, 1998.

[13] For an extremely lucid discussion of the ISO 9001:2000 and ISO 13485 issue, see Kimmelman, Edward R., "Is ISO Obsolete?" Medical Device and Diagnostic Industry, October 2001, p. 76. Mr. Kimmelman is currently the convener of the ISO/TC210, Working Group 1, on quality systems for the medical device industry.

[14] Software development standards include the Carnegie Mellon University Software Engineering Institute capability maturity model for software, which has become a de facto standard for bids to the Department of Defense and NASA, as well as the IEEE/EIA 12207:Software Life Cycle Processes. All standards of this type can be analyzed and integrated into a QMS using this book's design techniques. See also, Rakitin, Steven R., Software Verification and Validation: A Practitioner's Guide, Norwood, MA: Artech House, 1997, p. 7.

[15] Although it is possible to have the registrar declare the organization noncertifiable, I know of no such case in the hundreds of certifications with which I am familiar. The only situation under which this might occur, to my knowledge, is if the facility has obvious safety and/or hazardous waste nonconformances so that the assessors cannot perform their audit in a safe manner.