Endnotes

[1] Par. 3.7.4 of ISO 9000:2000.

[2] Par. 4.2.2 of ISO 9001:2000.

[3] ISO 9001:2000, Clause 4.2.2.

[4] "ISO Guidance on the Terminology Used in ISO 9001:2000 and ISO 9004:2000," Quality Systems Update, Vol. 11, No. 2, February 2001.

[5] See, for example, Kannan, V., et al., "Tools and Techniques of Quality Management: An Empirical Investigation of Their Impact on Performance," QMJ, Vol. 6, No. 3, 1999.

[6] See, for example, Russell, J. P., The Quality Audit Handbook, Second Edition, Milwaukee, WI: ASQ Quality Press, 2000.

[7] See, for example, "First Interpretations Stall Over Possible Lapse in Process," Quality Systems Update, Volume 11, Number 11, November 2001, at http://www.qsuonline.com.

[8] This observation is supported in part by data presented on p. 20 of Quality, (January 1997), which notes that, in general, larger companies have been registered longer than smaller companies.

[9] The Registered Company Directory, North America, 1999, McGraw-Hill Companies, publisher of Quality Systems Update, Columbus, OH (e-mail: <[e-mail]>) lists the profiles of 84 accredited registrars and four unaccredited registrars in North America.

[10] See, for example, Harwood, David, "Integrating Quality, Health, Safety, and Environmental (QHS&E) Management Systems with Central Document Control," Proc. Eighth Annual International Conference on ISO 9000, February 7–8, 2000, Orlando, Florida.

[11] Although there is a plethora of books on these subjects, Chapter 25 of Kotler, Philip, Marketing Management, Sixth Edition, Englewood Cliffs, NJ: Prentice Hall, 1988, provides a excellent and surprisingly up-to-date summary of the role of finance and marketing in the corrective and preventive action process.

[12] See, for example, Campanella, Jack (ed.), Principles of Quality Costs, Second Edition, Milwaukee, WI: ASQ Quality Press, 1990.

[13] See for example: Crist, Roger, "E-Documenting for Better Control," Quality Digest, March 2001, p. 41 (http://www.qualitydigest.com). Also, monthly publication Managing Automation, Thomas Publishing Co., New York (http://www.managingautomation.com), is a cornucopia of information related to the diverse methods in use today to automate enterprises (e.g., Neil, Stephanie, "The Untethered Terrain of Wireless," Managing Automation, April 2001, p. 26, and Rice, Valerie, "Success with Web Customer Service Depends on More than Technology," p. 34. The June 2001 issue of Managing Automation lists 96 companies that sell manufacturing software.

[14] There is a difference of opinion on whether the quality manual requires quality policy statements for each SHALL of the Standard. This remains a fundamental issue in manual structure. Our interpretation is based upon Annex C of the ISO 10013:1995 Guidelines for Developing Quality Manuals. In this annex, the example given is the set of quality policy statements that form a response to Element 4.17: Internal Quality Audits of the 1994 Standard. The ISO "Guidance on the Terminology Used in ISO 9001:2000 and ISO 9004:2000" defines "Shall (Shall not): Used to indicate a requirement strictly to be followed in order to conform to the standard and from that no deviation is permitted. Do not use 'may' or 'may not' as alternatives." (http://www.iso.ch).

[15] Edward P. Link publishes a pocket-sized booklet that stresses the value of reduced variation as it relates to ISO 9001:2000 [i.e., An Audit of the System, Not of the People, Quality Pursuit, Inc., Rochester, NY, tel: [phone]].

[16] "ISO Guidance on the Terminology Used in ISO 9001:2000 and ISO 9004:2000," Quality Systems Update, Vol. 11, No. 2, February 2001.

[17] Refer to "QS-9000 Quality System Requirements," obtainable from AIAG, [phone] for a sector specific definition and usage of "shall" and "should."

[18] Webster's Encyclopedic Unabridged Dictionary of the English Language, New York: Gramercy Books, 1996.

[19] Par. 5.6 Management Review.

[20] The controversy on quality manual design appears to have reached a level of concern sufficient to cause publications on the subject (e.g., Balano, Richard, "How to Avoid Creating the Dreaded 'Big Honkin' Binder," Quality Progress, March 1997, p. 152; and some years later, Wright, Tony, "ISO 9001 Without Tears," Quality Progress, August 2001, p. 57.

[21] See, for example, Wright, Tony, "ISO 9001 Without Tears," Quality Progress, August 2001, p. 57.

[22] See Shipley, David, "Destination: ISO 9001," Quality Progress, March 2002, p. 32, for an example of how one company faced this upgrade issue.

[23] ANS/ISO/ASQ Q9001-2000 Standard, pp. 19 and 20—refer to those pages for all 1994 clauses.

[24] "Top Three British Registrars Forecast Registration Push," Quality Systems Update, Vol. 11, No. 11, November 2001, and "Super Committee Tackles ISO 9000 Issues, Looks for Answers," Quality Systems Update, Vol. 12, No. 5, May 2002, at http://www.qsuonline.com.

[25] This assumption may eventually change because many suppliers state that they would prefer to stay with the manual:1994 format. It is subject of intense discussion at this writing. My experience to date with 12 manuals indicates that the 2000 format was preferred, so once people start working the problem they may change their preference. Of 12, 3 stayed with 20 clauses.

[26] For more information on the way a registrar views a client, see, for example, Taylor, C. Michael, "Meet the Registrar: Firsthand Accounts of ISO 9000 Success from the Registration Source," ASQ Publications, 1997, item: H0967, ISBN 0-87389-423-3.

[27] The 90% rule is not meant to negate the desire for perfection. It does emphasize the reality of life among those who already have a full-time job in addition to their ISO functions. At any time prior to certification, during certification, and after certification, there will always be about 10% to 20% of the system under revision. That is called continuous improvement. Any attempt to beat this fact of life will be met with extreme frustration followed by rebellion. Minor nonconformities due to fine tuning are a constant of the motion in ISO.

[28] The publication of the ANSI/ISO 14001-1996, Environmental Management Systems—Specification With Guidance for Use document is based upon the Shewhart cycle. ISO 9001:2000 then followed with its reconfiguration to essentially the Shewhart cycle.

[29] Based on the work of Dr. Anthony F. Costonis, president and founder of Corporate Development Services, Inc., of Lynnfield, MA, http://www.corpdevelopment.com. Although the Shewhart cycle was used to certify a client a number of years before the 2000 version release, the assessors had little trouble with the QMS structure because of a detailed cross-reference chart.

[30] See, for example, the ASQ Quality Press Publications Catalog, Fall/Winter 2001, pp. 92–95, at http://www.asq.org.

[31] The concept of a value chain was first introduced by Michael E. Porter in a series of business text books (e.g., Competitive Advantage, New York: The Free Press, 1985). The idea of "chains" finds many outlets (e.g., Troczynski, Tom, "The Quality Chain," Quality Progress, September 1996, p. 208.

[32] Quality System Regulation, Part VII, Department of Health and Human Services, Food and Drug Administration, 21 CFR, Part 820, Medical Devices; Current Good Manufacturing Practice; Final Rule, Monday, October 7, 1996.

[33] ANS/ISO/ASQ Q9001-2000 Standard, pp. 19 and 20—refer to those pages for all 1994 clauses and FDA/CGMP 820 National Standard (QSR).

[34] We do not wish to imply a dislike of the integrated manual. This is not the case because in my own practice I have designed integrated manual systems when it was required. However, as noted, this form of manual requires considerable thought with regard to ease of use, distribution, and maintenance.

[35] ISO 9000 astute purchasing agents, who are already on guard because it is not unusual for an ISO 9000-certified company to ship nonconforming product (the complexity of real-life shipping schedules and rapid technical changes are always with us), may tend to value less a nonaccredited registration. However, in most cases, purchasing agents tend to do what is best for their companies and get what they need when they need it. There are no simple answers in this case.

[36] See, for example, Tiratto, Joseph, "Registrar Accreditation," The ISO 9000 Handbook, Second Edition, Fairfax, VA: McGraw-Hill Companies. Another McGraw-Hill publication, ISO 9000 Registered Company Directory, North America, provides a running list of accredited and unaccredited registrars on a quarterly basis.

[37] Munro, Dr. Roderick A., "Future of APQP and PPAP in Doubt," Quality, January 2002, p. 28, at http://www.qualitymag.com, "Next TS 16495 to Require ISO 9001:2000 Registration," Quality Systems Update, October 2001, p. 1, and "The New Global Automotive Quality Management Standard ISO/TS 16949," May 2002, p. 17, at http://www.qsuonline.com.

[38] ISO 9000 and 13485 Essentials: A Practical Handbook for Implementing the ISO 9000 and 13485 Standards for Medical Device Manufacturers, Second Edition, CSA, Ontario, Canada, tel: [phone].