Ever since committee drafts of ISO 9001:2000 and ISO 9004:2000 began circulating in early August, concern has focused on changes to the requirements in the 20 "comfortable" clauses. Although the changes include new requirements that will themselves be subject to debate -- and probably will change before ISO 9001 is reissued -- the greatest change will affect the approach to ISO 9001-based quality management systems.
With these new editions posing their own "year 2000 problem," companies could experience difficulties switching to ISO 9001:2000 if they don't start thinking now about how to revise their QMSs to benefit from the significant change, dubbed the "process approach," in ISO/CD 9001.
Working Group 18, responsible for drafting ISO 9001:2000 and ISO 9004:2000, is committed to making the transition to the 2000 editions as smooth as possible for companies whose QMSs are registered to ISO 9001, 9002 or 9003. This is what I've been told by Robert W. Peach, who has experience with both the 1994 changes and the work so far on the year 2000 editions.
"People are asking, 'How much is the bar raised in ISO 9001:2000 in terms of new requirements?' " relates Peach. "ISO 9001:2000 involves a relatively minor raising of the requirements to provide a slightly more stringent QMS. However, the real change clarifies issues that have caused confusion to current users, especially serv-ice, software and small businesses, and focuses on a process approach model of quality management that will benefit all businesses trying to use ISO 9000."
The committee drafts contain eight sections that reorganize the four sections in ISO 9001:1994 (as well as Section Four's 20 comfortable clauses) and the 20 sections of ISO 9004:1994, making the two stand-ards a consistent pair in terms of content.
Yes, ISO/CD 9001 contains new or enhanced requirements, including customer satisfaction and continual QMS improvement. However, reorganizing the requirements represents the greatest change and improvement to ISO 9001 without actually establishing new requirements.
WG 18 uses the term process approach because the new edition reorganizes Section Four's 20 clauses into a radical new formation. Peach pointed out two key reasons behind WG 18's decision to alter ISO 9001 in this way:
The 20 clauses are manufacturing- oriented, which makes ISO 9001 difficult to use by organizations engaged in software design or service-related activities. What's more important to a hotel or restaurant -- customer needs and expectations, and communication with the customer, or calibration and control of measurement, testing and inspection equipment? Is Microsoft Corp. more concerned with design activities or subcontractor development? Increasingly, companies are devising nonmanufacturing applications of ISO 9001 that require a shift to a process approach model.
The ongoing migration from quality control to total quality management indicates that ISO 9001:1994 is more difficult to work with in a Baldrige-oriented world. ISO 9001:1987 was locked into the 20-clause structure of its predecessor, BS 5750, which borrowed its structure, in turn, from quality control standards for equipment procurement (manufacturing) by the U.S. military and NATO. A TQM approach, however, requires a company to look not only at design, production and delivery processes but also at management's leadership role, employee development and satisfaction, and total customer satisfaction goals.
Can organizations achieve Baldrige-level TQM with ISO/CD 9001? Not alone, but the standard is more compatible with the Baldrige Award's criteria and offers a more effective baseline to build on, particularly when paired with ISO/CD 9004, which provides guidelines for developing a comprehensive QMS.
The committee drafts provide ISO 9001:1994 requirements, with some adjustments. The new edition's reorganization removes the old restraints created by the 20-clause structure and helps companies in any business environment re-establish a baseline QMS (ISO 9001) upon which to build toward TQM (ISO 9004).
Will reorganizing your QMS be difficult and chaotic? Possibly, but the only companies that profit from static systems are fabric softener and dryer sheet manufacturers.
About the author
Jim Mroz is senior editor of The Informed Outlook, a twice-monthly newsletter providing information and guidance on ISO 9000, QS-9000 and ISO 14000, published by INFORM (International Forum for Management Systems Inc.), 15913 Edgewood Drive, Montclair, VA 22026; telephone (703) 680-1436, fax (703) 680-1356, e-mail firstname.lastname@example.org .
Mroz has accepted a position as editor-in-chief of a newsletter covering export control issues. Because he is leaving the international standards area, he has decided to relinquish his monthly column for Quality Digest. We wish him the best of luck in his new venture.