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Is an ISO 9000 -- QS-9000 marriage in the works? Three months ago, I brought to your attention a great deal of concern and speculation about the future "divorce" of QS-9000 and ISO 9001. Companies guided by the standards feared that sudden, dramatic changes to them would render the two incompatible. Well, now the old adage, "The more things change, the more things stay the same," may apply. Remember, quality means consistency when it comes to ISO 9000 and QS-9000, so this possible marriage may result in an excellent, if awkward, union after all. At this point, ISO Technical Committee 176, the group responsible for the ISO 9000 series of quality system standards, has developed a draft proposal for a pilot project whereby the automotive industry will form a task group within TC 176. The group will generate a technical report -- i.e., guidance and/or information relevant to a standard -- on quality system requirements for the automotive industry, based on ISO 9001. The national automotive groups within the International Automotive Sector Task Force (British, French, German, Italian and U.S. ) most likely will participate, and probably the group will encourage Japanese, Korean and other automotive manufacturers interested in joining. If the pilot project proves successful, it would result in an automotive-sector technical report supplementing ISO 9001 that TC 176 member countries would approve by vote. This report would become part of the ISO 9000 series and permanently couple automotive quality system requirements with ISO 9001. The proposal carries a lot of power, given the automotive industry's influence on ISO 9000 use and registration. The proposed marriage would help reduce the proliferation of automotive quality system standards. The U.S. TAG, whose opinion probably mirrors those of many nonautomotive companies, reacted with a mixture of frustration -- because the automotive industry might get its own ISO 9000 standard -- and understanding -- because QS-9000, VDA 6.1 and other automotive quality standards do exist and have made significant improvements in automotive quality, thanks largely to these standards' links to ISO 9001 and ISO 9004. However, not everyone is thrilled with the proposed task group. Joseph Tsiakals, director of quality management for the Biotech Group of Baxter Healthcare Inc., served as an active member of the U.S. TAGs to TC 176 and TC 210; the latter produced two medical device standards -- ISO 13485 and ISO 13488 -- based on ISO 9001 and ISO 9002. Tsiakals expressed his frustration to me that the medical device industry was asked to work on its sector-specific standards as TC 210, while the automotive industry may have a task group within TC 176. TC 176 and TC 210 have equal standing, technically, within ISO, although ISO 9000 applies to all industries and is, therefore, a greater among equals. ISO 13485 and ISO 13488, based on European adaptations of ISO 9001 and ISO 9002, will assure quality for medical devices subject to CE marking. A CE Mark is or will be required legally to sell most medical devices in EU countries. The automotive task group, on the other hand, probably will generate a technical report supplementing the requirements within ISO 9001 to suit automotive quality system needs, rather than create a separate registration certificate similar to the one required for a CE Mark. Why does the ISO Technical Management Board support the draft proposal? As Reginald Shaughnessy, former international chairman of TC 176, explained to me, "The TMB sought to do something meaningful and specific to solve the problem of meeting sector-specific needs within a framework that preserves a core generic quality standard." Those present at the U.S. TAG meeting examined many sector-specific standards based on ISO 9001 -- including QS-9000 -- to see if they shared common generic requirements of benefit to all industries using ISO 9001. They did so because the TC 176 working group that will draft ISO 9001:2000 and ISO 9004:2000 may consider generic supplementary adjustments in revising these standards, although major additions are highly unlikely. Thus, the same U.S. TAG meeting that expressed frustration with the automotive industry gaining its own task group within TC 176 may suggest additions to ISO 9001 commonly used in ISO 9001-based, sector-specific standards -- including the automotive industry's. Sounds to me like a typical family. About the author James G. 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 and e-mail jmroz@qualitydigest.com. |
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