The Pros and Cons of Sector-Specific Standards
Paperwork nightmare, or increased benefits?
by Leslie Norris
Sector-specific quality standards are requirements developed by a particular industry to address specific needs or requirements. Despite the perceived flexibility of the ISO 9000 series of quality management system (QMS) standards, the quality profession has witnessed the development of several sector-specific documents and standards, such as AS 9000 (aerospace), QS-9000 (automotive), TE Supplement to QS-9000 (tooling and equipment), VDA 6.1 (German automotive), TL 9000 (telecommunications), and MRA (medical devices).
Although the sector-specific requirements either directly or indirectly use the ISO 9001 QMS standard as a platform, maintaining at least some consistency among them, their impact on industry, and quality management cannot be ignored. This article takes a brief look at the pros and cons of sector-specific standards and the response of quality organizations to their creation.
It appears that although the sector-specific standards are based on ISO 9001, they will inevitably place increased pressures on industry suppliers. For example, Kathy Hinton, president of Sunrise Consulting and vice chairperson for the American National Standards Institute (ANSI) Z1 Executive Committee, stated, "For a typical manufacturing company that has customers in different industries, having to set up quality systems to meet each sector's requirements can be a nightmare from a documentation and employee-training standpoint. A company needs one standard quality system that it can comply with."
Jack West, chairman of the U.S. Technical Advisory Group (TAG) to ISO Technical Committee (TC) 176, shared many of Hinton's opinions, and was also concerned about the proliferation of certification schemes stemming from the creation of so many specialized standards.
"Take, for example, a microprocessor manufacturer or a packaging supplier. These organizations serve both the telecommunications and the automotive sectors. Having several sector documents, with each based on ISO 9001, helps make their job easier, but does not guarantee a consistent certification process," West stated.
Accentuating the positive
The impact of sector-specific standards is not all negative. The same experts who have shared their concerns about the development of sector-specific standards were also able to offer support for specialized requirements, provided their development occurs within certain parameters.
Hinton stated, "I can understand why there are currently so many sector-specific standards. There is no one standard that does it for everyone. The intent of the new ISO 9000 family [speaking in reference to the year-2000 revisions] should help this, although I think some sectors--aerospace and the Food and Drug Administration--will always have their own requirements."
West said, "In many cases, they [sector-specific standards] rationalize company-specific requirements that already exist. They go beyond ISO 9001 by adding requirements that are specific to the sector."
In the cases of both QS-9000 and TL 9000, the requirements of the large customers in the industry have been standardized, which should make compliance by their key suppliers much easier. So, for major suppliers to a specific sector, the effect of sector documents can be positive: They have one set of requirements rather than a set from each of their major customers.
Sandford Liebesman, ISO manager for quality and customer satisfaction at Lucent Technologies and a member of TC 176, stated, "Every industry is different and has different requirements. As long as they [sector-specific standards] are based on the ISO 9001 standard, they are good."
Liebesman is a member of the QuEST Forum, which is creating the TL 9000 standard. Drawing from that experience, he also explained, "In our case, we are extending the value of ISO 9001 by including performance measurements or metrics in our standard."
A mixed bag?
Robert W. Peach, QMS consultant, who was instrumental in the development and growth of several standards, added, "There are legitimate observations that ISO 9001 is either strict, definitive, or demanding for the suppliers to meet the individual needs. Evidence in the auto industry has proven that sector-specific requirements are a definite improvement on ISO 9001 for certain industries. ISO 9001 is a generic standard and when defined that way, how do you raise the bar where it applies or when it is necessary? We can't, however, raise the bar for everyone. For some, ISO 9001 would be appropriate; but for others, a sector-specific standard is necessary."
Sector-specific QMS standards have been the catalyst for increased opportunities, providing benefits that may not have been available through ISO 9001 alone. For example, the QuEST Forum found that simply working on TL 9000 together has brought companies and their suppliers closer, establishing new partnerships and increased communication. This input will ultimately allow suppliers to have greater influence and more control within their marketplace, a situation not readily available through ISO 9001.
The Registration Accreditation Board (RAB), responsible for providing accreditation services for ISO 9000 QMS registrars, believes the development of sector-specific standards is not only unnecessary, but also counterproductive.
RAB thinks the ISO 9000 family's flexibility allows for broad application to a full range of business activities, eliminating the need for specialized standards. In addition, RAB points out that sector-specific standards have also created a need for specialized auditors and auditor training courses, the impacts of which remain to be seen.
Nevertheless, RAB has addressed industry's desire to create specialized standards and developed a specific accreditation process. RAB explains the requirements of this process by stating, "For its part, the industry group that sponsors the program must maintain the supplementary requirements it has developed, define the auditor qualifications specific to that program, and sanction the training that is developed to provide those special auditor skills."
In addition, RAB said the industry group must also provide evidence of support of the program being proposed within its industry and must include the base requirements of ISO 9001 verbatim in its program.
ISO and TC 176 respond
The International Organization for Standardization's (ISO) primary purpose is to develop and publish international standards, while using input from and achieving consensus among government, industry, and others. ISO's TC 176 is responsible for the quality standards. Considering their role in standards development, how have ISO and TC 176 addressed the development of sector-specific standards, and more important, industry's specialized needs?
"Over the years, TC 176 has had a sector-specific standards policy which is included in ISO directives," said West. "This policy has discouraged the development of such documents within ISO. Consequently, most of the sector-specific documents we have seen have not been issued by ISO, but rather by industry consortia. Since most have been developed outside of ISO, there has been little opportunity to harmonize their requirements."
But ISO hasn't ignored industry's request for more specialized standards, and has been taking steps to further address them. "Using the evolution of draft technical report [DTR] 16949 as an example," West explained, "sector representatives state they have needs that they feel are not met by the basic ISO 9000 family.
"The ISO Technical Management Board [TMB] directed TC 176 to review the sector-specific standards policy with an eye toward meeting the sectors' needs. As a result, TMB authorized a pilot project with the automotive industry to create a document that harmonizes QS-9000, the German VDA 6.1, and other European auto industry documents [DTR 16949]. Based on the results of the pilot, I expect TC 176 to propose a revised sector-specific standards policy sometime in 1999."
Although we have witnessed the development of multiple sector-specific QMS standards, there are still fewer unique requirements for suppliers. Second, the sector-specific standards continue to reflect the widely used requirements of ISO 9001, maintaining consistency among industries. Finally, the new challenges for registrars, consultants, and trainers have yet to be fully evaluated, but are a variable that should be monitored.
So what have we learned? George Lofgren, QMS president of RAB, summarized the development of sector-specific standards by stating, "We're moving away from the generic into the specific. It is neither a positive nor a negative. What we don't want to see is a set of philosophies that would be counterproductive. So far, they offer refinements to the generic process."
LESLIE NORRIS is editor of THE INFORMED OUTLOOK, a monthly newsletter providing information and guidance on ISO 9000, QS-9000, ISO 14000, TL 9000, and other management system standards. Norris can be contacted at (703) 680-1436, fax (703) 680-1356, or e-mail INFORMintl@aol.com.