As secretary-general of the International Organization for Standardization in Geneva, Eicher heads up one of the biggest standards mills in the world. His Geneva staff coordinates upwards of 40,000 volunteers worldwide who serve on technical committees creating international standards to cover almost every process. The ISO has not traditionally enforced the implementation of any of the standards it develops, but ISO 9000 is a phenomenon that's swept the world. At this writing, 32 national accreditation bodies all administer their own form of ISO 9000; the Big Three have created an ISO 9000 hybrid, QS-9000; the Japanese have concocted JIS Z9901, aimed at the software industry; and the European Union seems hell-bent on moderating the ISO 9000 registration process.
What's a seemingly sleepy organization like the ISO to do under these circumstances? Eicher tackles the tough questions:
On QS-9000 and its potential for
splintering ISO 9000: "Are those valid worries? Is it discriminatory
to require a common quality system? Does that set up technical barriers
to trade? I'm not sure. I would want to see more clear evidence."QS-9000 contains every element of ISO 9001 and other things. The car manufacturers put in additional requirements. That's completely within what's accepted with TC 176 [the committee that creates ISO 9000 standards]. If you want to add something within a business relationship to a supplier, that's up to you. You can add what you want.
"We didn't see any problem with what the car manufacturers want to do: Create a common program for their suppliers. The suppliers wanted a single system. They said to us the single system has everything 9001 has in it, and we would like to make a deal with you-pay a copyright fee for reproduction of ISO 9001 requirements."
When standards are used as trade
barriers: "The ISO is an organization providing a system where people
can come to agreements and publish those agreements. People who make these
agreements aren't in Geneva. We provide a service by which agreements are
reached and documented. We don't own the decisions made by this consensus.
[With the advent of Quality System Assessment Recognition,] members seem
to be saying there is a need internationally that there should be uniform
use of the ISO 9000 standards. QSAR should help this to happen."If standards are misused, become barriers to trade, the World Trade Organization is the right place to bring it up. We have no trade negotiators operating in ISO."
On QSAR and regulation of ISO 9000
internationally: "For a start, ISO is nongovernmental. It has no regulatory
power and doesn't seek it. We advise accreditation bodies that they should
operate in a certain way. We don't dictate to them. We don't check on them."We do have a forum and guidelines available to those who want to get into the appropriate use of the standards, in this case ISO 9000 and the business activities of consultants and registrars working in that area.
"It takes time to get international agreement about how those things should get done. There are ISO/IEC guides for accreditation bodies, certification bodies. All are being put into the QSAR program, which will use the set of criteria where ISO 9000 standards are implemented. [For example,] we're specifying that someone shouldn't be both a consultant and a registrar.
"New proposals are fed into the system and then supported by member [nations]. Like anything international, you can't expect an overnight solution. It would be difficult for me or any member of my staff to be the god or king or queen of ISO 9000.
"The teeth of the QSAR program would be granting or allowing use of the ISO/IEC QSAR logo by a registrar or supplier, for example. QSAR could refuse to allow use of the ISO logo in accreditation. The only thing available [on a regulatory level] is to withdraw the right to use a protected logo or grant the right."
How QSAR would work: "This
is a voluntary program. It would have members-accreditation bodies like
the Registrar Accreditation Board. Those members would, after meeting QSAR
criteria, be able to authorize their accredited registrars to allow suppliers
to use the ISO logo in a way they're now able to use the certifier's logo
in advertising."There will be a QSAR board set up to run and oversee the program. Decisions about whether accreditors are meeting QSAR criteria would be done by the peer- assessment process. Conversely, the failure to meet criteria would mean taking away the right to use the logo and prosecution in the country where it's misused.
"The board will be made up of industry suppliers, certifiers and accreditors. This would level the playing field. The people who worry that practice is different [around the world] for ISO 9000 certification/registration may be solved. Certification for ISO 9001 will be valid no matter where you get it."
On ISO 9000 registrar reform efforts:
"The Supplier Audit Confirmation proposal has come into the ISO debates.
. . . We recognize that the conformity-assessment process can take many
forms with any standard. One can be a supplier's declaration, i.e., a supplier
contends they're doing what they're doing."SAC is a mix of supplier's declaration and third-party assessment. The electronics industry providing SAC says we want someone to look at our total quality assurance system and say it meets ISO 9001 requirements, but is not necessary to multiple-site audits. They've been talking to certifiers and accreditors, and seem to have gotten some support from those groups. They've gotten a lot of support from the industrial community in which they operate.
"Obviously, they're very keen to change the system by which all of this operates, and they may succeed. Normally, the ISO wouldn't have much to say about a pure supplier declaration. If they say this [SAC] is a mix of an audited system, then I think the debate will come to ISO.
"As we have created guidelines for a third-party [assessment] program, so we could create guidelines for something like SAC. We haven't agreed to create guidelines but have agreed to consider it. It's in a working group, CASCO No. 9."
About the author
Amy Zuckerman is author of ISO 9000 Made Easy: A Cost-Saving Guide to Documentation and Registration (AMACOM Books). She operates an international market research company based in Amherst, Massachusetts. S.A. Vlamis helped research this column.
