International Standards

by Amy Zuckerman

New European Approach


Jacques McMillan is determined to
shake up the European quality community.


On the hill overlooking the Grand Place in Brussels lies a maze of streets and back alleys housing European Union offices.

There are no signs to these offices, just street numbers. Locating 200 Rue de la Loi, the office of Directorate-General III for Industry, takes some persistence.

Locating Jacques McMillan proves far simpler. For McMillan, chief of the Senior Standards Policy Group for DG III, is one of the more accessible bureaucrats around.

But don't let McMillan's accessibility-let alone his wit and charm-fool you. A small, energetic man of half-British and half-French descent, McMillan is arguably one of the most knowledgeable standards experts in the world, having drafted and implemented in Europe the "Global Approach" to testing and certification in 1991.

McMillan is also one of the most powerful men in the industrialized world. Representatives of government standards agencies come courting McMillan. Multinationals come courting McMillan. Journalists come courting McMillan. The reason is that McMillan, who began service with the European Commission in 1974 as a trade-barrier specialist, now heads up the policy-making arm of EU standards. If McMillan wields a big stick, it's because standards in Europe are a government matter. The communications McMillan and his standards group draft may very well become EU directives, EU law.

And he is determined to shake up the European quality community, which he feels has become far too reliant on the ISO 9000 certification model and not enough concerned with making European companies truly competitive worldwide. In the winter of 1994, McMillan and his colleague Antonio Silva Mendes shocked the ISO 9000 community with a report calling for creation of a new European quality policy that would diminish the certification (registration in the United States) aspect of the ISO 9000 process. McMillan, who rarely minces words, openly condemned the rampant commercialization of ISO 9000.

Throughout the last year, he has continued to criticize any approach to quality that is quick and dirty, one that goes for a certificate rather than emphasizing the process. McMillan insists he has no intention of killing the ISO 9000 standards series. He has no intention, either, of boosting ISO 9000 certification in Europe. McMillan and Mendes consider the standard a good quality base, but inadequate as a total quality tool.

On June 6, his group released the final draft of "A European Quality Promotion Policy." The 50-page report calls for reinforcing the fairly new European Quality Award, which takes a Malcolm Baldrige approach. If all goes as planned, national accreditation bodies will operate under EU jurisdiction. They will no longer operate for profit or compete with each other. The EU also wants to strengthen a "harmonized European system for qualification of quality professionals, managers and auditors." According to the final draft report, which will not be considered for implementation until the end of this year, the proliferation of ISO 9000 certificates "throughout the world reveals to us that there is no relation between the number of certified companies and the competitiveness of the national economies . . .

"It is clear that if this 'boom' [in ISO 9000 certification] is beneficial for the distribution and promotion of quality, then it should be equally apparent that it has also involved some negative aspects linked to an excessively rigid use of standards, in particular a sometimes exaggerated recourse to certification . . ."

EU officials recommend the "use of these standards as a reference frame for the quality systems (and did not make the certification of the quality system obligatory, as was misinterpreted by many)."

What does this report mean for the future of ISO 9000? McMillan is far too cagey to make any definite prognostications. He says he's not even certain whether his standards group will push for an EC vote or let the report stand as a recommendation. The first sign of any movement on this subject will be in November when the European Council of Industries meets. McMillan expects the report will be on the agenda for discussion, not action.

"The debate taking place now will shape the future," predicts McMillan. "We're getting favorable feedback from industry, member states, national administrations and most who've read the paper."

As for ISO 9000, McMillan says: "In practical terms, we can't do anything about it. All we're trying to do in the marketplace is send the message to think of quality first. We can't tell the certifiers to go home, throw their pens away and change jobs.

"But we're trying to pass down the message to certifiers, manufacturers and customers repeatedly asking for ISO 9000 when they don't need it to think twice. If someone has earned a certificate in six months, they're thinking wrong. We're not saying certification is bad, but it's not necessarily indispensable in certain cases."

Whether words alone will stop the ISO 9000 juggernaut still remains to be seen. In the meantime, the report doesn't address the issue of EU directives that mandate European ISO 9000 equivalents for manufacturers of telecommunications equipment, pacemakers and other industries that McMillan has still to identify.

For example, the directive regarding "terminal equipment" relating to telecommunications was issued on April 29, 1991, and mandates EN 29001 and EN 29002 (ISO 9000 equivalents) as part of the requirement for passing an "EC-type examination." Without the appropriate certificates or proof of conformity with these standards, the directive allows member EU states to "take all appropriate measures to withdraw such products from the market, or to prohibit or restrict their being placed on the market."

U.S.-based electronics companies want to see McMillan go beyond criticizing ISO 9000 certification. They want McMillan and the EC to lift the directives that tacitly make the standards law in Europe. And if the standards are law, as these companies insist, then ISO 9000 can be considered a possible European trade barrier.

"We've never forced anyone into doing ISO 9000," insists McMillan. "That's rubbish. They have a choice of ISO 9000 or product certification in most cases. It's rare that the Council forces ISO 9000 as a mandate."

Even so, the EU directives call for companies doing business in Europe to have in place a quality system that meets or exceeds the ISO 9000 requirements. Outside of Germany, there reportedly is no guidance document outlining how a manufacturer's declaration would substitute for ISO 9000 certification. That means it's pretty much ISO 9000 in Europe for some industries or don't do business there.

Never one to be deterred, let alone back down in the face of confrontation, McMillan concedes that "there may not be a market option in some cases. I'm not too perturbed about that. If in some cases we've overshot the mark, we'll rethink it."

McMillan, who clearly gets a kick out of tweaking noses or even pushing noses out of joint, doesn't promise a timetable for the rethinking process. Tune in some time in the next few months for continued debate on this topic.

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.