Are You Making a Product or a Process?

Originally Published MDDI October 2002

EDITOR'S PAGE

For many in the medical device industry, the latest revision of ISO 9001 decreased the relevance of that quality standard. But in its emphasis on process over product, ISO 9001 may just be ahead of its time

In the mid-1990s, while preparing to revise the medical device GMPs, FDA rejected calls simply to adopt the text of ISO 9001. Among the reasons was the fact that the standard is subject to revision every five years. Understandably, the agency did not want to enforce a moving target.

More than a few people in industry pooh-poohed this fear as exaggerated. The standard, they said, just wouldn't change that much. Needless to say, those people are no longer quick to identify themselves. If the agency had taken their advice, the year 2000 revision of the standard would have meant chaos for FDA and industry alike.

This is not to suggest that ISO 9001:2000 has no value to medical device companies. Indeed, as argued by Curt Flemming in his cover story in this issue, the standard is more important to maintaining a competitive edge than ever before. As Flemming told us, FDA and many in industry "feel that ISO 9001's lack of documentation is inadequate." Their focus instead is on development of ISO 13485, which will be specific to the medical device industry. It is expected to incorporate much of ISO 9001:2000, but will also include many more specific requirements for documentation.

The central change in the revision of ISO 9001, Flemming notes in the article, involved a dramatic shift in perspective. The 20-element structure of previous versions was centered on the product being manufactured. In the latest revision, however, the product has receded into the background, having been displaced by process.

This is an unsettling change, Flemming writes. But on closer examination, it makes good sense. "This ISO revision," he writes, "will cause companies to think through the life cycle of a device in terms of smaller, interrelated processes that contain the 20 elements of ISO 9001."

Thinking of a product in terms of its life cycle is in effect to think of it as a process—a cycle of events from conception to obsolescence. As noted elsewhere in this issue, in our roundtable on contract manufacturing, beginning on page 60, outsourcing is growing rapidly thanks in part to this trend.

Increasingly, the emphasis in the medical device industry is no longer on products themselves. Device companies are finding, as B. Braun's Ron Earle says in the article, that "products and technology are changing so fast that, by the time they get a product up and approved, the trend has changed—and they're stuck with a factory."

In emphasizing process over product, the framers of ISO 9001 are clearly trying to move all of industry in a new direction. At first glance, FDA and others concerned with regulation do not seem ready to go along with such forward thinking.

But as often is the case, the agency deserves more credit. Two years ago, when CDRH director David Feigal unveiled his five-year plan for the device center, one of its four pillars was what he called the "total product life cycle." The goal, he said, was to foster a new way of thinking about FDA's role in regulating products. In other words, CDRH will be increasingly thinking of the product as a process.

For practical reasons, the agency will not soon embrace ISO 9001:2000. But the gradual shift in emphasis from product to process will continue nonetheless, and both FDA and industry are preparing for that change.

The Editors

Copyright ©2002 Medical Device & Diagnostic Industry