Medical Device Link.

Originally Published MDDI February 2003

NEWSTRENDS

Robert Drummond

Ed Kimmelman is the convener of TC 210.

In the area of quality, manufacturers have come to know well ISO 9000/ 9001 and ISO 13485. But now ISO 13485 is becoming a separate, standalone standard in an attempt to better serve the medical device industry.

The new ISO 13485 standard, “Quality management systems—Medical devices—System requirements for regulatory purposes,” diverges from ISO 9001 in three key areas: customer satisfaction, continual improvement, and procedural documentation. 

In revising 13485, ISO Technical Committee (TC) 210 had a specific goal in mind. “We wanted to make it clear that [the new] ISO 13485 is intended to reflect the current level of quality system regulation around the world,” says Ed Kimmelman, a regulatory affairs and quality systems consultant who also convenes TC 210. “It will serve as a model for any country that intends to begin regulation of their medical device quality management systems.” 

TC 176, which has the overall responsibility for quality systems standards, based the new ISO 9001 on the process approach. That system is based on four interrelated processes: management, resource-handling, product realization, and measurement and analysis. But according to Kimmelman, this system was not compatible with the medical device industry. TC 176 also reduced the procedural documentation requirements in an attempt to make 9001 more applicable to smaller organizations. Kimmelman says this too was inconsistent with 13485’s regulatory objective, since documentation is one form of objective evidence showing that the quality management system is in place.

Rather than targeting customer satisfaction—as the new ISO 9001 does—ISO 13485 targets customer requirements. 

“This objective is both more measurable and more consistent with regulatory goals,” Kimmelman says.

TC 210 also believed that ISO 9001 went a bit too far in its explicit requirement for improvement, Kimmelman says. The regulatory requirement is to have a quality system that continually assesses its effectiveness in meeting customer requirements and providing safe and effective medical devices—not necessarily one that continually improves. “You’ve got to keep assessing it, and keep searching for any deficiencies,” he says. Continually monitoring the quality management system, Kimmelman says, is more consistent with existing regulatory requirements. 

So what should a medical device manufacturer do with this knowledge? It depends on where that manufacturer is in quality management compliance. If your customers are not currently requiring you to comply with ISO 9001, or if you are certified only to ISO 9001:1994, Kimmelman’s advice is to “make your system comply with ISO 13485:1996 right away.” ISO 9001:1994 expires in December of 2003. So firms that want to maintain their ISO 9001 certification must change their quality systems over to the 2000 version before the end of 2003. Manufacturers that are certified to ISO 13485:1996 will likely have until the first quarter of 2006 to change their systems, because there will be a three-year transition period to the new ISO 13485. 

For those companies beginning their transition to the 2003 version of ISO 13485, the final draft international standard is the place to look. There are few substantive requirement changes between 1996 and 2003, Kimmelman says, but the organization of the requirements might take some getting used to. “In order to have the top-level documentation of your quality management system aligned with that standard, you’re going to have to change the documentation,” Kimmelman says. “I’m talking about your quality manual, your high-level, quality system procedures.”

For more information, visit ISO Online, at www.iso.org.

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