Originally Published EMDM
November 2003
A NOTE FROM THE EDITOR
All Aboard (Well, Almost All) for ISO 13485
The publication of ISO 13485:2003 this summer has been called a landmark event for the device industry. Written as a stand-alone standard, “Quality management systems—Medical devices—System requirements for regulatory purposes” is closely based on ISO 9001:2003. It is also surprisingly compatible with US FDA’s quality system regulation (QSR). In fact, “the standard represents a regulatory model for the world,” says Ed Kimmelman. He should know. He is the convener of ISO Technical Committee 210, Working Group (WG) 1, which drafted the document. But there are some caveats.
“Canada has incorporated ISO 13485 directly into its regulatory scheme,” says Kimmelman. “Compliance is mandatory, at least for the quality systems portion of its regulation.”
The EU is also on board. “Europe now has two live versions of the standard,” he notes, the original version (EN ISO 13485:2000) and the 2003 document. WG1 has proposed a three-year transition period to shift to the amended version, but the EU has yet to decide on a definitive timeframe.
Ever-surprising China has also adopted the QS approach. It differs from Canada in the auditing process, however. Canada relies on private entities. By contrast, audits in China are conducted by government bodies.
The world’s third-largest medical technology market, Japan, has had a reputation for moving forward at glacial speed, comments Kimmelman. There are undeniable financial incentives for Japan to adopt a QS approach, he notes. Local and international industry groups have been pushing the government very hard in this direction, and these efforts may yet pay off. “Movement toward a quality systems approach may be imminent,” says Kimmelman, citing recent conversations with Japanese colleagues.
And then there is the 800-lb gorilla. FDA has made it clear that it will not adopt the standard. This shouldn’t be viewed as yet one more example of unilateralism run amok, though.
“FDA spent a vast amount of energy developing the QSR in the mid-1990s,” says Kimmelman. “They have also worked very hard within the ISO working group to make ISO 13485 a useful model for international quality system regulation.” But currently there is no economic incentive for FDA to revisit the rule. “The fact of the matter is that the agency is hamstrung by the legislative and regulatory constraints placed upon it.” It comes down to a different set of mandates. The focus of the US rule is on the provision of safe and effective medical devices. ISO 13485, on the other hand, stresses meeting customer and regulatory requirements.
The good news is that manufacturers of medical equipment can develop a single quality management system that complies with the standard and the QSR. “The documents are not that far apart,” stresses Kimmelman. “One difference involves risk management. The standard has explicit risk management requirements that are not found in the QSR. FDA will tell you they have the same approach, but it has to turn to documents that are not part of the QSR to show that.” While there are other variances, a careful reading of the QSR and the standard can show a way to convergence.
On a global scale, stresses Kimmelman, “this standard is giving the world a model on which to base quality systems regulations. And there is evidence that most of the industrialized world is accepting or adopting it as such.”
Next on the working group’s agenda is the revision of ISO 14969, which will provide guidance on applying the standard. “I had hoped it would be available by the end of 2003,” says Kimmelman, “but we are now aiming to publish it in the second quarter of 2004.” The delay was caused by review comments that led to several revisions. “We made a number of changes that we felt were substantive, so we’re sending it out for another review cycle.” WG1 will address those comments when it meets in Sydney in February.
Kimmelman has prepared a 70-page matrix comparing ISO 9001:2000 and ISO 13485:2003 that he has presented at a seminar organized by US trade association AdvaMed. The paper is available free of charge via e-mail. Interested parties may request one by filling out a form at Comparing ISO 9001 and ISO 13485.
Copyright ©2003 European Medical Device Manufacturer
