ISO 13485 standard seen setting pace for device QS, not 9001.

NEW YORK Despite pending changes in ISO 9001 requiring continual improvement of a company's quality management system and requirements for customer satisfaction, FDA will still maintain its 1996 Quality System (QS) rules based on pending revisions to ISO 13485 rather than the ISO 9001:2001 update to the 1994 version of the ISO standard.

FDA compliance officer Erin Keith, who serves in the Division of Enforcement III, CDRH Office of Compliance, told the Medical Design & Manufacturing Show here June 7 that the continuous improvement and customer satisfaction provisions extend beyond the purview of FDA regulators, whose sole concern is to assure that safe and effective medical devices reach the market.

The provisions are considered a major change to the current 1994 ISO 9001, on which FDA's QS rules are based.

"We recognize firms need a level of quality systems to ensure safe and effective devices, but we don't require them to get better, more efficient at it," Keith said.

Wording to be excluded

FDA wants this wording excluded from the Quality System regulation, which, with other international quality regulations, is required to harmonize with ISO standards.

Keith also expressed FDA's concern over "permissible exclusions" in the proposed new ISO 9001 standard dealing with product planning, design and development, purchasing, production, and control of monitoring and measuring devices.

Regulatory agencies are concerned that organizations would be allowed to exclude parts of Clause 7 dealing with the product realization process. "It is not clear if the exclusion clause will be adopted," she said.

The Global Harmonization Task Force, a group composed of European, Japanese and U.S. regulators and industry, is working on these issues in the pending revisions to the devices version of 9001 ISO 13485:2002.

Keith said this is expected to be created independent of ISO 9001, which already is a draft international standard.

The plans for revising 13485 will actually continue through 2003, Keith noted. She said most of the meetings of Technical Committee 210 which drafted 13485 in the first place will be in Dublin, Tokyo and Barcelona.

Keith's presentation, which shows changes and deletions in ISO 13485, is $4 plus retrieval, Doc. 110905R.