ISO 9001:2000, ISO 13485:2003 Notes for Medical Device Manufacturers

In December, 2000 revisions to the ISO 9000 series of quality system standards were announced. The ISO 9001:2000 quality system standard represents a significant change to the ISO 9001:1994, and ISO 9002:1994 revisions. The revised quality system standard represents a process approach to quality system definition with an emphasis on management of the quality system and customer satisfaction.

Many medical device manufactures have demonstrated compliance to the Food and Drug Administration (FDA) Quality System Regulations, ISO 9001:1994 or ISO 9002:1994 and to support compliance with the European Medical Device Directive compliance with EN 46001 or EN 46002. The EN 46001 and EN 46002 standards use the ISO 9001:1994 and ISO 9002:1994 standards as a baseline, adding specific requirements for medical devices. A fundamental concern is what will happen with the EN 46001 and EN 46002 standards with the release and transition to the ISO 9001:2000 standard.

For active medical devices, a parallel standard to EN 46001 is ISO 13485:1996. ISO 13485:1996 is under revision to become a stand alone quality system standard. The revision is to be completed and approved by the middle of 2003. It is understood ISO 13485:2003 will be a harmonized standard and applicable to support CE Marking of medical devices. ISO 13485:2003 will have a 3-year transition period for required compliance. With the exception of continuous improvement and customer satisfaction process requirements, the ISO 13485:2003 standard will incorporate most of the requirements of the ISO 9001:2000 standard. The ISO 13485:2003 will be a stand alone, internationally accepted medical device quality system standard.

As of March, 2004 both EN 46001 and EN 46002 are no longer in force harmonized quality system standards. ISO 13485:1996 is now a recognized harmonized standard in the European union. The ISO 13485 quality system standard adds medical device specific requirements to the ISO 9001:1994 standard.

To allow CE marking under a full quality system assessment, compliance to ISO 9001:2000 is not required. Currently compliance to EN 46001 or EN 46002 is required. With obsolesce of the EN 46001 and EN 46002, compliance with ISO 13485:1996 will be necessary.

With very few exceptions, countries requiring a medical device manufacture to have a quality system compliant to the ISO 13485:1996 standard are anticipated to accept the upcoming ISO 13485:2003 standard. It is prudent to initiate evaluation of the current quality system to at a minimum the ISO 13485:1996 standard.

The Food and Drug Administration does not intend on changing the Quality System Regulation (QSR) in Title 21 Code of Federal Regulations Part 820. Medical device manufacturers with international sales will need to develop and maintain quality system compliance to both the FDA QSR and ISO 13485:1996 quality system standards. Within the three year transition period, ISO 13485:2003 quality system standard compliance will be required.

For support with quality system compliance and regulations, contact:

Gary Syring, PE, RAC
Quality and Regulatory Associates, LLC
800 Levanger Lane
Madison, WI 53589

Phone: 608 877-2635
Fax: 608 873-7382

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Updated: May 7, 2003