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Global Harmonization Task Force (GHTF) Statement on ISO 13485:2003

GHTF considers ISO13485:2003 "Medical devices - Quality management systems - Requirements for regulatory purposes" an adequate standard for a medical device quality management system. For the purpose of regulating medical devices, GHTF believes that:

• the generic ISO9001:2000 is insufficient by itself and
• ISO9001:2000 should not be required in addition to ISO13485:2003.

Countries considering incorporating quality management system requirements directly into their regulation and not citing ISO13485:2003 verbatim are encouraged to harmonize their regulation with ISO13485:2003.

Last Updated June 23, 2004