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Volume 5 · Issue 11 · November 2000


Medical Device Standard to Partly Align With ISO 9001:2000

The Ad Hoc Writing Group of TC 210 and the GHTF SG 3 held a joint meeting in September 2000 to advance revisions of ISO 13485 and determine if they could achieve its complete alignment with ISO 9001:2000. Indications are that while the new version would be "based" on ISO 9001:2000, the two groups are recommending that ISO 13485:200X not be completely aligned. The results of the joint meeting have not been accepted yet by TC 210 or the GHTF, and TC 210 may decide to amend the recommendations due to the risks involved with partial alignment.