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.