Hi all
I had a surprise this morning, a new version of ISO13485:2003 dropped on my desk. As far as I can tell, the only changes are to the forward:
a) dropping the references to EN46000 and to the older ISO13485:2001 and ISO15488:2001 which are all now obsolete.
b) Reference to Module E, the basis for Annex VI of drective 93/42/EEC, which allows various exclusions (7.3, 7.5.1, and 7.5.2)
Are there any other changes I have missed?
In practice I dont think these make much difference, however we should be aware of them.
Chris
I had a surprise this morning, a new version of ISO13485:2003 dropped on my desk. As far as I can tell, the only changes are to the forward:
a) dropping the references to EN46000 and to the older ISO13485:2001 and ISO15488:2001 which are all now obsolete.
b) Reference to Module E, the basis for Annex VI of drective 93/42/EEC, which allows various exclusions (7.3, 7.5.1, and 7.5.2)
Are there any other changes I have missed?
In practice I dont think these make much difference, however we should be aware of them.
Chris