New Clause Structure of ISO 13485:2003

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H

Hanson

#3
Basically I just want to know the clause-by-clause titles of ISO 13485:2003 and what's difference with ISO 9001:2000? As far as I know, the clause 8.5.1 of ISO 13485 is no longer to entitle as "Continual Improvement".
 
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Marc

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#4
I haven't seen a correspondence matrix with ISO 9001. Has anyone else?
 

Dave-h

Involved In Discussions
#5
Yes, If you get a copy of EN ISO 13485:2003, Annex B is a clause by clause comparison between ISO13485:2003 and ISO9001:2000, so you can easily see the differences and similarities.

Have fun,

Dave.
 
W

wrodnigg

#6
Also the Standard itself indicates the text which is identical from ISO 9001:2000 (normal style) and text which is not identical with ISO 9001 in blue italic style

Additional Notes explain the differencies to ISO 9001 and the relevant rationale.

Annex A also shows matirces with the correspondence between ISO 13485:2003 and ISO 13485:1996 (and reversed).
 
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