New Clause Structure of ISO 13485:2003

H

Hanson

Hi everyone

can anyone send me a clause structure of ISO 13485:2003 ? Thanks.
 
A

Aaron Lupo

Hanson said:
Hi everyone

can anyone send me a clause structure of ISO 13485:2003 ? Thanks.

Let me know if this is what you are looking for.
 

Attachments

  • Correspondence between ISO 13485.doc
    23.5 KB · Views: 704
H

Hanson

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".
 
Last edited by a moderator:

Marc

Fully vaccinated are you?
Leader
I haven't seen a correspondence matrix with ISO 9001. Has anyone else?
 

Dave-h

Involved In Discussions
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

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).
 
Top Bottom