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".
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.
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).
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to the use of cookies.