Hanson
16th September 2003, 08:15 AM
Hi everyone
can anyone send me a clause structure of ISO 13485:2003 ? Thanks.
can anyone send me a clause structure of ISO 13485:2003 ? Thanks.
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View Full Version : New Clause Structure of ISO 13485:2003 Aaron Lupo 16th September 2003, 10:00 AM 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. Hanson 16th September 2003, 11:40 PM 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". Marc 1st April 2004, 11:12 PM I haven't seen a correspondence matrix with ISO 9001. Has anyone else? Dave-h 2nd April 2004, 07:43 AM 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. wrodnigg 2nd April 2004, 08:48 AM 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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