D
duonghieu
what is the differences in the section 8.3 contained in ISO9001:2000 and ISO13485:2003??? Any one could help please. Thanx
Elsmar Forum Sponsor
The major differences arise when the nonconforming product is accepted by concession. You have to ensure that regulatory requirements are being met and maintain records of the identity of the person authorizing the concession.
Another difference is when the product needs to be reworked, you have to document the rework to be performed and ensure it has been authorized and approved by the same personnel authorizing the original work instruction.
Also the authorizers must determine if there will be any adverse effect of the rework upon the product and it has to be documented.
Danny
Another difference is when the product needs to be reworked, you have to document the rework to be performed and ensure it has been authorized and approved by the same personnel authorizing the original work instruction.
Also the authorizers must determine if there will be any adverse effect of the rework upon the product and it has to be documented.
Danny
Danny's got it exactly right.
By the way, Annex B of ISO 13485:2003 has a clause-by-clause comparison of ISO 9001:2000 and ISO 13485:2003. If you have a copy of the standard, this is the best place to find the kind of information you're asking for. In many clauses it also includes the reason for the differences.
By the way, Annex B of ISO 13485:2003 has a clause-by-clause comparison of ISO 9001:2000 and ISO 13485:2003. If you have a copy of the standard, this is the best place to find the kind of information you're asking for. In many clauses it also includes the reason for the differences.
D
duonghieu
thank you very much indeed
Similar threads
