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XeniAnnoula
Hello again --
Second post, this time on section 8.3 and that tricky "rework".
Our company sells and services (only) medical devices and we are now preparing to be certified against 13485. I am the QM for our company, and have worked with our ISO advisor for almost a decade, up to this point in regard only to our 9001 certification.
We are running into a couple of disagreements as we prepare for 13485. This is one of them: she is interpreting "If product needs to be reworked ..." in 8.3 to include any need for us to make a service visit (for the same reported issue) more than once. We consider this simply part of a normal service routine which sometimes requires more than one visit to resolve a problem. I'm afraid I feel she's misinterpreting the intention of this part of the standard, specifically the meaning of this word. While I have the utmost respect for her knowledge and brain-power under most circumstances, we may have a language issue here as her native language is not English while mine is (her command is superb, however -- don't misunderstand please).
I've read everything on this site regarding the meaning of "rework" and while I can see that there are some shades of difference between industries and applications, it seems quite clear that while both 'rework' and 'repair' can apply to the manufacturing process, I see no evidence of 'rework' per se applying to post-manufacture ('repair' however clearly can apply). And I find no support whatsoever for 'rework' being equivalent to 're-repair'.
If anyone's familiar with the paragraph to which I'm referring, you'll understand why I/we don't wish to be forced into this documentation/work instruction/authorization/approval loop unnecessarily, especially since we've taken great pains thus far with our QMS to weed out any administrative busy-work.
I'd hugely appreciate any opinions out there, pro or con. I'll stand up for my position on this if needed, but I don't want to cross our advisor without being 110% certain of my position.
Thanks!
Second post, this time on section 8.3 and that tricky "rework".
Our company sells and services (only) medical devices and we are now preparing to be certified against 13485. I am the QM for our company, and have worked with our ISO advisor for almost a decade, up to this point in regard only to our 9001 certification.
We are running into a couple of disagreements as we prepare for 13485. This is one of them: she is interpreting "If product needs to be reworked ..." in 8.3 to include any need for us to make a service visit (for the same reported issue) more than once. We consider this simply part of a normal service routine which sometimes requires more than one visit to resolve a problem. I'm afraid I feel she's misinterpreting the intention of this part of the standard, specifically the meaning of this word. While I have the utmost respect for her knowledge and brain-power under most circumstances, we may have a language issue here as her native language is not English while mine is (her command is superb, however -- don't misunderstand please).
I've read everything on this site regarding the meaning of "rework" and while I can see that there are some shades of difference between industries and applications, it seems quite clear that while both 'rework' and 'repair' can apply to the manufacturing process, I see no evidence of 'rework' per se applying to post-manufacture ('repair' however clearly can apply). And I find no support whatsoever for 'rework' being equivalent to 're-repair'.
If anyone's familiar with the paragraph to which I'm referring, you'll understand why I/we don't wish to be forced into this documentation/work instruction/authorization/approval loop unnecessarily, especially since we've taken great pains thus far with our QMS to weed out any administrative busy-work.
I'd hugely appreciate any opinions out there, pro or con. I'll stand up for my position on this if needed, but I don't want to cross our advisor without being 110% certain of my position.
Thanks!
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