K
Kymmie
Hello everyone!
After being investigated by the FDA last year and receiving several 483s (our company didn't even HAVE a QMS at the time) I believe I have our head above water again. Now that we have a QM department (me) and things seem to be starting to roll along I am looking toward the future. My first goal is to get our MDEL with Canada, and then after that I'm looking to get us ISO certified.
I am a littlel confused about which certification we should go for. Origionally I was thinking that we should go after ISO 13485, but now I am thinking that ISO 9001 is the better fit for us? We do not do any manufacturing - we simply repackage/relabel medical devices. As I'm beginning to understand it, ISO 13485 is more directed towards medical device manufacturers? And ISO 9001 simply qualifies that you have a QMS that is "up to snuff"? Am I correct in this thinking or am I off track?
If it matters, my main goal for getting ISO certification is to make us more marketable internationally. Thoughts?
Thanks again for all of the help I keep receiving here! I hope that someday I will have learned enough to contribute back
~Kymmie
After being investigated by the FDA last year and receiving several 483s (our company didn't even HAVE a QMS at the time) I believe I have our head above water again. Now that we have a QM department (me) and things seem to be starting to roll along I am looking toward the future. My first goal is to get our MDEL with Canada, and then after that I'm looking to get us ISO certified.
I am a littlel confused about which certification we should go for. Origionally I was thinking that we should go after ISO 13485, but now I am thinking that ISO 9001 is the better fit for us? We do not do any manufacturing - we simply repackage/relabel medical devices. As I'm beginning to understand it, ISO 13485 is more directed towards medical device manufacturers? And ISO 9001 simply qualifies that you have a QMS that is "up to snuff"? Am I correct in this thinking or am I off track?
If it matters, my main goal for getting ISO certification is to make us more marketable internationally. Thoughts?
Thanks again for all of the help I keep receiving here! I hope that someday I will have learned enough to contribute back
~Kymmie