N NikkiQSM Quite Involved in Discussions Nov 17, 2016 #1 Nov 17, 2016 #1 After 4.5 Days I have successfully gotten our company certified to the Medical Device Industry Standard! My boss is going to be so happy. And I've never been more proud of myself!
After 4.5 Days I have successfully gotten our company certified to the Medical Device Industry Standard! My boss is going to be so happy. And I've never been more proud of myself!
Y yodon Staff member Super Moderator Nov 17, 2016 #2 Nov 17, 2016 #2 Re: We Passed Our 13485:2003 Certification! Congrats!
R randomname Nov 17, 2016 #3 Nov 17, 2016 #3 Re: We Passed Our 13485:2003 Certification! Obviously good news, but didn't they release a new edition recently?
Re: We Passed Our 13485:2003 Certification! Obviously good news, but didn't they release a new edition recently?
Ajit Basrur Staff member Admin Nov 17, 2016 #4 Nov 17, 2016 #4 NikkiQSM said: After 4.5 Days I have successfully gotten our company certified to the Medical Device Industry Standard! My boss is going to be so happy. And I've never been more proud of myself! Click to expand... Congratulations. Do you want to share observations / recommendations ?
NikkiQSM said: After 4.5 Days I have successfully gotten our company certified to the Medical Device Industry Standard! My boss is going to be so happy. And I've never been more proud of myself! Click to expand... Congratulations. Do you want to share observations / recommendations ?
Ajit Basrur Staff member Admin Nov 17, 2016 #5 Nov 17, 2016 #5 Re: We Passed Our 13485:2003 Certification! randomname said: Obviously good news, but didn't they release a new edition recently? Click to expand... Yes; the new ISO 13485:2016 version. There is a transition period of three years, until 2019, and during which ISO 13485:2016 will co-exist with ISO 13485:2003; after which the 2003 version will be withdrawn.
Re: We Passed Our 13485:2003 Certification! randomname said: Obviously good news, but didn't they release a new edition recently? Click to expand... Yes; the new ISO 13485:2016 version. There is a transition period of three years, until 2019, and during which ISO 13485:2016 will co-exist with ISO 13485:2003; after which the 2003 version will be withdrawn.
N NikkiQSM Quite Involved in Discussions Nov 18, 2016 #6 Nov 18, 2016 #6 Re: We Passed Our 13485:2003 Certification! Yes, but this was our first certification to 13485, so we wanted to start with the 2003 version and then we will transition to the 2016.
Re: We Passed Our 13485:2003 Certification! Yes, but this was our first certification to 13485, so we wanted to start with the 2003 version and then we will transition to the 2016.
D dilemma Nov 29, 2016 #7 Nov 29, 2016 #7 Congrts But how come your company did not apply for 13485:2016 directly? Is that easier to get the certification for the first application?
Congrts But how come your company did not apply for 13485:2016 directly? Is that easier to get the certification for the first application?