We Passed Our ISO 13485:2003 Certification!

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randomname

#3
#3
Re: We Passed Our 13485:2003 Certification!

Obviously good news, but didn't they release a new edition recently?
 
Ajit Basrur

Ajit Basrur

Staff member
Admin
#5
#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until 2019, and during which ISO 13485:2016 will co-exist with ISO 13485:2003; after which the 2003 version will be withdrawn.
 
N

NikkiQSM

Quite Involved in Discussions
#6
#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.
 
D

dilemma

#7
#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?
 
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