Dobby1979
Involved In Discussions
Hello all.
I was wondering if anyone had experience of adding a new site to their 13485 certification and in a short summery, what is required and a realistic timeline.
Example being; We currently hold 13485 certification and are looking to open a manufacturing plant in the US so our scope would need to change to incorporate them. Is it the same practice as gaining the original certification, e.g. Stage 1 and Stage 2 audits? Would 6 - 9 months be a realistic timescale for this?
Thanks in advance
I was wondering if anyone had experience of adding a new site to their 13485 certification and in a short summery, what is required and a realistic timeline.
Example being; We currently hold 13485 certification and are looking to open a manufacturing plant in the US so our scope would need to change to incorporate them. Is it the same practice as gaining the original certification, e.g. Stage 1 and Stage 2 audits? Would 6 - 9 months be a realistic timescale for this?
Thanks in advance