V
vincentgau
Hi,
We already have a ISO 13485 QMS in placed and we have passed the Stage I audit. We just found that we put SOP Technical File in 8.5.5, which I know this might not be right.
Where should we put the SOP Technical File in ISO13485?
Thanks.
We already have a ISO 13485 QMS in placed and we have passed the Stage I audit. We just found that we put SOP Technical File in 8.5.5, which I know this might not be right.
Where should we put the SOP Technical File in ISO13485?
Thanks.