D
This is my first post.
I work for a small contract manufacturer accredited to ISO 9001. 60% of our CURRENT business would fit the description of medical devices. These CURRENT medical device customers only require ISO 9001:2000. The balance is mixed industries.
We have a potential NEW medical device customer that is requesting ISO 13485 certification for the sub assemblies that we would manufacture. We have had a couple of gap audits. If we continue to proceed with 13485 certification, could our CURRENT medical device customers be excluded since they only require 9001?
We need to evaluate our resource requirements should we continue with 13485 and the risk analysis that would be required for our current business.
Thanks in advance for your help.
I work for a small contract manufacturer accredited to ISO 9001. 60% of our CURRENT business would fit the description of medical devices. These CURRENT medical device customers only require ISO 9001:2000. The balance is mixed industries.
We have a potential NEW medical device customer that is requesting ISO 13485 certification for the sub assemblies that we would manufacture. We have had a couple of gap audits. If we continue to proceed with 13485 certification, could our CURRENT medical device customers be excluded since they only require 9001?
We need to evaluate our resource requirements should we continue with 13485 and the risk analysis that would be required for our current business.
Thanks in advance for your help.