M
MichelleMcR
Hello Cove. 
I have spent much of this last week logged in and searching The Cove and other resources for answers for top management at my company. They have asked me to research what it would take to add 13485 to our existing 9001:2008 certification. Primarily, however, my question is how do you know you actually need to seek 13485 certification?
Here is some basic background information about our company: We are an EMS provider that manufactures circuit boards primarily for industrial and agricultural products. We have not done any Design outside of DFM and are exempt (under 9001) from all parts of 7.3, but 7.3.1, 7.3.2, and 7.3.7. We have only been involved in medical devices through the production of circuit boards used in the analysis of medical samples (cell analysis devices, sample preparation devices, lasers).
After some research on The Cove, I've found multiple resources and tools that delineate the differences between the two standards that have been quite helpful. I also found a document (of which I didn't keep a copy & that I have, of course, been unable to find again) that stated that it may be unnecessary for circuit board manufacturers to be 13485 certified as long as our device is a part of a greater assembly and does not come into direct contact with a customer? If this is true we'll just need to educate our sales team on how to respond to that question in a sales call, but my knowledge is very limited beyond 9001.
So, I guess what I'm asking is, outside of a specific customer request/requirement, when does it benefit a circuit board manufacturer to seek 13485 certification?
I have spent much of this last week logged in and searching The Cove and other resources for answers for top management at my company. They have asked me to research what it would take to add 13485 to our existing 9001:2008 certification. Primarily, however, my question is how do you know you actually need to seek 13485 certification?
Here is some basic background information about our company: We are an EMS provider that manufactures circuit boards primarily for industrial and agricultural products. We have not done any Design outside of DFM and are exempt (under 9001) from all parts of 7.3, but 7.3.1, 7.3.2, and 7.3.7. We have only been involved in medical devices through the production of circuit boards used in the analysis of medical samples (cell analysis devices, sample preparation devices, lasers).
After some research on The Cove, I've found multiple resources and tools that delineate the differences between the two standards that have been quite helpful. I also found a document (of which I didn't keep a copy & that I have, of course, been unable to find again) that stated that it may be unnecessary for circuit board manufacturers to be 13485 certified as long as our device is a part of a greater assembly and does not come into direct contact with a customer? If this is true we'll just need to educate our sales team on how to respond to that question in a sales call, but my knowledge is very limited beyond 9001.
So, I guess what I'm asking is, outside of a specific customer request/requirement, when does it benefit a circuit board manufacturer to seek 13485 certification?
