Greetings, friends!
My facility is having a bit of a debate on the benefit of getting ISO 13485 certified prior to booking any Medical Device related business. Just as some background, we are a small OEM that makes both PCBs and cable assemblies/box builds. Most of our business is in government, but we all know the ebb and flow of government work. As a way to diversify our incoming work flow, the CEO wants us to get certified to 13485. (We have been 9001 certified for years)
He sees it sort of like a, "If you build it, they will come"... others think it is a big expense for a small company to undertake. While I've worked in medical device, heavily, and am more than happy to align our systems, I too wonder if there is truly a benefit to our company going forward with this. There would be some culture shock - expected - but moreso we would need to pay to have me certified as a lead auditor in order to teach our internal audit team how to audit for 13485.
What are your thoughts, all? Do you think there is a benefit to be had to gaining this certification versus keeping aligned with just 9001 as we will most likely NOT produce our own medical devices or produce a board that, on its own, would be a device?
My facility is having a bit of a debate on the benefit of getting ISO 13485 certified prior to booking any Medical Device related business. Just as some background, we are a small OEM that makes both PCBs and cable assemblies/box builds. Most of our business is in government, but we all know the ebb and flow of government work. As a way to diversify our incoming work flow, the CEO wants us to get certified to 13485. (We have been 9001 certified for years)
He sees it sort of like a, "If you build it, they will come"... others think it is a big expense for a small company to undertake. While I've worked in medical device, heavily, and am more than happy to align our systems, I too wonder if there is truly a benefit to our company going forward with this. There would be some culture shock - expected - but moreso we would need to pay to have me certified as a lead auditor in order to teach our internal audit team how to audit for 13485.
What are your thoughts, all? Do you think there is a benefit to be had to gaining this certification versus keeping aligned with just 9001 as we will most likely NOT produce our own medical devices or produce a board that, on its own, would be a device?