ISO 13485 certification prior to Medical Device Manufacturing... worth it?

[blackholequasar]

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?

 

[Jean_B]

It's not sensible to do 13485 in addition to 9001 if you're not the contract mfg or legal mfg for an operable medical device. Any company that needs you can qualify you against your existing qms, and if they are silly enough to require a component supplier to be 13485 certified they should either pay you the big bucks for it (unlikely) or they don't know what they're doing and you might not want to deal with their hassle anyway.

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.

And no you don't. Lead auditor training does not qualify for trainer.

 

[Big Jim]

I have a client that didn't really need to move from ISO 9001 to AS9100 but chose to anyway. They are on the fringe of aerospace and deal with a lot of aerospace interested parties. It was very beneficial as they have gained market share. It was a more difficult transition than they expected due to some overbearing CB auditors, but paid off for them.

Theirs was a interesting case, as they really didn't need a more involved QMS.

I have had two clients that were in the printing business that decided to move to ISO 13485 because some of their business was for the medical industry, mostly printing IFUs (Instructions for Use) and some packaging. One has had an increase in business, the other one did not.

ISO 13485 is a lot more involved than ISO 9001. I would not recommend making things harder for yourself unless you can clearly see more business for it. Jean B is really leading you in the right direction. Go after the business if you want to, and you should get help from the customer as to what they may you to do differently for them, and if you start getting enough business to make it more attractive, consider moving to ISO 13485 at that time.

You would benefit greatly from purchasing the ISO 13485:2016 Standard and reading it to see how much more involved it is. That alone would also help you see what those customers might require.

 

[Jean_B]

You would benefit greatly from purchasing the ISO 13485:2016 Standard and reading it to see how much more involved it is. That alone would also help you see what those customers might require.

The standard itself doesn't really show the how much more involved it is. Try ISO - ISO 13485:2016 - Medical devices - A practical guide , which contains the full standard with guidance/interpretation for each of its sections (and is cheaper). You would only be missing certain Z annexes, which (once again) are only important to the legal manufacturer.

 

[blackholequasar]

Thank you, all!

@Jean_B - I've sent that on over to our purchasing department. I think that would be a good help!

I do have the older standard that I purchased at another facility where I worked. I worked for major distributors of medical devices and pharmaceuticals in which we were 13485 certified... and yeah, I just don't know that there would be a benefit to having it HERE unless there was a clear cut business plan with a device who was going to use us exclusively or partnered with us.

Thanks for the input, everyone!