Who here is ISO 13845?

Folks,

Just got two 5 Axis prototype orders for a medical customer. If these prototypes work out on animals, they move to human trials in the summer. If those work out, then we make thousands of them and we all get rich and fat.

But, for the human trials the 40 he would would order for that phase actually need to be completed by an ISO 13845 shop. We're ISO nothing currently. I see no way that we could be ISO Anything by summer, but if the trials went exceptionally well, we knock it out of the park, and they want us to make these things on a production level, just wondering what's involved beyond an ISO:9001 certification. I at least understand what's involved with that and could implement it if needed. I don't have the slightest clue how much more is involved with 13845. Can anyone shed some light?

StreetSpeed said:

Folks,

Just got two 5 Axis prototype orders for a medical customer. If these prototypes work out on animals, they move to human trials in the summer. If those work out, then we make thousands of them and we all get rich and fat.

But, for the human trials the 40 he would would order for that phase actually need to be completed by an ISO 13845 shop. We're ISO nothing currently. I see no way that we could be ISO Anything by summer, but if the trials went exceptionally well, we knock it out of the park, and they want us to make these things on a production level, just wondering what's involved beyond an ISO:9001 certification. I at least understand what's involved with that and could implement it if needed. I don't have the slightest clue how much more is involved with 13845. Can anyone shed some light?

Click to expand...

Ugh. I have been down this road. Unless they give you an actual contract that they are more beholden to than you are, do not bother. The hassle is large, and the monetary cost larger. In the end, it was more profitable for us to simply continue to limit ourselves to Prototyping and Customs for our Surgical customers.

There are PLENTY of online descriptions and guidelines available via Google about this. Unless, you already have the infrastructure, groundwork, machines and capacity in place, AND a ready to be signed commitment, my opinion is that it is not worth it.

If I recall correctly ( been a couple years since ), it was something like $25K just to get the consultant in the door to start working on the process. We were told that by the time it was all said and done, that it would wind up being about year's worth of work and $75K.

It is possible that you can do a certification process for ISO 13485 without worrying about ISO 9xxx, as some of the requirements do not overlap. Doing one or the other may make the OTHER one easier down the road, if that's what works for you.

As ZK states above, you will pay a lot for the registration process, it will take the best part of a year, you will need to hire a person (or people) to administer the program internally, your employees need to learn some new skills, and then you may still be competing for the work, so you basically need to decide whether you want to invest that money in potential business.

Zahnrad Kopf said:

Ugh. I have been down this road. Unless they give you an actual contract that they are more beholden to than you are, do not bother. The hassle is large, and the monetary cost larger. In the end, it was more profitable for us to simply continue to limit ourselves to Prototyping and Customs for our Surgical customers.

There are PLENTY of online descriptions and guidelines available via Google about this. Unless, you already have the infrastructure, groundwork, machines and capacity in place, AND a ready to be signed commitment, my opinion is that it is not worth it.

If I recall correctly ( been a couple years since ), it was something like $25K just to get the consultant in the door to start working on the process. We were told that by the time it was all said and done, that it would wind up being about year's worth of work and $75K.

Click to expand...

Thanks for the feedback. None of what you said surprises me. How big is your organization? I understand the smaller ones are generally faster and cheaper to get through the process. We're only 8 full timers. But either way I hear where you're coming from. I know what the customer wants to pay for the end product. I know we can make it for a price we could make a lot of money on, so as you said if the numbers work out and there would be a contract, certainly seems like it'd be worth considering.

specfab said:

It is possible that you can do a certification process for ISO 13485 without worrying about ISO 9xxx, as some of the requirements do not overlap. Doing one or the other may make the OTHER one easier down the road, if that's what works for you.

Click to expand...

We actually asked this question specifically. The bottom line is that if one is already 9001, it makes it slightly less painful to accomplish 13485, but the result is that is doesn't make much whit of a difference beyond that. Now, our experience is that customers only really care whether you are 13485 or not. The rub is that 9001 is easier if you are capable of attaining 13485. So, with that realization in hand combined with the fact that the 9001 will open other doors, it makes sense to actually go ahead and do both. Bear in mind though - In the end, you still have to pay for both, and they are still separate processes.

specfab said:

As ZK states above, you will pay a lot for the registration process, it will take the best part of a year, you will need to hire a person (or people) to administer the program internally, your employees need to learn some new skills, and then you may still be competing for the work, so you basically need to decide whether you want to invest that money in potential business.

Click to expand...

For us, the key was being lucky enough to have other good acquaintances in the field that were willing to speak frankly with us. The truth of it is that 13485 doesn't guarantee squat. The players are so cut-throat that you'll be begging for "weekend racing" and "custom motorcycle parts" business for their relatively better customer loyalty and looser wallets. They will skip out over 1 cent, because at that point you are discussing millions.

I don't relish that level of concern. I LOVE doing the Prototype Instruments and Implants with the occasional custom job here and there. For me, it is a lot of fun. I enjoy the process. I don't need the headaches associated with the production level concerns.

Its not so much beyond 9001 as different.
You can't claim 9001 if you are 13845 as much of 9001 is not required. 9001 won't make you 13845 compliant.
It is painful. Think about not being able to change one line in your cnc code without going back through the testing process in some cases.
Jump into medical and you will have to have it It's kind of a price of entry.
Daunting for a small shop but download the standards and read every sentence. Then download the regulations for the devices you are into.
Get used to the fact that a know nothing auditor is going to come in and ask for lots of proof of things being tracked.
OSHA inspections are a breeze compared to this stuff.
The good side is it helps insulate you from lawsuits and if you make medical you will get sued by some yahoo. Make sure your insurance covers this legal cost for nuisance law suits.

9001 has now changed also. 9001:2015 means many have 3 years to change a lot of things upstairs.
It is a much higher dollar parts world but full of extra costs. These extras can double or triple what you need to charge per hour to stay alive.
Bob

StreetSpeed said:

Thanks for the feedback. None of what you said surprises me. How big is your organization? I understand the smaller ones are generally faster and cheaper to get through the process. We're only 8 full timers. But either way I hear where you're coming from. I know what the customer wants to pay for the end product. I know we can make it for a price we could make a lot of money on, so as you said if the numbers work out and there would be a contract, certainly seems like it'd be worth considering.

Click to expand...

We are small. Tiny. There are only Five of us. - Me, Myself, and I + SetUp Devil and SWMBO. So, technically, One in the shop.




From what was conveyed to me, hire a lawyer and make damn sure that the contract is bullet proof for you because it is ridiculously easy for them to simply walk away from it with very little consequence, taking their business and parts elsewhere.

Good luck whichever you decide.

As I believe already suggested do nothing until you have something tangible. I've frequently found that these "demands" get dropped especially when the shop is your size. There must be a reason why they contacted you in the first place.

Doing what they want is going to cost you and getting something fast wouldn't be worth the paper the "certificate" was written on.

There is a huge difference between "your buddy the engineer" who gave you a PO for prototype parts and promised you the world and the corporate purchasing puke giving you a big $$ contract. Usually purchasing looks the other way when R&D wants to get parts in quick for prototypes, but when it comes to production quantities when a big buck production line could go down, they usually go to their preferred vendors that have excess capacity or are big enough to run 24-7 to get those parts delivered when the stuff hits the fan. Notice this is all without even considering the 13485 Medical Device certification stuff getting in the way. I wish you the best of luck.

All good advice folks. If this was Medtronic, I wouldn't even be bringing the question up. But the company in question is another small company with 2 MDs, a PhD, and an MBA. They're talking thousands of parts, not millions. Realistic expectations from a new customer attract me much more than some company saying "we're gonna make billions off of these!" They way I see it is, if a contract were to made that would easily cover the cost of the ISO process and whoever needs to be hired to maintain it, then it can be a huge base to continue the growth of the business in an upward direction. Again, there are guys out there with huge profitable companies just like ours that started in their basements. They didn't get there without taking some risks and taking the hard road from time to time.

Edit: BTW our most profitable job by far is production wire EDM parts for calibrating medical imaging machines. Also a small company, so as long as we deliver quality parts on time they don't care whether we're ISO or not. We're not unfamiliar with the medical industry or the money that can be made.