Can a Fabless Semiconductor Company achieve TS16949 Certification (Registration)?

Howard Atkins

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Sidney and everyone,
I have also heard that there will be a possibility for a company that subcontracts production to qualify.
This was in a memo from a CB and does not appear in the rules.
 
I

isotsadmin

Re: Can a Fabless Semiconductor Company acheive TS16949 Certification (Registration)?

I may be very late in posting but I need my questions to be answered as well.

I am currently working in a semiconductor manufacturing company and we have a few automotive customers. We are currently ISO/TS certified but as the sales for automotive products decreases and the company found it not cost effective anymore to manufacture these few devices in our fab. We plan to outsource automotive parts fab production as well as back end processes so what remains in our fab would be non-automotive production. Would it be possible to retain our ISO/TS certification? Of course we will required our fab subcontractors to be ISO/TS 1649 certified. Would it be possible to have TS certification without any automotive parts manufactured in our fab due to cost limitations? Just to let you know that we design these automotive parts. We only outsource the production process.

We dont want to loose out automotive customers just because we dont have a TS certificate. Would it be possible to be still an automotive supplier eventhough we are not ISO/TS certified? I understand the rule of IATF that to be able to obtain TS certification, the manufacturing aspect should be satisifed.

Would it be OK to go ISO 9001 certified and just monitor supplier ( ISO/TS certified fab subcontractors) per 7.4.1? Do you think we are able to retain our automotive customers? It is possible under the IATF rule?

Appreciate your response on this.
 
M

Murphys Law

Iso - I'm not sure I fully understand your question.

If you are saying you will offload your auto products to a foundry, then you no longer need to maintain a TS16949 certification for your wafer fab. Just notify your customer of this in a PCN of the site offload. After your last wafers, you can downgrade your quality system to an IS09001 certification and stop maintenance of TS mandated add ons such as Control plans, PFMEAs, MSA etc.

Your subcon however, needs to have TS16949 and you need to have a foundry QA that manages that new foundry site. Essentially, treat them as a supplier but with same expectations as your own fab: you need them to have full TS16949 expectations: All the things your drop in your fab plus one of your own companies overseer that gives them direction, feedback reviews etc.

You can be fabless and still have TS16949. You just have to be clear with your certifying body on the business model and boundaries.

Btw: many foundries will charge you a per $ wafer extra for supplying to automotive industry. This covers their additional inspections, documentation, tighter Cpk requirements.

The other thing to keep in you pocket is that you can be an automotive supplier with just ISO9001.... You just need a customer waiver - tell them upfront and declare it in the PPAP. This is generally ok if your automotive business is small as a % of overall total and you follow the intent of TS16949. In my example, the factories with TS but BU was only ISO.
 
M

Murphys Law

PS: I should have mentioned that you may still be on the hook for the automotive requirements for longer record keeping of stuff you've already shipped even if you downgrade to ISO.
 
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isotsadmin

Thanks Murphys Law. Surely the information you provided are the things I really want to know. By the way, instead of certifying to ISO 9001, would you advice us certifying to ISO 13845 since 40-60% of our customers are into medical? What do you think?
 
M

Murphys Law

ISO - I don't think an SC company can pursue ISO 13845 in the it applies to the medical device manufacturer not the suppliers to them.

However, I understand there is overlap with ISO9001 which I believe you need for all your other customers.

The way I would treat this is that unless your end customers are defining in their General specifications a need for ISO 13845, I wouldn't worry about it. Stick with ISO9001 and even if risk assessments are done, it is at IC product level not at factory.

What you may want to do for medical semiconductors is treat them differently if they tell you the using it for FDA Class III applications. One company I know of, requires Vp approval to support that business and a special waiver from end customer to exempt them from liability that can only be signed by a customer Vp level. (Class I and Class II don't need that).
 
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isotsadmin

Awesome!. It really makes sense to me. Thanks much Murphys Law!
 

qusys

Trusted Information Resource
Awesome!. It really makes sense to me. Thanks much Murphys Law!

However I have seen that some customer ( that market the final product) also ask for ISO 13485 certification to their suppliers ( semicon firms that supply sensors, IC etc to be installed in the final product) as per a requirement collected by marketing, in order to assure the most valuable supply chain ( also for class I devices).
It is clear that ISO TS certifcation will help to gain the certification to ISO 13485, because the mentality that ispire the organization is the same for both critical standards.
 
W

w_grunfeld

The last message in this thread is over a year old. Is anyone aware /know about any news on this matter? New interpretation?
 
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