"Partial Design" Designation and Applicable ISO 9001:2015 Exemptions

[MichelleMcR]

My company is an EMS provider for a variety of customers. As a result, we do not do PCB design or participate in the design process for the most part; however, we provide do DFM analyses when we run into a problem or in order to provide cost savings, etc.

We also provide a workspace for our customers' engineers to come and work on their prototypes and have some techs available to assist them with the practical assembly-based issues. The tech, however, is not responsible for design, as s/he only applies practical knowledge for the engineer's consideration.

Under ISO 9001:2008 our CB certified us as a "partial design" company and our exclusions were as follows:

Exclusions: 7.3.3, 7.3.4, 7.3.5, 7.3.6: "The company" is ISO-registered for Partial Design. This rating allows "The company" to offer design input to our customers. The goal is to help continually improve upon the manufacturability, reliability and other aspects of customer-designed product including cost-reduction.

Can someone help me determine which items from the new 2015 standard I should deem as not applicable in order to maintain this designation? I wasn't here when the original determination was made and those that determined the original designation are no longer here for consultation.

 

[Ninja]

Re: "Partial Design" designation and applicable exemptions

Have you considered simply calling it "Consulting" ?
Seems like a terminology issue costing you time and effort.

 

[MichelleMcR]

My only issue with considering it consulting is that our sometimes our suggestions feed into practical changes that feed our ECO process and all changes to design (from a simple component substitution to adding rails or fiducials to a PCB) have to be specifically approved by the customer.

Or maybe I just don't see how that eliminates the burden of tracking and controlling these as design changes...

 

[Ninja]

...sometimes our suggestions feed into practical changes that feed our ECO process (which does not make anything tangible) and all changes to our customers design (from a simple component substitution to adding rails or fiducials to a PCB) have to be specifically approved by the customer because, after all, it is not our part...it is our customer's part and they are completely responsible for design...not us..

I added emphasis in bold, and words in red...

Are my additions consistent with your reality?

 

[howste]

I've never seen a "partial design" certificate. You are either responsible for design or you're not. In your case, the customer is responsible for their designs. You shouldn't make any design changes without customer authorization. You should track the customer design changes just as you would if the customer changed the design without your input.

 

[Ninja]

...also realized that EMS and ECO can mean a number of different things, and that I'm assuming.... please spell these out...Emergency Medical Service and Electronic manufacturing Service are pretty different...

ECO is Engineering Change Order for you?

 

[MichelleMcR]

Ninja:

Yes...Electronics Manufacturing Service & Engineering Change Order

And yes your changes are consistent with the reality here.

Howste:

Yes. We have a certificate that specifies Partial design.

But I don't honestly know why it was added at all. I wasn't here during that revision of the QMS, all I know is that we were previously not design-responsible, but the QMS was revised to incorporate partial design...and the leadership seems to think we need to remain that way. It isn't that I disagree with either of you, at all.

 

[Sidney Vianna]

Can someone help me determine which items from the new 2015 standard I should deem as not applicable in order to maintain this designation?

From what you describe there are some aspects of 9001:2015 8.3.2 and 8.3.3 that your organization might have influence over. Especially with the linkage from 8.2.3.1 b)

requirements not stated by the customer, but necessary for the specified or intended use, when known;

Sometimes, suppliers as your organization have to assist customers in better designing/specifying their products because you have more knowledge than the customer does.

 

[speck]

Hello all. Thanks for the input. I searched what I could and found this. Not sure whether to ask here or start a new post about exemptions to the new AS9100 rev D. All the examples I was able to find did not address my situation exactly. I think mine is much less "gray". We have been design exempt for AS9100 as a commercial Aerospace heat treater. We simply receive customer machined parts, heat treat them to the given requirements and then return them with compliance statements. My question is we provide a "service" not a "product" and want to verify this is not the type of "service" mentioned in "8.3 Design and development of Products and Services" in the standard.

I guess my question that may have been asked elsewhere in the cove and may help many others in the future is:

1. Can we claim exemption?
2. To what clauses and what extent can we claim exemption?

I have been given the wonderful task of doing the ISO9001AS9100D upgrade and I do not have the internal leadership I can bounce any of this off of. I would hate to go down the wrong road here before I even start. Thank you so much for any input and be Blessed.

 

[Sidney Vianna]

Heat treating is a (so-called) special process. Do you develop the heat treating spec? Do you validate them?

If you just heat treat parts against customer specified processes, then you are not developing the "product/service" and you can disregard the service development aspects of AS9100.

Since OASIS identifies the elements of AS9100 that doesn't apply to you, you should have this already established. The Transition from AS9100C to D should not make any difference whatsoever about this aspect of the QMS.