ISO 9001 Scope - Exclusion of Design in an engineered solutions company

I am currently working on getting my company accredited to ISO 9001. I have found a lot of semi-helpful answers to this question, but after a long time of looking at previous threads to try to find an answer, I decided that I just needed my specific case to be addressed. (Which means that yes, this is a loooong post, so I apologize right now)

I work for an engineered solutions company that manufactures mostly control panels. Now, based on that statement, I know it will sound absurd to ask if I would be able to exclude Design, but here's my reasoning. First off, I'm not certain that what we do would be considered design, because we are not doing R&D type work of developing new products; we are given specs from customers which one engineer then sits down and "customizes." Our customers have a varying degree of knowledge of the technical side of what they want, so one customer might say "we want a panel that can do XYZ, now you figure out what that needs" and then there's some customers that say "We want THIS drive, THESE terminal blocks, THIS colored pilot light". The thing is, even for the first case, they're all still control panels, we're just customizing what goes on it and where, we're not designing a whole new product line or anything. Maybe that is blatantly design, but I'm hoping there's a difference. :

Regardless, we didn't want to even include Design in our Scope, because honestly, we think we can get what we want from ISO 9001 without including it, and we can't think of a way in which it wouldn't be a massive headache for most Jobs we do. Here's why:

Our company is a customization company based on EVER-CHANGING customer specifications (even long into the manufacturing stage), so having to set up a Plan (7.3.1) and add inputs that would just be constantly changed seems rather pointless. There is an unbelievable amount of change during the process based on dynamic customer desires, realizations of a lack of feasibility for certain layouts from the manufacturing technicians, and so on. Basically, it's a process that constantly gets new inputs (that can't be foreseen at the beginning), all the way up and through the testing of the product, from the customer, engineer, and builder.

Therefore, trying to formalize an ISO compliant process for "Design" (which I'm still hopelessly hoping our process doesn't apply to) not only seems pointless, but also would slow down/deter our prized flexibility. Many bigger companies outsource our type of work to us because they are ISO 9001 compliant and it doesn't allow them the flexibility and speed we have. It would take them far too long and far too much work to do what we do with their ISO certification. I'm not blaming ISO of course, because I'm sure it's great for most cases (and, in fact, for most of our processes), and maybe the companies that outsource to us have an over-complicated QMS.

The point is, I'm hoping I can just exclude design because it doesn't apply, but if not, I want to exclude it from our Scope because my company thinks (based on discussing it as well as examples of other companies) it will literally make us less efficient and valuable to our customers.

P.S. I know it's been a big discussion that we would then be misleading customers to say we're ISO certified, but I would make it clear on our ISO claim on our website and Scope which processes are certified and that it EXCLUDES design.

P.P.S. I will also discuss this with the CB's we're looking at, but I have seen a lot of valuable information on this site and I want to hear what you guys say.

Thank you.

Your customers give you requirements (design inputs) and you design (design output) panels to meet their requirements. They are your design input.

Nope - My opinion is you won't be able to exclude design in your ISO 9001 certification scope. Whether or not your current related system(s) are compliant or not is a different question to assess.

We do a lot of prototyping for one of our customers, but we don't design anything. I'm not sure if that's what you mean, but basically everything on the prototypes is in a constant state of change by our customers. We have excluded design from our business and just set up different procedures for prototype stuff from production runs.

I side with Marc here. It doesn't appear that this is prototyping. It is clearly design.

As for your fear that the specs are constantly changing, that isn't really unusual. That is what design review is for (7.3.4) among other things, and control of changes (7.3.7).

Don't forget the last sentence is 7.3.1 (design planning): "Planning output shall be updated, as appropriate, as the design and development progresses".

As the reviews dictate, planning is altered.

What you really have is a collaboration of design with both you and the customer. That is why they need to be involved with the reviews ("Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed.").

Call it design, configuration, customisation or whatever you want to - it is a process which requires control. Clause 7.3 is probably the most detailed of all the clauses, it gives you a structure (is you wish to adopt it) to work to with 7 neat sub-sections - just follow the path provided and you have a well controlled process. It doesn't have to be difficult.

You mention having a plan would make you less efficient, are you saying that you don't already plan? or that you don't have a separate form which is called a design plan and is created for each design, because the clause doesn't call for that. It could be a generic plan.

Do not confuse R&D to design and development.
A wheel is already invented.
You can design and develop yet an other wheel to meet your requirement / customer requirement.
You should be proud that you have designed and developed so many control panels to EVER-CHANGING customer specifications. A wealth of learning is available with you as a design input to any new design and development requirement.
Please do not see a devil in the design and development process....

Colin said:

You mention having a plan would make you less efficient, are you saying that you don't already plan? or that you don't have a separate form which is called a design plan and is created for each design, because the clause doesn't call for that. It could be a generic plan.

Click to expand...

So, just confirming what you're saying here, I can just make a generic/broad form for 7.3.1 that applies to all Jobs (rather than a new one for each Job)? Then just maintain the records of 7.3.2-7 for each Job? For example:

Responsibilites:
1. Aquire Inputs: Design Engineer & Sales
2. Design: Design Engineer & Drafting (and sometimes Customer)
3. Design Review & Verification: Manager of Operations and Operations Manager (and sometimes Customer)
4. Manufacturing: Operations Manager
5. Test (Manufacturing Review, Verification, & Validation): Operations Manager, Test Technician (sometimes Design Engineer & Customer)
6. Maintain Records: Design Engineer

Stages:
Stage 1: Aquire Inputs (PO)
Stage 2: Design (Create BOM & Draft Drawings)
- Review and Verify
Stage 3: Manufacture
Stage 4: Test
- Review, Verify, Validate


Secondly, so it seems what my company does is DEFINITELY design, and the vibe I've gotten is that yes, I CANNOT exclude design. I'm NOT talking about whether it's a good idea or not to exclude it (I've taken your opinions into account and I appreciate them), but whether or not I HAVE to include design. I have read elsewhere in this forum that even if you do design, you do NOT have to include it in your scope if you don't want to, merely that it would be foolish not to do so (as long as you make it clear that your certification does not include Design) or that you can even consider it an outsourced process if you want to exclude it? Again, I'm looking for what is ALLOWED technically, not the wiseness of one course over another; I already know the majority of this forum's stance on that

(The reason I don't seem to care if it is wise or not to exclude design is because I may not be able to convince Top Management that ISO is for us if we have to include design...)

This is a conversation you need to have with your prospective certification body.

My opinion is that you do need to include it. If top management is too narrow in their thinking to handle design in the ISO 9001 context, then it may not be for them, and neither would the market share that would come with it. It is their loss, and it is a HUGE one.

Design controls are necessary for safety and liability reasons as well as common sense and good business practices. They need not be oppressive. They bring order and well being to the company and help them with safe and robust designs while taking much of the aggravation out of of day to day operation of the business.

If that is how it is, it is time to dust off your resume. You belong somewhere that you will be appreciated.

Thanks; the reason they don't want to include it is because many of our customers are bigger companies that have ISO and it drastically decreases their speed and flexibility of Design apparently -- I guess those companies just aren't using ISO right in that case, but that's the examples my Top Management has seen.

I will definitely bring this up with my potential CB though.

Anyway, anybody have any comments on the first part of my comment about the Design plan?

Two fundamental questions may be asked to determine the answer:

Who authorizes changes to product specifications?
What 's the wording of your customers' agreement/contracts with you?