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Do we need to include ISO 9001 Clause 7.3? Design and Development Exclusion

D

dgregory2

#1
Hello all,
I've found a tremendous amount of info on the forums but this is my first post.

I'm in the process of writing a quality manual and ISO9001:2008 certification process for a small casting/manufacturing company. We cast and manufacture product to our customers' spec's. We design the molds for casting and the fixturing for machining the product. We typically revise a CAD model supplied by the customer for ease of the casting and manufacturing processes. We then submit the model for the customer's approval. Do we need to include Clause 7.3, Design & Developement?
 
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Helmut Jilling

Auditor / Consultant
#2
Re: Do we need to include Clause 7.3?

The standard is not real clear. In the old 1994 standard, the approach was to exclude the whole Design element (4.4) if you were not "responsible" for Design. In the new standard, it is process based, so should you exclude processes that are not applicable? It does not specifically say. To further confuse things, many companies are not "responsible" for Design, but collaborate with the customer.

What I suggest to clients is 2 points.
1. Read the section and understand the requirements.
2. Exclude the parts that do not apply to your operations, but leave in the parts that do apply.

For example, from your description, you would not do Design Planning or Validation, would not do prototyping, and some other things. But, you might do some design review, some verification, control some design changes from the customer. If the standard has useful info about some of these relevant bits your organization does, why not capture them into your system, so you can control the best ways for people to do them.

The key point is they are things you do, why not include them.

If you were a distributor of hardware parts, perhaps my recommendation would be to leave out the whole thing, because maybe none of it would apply at that point.
 
S

Sorin

#3
In my opinion you can exclude 7.3 because you do not have the authority to change the design of the castings.

The castings are manufactured per your customer requirements.
As your customer is providing ALL the specs (including the DWG), he's the only one who can modify/change the part in question.
 
A

amariepsu

#4
Re: Do we need to include Clause 7.3?

We took an exclusion to this clause because our customers are in charge of their design and development as well. However I often reference this section for guidance while implementing or designing new processes, it does have useful info, however the registrar will most likely see why you took the exclusion and be fine with it.
 

Helmut Jilling

Auditor / Consultant
#5
Re: Do we need to include Clause 7.3?

We took an exclusion to this clause because our customers are in charge of their design and development as well. However I often reference this section for guidance while implementing or designing new processes, it does have useful info, however the registrar will most likely see why you took the exclusion and be fine with it.
Your comment is a perfect example for the suggestion I made in post #2. You exclude the clause, but you find value in referring to it "frequently" for guidance. That may be compliant. But, if you find value in referring to it frequently, why not incorporate the relevant bits into your system so other members of your company can refer to it too. You appear to be using some of it, which is fine. But, why exclude it, then. There are activities in there that must be relevant to you.
 

Big Jim

Super Moderator
#6
Hello all,
I've found a tremendous amount of info on the forums but this is my first post.

I'm in the process of writing a quality manual and ISO9001:2008 certification process for a small casting/manufacturing company. We cast and manufacture product to our customers' spec's. We design the molds for casting and the fixturing for machining the product. We typically revise a CAD model supplied by the customer for ease of the casting and manufacturing processes. We then submit the model for the customer's approval. Do we need to include Clause 7.3, Design & Developement?
You are permitted to do planning for production as part of 7.1, without being involved with design. You should read 7.1 to see how it applies to you.

Your designing of the molds and fixturing fall into 7.1.

As to if you would have a problem with modifying the model without crossing over into design, you may be on the edge of design even if you don't cross over the line. This would be a very good question for your Certification Body. I have seen this applied differently by different CBs.
 

somashekar

Staff member
Super Moderator
#8
Hello all,
I've found a tremendous amount of info on the forums but this is my first post.

I'm in the process of writing a quality manual and ISO9001:2008 certification process for a small casting/manufacturing company. We cast and manufacture product to our customers' spec's. We design the molds for casting and the fixturing for machining the product. We typically revise a CAD model supplied by the customer for ease of the casting and manufacturing processes. We then submit the model for the customer's approval. Do we need to include Clause 7.3, Design & Developement?
Look more closely ... deeper ... well, what you can see is a design input from customer by way of spec and cad model. To make the product out and deliver you need to design many things for the casting and machining, and hence you will use several other design inputs along with what customer provides. This will also include learnings from other casting and machining knowledges that you have acquired.
So part of the input and part of the design varification and validation may be the customer domine. Your process here is not as simple as nut and bolt, that customer gives the nut and bolt and you just thread them in (assembly) and deliver.
Your scope must have design and development and the design and development stages will have appropriate customer interface at appropriate stages.
On the long run you will feel more confident including 7.3.
This is my opinion on your situation.
 
S

scoraccio

#9
Hello all,
I've found a tremendous amount of info on the forums but this is my first post.

I'm in the process of writing a quality manual and ISO9001:2008 certification process for a small casting/manufacturing company. We cast and manufacture product to our customers' spec's. We design the molds for casting and the fixturing for machining the product. We typically revise a CAD model supplied by the customer for ease of the casting and manufacturing processes. We then submit the model for the customer's approval. Do we need to include Clause 7.3, Design & Developement?
I think you've gotten very good answers, here - or at least ones that I can concur with.

So, for what it's worth, I can support the opinion that you can safely exclude 7.3, use the bits in 7.1 to cover your mold design, and - and down the road, if you find value in the planning and other control parts of 7.3, then include that as well.

I find this fairly exact situation quite often.
 
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