Question about Design Exclusions - Clause 7.3 of ISO 9001

Hi,

My company doesn't actually design anything, we recieve the designs for the product we produce and then seek approval from the industry regulators (Mastercard and Visa) for the designs. Once the designs are approved by the customer and the industry regulators, we simply produce the product according to the designs. Does this mean I can exclude clause 7.3 ?

Thanks

From your brief description, I would say yes.

This is a very common question here: Design Exclusions

As long as you include the exclusion in the Scope section of your Quality Manual, it shouldn't be a problem.

Houcka said:

As long as you include the exclusion in the Scope section of your Quality Manual, it shouldn't be a problem.

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You can not just "exclude." The justification for such exclusion must be provided as well.

Stijloor.

Benjibb said:

Hi,

My company doesn't actually design anything, we recieve the designs for the product we produce and then seek approval from the industry regulators (Mastercard and Visa) for the designs. Once the designs are approved by the customer and the industry regulators, we simply produce the product according to the designs. Does this mean I can exclude clause 7.3 ?

Thanks

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Who actually does the design? Who do you receive it from? Is design sublet?

You have not given us enough information to determine clearly that an exclusion is appropriate.

Ok, so we get the artwork designs from the customer and the pass them on to the supplier who seek approval from the industry regulators. Once approved the designs are passed back to us, with samples which we then pass on to the customer for approval before the purchasing process can begin.

Benjibb said:

Ok, so we get the artwork designs from the customer and the pass them on to the supplier who seek approval from the industry regulators. Once approved the designs are passed back to us, with samples which we then pass on to the customer for approval before the purchasing process can begin.

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Clearly a case for exclusion as you can justify the same. Any other stuff that you do on behalf of your customer is a part of the validation more under the 7.5.2

Just becaue the word 'design' is used doesn't mean it is covered by clause 7.3 of ISO

It looks to me as if the OP is not actually designing. We can call it what we like but if someone supplies you with a specification (written spec, drawing, artwork, representative sample) and you manufacture to that specification you are not designing and therefore there is no need to justify an exclusion.

Design is involved when a customer comes to you with a set of requirements to be met and leaves it to you (as the expert) to propose a product or service that meets those requirements.

Re: Just becaue the word 'design' is used doesn't mean it is covered by clause 7.3 of

BorisS said:

It looks to me as if the OP is not actually designing. We can call it what we like but if someone supplies you with a specification (written spec, drawing, artwork, representative sample) and you manufacture to that specification you are not designing and therefore there is no need to justify an exclusion.

Design is involved when a customer comes to you with a set of requirements to be met and leaves it to you (as the expert) to propose a product or service that meets those requirements.

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you have said the justification for exclusion and this is simply put in the quality manual.

Re: Just becaue the word 'design' is used doesn't mean it is covered by clause 7.3 of

somashekar said:

you have said the justification for exclusion and this is simply put in the quality manual.

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Well put.

My only point was that I don't believe anyone in this scenario is 'designing.'