Design vs. Repair / Refurbishment Modifications - ISO 9001 Design Exclusions

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Greg P

I would like to pose a question to anyone who may know the answer. Under clause 1.2 of ISO 9001 "Exclusions" The intent is to allow exclusion of design control requirements. My business is with repair/refurbishment. My question is: Where is the line drawn between what is design and what is rework/modifications to allow a device to function. I am in the process of writing our quality manual, and eventually when we get to a point that we want to apply for ISO certification I wouldn't want to get dinged by this clause. Any thoughts?

Greg P.
 
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ralphsulser

Re: Exclusions of ISO 9001 requirements

I would think that you are repairing something that has already been designed. Even if you rebuild it, it would be to the original design by someone else. Do you work to prints and drawings? Whoever provides the drawings are responsible for design.:2cents:
 
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Greg P

Re: Exclusions of ISO 9001 requirements

We refurbish game consoles. Sometimes we may replace original parts with sourced parts, and may add some rework or modifications which would not change any of the functionality of the device, but I am wondering if ISO would consider these activities design.
 
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ralphsulser

Re: Exclusions of ISO 9001 requirements

We refurbish game consoles. Sometimes we may replace original parts with sourced parts, and may add some rework or modifications which would not change any of the functionality of the device, but I am wondering if ISO would consider these activities design.

IMHO I think you can exclude design without any hassle from an ISO9001 auditor. It is still someone else's design.
 
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Greg P

Re: Exclusions of ISO 9001 requirements

Great! I appreciate your input. One last thought. We have a department within the refurbishment center that we call "R&D", what this group of guy's do is research and develop tests and fixes to product that even the original manufacturer does not do. In some cases they come up with fixes where the OM would just replace a part. Do you think the "R&D" label will get us into any trouble?
 
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