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Conception and development in ISO 9001

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Guest user Created:   Jan 04, 2021 Last commented:   Jan 04, 2021

Conception and development in ISO 9001

May I ask you about the conception and development paragraph of ISO 9001: 2015.
Does it apply in the case of imitating a model part given by the client?
We are just measuring its dimensions to draw our manufacturing plan which will be displayed in the plant.

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Carlos Pereira da Cruz Jan 04, 2021

I do not have enough information to give a definitive answer.

If a client provides a sample and information about specifications – normally, organizations consider design and development as not applicable to their QMS.

If a client provides a sample and the organization has to design specifications – normally, organizations consider design and development as applicable to their QMS.

You must also consider what is the scope of your QMS. For example, in this free webinar on demand - Clause 4: Context of the organization, interested parties, and scope - - I present several alternatives to include or not include clause 8.3 in a QMS based on the choice of scope.

You can find more information below:

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SAFA Jan 04, 2021

Hello Mr Carlos
thank you for replying

the customer provides the sample and we're just measuring its dimensions to manufacture it
also we can develop mold to obtain the part by a plastic injection
so any recommandations to manage this
thnak you so much

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Carlos Pereira da Cruz Jan 04, 2021

I can say that I already worked with organizations in that situation and they decided to consider clause 8.3 as non-applicable. They decided and explained that their business is not developing or designing parts, their business is manufacturing parts according to customer requirements. The molds were approved by the customer indirectly when the customer approved the injected parts.
If your organization has already decided who is going to be your certification body, remember that you can explain to them the situation and ask for a statement.

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Jan 04, 2021

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