AS9100C Clause 7.5 Applicability for Design House

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AS9100_User

Hello,
We are a design house, where we design the h/w or system proto type as per specification, validate it and hand over it for production with necessary documents. We don’t have production facility. In this scenario, how much of AS9100C clause 7.5 is applicable to our organization? What all need to be addressed as per this clause?
We are in the process of getting audited for AS9100C standard.
Thanks in advance.
 

Big Jim

Admin
Don't forget that product and service are interchangeable, or perhaps better said, service is a product.

What wervice do you provide? You provide designs. I would think that assuring that production (design) takes place under controlled conditions is an application of 7.5.1.

It may be a bit of a stretch to try to bring 7.5.2 (special processes), 7.5.3 (traceability), or 7.5.5 (preservation of product) into your scenario though.

7.5.4 (customer property) would apply if you have any personal data (including credit card information), customer specifications, customer drawings, or customer provided samples.

Other comments are welcome.
 
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AS9100_User

Thanks JIM.
We are in SW, HW & even integrated products development. What is the process we need to have in place to ensure (monitor & control) the outsourced production (to OEM) is taking place as per the requirements?
 

Big Jim

Admin
Thanks JIM.
We are in SW, HW & even integrated products development. What is the process we need to have in place to ensure (monitor & control) the outsourced production (to OEM) is taking place as per the requirements?

Such a simple question with such a complex answer.

7.4 provides the requirements for controlling suppliers and what you buy from them. This says that you need to approve suppliers, appropriately describe what you are buying, and that you confirm that you got what you ordered.

4.1 deals with outsourcing, basically saying that it is controlled through purchasing (7.4). This says that controls over outsourcing needs to be defined within your quality management system.

So you need to define how you are going to do it.

You need qualify the supplier and keep records showing that you have done so. That may entail visiting them to confirm they have the ability to provide what you are after. There may be other ways to check them out, but whatever you do, keep a record of it.

You need to clearly describe what you want, typically with a contract or with a purchase order.

You need to confirm you got what you ordered. That may entail inspection and/or testing.

That is sort of a basic outline. There is likely more to it depending on the circumstances.
 
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