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Is software developed for Internal Use covered by ISO 9001:2008 Sec 7.3?

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stephenliu

#1
I'm assist my company get 9001:2008 certification. We design and manufacture IT hardware like PC, servers. Our IT department have developed several testing software for production. The software make decision if the test PASS or FAIL. So it's very important for our production. The software is only for internal usage and never been sold to any customer.

In addition, our IT department also developed some applications for operation, sales and purchasing departments. For example, they developed application for customer inquiry from website directly.

I wonder whether or not the software development will be covered by ISO9001 in section 7.3 design and development. In my company, the software development is done by IT department.
 
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#2
No, the requirements apply to product delivered to customers, not for internal use. However, any software used to help make the accept/reject decision must be controlled under 7.6.
 
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stephenliu

#3
No, the requirements apply to product delivered to customers, not for internal use. However, any software used to help make the accept/reject decision must be controlled under 7.6.
Thanks Andy! Do you think I should provide validation document for the testing software, as required in 7.5.2?
 
#4
Thanks Andy! Do you think I should provide validation document for the testing software, as required in 7.5.2?
Stephen, you can, but if the software is used as a test product, to decide if a product is good or not, then you should consider it under 7.6, really. 7.5.2 is for the product/process really.
 
S

stephenliu

#5
Stephen, you can, but if the software is used as a test product, to decide if a product is good or not, then you should consider it under 7.6, really. 7.5.2 is for the product/process really.
I understand.... Thanks Andy. I appreciate your help!
 
S

supermac

#9
:)I agree AndyN. However, I would suggest that it is good business practice to keep the test software under configuration control. It doesn't need to be heavy duty stuff. I've seen Excel spreadsheets (with really simple macros) used to control processes. Because of their simplicity no one considers the possible impact of error. Or the guy who wrote it and understands it leaving. Or someone making a 'one line change'. Been there, filled the body bags.

I would contend that this requirement in ISO 9001:2008 is the most problematic for folks using software in any of their business production processes -
'When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.'
OK - I've got to confirm it. Ah, now that means verify it. Make up your mind guys!

This a whole thread of its own. :)
 
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