Complying with ISO 9001 7.6 - Customer Provided Computer and Software

[nmcelrath]

Here is the scenario. We build a product for our customer. The customer consigns the test equipment which may be a computer with test software installed. The test procedure says to turn on the computer, install a device to be tested and click on an icon. If the computer says pass then the device is good. If the computer says fail then the device is not good.
With what I know; I have a computer and it has software.
And what I don?t know; what the requirements of the computer are, what the software is doing or what the customer (supplier and owner of the computer and software) has done to verify or validate the test.
My question is; what is my responsibility in my QMS to satisfy the requirements of ISO9001:2008 7.6?

 

[Stijloor]

Re: Complying with ISO 9001 7.6

Here is the scenario. We build a product for our customer. The customer consigns the test equipment which may be a computer with test software installed. The test procedure says to turn on the computer, install a device to be tested and click on an icon. If the computer says pass then the device is good. If the computer says fail then the device is not good.
With what I know; I have a computer and it has software.
And what I don’t know; what the requirements of the computer are, what the software is doing or what the customer (supplier and owner of the computer and software) has done to verify or validate the test.
My question is; what is my responsibility in my QMS to satisfy the requirements of ISO9001:2008 7.6?

I am not a computer software expert.

But this is what the Standard says:

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.

 

[nmcelrath]

Re: Complying with ISO 9001 7.6

I am not a computer software expert.

But this is what the Standard says:

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.

As I understand it then… if I have a procedure that requires the test set up is verified and a known good (gold board) be tested and passed prior to running the production lot, I should meet the requirement.

 

[Stijloor]

Re: Complying with ISO 9001 7.6

As I understand it then? if I have a procedure that requires the test set up is verified and a known good (gold board) be tested and passed prior to running the production lot, I should meet the requirement.

That's one way to do this. Let's see what other Members have to say...

 

[Mikishots]

Re: Complying with ISO 9001 7.6

Here is the scenario. We build a product for our customer. The customer consigns the test equipment which may be a computer with test software installed. The test procedure says to turn on the computer, install a device to be tested and click on an icon. If the computer says pass then the device is good. If the computer says fail then the device is not good.
With what I know; I have a computer and it has software.
And what I don?t know; what the requirements of the computer are, what the software is doing or what the customer (supplier and owner of the computer and software) has done to verify or validate the test.
My question is; what is my responsibility in my QMS to satisfy the requirements of ISO9001:2008 7.6?

If the test equipment is provided to you by the customer as part of the verification of product for that customer, the customer bears the responsibility for ensuring it can adequately satisfy the requirements for which it is intended. If the customer did not provide you with any other information on the test gear or its functions, they cannot expect you to be responsible for verification or validation of the test.

The monitoring and measuring requirements are stipulated by the customer and are clear from your post: "turn on the computer, install a device to be tested and click on an icon. If the computer says pass then the device is good. If the computer says fail then the device is not good."

Any other wording in the contract?

 

[insect warfare]

Re: Complying with ISO 9001 7.6

Your test procedure should be all you need to show compliance to 7.6. It is the basis used for verification, and it is recorded per subparagraph (a). If the software itself or its configuration changes (such as a new SW version or bundle is made available by the customer) then the test procedure can simply be updated to include the new requirements.

The part of 7.6 dealing with "the ability of computer software to satisy the intended application" would also tie in with 7.5.4 Customer Property, since your customer provides the software and equipment, and they must be maintained in accordance with those requirements, plus any other applicable customer requirements.

Brian

 

[nmcelrath]

Re: Complying with ISO 9001 7.6

Thank you to all who posted. I believe this dicussion has provided me a sound understanding.