Control of Monitoring & Measuring Devices

[AnneG]

Conrol of Monitoring & Measuring Devices

How do you apply Section 7.6 Control of Monitoring and Measuring Devices of the standard, where the product being produced is a software product? To design, develop, code, test, deliver, etc., this software product, there are no monitoring or measuring devices used, or needed, to provide evidence of conformity of the product to determine requirements.

 

[tomvehoski]

If you don't use monitoring or measuring devices, you can exclude the requirements. I am working with a software company now and this is the approach we are taking. I have also excluded it several times for operations that rely only on visual inspection.

In you policy manual just put something to the effect "There are no monitoring or measuring devices required for our products, therefore the requirements of ISO 9001: 2000 section 7.6 have been excluded from the scope of the quality system. In the event measuring or monitoring devices are incorporated in the system at a later date, the appropriate requirements will be implemented."

We are also considering excluding purchasing since we have determined that there are no critical purchased products for writing custom software applications. I will probably leave it in since there is a good chance they will be outsourcing web hosting or similar services that will be deemed critical.

Hope this helps,

Tom

 

[Marc]

Also see:

https://elsmar.com/elsmarqualityforum/showthread.php?s=&threadid=2687

and

https://elsmar.com/elsmarqualityforum/showthread.php?s=&threadid=4535