Hi
Has anyone out there implemented ISO9001:2000 for software providers. I am in the middle of the implementation program and am intrigued by the following two requiremnts

7.5.2 Validation of processes for production and service provision.
I am seeking an exclusion on this one as we test our products in likely client environments in trying to identify bugs when the product is in use. But does this mean the product should be 100% defect free? There could be some client environments which could throw up a bug. We use a risk based approach and it is not possible to test the product in all possible permutations and combinations of environments. We have a robust process for managing bugs reported by clients. Can i claim an exclusion?

7.6 Control of monitoring and measuring devices. I would like to think that calibration is reserved for "physical" equipment. We dont use any physical equipment for monitoring and measuring our software. So i have said i dont need to calibrate or adjust any device. Our software testing tools are validated before they are used in production. Ongoing verification that these tools are doing their job is by verfication of test results and test plans. What do you think?

Hi
Has anyone out there implemented ISO9001:2000 for software providers. I am in the middle of the implementation program and am intrigued by the following two requiremnts

7.5.2 Validation of processes for production and service provision.
I am seeking an exclusion on this one as we test our products in likely client environments in trying to identify bugs when the product is in use. But does this mean the product should be 100% defect free? There could be some client environments which could throw up a bug. We use a risk based approach and it is not possible to test the product in all possible permutations and combinations of environments. We have a robust process for managing bugs reported by clients. Can i claim an exclusion?No, you are mixing up process validation with Design & Development Validation, 7.3.6. &.5.2 deals with the validation of the process used to create the product.

See this thread, Software Validation Processes - Telecommunications software (http://elsmar.com/Forums/showthread.php?t=15524&highlight=software), for a discussion on this subject.

7.6 Control of monitoring and measuring devices. I would like to think that calibration is reserved for "physical" equipment. We dont use any physical equipment for monitoring and measuring our software. So i have said i dont need to calibrate or adjust any device. Our software testing tools are validated before they are used in production. Ongoing verification that these tools are doing their job is by verfication of test results and test plans. What do you think?It's not necessarily "physical equipment". Also covered under 7.6 is software used for this purpose as well. Look at the last part of 7.6.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. I don't think you may take an exclusion to a clause if part of it is applicable. I don't know enough about your operation, so I can't say definitely, but you should look at your processes again.

Hi Al that was extremely useful. Thanks a ton
By the way, how do you search forums by keywords?
Chandra

Hi Al that was extremely useful. Thanks a ton
By the way, how do you search forums by keywords?
ChandraHi and welcome to the Cove. Towards the top right of the page is a search feature.