The last paragraph of ISO 9001 section 7.6 is often overlooked, perhaps because the requirements are easily misunderstood. Dan Nelson of Cavendish Scott (www.cavendishscott.com) has provided us a worthwhile discussion on confirmation of the ability of software to satisfy its intended application.

ISO 9001:2000, 7.6 (final paragraph) states: 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.

This requirement can be broken down into three portions:

1) When used in the monitoring and measurement of specified requirements . . .
This language scopes the requirement, identifying when it applies. It squarely applies to software that is directly responsible for measuring or monitoring specified requirements. Since it does not distinguish specified product requirements, and states, specified requirements, it can also be applied to software used in monitoring processes in relation to specified performance requirements. For example, software monitoring a process via statistical process control, would be used in the monitoring and measurement of specified requirements. Such software is reasonably subject to the intent of this requirement.

2) . . . the ability of computer software to satisfy the intended application shall be confirmed.
When software is used as described above, the ability of the software to perform as expected must be confirmed. Notice verification or calibration of such software is not required. Instead, it needs to be confirmed. In confirming software, questions that could be confirmed may include:
Is the software suitable for its application?
Does the software adequately measure all parameters identified for its intended use?
Does the software return the correct results based on the provided inputs?

3) This shall be undertaken prior to initial use and reconfirmed as necessary.
Before using software in measurement, it must be confirmed to be capable of measuring that which it is intended to measure (above). Once confirmed and in use, the software needs to be confirmed again whenever modifications are made to it (or to the parameters being measured). Like many of the requirements, this one arises as the result of a known source of error: requirement creep. As new features are added, or as functionality is improved for products, software used to verify conformity to requirements is overlooked and is not updated to measure new or modified parameters. Yet the software is used and considered reliable. So, as products or processes improve and exceed previous requirements, these upgraded requirements may creep toward the limits of the original softwares intended application. So, as products or processes meet new requirements, inspection or test software must be upgraded accordingly.

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