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ISO 9000 Quality Systems Handbook, Fifth Edition

Control of measuring and monitoring devices (7.6)

Determining monitoring and measurements to be undertaken (7.6)

The standard requires the organization to identify the monitoring and measurement to be undertaken to provide evidence of conformity of product to determined requirements.

What does this mean?

This requirement should strictly be located in Section 8 but has been included in Section 7 because it is believed that there are some applications where it does not apply. Clearly there are no applications where monitoring and measurement do not apply but there may be applications where physical calibration of measuring devices may not be applicable in the traditional sense of the word devices. The monitoring and measurements referred to are those required to carry out product verification rather than the measurements to calibrate a measuring device. The requirement is under product realization and not a subsection, and therefore applies equally to product or service design, purchasing and production or service delivery. It should not be interpreted as only applying to the characteristics of a product that can be measured through examination. It applies equally to performance characteristics that are inherent in the product design such as durability, safety and security and to intangible characteristics such as courtesy, respect and integrity in service design.

Measurement is the process of associating numbers with physical quantities and phenomena. Measurements may be made by unaided human senses in which case they are often called estimates or, more usually, by the use of instruments, which may range...

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