All monitoring and measurement equipment used for product and process verification must be controlled and calibrated against nationally traceable standards at specified intervals.
You should ensure that such devices are available to guarantee continuity of in-process measurement capabilities. All test equipment must be calibrated either:
In either case the basis of calibration must be traceable back to an approved laboratory. You must check the laboratory's credentials, this links to Supplier evaluation.
Monitoring and measuring equipment must be:
Decide what action will be taken where test equipment fails calibration, e.g. decide if a product recall is necessary or try to revalidate previous measurements using calibrated equipment. This links to Control of non-conformance.
Each instrument should be traceable through its own calibration record which contains:
Some organisations do not utilise monitoring and measuring equipment; if this is the case, you are free to exclude this requirement from your quality management system - so long as the excluded requirement does not:
It is not a mandatory requirement to document your control of monitoring and measuring equipment process. However, you should always look to adequately define and control any operational processes that directly impact upon product quality. Therefore, the implementation of a control of monitoring and measuring equipment procedure will be appropriate to most businesses where such activities are undertaken.
Develop and implement a procedure that defines:
We provide a Control of Monitoring and Measuring Equipment Procedure template to help you manage this process in many of our ISO Templates.
The effectiveness of the control of monitoring and measuring equipment process is often determined by how an organisation validates its controlled equipment and how it assures validity of subsequent measurements. The competence of staff using monitoring and measuring equipment is sometimes scrutinised.