ISO 9001 Calibration Requirements
- Clause 7.1.2 People.
- Clause 7.1.4 Environment for the operation of processes.
- Clause 184.108.40.206 General monitoring and measuring requirements
- Clause 220.127.116.11 Measurement traceability.
- Clause 7.2 Competence.
- Clause 9.1.1 General requirements for monitoring, measurement, analysis, and evaluation
Clause 7.1.4 Environment for the operation of processes
This clause necessitates the monitoring and control of the environment in order for calibration to be performed correctly. Environmental conditions that influence the final output of calibration results should be monitored and controlled, as per ISO 17025 requirements.
The following are some examples of environmental conditions that we must monitor and control:
Not all of the items listed above must be controlled at the same time in a lab. This is determined by the criticality and the impact it can have on the calibration process.
Temperature and humidity are the two environmental conditions that are always controlled because almost all instruments require them for proper operation, as detailed in their specifications.
Clause 7.1.5. monitoring and measuring requirements
“It is either we perform a measurement to monitor and control a process or we perform measurement for verification of the output of our process.”
Keeping this in mind, all monitoring and measurement instruments should be controlled.
- The instrument to be used should be suitable. Suitable means it covers the range and accuracy requirement. For every monitoring and measuring instrument we use, we should ensure that the usable range can be covered and as much as possible, it has higher accuracy than the process to be measured. Recommended is to maintain the Test Uncertainty Ratio.
- Every monitoring and measuring instrument should be maintained to ensure confidence while using or within its calibration interval. Maintained means:
Clause 7.2 Competence
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