Calibration requirements for ISO 9001:2015
ISO 9001:2015 lays out the requirements for organizations utilizing devise that require calibration. While not all organization need calibrated devices for their operations many do.
For organization utilizing devices that require calibration, section 7.1.5 Monitoring and measuring resources will apply. In section 7.1.5.1 General – it states that the organization needs to first determine and provide resources needed to ensure valid and reliable results when monitoring or measuring is used. There are two main requirements in this section:
1) The organization is required to ensure that resources provided are adequate and suitable for the monitoring and measurement being undertaken.
2) Additionally, the organization has to maintain the resources to ensure that these devices are maintained for their purpose.
To determine the resources necessary, it is generally advised to document and catalog all devices at the facility that require calibrations. Once the number and type of devices are determined the resources needed to maintain a calibration program can be determined.
It is required that the organization keep good documentation and records as evidence, as the standard puts it “evidence of fitness of purpose” of these devices requiring calibration. Essentially, you just need to be able to demonstrate that the device is measuring accurately and has been appropriately calibrated so the measurements can be trusted and relied on.
Furthermore, in section 7.1.5.2 Measurement Traceability ISO 9001:2015 further spells out requirements for ensuring the accuracy and precision of the measurements being made. The organization has to ensure the validity of the measurements being made with these calibrated devices. It states: “calibrated or verified, or both, at specific intervals, or prior to use, against measurement standards traceable to international measurement standards…”
When measurement traceability is required by the organization due to the nature of their products and services or customer requirements the organization needs to ensure that measurement standards a traceable to international measurement standards.
Furthermore, the devices need to be identified in order to determine their status as well as safeguarded from adjustments, damage or deterioration that would invalidate the calibration status. Which essentially just means the device should be able to be individually identified with a serial number, model number or device ID and that identification should be tied to its calibration status. The device needs to be treated with care and maintained properly to ensure that measurement results can be trusted. If the device is being moved around the facility and then precision measurements are to be made, then it should be questioned if the device is still calibrated appropriately after moving. In this case, the organization shall validate the measure in so way to ensure the device is still in calibration.
Lastly, if any calibrated device is suspected of being out of calibration that device should be labeled appropriately and/or tagged and removed from service until it has been determined to be in good calibration status and then is maybe restored to service.
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Equipment Calibration Log: Equipment Calibration Log – Wilkshire Consulting Online Store (wilkshire-consulting-online-store.myshopify.com)
Take a look at our past blog post on Iso 9001:2015 Equipment Maintenance for additional information and help! ISO 9001: Quality Management System – Equipment Maintenance (wilkshireconsulting.com)
