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ISO9001:2015 Section 7.1.5 is all about the how you look after measuring devices, calibration and measurement traceability. It's not a massive change from the previous standard but what does it mean and what do you have to do?
Firstly, you need to ensure that you have the resources required to carry out the measurements required by your operation. For instance, if you must weigh things do you have scales that are accurate enough to meet your specification? If you must measure a diameter or length do you have a device that is capable of repeatably and reliably measuring this to the required tolerances? What about temperature? Moisture? And so on. You need the right tool for the job.
Organisations need to determine the amount of measurement traceability that is required and on what devices it is required on. Drivers for the traceability may be regulatory requirements, international standards (ISO / NIST) customer requirements or organisational requirements. There needs to be a process to establish and manage this traceability to ensure that device is in calibration or have been verified while in use.
You should visually identify the devices that are calibrated by using a label showing the calibrated condition, there is no set standard for this but something like the one shown here is typically used as it gives all the information required.
If your device can be adjusted, you know that someone in your organisation is going to adjust it. The standard requires you to safeguard against this happening. This may include lock nuts, tamper proof labels, lock wires and many more options. As part of your maintenance routine, you should be checking these are still in place. Again, if they are in doubt you need to track back to the last known good state and question all products the item has been used on.
Increasingly software is used in measurement systems, you must then, also verify that the software is performing as expected and giving the correct result. It should fall inside your calibration program.
The calibration element of the organisation is frequently one of the tricky ones when it comes to determining what is required. It is good to document your rationale for the decisions that you make. Contract external calibration specialists who can take care of the tricky units and document procedures for any internal calibration work that you do. Finally get a system that will control, track & remind you of what is and isn't calibrated, what needs to be done and what has been done so you can demonstrate historical records.
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