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ISO9001 and The Monitoring and Measuring Resources

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?

Resources

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.

Now that you have the right tool for the job do you have a program in place to maintain the devices to ensure that they are still fit for purpose? This typically means you need some form maintenance plan for your devices and you need to keep this documented information as evidence that you have been doing what you say and the equipment does indeed meet the specification requirements.

Measurement Traceability

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.

In fact, there is a requirement for the organisation to remove from operation any device that is damaged, suspected of giving a false reading or out of calibration. As part of this, you need to be able to trace the parts that have been tested/manufactured with this device back to it's last known good state which the date of the last calibration would typically be. This should form part of your thinking when you are working out how frequently you should be recalibrating items and what your maintenance/inspection routines would be for them.
Again you must document the calibration status of the device and track when it is due to be recalibrated, this can be tricky if you have a large (or even a small) number of devices and perhaps only 1 or 2 of a specific type that you just can't take out of operation. Organisations typically use some form of database to manage this and hope that people review it. This is a great example of where the MANGO system can help where it can both track your devices, hold all the maintenance records, the device history and alert you in advance of when work needs doing.

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.

Safe Guard from Adjustment

 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.

Software

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.

Summary

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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ISO9001 and Organisational Knowledge
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Monday, 20 May 2019

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