And now, for the rest of the related findings for equipment as most often cited in accreditation audits....
In August 2019, we explored the first 2 of 5 findings regarding equipment when assessed to ISO/IEC 17025:
1. Verifying Equipment (6.4.4)
2. Labeling (6.4.8)
And remember to save $200 instead of buying ISO/IEC Guide 99:2007, just download the same thing for FREE at: https://www.bipm.org/en/publications/guides/vim.html).
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Here are the top equipment findings #3 through #5:
3. Handling (6.4.3)
However equipment are handled, stored, used, maintained, transported, there must be a procedure that details these so the equipment doesn’t become contaminated or damaged and that it functions properly.
4. Performing Calibrations (6.4.6)
Do you know which equipment need calibration and on-going verification?
Not all equipment needs to be calibrated. Ask yourself this – does either the measurement accuracy or the measurement uncertainty affect the validity of reported results? If there are direct, indirect, and calculations made by the equipment’s measurement results, then there’s a very good chance it requires calibration.
Invest your time, money, and resources to calibrate the equipment that require it.
Measurement uncertainty, as part of calibration, is required to establish metrological traceability of reported results.
HINT: Using your free copy of JCGM 200:2012 (the VIM), you’ll see that metrological traceability is defined as “property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty.”
5. Retaining Records (6.4.13)
Just as an auditor must have a written reference against which to write a finding (’if they can’t cite it, they can’t write it’), there must be records retained for equipment where they can influence laboratory activities. These records must have enough information so that one can easily interpret what was done to what, by whom, when, where, and what the results were.
To quote another audit saying, “If it's not written down, then it didn’t happen.”
In addition to recording equipment information, these records need to be legible and readily accessible. Records can be electronic or paper-based. It depends on your capabilities, needs, and risks.
By making sure you’re meeting all of the ISO/IEC 17025:2017 requirements, you’re on your way to better measurements, fewer audit findings, and happier customers. By reducing and controlling risk, you reduce and control costs. This will save you money.
Want to save more money? Contact me and set up a consultation. Let Heather Wade Group, LLC be your first choice pain relief for your measurement (and equipment) headaches.