The #1 ISO/IEC 17025:2017 Accreditation Audit finding is EQUIPMENT.
Test or calibration equipment are still a major part of ISO/IEC 17025:2017 and are, even more so, a challenge for accredited (and in-process of becoming accredited) test and calibration labs. Are you ready? Will you receive audit findings or commendations?
I believe in the Pareto Principle (80:20 rule), so let’s get the most return for our efforts by focusing on the five most-often cited equipment clauses resulting in written audit findings.
Here are the first two of the five most-often cited equipment clauses...
1. Verifying Equipment (6.4.4)
Verification is defined at “provision of objective evidence that a given item fulfils specified requirements”. Source = ISO/IEC Guide 99:2007 International vocabulary of metrology -- Basic and general concepts and associated terms (VIM)
And instead of paying $200 for a copy of ISO/IEC Guide 99:2007, just download for FREE the original document, JCGM 100:2008 (2012) Evaluation of Measurement Data - Guide to the Expression of Uncertainty in Measurement, aka "The GUM". See? You’re saving money already!
Are you verifying the equipment to ensure it conforms to your specified requirements before placing or returning to service?
I often was asked to calibrate equipment, with no information as to how it was to be used and how accurate it needed to be. In these cases, I gave the user the example that I could calibrate a pressure gauge by placing the pressure gauge on a calibrated balance and reporting the gauge’s weight as a calibrated value. Along with estimating the measurement uncertainty, I could provide a valid & traceable calibration. However, not the one they actually needed! The user quickly realized that they needed to tell me they needed the pressure calibrated, in which measurement units, and how accurate it needed to be.
2. Labeling (6.4.8)
Are you labeling or otherwise identifying calibrated equipment so the user can easily identify the calibration or validity status of the equipment?
Can someone pick up a piece of equipment and quickly identify if it is valid for use? It should be!
Labels should include at least the unique identifier of the equipment and calibration due date.
Other info to include on labels: calibration date, initials of person who performed the calibration, company who performed the calibration, calibrated ranges, accuracy, other limits.
Conclusion:
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? Let Heather Wade Group, LLC be your first choice quality solution to your measurement equipment headaches.