Article written by PCI, a subsidiary of FCX Performance, Inc.
Measurement is important in any industry but without calibration and traceability, it is an unreliable science. Thus, in the human condition, pharmaceutical, biotechnology, medical device, and clinical research industries, calibration services are essential for their equipment to produce accurate and complete measurement data. Without instrumentation calibration, equipment like pressure gauges and temperature sensors can drift over time, becoming unreliable and producing inaccurate data.
To prevent drift and other safety issues, there are two options for calibrations: accredited and non-accredited calibrations. PCI is an ISO:17025 accredited calibration provider. The certification provides peace of mind to our customers, ensuring their equipment operates effectively through scheduled monitoring and precise calibration. All calibrations performed out of PCI are traceable to NIST standard to accommodate customer’s calibration requirements. However, there are key differences between requiring an accredited or non-accredited calibration, but how do you know which one is right for your instrument? Let’s begin!
What are Accredited Calibration Services?
Accredited calibrations can only be performed by vendors who have earned the certification granted by an accrediting body. The accrediting body determines if the calibration provider meets the general requirements and international standards of ISO:17025. If the calibration providers prove the competence of their testing and calibration laboratories, they are awarded the ISO:17025 certification. Perry Johnson Laboratory Accreditation, Inc granted PCI the ISO:17025 Certificate of Accreditation; allowing us to offer the highest quality of calibration services to our customers.
What are Non-Accredited Calibration Services?
Non-Accredited calibration can be referred to as NIST traceable calibration, commercial calibration, or standard calibration. Non-accredited calibration relies on the accuracy of lab equipment available at the calibration lab. It is not required to have any formal quality system in place when you receive this type of calibration service. Therefore, non-accredited calibrations are not performed under the specific guidelines outlined in ISO:17025.
How Do I Know if I Need an Accredited Calibration?
To determine if you need an accredited calibration, know what your quality policy is and whether or not you require measurement uncertainties.
Your quality policy can be found within your quality management system, and it should clearly state when your equipment requires accredited calibration. When it is not required, your quality statement might read “Calibrations should contain As-Found, As-Left data and be NIST traceable...” or "Calibrations should be performed by an ISO 17025 Accredited lab..." to indicate a standard calibration is sufficient.
Secondly, if you require measurement uncertainty (MU), then you will need an accredited calibration for your equipment. Measurement uncertainty determines the potential margin of error within a measurement. It represents the doubt, or uncertainty, of your measurement during calibration and can be combined with the lab’s stated error range to decide if the standard produced is in or out of tolerance for the instrument you need calibrated.
Surprisingly, most calibrations do not need to be accredited. It is still good practice to use a lab that is ISO:17025 accredited for non-accredited calibrations if your company does not require accredited calibration for your instruments. In an ISO:17025 lab, their quality management system has been evaluated, technicians have been deemed competent to perform calibrations and the independent accrediting body has determined that their organization is making traceable measurements.
For a simple check, use the chart below to determine whether your instrumentation requires accredited or non-accredited calibration:
| Non-Accredited, or NIST Traceable | Accredited Calibrations |
| ‘as-found’ and ‘as-left’ measurement data | ‘as-found’ and ‘as-left’ measurement data |
| Standards traceable to NIST | Standards traceable to NIST |
| Measurement Uncertainty Values | |
| Accreditation Logo |
Calibration is very important to equipment safety and accuracy. Out-of-tolerance instruments can lead to unreliable products and dissatisfied customers. Using an ISO 17025 accredited lab is still recommended for non-accredited calibrations to save time on auditing labs and producing proof of measurement traceability.
In any case, an effective calibration program should boost customer and regulatory satisfaction, confidence in the product quality, reduce down-time, and maximize the equipment’s useful life. Whether you need an accredited or non-accreted calibration, PCI cares about the quality and reliability of your instruments and will offer the best possible service to ensure you are satisfied with your calibration.
