ISO/IEC 17025:2017 vs ISO 8655:2022: Pharmaceutical Considerations for Pipette Calibration
A very commonly asked question is “Is your pipette calibration lab accredited to ISO 8655:2022 for pipette calibration?”. It’s a simple question with a misleading answer. No, pipette calibration labs do not get accredited for standard calibration methods like “ISO 8655:2022;” they get accredited for “ISO/IEC 17025:2017”. However, the lab is accredited to ISO/IEC 17025:2017, and in their Scope of Accreditation, they may list ISO 8655:2022 as a reference method, along with their pipette calibration capabilities. You might be wondering what the difference between these two ISO standards is, and what a Scope of Accreditation document is.
In this post, we will discuss what ISO/IEC 17025:2017 accreditation is and why it remains an important consideration when selecting calibration providers. We will also discuss what calibration reference methods, such as ISO 8655, are and how they are different from ISO/IEC 17025:2017. There will also be a section on how a reference method like ISO 8655:2022 and labs’ ISO/IEC 17025:2017 capabilities can overlap, and how you can check labs’ capabilities (Scope of Accreditation) to see which calibration method they use.
What ISO/IEC 17025:2017 Actually Covers (and What It Doesn’t)
What it means for a lab to have ISO/IEC 17025:2017 accreditation is that it has undergone a surveillance audit demonstrating to an accreditation body that it meets the minimum requirements detailed in the ISO/IEC 17025:2017 standard. An accreditation company is a company qualified to determine whether labs meet the requirements of ISO/IEC 17025:2017. The accreditation company sends an auditor to the laboratory to perform a surveillance audit and award the lab accreditation status.
What are some of the requirements of the ISO/IEC 17025:2017 standard:
There are too many requirements to list here. Still, the list above demonstrates that when a lab is ISO/IEC 17025:2017 accredited, it must meet many requirements to report accredited calibration results to its customers.
See our previous blog for more information about why it’s important to outsource calibrations to an ISO 17025 accredited laboratory: https://biocalibrationcompany.com/blog/accredited-labs-for-calibration-services-versus-non-accredited
What ISO/IEC 17025:2017 doesn’t cover:
Recall, that ISO/IEC 17025:2017 is not a calibration method or test procedure. Labs that are accredited to ISO/IEC 17025:2017 may or may not use the method that you want them to when performing calibrations, such as pipette calibrations. ISO/IEC 17025:2017 accreditation is something to look for when selecting calibration providers but remember that when you require a specific calibration method or specific decision criteria, you must look further than the lab just having the ISO/IEC 17025:2017certificate.
What is ISO 8655:2022, and Why It Keeps Showing Up in Pipette Discussions
ISO 8655:2022 – Piston-Operated Volumetric Apparatus Collection is also a standard, but it’s a reference method for calibration labs to follow when performing pipette calibrations.
This is why a laboratory is not accredited to ISO 8655:2022; however, they may reference this method on their capabilities document. This document is known as the Scope of Accreditation. The scope of accreditation is a document approved by an accreditation body when a lab is accredited to the ISO/IEC 17025:2017 standard. For example, if we look at Bio Calibration Companies Scope of Accreditation:
This document demonstrates that the lab is ISO/IEC 17025:2017 compliant for Piston Operated Volumetric Apparatus. The highlighted column also shows that they reference ISO 8655:2022 as their calibration procedure. This is the crucial thing to look at. In this case, Bio Calibration Company is using ISO 8655:2022 for pipette calibration. Other labs, however, may have a different method listed in this column. In that case, it is worth investigating whether the lab’s calibration methods are suitable for your case.
It’s important to determine what methods calibration labs are using and if they are suitable for your needs. This is a great example of referencing ISO 8655:2022 for calibration, as it communicates to potential customers that Bio Calibration Company is ISO/IEC 17025:2017 compliant and uses the ISO 8655:2022 method for calibration.
More about the ISO 8655:2022 Standard
The standard calibration method ISO 8655:2022 defines the following:
The definitions of ISO 8655:2022 listed above are why many pharmaceutical companies seeking pipette calibration ask whether the lab is “accredited” to ISO 8655:2022. Which we now know is not the correct question to ask. The better question is, does your lab perform calibrations using the method ISO 8655:2022, or is ISO 8655:2022 listed on your lab’s Scope of Accreditation (if you are asking for an ISO/IEC 17025:2017 accredited laboratory)? Bio Calibration Company performs calibrations according to this standard and uses the specification limits for random and systematic errors to determine whether your pipettes are within tolerance.
What Pharma Should Ask Pipette Calibration Providers
Pipette Calibration Service Standards
In the end, ISO/IEC 17025:2017 and ISO 8655:2022 are not competing standards and they are not interchangeable. ISO/IEC 17025:2017 indicates whether a lab operates under a quality system that ensures competency, traceability, validated methods, and reliable reporting. ISO 8655:2022 is the actual method that defines how pipette calibration must be performed. When a pharma team is evaluating calibration providers, both pieces matter. You need to know whether the lab is accredited to ISO/IEC 17025:2017, and confirm that ISO 8655:2022 is the method they use for pipette work. The only way to verify this is to review the lab’s Scope of Accreditation and check the method listed under their pipette capabilities. If ISO 8655:2022 is referenced, you know exactly how they are performing the calibration and what tolerances they are using. If it isn’t, you know to ask more questions. Understanding this difference helps you pick a calibration provider that will meet your compliance needs and support your quality system without any surprises.