Recently, A2LA updated R103 – General Requirements – Proficiency Testing for Conformity Assessment Bodies. Two significant changes include incorporating more credence into interlaboratory comparisons (ILCs) throughout the document and adding a new requirement for conformity assessment bodies (CABs) that are utilizing an ILC. The new addition to R103, section PT6, now requires “CABs performing ILCs other than PT must retain appropriate evidence of the competence of the CAB(s) providing the ILC.” But what does this mean for CABs and what exactly is “appropriate evidence”?
ILCs are not a new thing in the accreditation world. ISO/IEC 17025:2017 emphasizes them in clause 7.7.2, which notes them as a valid option for meeting the requirement to plan for and monitor performance, along with participation in proficiency testing. However, unlike proficiency testing, ILCs are not always performed by an accredited third party. Because of this, CABs and accreditation bodies must ensure the same level of quality is maintained with the utilization of an ILC. This is highlighted in the new PT6, which requires CABs that are participating in ILCs to retain evidence of the competence of the “lead CAB” or the CAB that is running the ILC. While less prescriptive than a proficiency test, an ILC must still be organized and have a predetermined criteria of which an organization must meet.
So, what is “appropriate evidence”? Well, because an organization is choosing to go with an ILC that is not accredited (like a proficiency testing provider might be), the accreditation body must review evidence of the competence of the ILC they choose to participate with. Even if it is the only option, why did an organization decide to participate with a certain CAB (or group of CABs) for their ILC? It’s a requirement for CABs that have chosen a provider outside their organization to obtain a service or product. This all sounds vaguely familiar; something like clause 6.6 in ISO/IEC 17025?
Clause 6.6.1 in ISO/IEC 17025:2017 notes that “The laboratory shall ensure that only suitable externally provided products and services that affect laboratory activities are used, when such products and services: c) are used to support the operation of the laboratory.” Ensuring the validity of the results is critical in supporting the operation of the laboratory, meaning that an organization shall ensure only a suitable ILC is being utilized. Clause 6.6.2 continues on to talk about how a CAB must document their criteria for evaluation, selection, monitoring and re-evaluation of external providers, and then maintain records of all of those items. The records of the evaluation, the selection, the re-evaluation are all very “appropriate” when it comes to maintaining evidence for an ILC. The standard also allows the CAB to dictate and document their requirements for external providers, so they are given some flexibility in what constitutes “appropriate” for an ILC. The power is with the CAB, and as an accreditation body, we simply need to ensure they are retaining appropriate records.
At the end of the day, an ILC can be a great tool for ensuring the validity of the results for a CAB. While they are typically not as structured as a proficiency testing provider, they are a great option for CABs that might be doing a more specialized test or want to do a tighter comparison of their results. CABs should be comfortable taking part in ILCs; we as accreditation providers just want to ensure CABs are considering the competence of the ILCs they take part in and have suitable records available to demonstrate these competencies. This is no different than what CABs are required to do for all other external providers that they utilize. As a CAB, being informed and educated on these requirements aids in getting the most out of an ILC or a PT, and in turn leads to a higher level of assurance as to the competency of your organization and to the validity of reported results for your customers.
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