When a standard refers to the requirements in another standard, how far should organizations and assessors go to meet the “relevant requirements”?
The new ISO/IEC 17043 standard for proficiency testing (PT) providers was published May 2023; and while these updates mainly aligned the standard with the new format featuring eight sections, there are also a few new requirements for proficiency testing providers.
Two of these requirements are nestled in the beginning of section 6 and detail the requirements for testing of PT items and for the production of PT items. Not only has ISO/IEC 17043 created new conditions for PT test items, but it also refers to two different ISO standards. This is not the first time an ISO standard has called out another, but when these instances occur, how do organizations properly meet these requirements?
There are three main standards that ask organizations to meet the requirements of another standard: ISO/IEC 17065, ISO 17034, and ISO/IEC 17043. All three standards require that the organization abide by the “relevant requirements” of whatever standard they require.
This wording— relevant requirements or applicable requirements—first appears in ISO/IEC 17065 and is intentionally vague, spurring questions like, “What makes a requirement relevant to an organization?”, “Who makes that determination?”, and “How is that accounted for in an assessment?” However, the answers to these questions can differ based on the standard that an organization wishes to be accredited for. All three standards have a bit of a different view on how to determine relevancy in these standards within standards.
Standards in ISO/IEC 17065
Sections 6.2.1 and 6.2.2 of ISO/IEC 17065 call out a variety of other standards. When the product certification body (PCB) has evaluation activities that must be performed, those must meet the applicable requirements of either ISO/IEC 17025 for testing and calibration, ISO/IEC 17020 for inspection, or ISO/IEC 17021 for management system auditing.
For PCBs, the “applicable requirements” are very straightforward; they mainly come from the regulators and the certification schemes themselves. The vague language allows the requirements to be both defined and flexible depending on the scheme or the regulatory body administering the scheme. The product certification body will simply need to look for what is written in the scheme itself. It also helps in having some ubiquity across all product certification bodies and accreditation bodies in assessing and being assessed to this clause.
Standards in ISO 17034
ISO 17034 references ISO/IEC 17025 in section 7.6 where it notes “The RMP (reference material producer) shall ensure that the relevant requirements of ISO/IEC 17025 are met with respect to calibration and testing.”
Reference materials and certified reference materials are utilized by testing and calibration labs, and because of this, they are made to have specific values and to have their production be traceable to a National Metrological Institute, such as NIST.
In testing for those values, ISO 17034 references ISO/IEC 17025 to ensure that the RMP considers how they might select the test method, ensure their equipment is calibrated and verified, and ensure that the individuals are trained in a way that makes sense for testing and calibration labs accredited to ISO/IEC 17025. However, unlike ISO/IEC 17065, there are not many regulators or schemes that dictate exactly what those requirements are. The RMP will need to understand what materials they are looking to make, what values they want those materials to have, and what traceability they will need before working with their accreditation body and assessor to ensure that they fit the purpose of the RMP.
Standards in ISO/IEC 17043
Lastly, the new ISO/IEC 17043 published in 2023 has invoked both ISO 17034 in section 6.1.3 and ISO/IEC 17025 in section 6.1.2. These are new requirements for the standard and better describe what Proficiency Testing Providers (PTPs) must consider if they are creating their own PT test items and testing those items for their characterization or homogeneity and stability.
PTPs not only need to know requirements from their own standard, but they will also need to be familiar with the other two to ensure that they are meeting the requirements of accreditation. The requirements they specifically need to be familiar with will depend on the PT scheme that they wish to provide.
Like ISO 17034, there are no major regulators or stated requirements for PTPs. They must consider their own PT schemes and what those will require for them to be successful. What range of values does the PT provider want to present in their scheme? What type of test item will it be? How do we show that these items are homogenous so that all participants can get similar results? Those are a few of the questions that can lead to a PTP understanding what requirements are necessary to meet the standards within the standard.
Assessing to Multiple Standards
Assessing multiple standards is something that many assessors are able to do and with ISO making efforts to harmonize their standards, it is becoming easier to cover a couple during one assessment. However, with the three standards discussed here (ISO/IEC 17065, ISO 17034, and ISO/IEC 17043), the use of “relevant requirements” or “applicable requirements” can make things a little less definitive.
ISO/IEC 17065 can usually rely on the certification scheme or the regulator requirements, but ISO 17034 and ISO/IEC 17043 both require a conversation between the organization and the assessor. The RMP or PTP will need to discuss what requirements they are meeting and why they think those are the relevant ones. In turn, the assessor will need to listen and review the information that aligns with what the RMP or PTP has stated. This process requires the assessors to be knowledgeable not only in the requested standard (be it ISO 17034 or ISO/IEC 17043) but also in ISO/IEC 17025, along with having knowledge of the material being created or the PT scheme being offered. The expertise of the assessor and their ability to communicate with the organization is key for deciphering these clauses.
It is strange to think about an organization needing to know a standard that they are not accredited to, but as shown in ISO 17034, ISO/IEC 17065, and ISO/IEC 17043, there are situations when it is required.
Organizations in the RMP and PTP world often choose to become accredited to ISO/IEC 17025 (and ISO 17034 for PTP) for the sake of simplicity and allows them other avenues of services for their organization to offer. Others choose to outsource and will contract the creation of their PT test item, or the testing of their created reference materials or item. These are both valid options, but the organization must get work done from someone who is meeting the requirements that they have deemed necessary. Although it can seem a little confusing at first, once organizations think deeply about their work, they often find that the “relevant requirements” are pretty easy to determine and defend.
For more information about these standards, or to learn more about A2LA’s accreditation programs, contact us at info@A2LA.org!