What is impartiality in ISO 17025?

What is impartiality in ISO 17025? Did you know? Many in industry and society are interested in the question of “impartiality“ when it used to describe an entity being independent of undue influence by interest groups.

Achieving and maintaining ISO 17025 accreditation requires that you be both technically competent and impartial. This article provided an overview of what “impartiality” means in ISO 17025 and how this applies in practice within an organization. It also provided some suggestions on how to achieve and maintain impartiality in your laboratory.

Under ISO 17025, the concept of impartiality carries a significantly different meaning than what is found in industry and society. This article describes the nature of impartiality as it is used in ISO 17025 and how it impacts the work of an accreditation lab.

What is impartiality?

In brief, it is the absence of bias. Does that mean that you remove all traces of individual opinion from your work? Not at all. Impartiality is about the absence of bias, not lack of opinion.

Is impartiality a core standard requirement in ISO/IEC 17025? Yes. Impartiality is defined very specifically and appears in the glossary:

“Independence: freedom from influences that might affect impartiality, including those that could arise from undue pressures or inducements, conflict of interest, and personal, financial, or other non-professional considerations. The crucial factor is the absence of bias, not the absence of more subtle influences, such as those relating to an individual’s education, training, and experience.”

What are some examples of the influence that might make it difficult to be impartial?

An organization carries on business activities that are affected by national or international government policies. There is a significant amount of government funding involved in the operation or qualification of the organization’s product or activity. The organization belongs to an industry association that is actively engaged with government regulators. There are key individuals in the organization who have been directly or indirectly involved in creating the organization’s standards. These people also have significant ongoing interactions with government regulators.

What would happen if you were not impartial?

The credibility of your work and your organization could be damaged. In some cases, your accreditation decisions could lose all credibility. In other cases, you could lose the trust and confidence of your stakeholders. Either way, you would not be operating in accordance with ISO 17025.

Is impartiality in ISO 17025 even possible to achieve?

Scientific and technical organizations are rarely 100% impartial when it comes to their work. Even the most independent of standards committees will likely have had ongoing interactions with industry and government regulators. So, how can they be impartial?

ISO 17025 provides a clear definition of impartiality. This definition is based on the nature of the conflict of interest and undue influence, not the kind (or lack of kind) of interactions one has with outside stakeholders.

How can we achieve impartiality within our organization?

First of all, you have to understand what influences your organization’s work and how these could impact your decisions. You must educate yourself and other key personnel on the concept of impartiality as it is used in ISO 17025. You must also have a written policy on impartiality that can be communicated to employees and stakeholders.

The next step is to put your procedures in place so that potential influences are identified and managed. For example, you could develop systems for conflict of interest declarations and/or potential future interactions with your organization or standards writing group.

What you decide to do will depend on the nature of your organization, the nature of the development of your standard, and work with outside stakeholders. You may find that you have no need for any additional procedures or policies. If this is the case, that is fine. What is most important is that you understand what influences your organization’s work and how these could impact your decisions. You must educate yourself and other key personnel on the concept of impartiality as it is used in ISO 17025. You must also have a written policy on impartiality that can be communicated to employees and stakeholders.

How to achieve impartiality in laboratories?

At the heart of ISO 17025 is a system for achieving impartiality. It begins with a clearly defined scope for the work that is being qualified. The scope should be rigorously and impartially defined. There are then specific procedures to ensure that all work carried out under the scope meets and maintains the appropriate level of quality. The overall procedure should then be independently audited and documented. And finally, at least annually, accreditation bodies must carry out an evaluation to confirm that all requirements within this system are being met.

The key point here is that impartiality is a fundamental part of ISO 17025 and how it works in practice. As an accredited laboratory, you are required to demonstrate your impartiality. It is not enough to just claim that you are impartial. You must be able to back it up with the appropriate policies, procedures and documentation. Otherwise, there is a risk that your accreditation will become invalid.