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ISO/IEC 17025 Blog

How to ensure impartiality in an ISO 17025 laboratory

If your testing or calibration laboratory is looking to achieve accreditation to ISO/IEC 17025:2017, you may be unclear as to how to practically address the requirement of impartiality and how much effort to go to. This article will assist with this, by providing an overview of what is required by ISO 17025, along with some examples and practical tips.

What is impartiality?

It is crucial upfront to understand the definition of impartiality. Impartiality is simply defined in ISO/IEC 17025 as the presence of objectivity. This means that the outcome or result of an activity is not compromised by a situation or action of a person.

How important is impartiality for accreditation of laboratories?

It is mandatory to identify and address risks to impartiality on an ongoing basis, as part of the general requirements of ISO 17025 implementation. The scope of ISO/IEC 17025:2017 specifically includes impartiality as one of the three elements that the accreditation body will attest to during laboratory accreditation. Along with competence and consistent operation of laboratories, impartiality must be ensured.

The purpose of including the impartiality clause is not only to safeguard the validity of test results or calibration results. The objective is to avoid conflicts of interest and ensure that the management structure, the use of resources, and the execution of processes are implemented and maintained in a way to avoid any compromising situations or actions.

What compromising situations or actions must be avoided?

Compromising situations are any situations that could result in a conflict of interest, prejudice, favoritism, one-sidedness, favor, or bias, and that could result in the laboratory not functioning optimally. The impact could be that policies and objectives are made vulnerable, where they would either be damaged (for example, reputation) or weakened (requirements likely to not be met).
Compromising situations could arise from financial, commercial, or other pressures. Threats to impartiality could arise because of:

  • Governance or ownership structure in terms of laboratory relationships, or the relationships of personnel
  • Relationships and actions of personnel during financial activities involving procurement or tenders and contracts
  • Relationships and actions of personnel during marketing activities
  • Sharing or allocation of resources with other organizations, the laboratory’s organization, or between departments of the laboratory

Five steps to ensure impartiality

A practical approach to meeting the ISO 17025:2017 requirements for impartiality is to address it in five main steps. These are a combination of proactive and reactive steps.

A proactive approach is required through structuring and performing laboratory activities in a way to safeguard impartiality, so that personnel are free from both internal and external pressures that may compromise impartiality. A reactive approach may also be required if risks are not foreseen in advance, and a threat is identified later on.

Steps to ensure impartiality required by ISO 17025


Step 1. Develop a Culture and Awareness of Impartiality

The starting point is awareness and commitment from management:

  • Include impartiality in your Quality Policy or create a separate policy.
  • Allocate resources to develop a culture to strengthen ongoing quality awareness through communication channels and meetings.

Follow with personnel awareness:

  • Use engaging team role playing or case studies to illustrate the impact on the laboratory and personnel themselves.

Step 2. Obtain Personnel Declarations and Commitment

Personnel should sign a code of conduct or some declaration that includes commitment to the impartiality policy. Although prior or current relationships are not necessarily an impartiality risk, possible conflicts of interests should be declared by personnel regarding:

  • Personal relationships – e.g., close family members working in the department they are required to audit, or a spouse or close friend in a position of authority in the procurement department.
  • Prior relationships – e.g., previous employment by a client, supplier, or production department for which the laboratory performs tests.
  • Financial interests – e.g., ownership or shares in a client company, or in a venture related to the test results. For example, a laboratory technician has part ownership in a land development. The engineering company is testing the soil on the site prior to getting permits for the development.
  • All other situations which may reasonably be considered as a possible conflict of interest.

Step 3. Identify and Address Impartiality Risks

Asking personnel to sign a declaration or code of conduct is one action, but not the only action to take. Commitment does not guarantee compliance. Risks to impartiality must be identified on an ongoing basis during routine laboratory activities. This is important as there are ongoing changes to operations, for example taking on new customers, external providers, and personnel, which may result in a new or changed level of risk.

  • Assign management responsibly and empower personnel with training and mentoring to take a risk-based approach to identify and minimize any identified risks.
  • Integrate impartiality risks as part of meeting the requirements of clause 8.5, Actions to address risks and opportunities. Document what you do to safeguard impartiality, identify threats, and minimize or eliminate risks.
  • Perform a specific impartiality risk assessment. Follow your procedure for addressing risks to identify, analyze, and then select suitable actions to treat identified risks.
    For example, in the context of a laboratory that is in a small-town community, a likely source of risk could be due to personal relationships. A risk may be that “the technician performing the test could modify the standard approach, using more resources or manipulating the results to benefit the customer.” Do the assessment and state the controls in place, e.g., “Samples are only identified by bar codes. Technicians do not know who the customers are.” Finally, state if the risk level and controls in place are acceptable, or if further treatment of risk is required. (See webinar How to manage risks in laboratories according to ISO 17025)

Step 4. Safeguard the Impartiality Status

It is important to manage changes in laboratory activities. Safeguard the impartiality status by considering risks to impartiality upfront during activities such as personnel recruitment, client contracts, and evaluating external providers. For example, during contract review, ask and document the absence or presence of risks, accepted level of risk, and any action taken.

Step 5. Monitor Appropriately

Besides risk assessments, identify and safeguard impartiality on a continual basis in an integrated way, during monitoring and assessment activities. This means that these activities should be integrated into other laboratory activities such as quality meetings, internal audits, root cause analysis, corrective action, and review of the management system.

  • Add the following question to your internal audit criteria for each audit: “What controls are implemented to safeguard impartiality of this activity?” Look for evidence that controls are effective, e.g., review nonconforming events and corrective actions, as well as handling of complaints.
  • Interview personnel to see if the level of awareness is acceptable.
  • Review the risk register regularly and update it based on current operations.
  • Ensure that impartiality is given sufficient consideration during management review.

Benefit of a Systematic Approach

Following a practical, stepwise approach makes tackling any new activity easier. Your uncertainty of how to address impartiality will be replaced with confidence. Stating your methodical approach upfront, before getting going, provides assurance to all interested parties that you are committed and have a way to address the issue on hand. Review your process more frequently at the beginning, as this will develop your skill and drive improvements.

To learn more about impartiality and the other requirements of the ISO/IEC 17025 standard, and how to implement them in your laboratory, download this free white paper: Clause-by-clause explanation of ISO 17025:2017.

Advisera Tracey Evans
Author
Tracey Evans
Tracey Evans is an ISO 17025 expert with an MSc degree in Biochemistry, and more than 15 years’ experience in Laboratory Management Systems. This experience includes a variety of testing and calibration laboratories in the pharmaceutical, biotechnology, medical pathology, veterinary, engineering, mining, water and agricultural sectors. Tracey has used her insight into ISO 17025 and ISO 9001 to assist clients in developing and implementing systems, performing method validation and internal audits, addressing risks and opportunities, and achieving ISO 17025 accreditation. Tracey also has a working knowledge of GLP and GCP, and has expertise as an internal auditor for a GCP laboratory.