Procedure for impartiality

Thank you for your comments. You said:

From my point of view, one item which is not fully covered in the suite of templates is a procedure to define how impartiality is dealt with (reference 17025:4.1.4).

To reply to the above, note that the structure of the toolkit includes the Quality Policy and Quality Manual. The Quality Policy documents the commitment to ensuring impartiality, through the process of continually identifying risks to its impartiality and taking appropriate action to mitigate them. As there is no mandatory requirement for an Impartiality procedure, the requirements of impartiality are covered in the Quality Manual. Safeguarding impartiality is approached the same way as other risks and opportunities related to the Quality Management System, documented in the procedure Addressing Risks and Opportunities. It is important that it is integrated there, as impartiality and confidentially are key components of all laboratory risks. The procedure states that the following question should be asked during each risk assessment - Is confidentiality and impartiality safeguarded?

You asked:

I guess that the procedural steps would be something like:

• Document anticipated risks which compromise the effective management of impartiality
• Develop counter-measures to those mitigate risks which are currently unacceptable
• Monitor and improve as time goes by, especially by making this an agenda item for management review

Do you have a draft procedure which I could use as a starting point for this area?"

Yes, that is correct. The procedural steps are detailed in the procedure Addressing Risks and Opportunities. This covers Identification, determining the risk level, actions to address risks; and the evaluation of the effectiveness of actions.

The procedure states that the activity takes place on an ongoing basis and identifies the person responsible for identifying risks to impartiality and taking action to safeguard impartiality. The Registry of Key Risks and Opportunities is provided to record the evaluation and monitoring of key risks. You can also customize the procedure and record as suites your laboratory. There are many tools for assessing and evaluating risks and opportunities, so you can add them to your documentation and list them in the table of records in the procedure.

The following ISO 17025 article provides further insight on how to manage risks, applicable to impartiality as well: Five-step laboratory risk management according to ISO 17025:2017 https://advisera.com/17025academy/blog/2019/12/05/iso-17025-risk-management-in-five-steps/

The following may also be of interest: Compliance with the ISO/IEC 17025:2017 requirement for Impartiality https://community.advisera.com/topic/compliance-with-the-isoiec-170252017-requirement-for-impartiality/