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Impartiality is the presence of objectivity. In the context of the owner being the lab manager this means that through the recruitment and management of personnel, taking on and dealing with external providers of services and clients , the manager /owner needs to show awareness of impartiality risks, commitment and fair unbiased behaviour. This is to ensure that the outcome or result of an activity is not compromised by a situation or action of the owner.
Have a look at the article How to ensure impartiality in an ISO 17025 laboratory at https://advisera.com/17025academy/blog/2020/10/12/ensuring-impartiality-in-an-iso-17025-laboratory/ for further guidance.
Meeting requirements for impartiality is about firstly structuring the organisational responsibilities and management to safeguard impartiality, then identifying and eliminating impartiality risks on an ongoing basis.
An independent auditor is essential and appointment of a (contract) independent quality manager would be a good mitigation of this risk. This is the best approach by having an organisational structure that safeguards and avoids any conflict of interest all risk to impartiality.
The managers commitment to safeguarding impartiality must be aligned to the objectives of the laboratory. This can be shown through a statement in the quality policy, ongoing discussions about impartiality with personnel, performing risk assessments and discussion in Management reviews.
Lastly, it is essential to have a positive culture about quality so that personnel reporting to the manager are given the responsibility and authority to safeguard the quality and objectives of the laboratory. If for example, the owner decides to procure inferior quality reagents from a family member, this is an obvious risk to impartiality and risk to the quality of the laboratory results. In this case independent people (personnel and/or contract Quality manager) should be responsible for review of client contracts and new supplier and should be able to bring it to the owner / manager without any consequences.
The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/ may also be useful.
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Jul 29, 2021