ISO 17025 2017 Impartiality and Confidentiality

ISO 17025 2017 Impartiality and Confidentiality

Chapter 4: General requirements: Impartiality and Confidentiality

4.1 Impartiality

The definition in ISO/IEC 17025 2017 Impartiality  is  “Presence of objectivity“ and is further clarified in a note saying, “Objectivity means that conflicts of interest do not exist, or are resolved so as not to adversely influence subsequent activities of the laboratory.“

In the context of testing or calibration Laboratories, Lab results cannot be influenced, or have the appearance of being influenced by any relationships the laboratory or the people involved in laboratory activities may have with the client.

Laboratory activities also cannot be influenced by any undue pressure being put on the people involved in conducting those laboratory activities.

To safeguard ISO 17025 2017 Impartiality, laboratories shall:

– Establish structure.

– Mitigate pressures.

– Identify & manage risks on an ongoing basis.

Risks may come from…….

– It’s activities.

– It’s relationships.

– The relationship of its personnel.

– The labs should also demonstrate how to minimize or eliminate those risks.

Hom to implement the changes : 

It is recommended to write down a document in which, depending on the needs, the following steps should be included:

• Analysis of potential impartiality risks, including risks arising from the laboratory activities, its relationships, and the relationships of its personnel
• Measures to eliminate or minimize risks concerning impartiality
• Action plan: design and implement pertinent actions
• A commitment of the laboratory to its integrity, through the signature of a statement by the top management

This analysis should be reviewed at the Management review and, if necessary, revised.

4.2 Confidentiality

The lab shall be responsible through legally enforceable commitments for the management of all information obtained during the performance of lab activities.

The customer should be informed in writing if the laboratory intends to make publicly available any information about an assignment.

The laboratory personnel, providers, external personnel, etc. should also sign a confidentiality declaration.

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