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How do you audit impartiality
Auditing impartiality involves systematically determining the extent to which the requirements for safegaurding impartiality are met. i.e. needs identified, processes in place. This is achieved by stating each clause requirement as audit criteria, obtaining objective evidence and evaluating it to confirm conformity or not. Objective evidence is data that supports the existence of something. The evidence itself is usually a document, record or could be a statement of fact, for example, “at the time of the audit, the Quality Policy was displayed in the laboratory". In an audit, evidence can be obtained through various means, for example document review, or interviews and observation. What you need to look for is covered in the answer below.
how do you ensure impartiality in a testing laboratory according to ISO17025:2017?"
Impartiality is important to maintain the trust and confidence of customers and other involved parties. It means that a laboratory must not be influenced or appear to be influenced in any way that would affect laboratory activities. These activities include processes of the ISO 17025 management system, including for example procurement and maintenance. A laboratory must structure the organization and activities in a way that will safeguard impartiality – i.e. not allow commercial, financial, or other pressures to compromise the quality of results or objectives.
To achieve this:
- Avoid potential conflict of interest and ensure fairness / unbiased actions by structuring the laboratory and greater organization reporting lines to ensure independence.
- Structure Management commitment by establishing an impartiality policy, facilitating training, developing the quality culture, including communicating the importance of safeguarding impartiality. Keep records to provide evidence.
- Perform risk and opportunity assessments to identify where risks may arise and opportunities for improvement and minimizing or eliminating risks to impartiality.
- Include impartiality in Management Review discussion of policies, risk assessments and other activities.
- Establish processes to identify and evaluate ongoing threats to impartiality through for example, internal audits, root cause analysis and effective corrective actions, including management support of the corrective action process.
The ISO 17025 toolkit at https://advisera.com/17025academy/iso-17025-documentation-toolkit/, covers this requirement; specifically through the Quality Manual https://advisera.com/17025academy/documentation/quality-manual/ and the ISO 17025 document template: Addressing Risks and Opportunities Procedure at https://advisera.com/17025academy/documentation/addressing-risks-and-opportunities-procedure/
For more information, have a look at other advice answers on the topic of impartiality:
- Assuring impartiality and confidentiality - https://community.advisera.com/topic/assuring-impartiality-and-confidentiality/
- Compliance with the ISO/IEC 17025:2017 requirement for Impartiality - https://community.advisera.com/topic/compliance-with-the-isoiec-170252017-requirement-for-impartiality/
- Procedure for impartiality - https://community.advisera.com/topic/procedure-for-impartiality/
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Jun 10, 2020