ISO 17025-2017. 4.1.1 “Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality.”
Impartiality, as emphasized in ISO 17025, refers to the quality of being independent, unbiased, and free from conflicts of interest. It is an essential element in laboratory operations to ensure the integrity and credibility of the results generated. The standard requires laboratories to establish and maintain a management system that safeguards impartiality throughout all aspects of their activities.
To fulfill the requirement of impartiality, laboratories should implement several key practices:
Independence: The laboratory should have autonomy in decision-making processes and operate independently from any external influences that could compromise its impartiality. This includes maintaining independence from any undue commercial, financial, or other pressures that could affect the quality or integrity of the testing or calibration activities. Independence needs to be evaluated and the statement needs to be incorporated into the Quality System
Conflict of Interest Management: Laboratories should identify and evaluate any potential or actual conflicts of interest that could arise within their operations. This involves establishing policies and procedures to disclose and address conflicts, ensuring that personnel involved in testing or calibration activities are not influenced by conflicting interests that may compromise impartiality.
Impartiality Policy: The laboratory should develop and implement an impartiality policy that outlines its commitment to impartiality and describes the measures in place to achieve and maintain it. This policy should be communicated to all personnel within the organization and made available to relevant stakeholders. The signed statement on impartiality must be filed with other employees’ documents.
Organizational Structure and Reporting Lines: The laboratory’s organizational structure should be designed in a way that supports impartiality. This includes clearly defining roles, responsibilities, and reporting lines to minimize the potential for bias or undue influence in decision-making processes.
Risk Assessment: Laboratories should conduct regular risk assessments to identify potential threats to impartiality and implement appropriate controls to mitigate those risks. Usually, the evaluation of risks is performed annually. This may include evaluating relationships with clients, suppliers, and other relevant parties, as well as family relationships within the company, to ensure that they do not compromise impartiality.
By adhering to these principles, laboratories can establish a culture of impartiality and maintain the integrity of their testing or calibration activities. Quality control consultants must work closely with laboratories to ensure that these requirements are understood, implemented effectively, and continuously monitored for compliance with ISO 17025 standards.
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