ISO 15189:2022 - Medical Laboratories Internal Auditor Quiz 01 26Jul25 - Practice Quiz

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Question 1 of 30

An internal auditor is reviewing the laboratory information management system (LIMS) at a clinical diagnostics facility. The auditor notes that while the LIMS effectively manages patient data and test results, there are no documented procedures for regular system validation or comprehensive audit trails for data modifications. The laboratory director states that the system was purchased from a reputable vendor and is widely used in the industry. Which of the following findings would represent the most significant non-conformity with ISO 15189:2022 requirements regarding data integrity and system management?

Lack of documented validation of the LIMS and absence of a comprehensive audit trail for data alterations.

The LIMS is not integrated with the laboratory's quality management system documentation.

The laboratory uses a proprietary software solution not commonly found in the market.

The LIMS does not offer advanced predictive analytics for workload forecasting.

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