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ISO 15189 Requirements

ISO 15189 Requirements

Requirement:

Design internal quality control systems to verify the intended quality of results.

  • Intralaboratory Reports and Charts:

    Point Data Report

    Summary Data Report

    Supervisor's Report

    Operator Report

    Data Review Report

    Levey-Jennings Chart

  • Unity™ Interlaboratory Reports:

    Monthly Evaluation Report

    Data Rejection Report

    Laboratory Performance Overview

    Laboratory Comparison Report

    Laboratory Histogram Report

    Bias and Imprecision Histogram

    Statistical Profile Report

    Affiliated Data Exception Report

    Affiliated Laboratory Comparison Report

  • InstantQC™ Reports and Charts:

    InstantQC Report

    InstantQC Chart

Requirement:

Provide staff members with clear and easily understood information on which to base technical and medical decisions.

  • Intralaboratory Reports and Charts:

    Point Data Report

    Summary Data Report

    Supervisor's Report

    Operator Report

    Data Review Report

    Levey-Jennings Chart

  • Unity™ Interlaboratory Reports:

    Monthly Evaluation Report

    Data Rejection Report

    Laboratory Performance Overview

    Laboratory Comparison Report

    Laboratory Histogram Report

    Bias and Imprecision Histogram

    Statistical Profile Report

    Affiliated Data Exception Report

    Affiliated Laboratory Comparison Report

  • InstantQC™ Reports and Charts:

    InstantQC Report

    InstantQC Chart