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    PRD-2

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    surafel

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    PRD-2

    Uploaded by

    surafel
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    3 views1 page

    PRD-2

    Uploaded by

    surafel

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    © All Rights Reserved
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    6-1: Introduction

    Role in quality Process control is an essential element


    management of the quality management system, Organization Personnel Equipment
    system and refers to control of the activities
    employed in the handling of samples
    and examination processes in order
    to ensure accurate and reliable testing. Purchasing
    Process Information
    and
    Sample management, discussed in inventory
    control management

    Chapter 5, and all quality control


    (QC) processes are a part of process
    control. Documents
    Occurrence
    and Assessment
    management
    records
    QC monitors activities related to the
    examination (analytic) phase of testing.
    The goal of QC is to detect, evaluate, Process Customer
    Facilities
    nd correct errors due to test system improvement service
    and
    safety
    failure, environmental conditions or
    operator performance, before patient
    results are reported.

    What is QC? QC is the part of quality management focused on fulfilling quality requirements
    (ISO 9000:2000 [3.2.10]). Simply put, it is examining “control” materials of known
    substances along with patient samples to monitor the accuracy and precision of the
    complete analytic process. QC is required for accreditation purposes.

    In 1981, the World Health Organization (WHO) used the term "internal quality
    control" (IQC), which it defined as “a set of procedures for continuously assessing
    laboratory work and the emergent results”. The terms QC and IQC are sometimes
    used interchangeably; cultural setting and country may influence preferences for
    these terms.

    In the past few years, "internal quality control' has become confusing
    in some settings because of the different meanings that have been
    associated with the term. Some manufacturers of test kits for qualitative tests have
    integrated "built-in" controls in the design of their kits, which they sometimes refer
    to as internal controls. Other manufacturers include their own control materials
    with the kits they sell and they refer to these as "internal controls", meaning that
    the materials are meant specifically for that manufacturer’s kit. Finally, some people
    refer to any quality control materials that are used in conjunction with test runs as
    IQC, as in the 1981 WHO definition.

    72 Laboratory Quality Management System

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