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U.S. Department of Health and Human Services

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Volume I - 5.1 General

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ORA Laboratory Policies

Food and Drug Administration

DOCUMENT NO.:
ORA-LAB.QM

VERSION NO.:2.0

ORA Laboratory Manual of Quality Policies

EFFECTIVE DATE:
10-01-03
REVISED:
05-02-14

The sections following below address the factors affecting the correctness and reliability of the tests performed by a laboratory. These factors include contributions from:

The procedures listed in each section address these factors.

5.1.2 Contribution to Total Uncertainty of Measurement

These factors are considered in determining total measurement uncertainty and in developing uncertainty budgets. Additionally, these factors are considered by the laboratory when developing test procedures, in the training and qualification of personnel, and in the selection of the equipment utilized.