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U.S. Department of Health and Human Services

Science & Research

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Volume I - 2.0 Controlled Distribution of the Quality Manual

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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 Office of Regulatory Science (ORS) is responsible for maintaining the official master copy of the ORA Laboratory Manual which contains the ORA Quality Manual. The ORA Quality Manual consists of Volume I, ORA Laboratory Manual of Quality Policies and Volume II, ISO 17025 ORA Laboratory Procedures. General distribution of this manual is accomplished using a computer network. Annual review is coordinated by the Office of Regulatory Science.