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Volume I - 1.0 Introduction

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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

This Office of Regulatory Affairs (ORA) Laboratory Manual of Quality Policies (hereafter referred to as Volume I) has been prepared to meet the requirements for laboratory accreditation of the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025). It has been formatted using clause numbers from ISO/IEC 17025 to provide ease in review.