ASTM C1009-96e1

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e1
Designation:C1009–96
Standard Guide for
Establishing a Quality Assurance Program for Analytical
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Chemistry Laboratories Within the Nuclear Industry
This standard is issued under the fixed designation C 1009; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
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e NOTE—Figure 1 was corrected editorially in February 1997.
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1. Scope ratories Within the Nuclear Industry
C 1215 Guide for Preparing and Interpreting Precision and
1.1 This guide covers the establishment of a quality assur-
Bias Statements in Test Method Standards Used in the
ance(QA)programforanalyticalchemistrylaboratorieswithin
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Nuclear Industry
the nuclear industry. Reference to key elements of ANSI/ISO/
C 1297 Guide for Laboratory Analysts for the Analysis of
ASQC Q9001-1994, Quality Systems, provides guidance to
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Nuclear Fuel Cycle Materials
the functional aspects of analytical laboratory operation. When
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D 1193 Specification for Reagent Water
implemented, the recommended practices presented in this
E 380 Practice for Use of the International System of Units
guide will provide a comprehensive QA program for the
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(SI) (the Modernized Metric System)
laboratory. The recommended practices are grouped by func-
E 542 Practice for Calibration of Laboratory Volumetric
tions, which are the basic elements of a QA program.
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Apparatus
1.2 The basic elements of a QA program appear in the
E 617 Specification for Laboratory Weights and Precision
following order:
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Mass Standards
Section
E 694 Specification for Laboratory Glass VolumetricAppa-
Organization 5
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Quality Assurance Program 6
ratus
Training and Qualification 7
2.2 ANSI Standard:
Procedures 8
Laboratory Records 9 ANSI/ISO/ASQC Q9001-1994 Quality Systems—Model
Control of Records 10
for Quality Assurance in Design, Development, Produc-
Control of Procurement 11
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tion, Installation, and Servicing
Control of Measuring Equipment and Materials 12
2.3 NIST Standard:
Control of Measurements 13
Deficiencies and Corrective Actions 14
NIST IR74-461 The Calibration of Small Volumetric Labo-
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ratory Glassware (1974)
2. Referenced Documents
2.4 Government Documents:
2.1 ASTM Standards:
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10 CFR 830.120 Quality Assurance Requirements
C 986 Guide for Developing Training Programs in the
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Nuclear Fuel Cycle
3. Terminology
C 1068 Guide for Qualification of Measurement Methods
3.1 Definitions:
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by a Laboratory Within the Nuclear Industry
3.1.1 laboratory quality assurance, n—all those planned
C 1128 Guide for Preparation of Working Reference Mate-
and systematic actions necessary to provide adequate confi-
rials for Use in the Analysis of Nuclear Fuel Cycle
dence in each analytical result reported by a laboratory.
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Materials
3.2 Definitions of Terms Specific to This Standard:
C 1156 Guide for Establishing Calibration for a Measure-
3.2.1 chain of custody, n—a procedure that documents
ment Method Used to Analyze Nuclear Fuel Cycle Mate-
continuous sample control and security.
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rials
C 1210 Guide for Establishing a Measurement System
Quality Control Program for Analytical Chemistry Labo-
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Annual Book of ASTM Standards, Vol 11.01.
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Annual Book of ASTM Standards, Vol 14.02.
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Available from American National Standards Institute, 11 W. 42nd St., 13th
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This guide is under the jurisdiction ofASTM Committee C-26 on Nuclear Fuel Floor, New York, NY 10036.
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CycleandisthedirectresponsibilityofSubcommitteeC26.08onQualityAssurance Available from National Institute of Standards and Technology, Gaithersburg,
Applications. MD 20899.
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Current edition approved July 10, 1996. Published September 1996. AvailablefromSuperintendentofDocuments,P.O.Box371954,Pittsburgh,PA
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Annual Book of ASTM Standards, Vol 12.01. 15250-7954.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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C1009
3.2.2 custody, n—analytical laboratories may prevent tam-
pering and secure possession of a sample by any of the
following means: (1) the sample is in actual physical posses-
sion, (2) the sample is in view after being in possession, (3) the
sample is in a locked area after being in possession, or (4) the
sample is in a designated secure area.
3.2.3 laboratory, n—an organization established to provide
analyses of materials for other organizations requiring those
analyses. In general, the laboratory exists within a larger,
parent organization, although it may exist as an independent
organization. It can range from an organization with a small
number of employees to a multi-group organization.
3.2.4 out-of-control, n—a system
...