ASTM E1323-09

Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data

SIGNIFICANCE AND USE
This guide is intended to provide guidance for an assessor to evaluate measurement practices of laboratories, the protocol for statistically analyzing the resulting data from these practices, and the statistical results from these practices.
This guide is generic in the sense that it covers the entire range of in-house quality measurement practices found in a testing laboratory, but the results of the described evaluation may be used by accrediting agencies if their requirements can be satisfied through the laboratory's existing quality data.
It is not the intent of this guide to serve as sole criterion for evaluating and accrediting laboratories. It is not intended to cover the important generic guidelines for evaluating the laboratory's quality program, which are contained in ISO/IEC 17025 and other equivalent standards.
SCOPE
1.1 This guide covers key elements of an evaluation of a laboratory's measurement practices and the statistical analysis of the resulting data. This guide addresses an evaluation that covers a broad range of in-house quality measurements, some of which may be directly related to accreditation requirements.
1.2 This guide describes the documentation needed to verify the operation of the practices, and what parts of the data, to test and interpret to verify the quality of data being generated by the laboratory.
1.3 This guide does not specify or provide guidance for the establishment or assessment of a quality program.

General Information

• Status: Historical
• Publication Date: 14-Jun-2009
• ICS: 03.120.10 - Quality management and quality assurance
• Technical Committee: E11 - Quality and Statistics
• Drafting Committee: E11.20 - Test Method Evaluation and Quality Control

Relations

• Replaces: ASTM E1323-89(2002) - Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data
• Effective Date: 15-Jun-2009
• Referred By: ASTM C1592/C1592M-21 - Standard Guide for Making Quality Nondestructive Assay Measurements
• Effective Date: 15-Jun-2009
• Referred By: ASTM D6792-23a - Standard Practice for Quality Management Systems in Petroleum Products, Liquid Fuels, and Lubricants Testing Laboratories
• Effective Date: 15-Jun-2009
• Referred By: ASTM E2677-20 - Standard Test Method for Estimating Limits of Detection in Trace Detectors for Explosives and Drugs of Interest
• Effective Date: 15-Jun-2009
• Referred By: ASTM G158-98(2021) - Standard Guide for Three Methods of Assessing Buried Steel Tanks
• Effective Date: 15-Jun-2009
• Referred By: ASTM C1021-08(2023) - Standard Practice for Laboratories Engaged in Testing of Building Sealants
• Effective Date: 15-Jun-2009

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E1323 − 09 AnAmerican National Standard
Standard Guide for
Evaluating Laboratory Measurement Practices and the
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Statistical Analysis of the Resulting Data
This standard is issued under the fixed designation E1323; 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 (´) indicates an editorial change since the last revision or reapproval.
1. Scope 2.3 Other Standard:
ILAC/ISO Laboratory Accreditation Principles and
1.1 This guide covers key elements of an evaluation of a
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Practice—Collected Reports 1979–1983
laboratory’s measurement practices and the statistical analysis
of the resulting data. This guide addresses an evaluation that
3. Terminology
covers a broad range of in-house quality measurements, some
3.1 Terms are defined in Terminology E456.
of which may be directly related to accreditation requirements.
1.2 Thisguidedescribesthedocumentationneededtoverify
4. Significance and Use
the operation of the practices, and what parts of the data, to test
4.1 This guide is intended to provide guidance for an
and interpret to verify the quality of data being generated by
assessor to evaluate measurement practices of laboratories, the
the laboratory.
protocol for statistically analyzing the resulting data from these
1.3 This guide does not specify or provide guidance for the
practices, and the statistical results from these practices.
establishment or assessment of a quality program.
4.2 Thisguideisgenericinthesensethatitcoverstheentire
range of in-house quality measurement practices found in a
2. Referenced Documents
testing laboratory, but the results of the described evaluation
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2.1 ASTM Standards:
may be used by accrediting agencies if their requirements can
E178 Practice for Dealing With Outlying Observations
be satisfied through the laboratory’s existing quality data.
E456 Terminology Relating to Quality and Statistics
4.3 It is not the intent of this guide to serve as sole criterion
E691 Practice for Conducting an Interlaboratory Study to
for evaluating and accrediting laboratories. It is not intended to
Determine the Precision of a Test Method
cover the important generic guidelines for evaluating the
E1169 Practice for Conducting Ruggedness Tests
laboratory’s quality program, which are contained in ISO/
E2554 Practice for Estimating and Monitoring the Uncer-
IEC 17025 and other equivalent standards.
tainty of Test Results of a Test Method in a Single
Laboratory Using a Control Sample Program
5. Purpose of Evaluating Measurement Practices and the
E2587 Practice for Use of Control Charts in Statistical
Statistical Analysis of the Resulting Data
Process Control
5.1 Data generated from the measurement practices of a
2.2 ISO Standard:
laboratory are evaluated to determine its capability to obtain
ISO 9000–9001 Quality Management and Quality Assur-
accurate and precise data, and to determine if the laboratory
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ance Standards
correctly and efficiently analyzes and reacts to its own data.
ISO/IEC 17025 General Requirements for the Competence
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of Testing and Calibration Laboratories
6. Documentation of Measurement Practices and the
Statistical Protocol for Analyzing the Resulting Data
6.1 Documentation Relative to Calibration:
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This guide is under the jurisdiction of ASTM Committee E11 on Quality and
6.1.1 The material to be measured should be documented
Statistics and is the direct responsibility of Subcommittee E11.20 on Test Method
Evaluation and Quality Control.
together with its source, expiration or shelf-life date, the
Current edition approved June 15, 2009. Published August 2009. Originally
accuracy and its source, and any preparations or conditions
approved in 1989. Last previous edition approved in 2002 as E1323 – 98 (2002).
required which are specific to this material before it can be
DOI: 10.1520/E1323-09.
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utilized as a calibration material. Any additional components,
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
4
the ASTM website. ILAC/ISO LaboratoryAccreditation-Principles and Practice-Collected Reports
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 1979–1983. American Association for Laboratory Accreditation, 656 Quince Or-
4th Floor, New York, NY 10036, http://www.ansi.org. chard Rd. #704 Gaithersburg, MD 20878.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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E1323 − 09
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