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.

1. 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.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E178 Practice for Dealing With Outlying Observations

E456 Terminology Relating to Quality and Statistics

E691 Practice for Conducting an Interlaboratory Study to Determine the Precision of a Test Method

E1169 Practice for Conducting Ruggedness Tests

E2554 Practice for Estimating and Monitoring the Uncertainty of Test Results of a Test Method in a Single Laboratory Using a Control Sample Program

E2587 Practice for Use of Control Charts in Statistical Process Control

ISO Standard

Other Standard

Keywords

accreditation; laboratory accreditation; laboratory measurement practices; statistical analysis; Accreditation practice; Calibration--laboratory analysis instrumentation; Data analysis--computerized; Documents/documentation; Laboratory--clinical; Measurement processes/systems; Operator precision; Precision instrumentation; Statistical methods; Training programs;

ICS Code

ICS Number Code 03.120.10 (Quality management and quality assurance)

DOI: 10.1520/E1323-09

ASTM International is a member of CrossRef.

ASTM E1323