Document Center is acquired by Nimonik

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.

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.

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 Number Code 03.120.10 (Quality management and quality assurance)

To find similar documents by ASTM Volume:

14.02 (General Test Methods; Forensic Psychophysiology; Forensic Sciences; Terminology; Conformity Assessment; Statistical Methods; Nanotechnology; Forensic Engineering; Manufacture of Pharmaceutical Products)

To find similar documents by classification:

03.120.10 (Quality management and quality assurance)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.