【国外标准】 Standard Guide for Evaluating Laboratory Measurement Practices and the Statistical Analysis of the Resulting Data

4.1 This guide is intended to provide guidance for laboratory quality managers, accrediting bodies and assessors in evaluating the measurement practices of a laboratory, the protocol for statistically analyzing the resulting data from these practices, and the statistical results from these practices.4.2 This guide is generic in the sense that it covers the entire range of in-house quality measurement practices found in a testing laboratory, and the results of the described evaluation may be used by accrediting agencies for assessment purposes to determine whether their requirements can be satisfied through the laboratory’s existing quality data program.4.3 It is not the intent of this guide to serve as sole criterion for evaluating and accrediting laboratories. Evaluation of measurement practices is only one aspect in a comprehensive quality program.AbstractThis guide covers key elements of an evaluation of a laboratory’s measurement practices and the statistical analysis of the resulting data, as well as addresses an evaluation that covers a broad range of in-house quality measurements, some of which may be directly related to accreditation requirements. It provides an overview of the documentation needed for verification and monitoring of the practices used in the laboratory for measurement. In addition, it guides the user in verifying that the extent of documentation and the quality of statistical evaluations performed on the data being generated is sufficient. This guide is also intended to provide guidance for laboratory quality managers, accrediting bodies and assessors in evaluating the measurement practices of a laboratory and statistically analyzing the resulting data from these practices.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 provides an overview of the documentation needed for verification and monitoring of the practices used in the laboratory for measurement. In addition, it guides the user in verifying that the extent of documentation and the quality of statistical evaluations performed on the data being generated is sufficient. The user is advised to fully document all work covered by the scope of this guide as a general principle of laboratory practice and for audit purposes, whether internal or external.1.3 This guide is not designed to be exhaustive for all aspects of work realized under its scope. The user is encouraged to thoroughly realize (achieve in practice) the principles set forth in this guide, consulting other relevant standards and industry documents when appropriate.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.