scope:

This guide provides guidance for selecting, validating, and qualifying measurement methods when qualification is required for a specific program. The recommended practices presented in this guide provide a major part of a quality assurance program for the laboratory data (see Fig. 1). Qualification helps to assure that the data produced will meet established requirements.

The activities intended to assure the quality of analytical laboratory measurement data are diagrammed in Fig. 1. Discussion and guidance related to some of these activities appear in the following sections:

This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

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.