ASQ Q2

Abstract

<strong>SCOPE AND FIELD OF APPLICATION</strong> <br>This standard describes a basic set of elements by which laboratory quality management systems can be developed and implemented. <br>It is intended as a guideline and model for a quality system operating within an overall testing or analytical laboratory system, excluding laboratories devoted only to research. As such, it attempts to encompass quality provisions at all stages and levels of a sample's total life cycle, from collection or selection through its receipt, identification, analysis or testing and reporting of results, and retention or disposal. It is not limited to the specific assignment of a quality control department. <br>The selection of appropriate elements contained in this standard and the extent to which these elements are adopted and applied by a laboratory depend upon such factors as: market served, nature of services, methods, and consumer needs. <br>This standard is particularly relevant to laboratories performing chemical analyses and environmental testing and calibration, where statistical control methods have been effectively integrated into the analytical or testing process. Although such elements may not be appropriate for all other fields of testing, the concept of statistical control is applicable to many of these fields. <br>The very existence of this standard can incorrectly imply that one basic quality system will suffice in a given laboratory, indeed in <em>any</em> situation. <br>Experience shows that the order of presentation (format) of subjects described here may vary from one laboratory to another depending upon factors such as regulatory requirements; the needs, customer, and field of competence of the laboratory; practices in the various methodologies used in the laboratory; and the needs of the laboratory's customers. <br>It may be impractical for all subjects identified intheseguidelines to be contained within a single document. It is therefore acceptable to produce separate documents. However, all these documents should be cross-referenced to a single document, generally called Quality Manual, which specifies their location and updating and control procedures. <br>These guidelines supplement and expand upon the items relating to a quality system identified in ANSUASQC 494-1987.