ISO 15189 Quality Manual

Tuesday, December 19, 2006

Infrastructure of the laboratory

The laboratory infrastructure is the work space and building(s) in which the laboratory conducts its business, together with the necessary testing and analytical equipment and supplies, and its administrative support such as clerical, financial, and purchasing activities.

In addition to the required control of environmental conditions for calibration activities it may often be necessary for the laboratory to control the atmospheric and other working conditions for all laboratory operations to the extent necessary to ensure the precision and accuracy of laboratory results. Where the test or method explicitly states specified ambient conditions for the conduct of the test or analysis, the measures taken to control environmental conditions should be described and the resulting data defining working conditions recorded. Such activities include not only elements such as those discussed below but also such things as restricted access provisions, clean room operations (including standard operating procedures), and special housekeeping and safety activities carried out on a routine basis.

Measuring and test equipment and calibration standards should always be calibrated in an area that provides for control of environmental conditions to the degree necessary to assure the required precision and accuracy of results.