Abstract

Process, this will generally involve the clinical laboratory in activities in which they may not be directly interested, but which are necessary to validate their results. Recognizing that many items of equipment may require characterization using equipment which it is not reasonable to expect the clinical laboratory to have access to, tests may be split into Manufacturers’ product tests and Clinical Users’ specimen tests. The specimen tests. Confirmation and routine checking of the measuring instrument: this should involve checking the performance of the instrumentation across time and relate output to that of similar equipment at a colleague’s laboratory, ideally through the use of a traceability chain to appropriate National Standards. These tests may be divided into metrological confirmation; this is the set of operations to confirm that an item of measuring equipment is in a state fit for use, including calibration, and spot checks, which may be used to validate the system on a more frequent basis.

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