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Combined Interpretations of the 2003, 2009, and 2016 Standards that apply to Volume 1 of the 2016 TNI Standard


MODULE 2: QUALITY SYSTEM GENERAL REQUIREMENTS
Section: 5.5.8

Question:  The section of the Standard states "Whenever practicable, all equipment under the control of the laboratory and requiring calibration shall be labelled, coded or otherwise identified to indicate the status of calibration, including the date when last calibrated and the date or expiration criteria when recalibration is due."

Most labs have interpreted that this requirement applies to support equipment such as balances and pipettors. Does this section apply to analytical equipment such as turbidimeters, spectrophotometers, pH meters, ICP-MS, etc?

TNI Response:  While yes, this statement does apply to analytical equipment, the more important consideration is the phrase “labelled, coded or otherwise identified”. “Otherwise identified” incorporates a multitude of processes for ensuring equipment is currently calibrated when in use. Analytical equipment will have more practicable manners of linking calibration status to the equipment, such as is likely found in run logs, data packets, or whatever system the laboratory uses for its analytical records. It isn’t always practicable (possible, yes, but impracticable) to label analytical instrumentation with calibration status but it is still required to have calibration status readily available.