SIR #: 387
Section: V1M4, Section 22.214.171.124
Some instrumentation, such as turbidimeters, spectrophotometers, etc. are purchased and received with an internal calibration performed by the manufacturer. Can these internal calibration be used to calculate test results?
TNI FINAL RESPONSE:
It is recognized that the calibration capabilities and sample analysis applications for this type of equipment varies. Yes, the manufacturer established initial calibration may be used for an accredited analysis if the requirements of V1M4 1.7, the method, and any applicable regulations can be met and documented by the laboratory.
If the manufacturer established initial calibration is used to calculate test results the manufacturer shall meet all of the requirements for initial calibration as listed in V1M4 126.96.36.199 and shall provide the accredited laboratory applicable data and records for the calibration in order to meet the requirements of V1M4 188.8.131.52. The laboratory must maintain these records per V1M4 184.108.40.206 b).