How to Plan Calibration for NABL/ISO/IEC 17025:2017

 Defining the scope of work in terms of facility to be developed for the calibration of which disciplines as well as type of equipment. In this stage, the detail discussion is done with the customer and list of equipment to be calibrated is prepared with the details of name, range, resolution / least count etc.

All automated Instruments such as cell counters, Clinical Biochemistry automated analysers, automated coagulometers and ELISA readers shall be calibrated by manufacturer at least once a year and be verified for calibration after preventive maintenance.

 The calibration certificate shall contain raw data; just a certificate that the apparatus has been calibrated is not sufficient. All raw data or machine printout / screen shots should be captured and documented for future use. The calibration should be as per manufacturer’s recommendations and criteria for acceptance of verification.

 During calibration of autoanalysers verification of power supply, photometer / Illuminometer /

fluorimeter / LED that may / may not be dye based, filter or emission light source lamps, pipettor assembly inclusive of metering pump and syringe, pressure checks wherever applicable, probe alignment and their carry over checks, temperature of temperature-controlled chambers, cuvette calibration (wherever applicable) and system checks should be carried out. In addition to the verification, analyte calibration may be performed and appended.

 In case of semi-automated photometers, sipper calibration is also required wherever applicable.

 In-house calibration of equipment:

Certain Instrument may be calibrated by the laboratory itself without the service of an external calibration body, provided the laboratory has necessary reference standards and materials (with traceability) and such calibration procedures do not demand special techniques which are outside the capability and experience of the laboratory staff. The calibration status, date of calibration and due date shall be exhibited on the equipment.

 pH Meter:

pH meter shall be calibrated each time before use. This is done by using two standard buffer

solutions appropriate to the expected pH of the sample being tested and the records of the

same to be maintained.

ISE analyzers & ABG analyzers:

Calibration verification is in the form of self calibration. However, the electrode slope should be

recorded to ensure that there is no deviation. Thereby requirement for change of electrodes is

not missed.

Spectrophotometer and Colorimeter:

Calibration checks on all spectrophotometers or colorimeters shall be performed at six months /one year interval preferably by manufacturer or AMC agency.

Electrophoresis Apparatus:

Instrument performance shall be routinely monitored during use with appropriate controls.

System components (e.g. electrodes, tank and power supply), must be checked periodically.

Temperature-Controlled Equipment:

Equipment such as water baths, incubators, ovens, refrigerators and deep freezers are verified

for accuracy / performance (with calibrated temperature-recording devices) for the intended

temperature required. The temperature shall be monitored daily, especially where the

deterioration of material (sample or reagents) affects the test results.

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