Laboratory Services Sir T Hospital, Bhavnagar
Header
| Name | Unique ID | Edition | Date of Edition |
|---|---|---|---|
| Documentary Procedures for the calibration of equipment | LSSTH/B/Central/DP/6.5.2/23 | 1 | 01-03-2023 |
| Preparing authority | Approving authority | Review period | Review Date |
|---|---|---|---|
| All teaching staff | Quality Manager | 2 year | 10/09/2025 |
| Printed copy of this document is considered uncontrolled. It should be compared with controlled electronic copy before use |
Amendment Log
| Sr. No | Date of Amendment | Page & Clause Number of Amendment | Amendment detail | Reason for Amendment |
|---|---|---|---|---|
| 1 |
Purpose: To ensure accurate and reliable results from laboratory equipment through regular calibration.
Scope: This procedure applies to all laboratory equipment requiring calibration.
Responsibilities: Laboratory Director has overall responsibility to follow this procedure.
Procedure:
At the time of installation of new equipment, the Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) should be performed and documented.
Verify the performance of equipment after calibration.
| Sr. No | Equipment | Method of calibration | Frequency of calibration |
|---|---|---|---|
| 1 | Centrifuge | (1) Inhouse calibration by Tachometer for speed & time by the Digital stopwatch, Multipoint calibration should be done & evaluated by calculating CV or MU (2) By calibrating agency | Once in year |
| 2 | ARCHITECT PLUS C 8000 & ARCHITECT PLUS I1000sr | Calibrated by the manufacturer.During calibration of auto analysers verification of power supply, Light Source, filter, 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. | Once a year and after major maintenance. |
| 3 | Pipette | (1) Inhouse calibration by gravimetric checks: Repeat at least 10 times volume delivery and weighing. (The laboratory may refer ISO 8655-6:2002 for guidance). (2) By calibrating agency or Biomedical Engineer | At the time of purchase and every one year thereafter |
| 4 | Refrigerator | Refrigerators and deep freezers are verified with calibrated temperature-recording devices for the intended temperature required. An attempt will be made to cover various chambers of the refrigerator and deep freezer. The temperature is monitored with calibrated recording devices at multiple points with the doors shut. | Once a year and after any Corrective actions |
| 5 |
- Calibration intervals depend upon ruggedness of the equipment, frequency of use, quality & periodicity of maintenance and life of the equipment.
- All equipment must be calibrated following preventive maintenance, breakdown and repairs or more frequently as recommended by the manufacturers.
- Whenever there is a requirement of a corrective factor it will be displayed on the instrument.
- Final authorization & approval of calibration will be done by the quality manager.
- Record:
- Calibration certificate
- Calibration raw data