ISO 15189 clause 5.3.1.4 (d) Recording calibration status and date of recalibration:

Elizabeth NAMPEWO

How do you maintain records of calibration of clinical chemistry analyzers i.e Cobas integra 400 plus analyzer is calibrated at every change of reagent lot and incase of IQC failure especially for electrolytes, Cobas e411 analyzer has an automatic calibration query that prompts calibration?

Elde Mel Paladar

5.3.1.4 requirement is a "documented procedure for the calibration of equipment". "This procedure includes: (d) recording the calibration status and date of recalibration". To guide you, do the following:

1. SOP for calibrating Cobas Integra 400 plus? Yes or No. If NO, create one and make sure that SOP includes recording the calibration status and date of recalibration (the user manual is a good source of information in creating this SOP, I believe, it has a maintenance log, which can be used to record calibration status). If, YES, then follow the steps on HOW to calibrate which should specify where to RECORD i.e. forms to use.
2. If your challenge is that calibration is 'pre-programmed i.e. automatically, ( although, I think you can request for calibration (it's been a long time since the last time I used Cobas Integra), then, these electronic records (calibration, QC, results, etc) can be ARCHIVED and can then be saved in my documents (please make sure this is how to record calibration as stipulated in your SOP)
3. Please remember, 5.3.1.4 also talks about metrological traceability.

Jacqueline Mukhaye Amira

My thought, never used cobas except interacting with it during my mentorships in other facilities. However, when you refer to it's user manual, do you find any beneficial information on the same? It's our main reference for particular equipment use.

Horace Gumba

Thanks Elde. That's well expounded!

Andrew Baguma

According to ISO 5.3.1.4 "documented procedure for the calibration of equipment" requires you to document or record the calibration status and date of recalibration, Even though your calibration status can be electronic, it is important you have them registered in a hard copy or softcopy for traceability!