Calibration Tracking

[Timbogates]

Our small organization has calibration requrements for Medical Devices following 13485. We track and update spreadsheets. We store the spreadsheet in a validated system and it is reviewed plus approved on a regular basis. This document is a reference document for us to know when we need to plan calibrations. It does not send out any notifications or create any job-related task. Q: What is wrong or why can one not do this type of activity?

 

[dwperron]

We need a lot more information to help here.

Do you calibrate your own equipment or outsource that service?

We track and update spreadsheets. What are these spreadsheets, what information do they contain?

Section 7.6 of ISO 13485 is not particularly rigorous for setting up a compliant calibration program, but you need to read through it and find all the "shall" statements and make sure that you are fulfilling them and that you have documented all the cases where it calls for documents and records. Those are the little details that can kill your program.

 

[Timbogates]

Yes we calibrate our own items through our Metrology group. These spreadsheets have due dates and when an item was calibrated with equipment used for calibration. Spreadsheets have information on when it is due calibration and when the calibration was performed plus the planned interval for recalibration. We have a different system for the equipment used for calibration and their certification process is separate.

 

[Funboi]

What is wrong or why can one not do this type of activity?

What’s behind this question? Did someone suggest it is wrong?

 

[ChrisM01]

It isn't wrong, as long as it works.
Is there a work instruction detailing who is responsible for checking the spreadsheet and how often it is to be checked?