Hi,
Is anyone have an SOP for the calibration of the lab equipment?
Thanks,
Alexander

Can you be more specific? What kind of laboratory equipment?

- oscilloscope
- waveform gerenerator
- power supply
etc.

thanks,
alex

What are the model # 's for each?

Have you tried, or are you familar with GIDEP? They have procedures for most every type of main stream process instrumentation.

Hi,
Is anyone have an SOP for the calibration of the lab equipment?
Thanks,
Alexander

Are you looking to calibrate in house? If so, could you contact the OEM and find out what their standard procedures are.

if we calibrate outside, do we need to have something in terms procedures: what, how and who?
what fda would want to see during the audit?
thanks

Alexander,

The short answer to your question is "yes".

Is this a new process/organization/startup? Is the organization ISO registered? Is there a quality program in place? Are you waiting on FDA approval?

Say you have instruments that you want to get calibrated. You either have the capability of performing them in-house, or not. If you are going to send them out, you would do good at this point to find an ISO 17025 lab to calibrate your instruments for you.

You need to identify what process this equipment will be used for. This should help you identify what criteria you will need for the equipment. The equipment you have should be calibrated to MFG. specifications. However, you still need to assure the equipment will satisfy your process requirements.

If you are going to outsource your calibration which I HIGHLY recommend then you should use a calibration provider accredited to ANS/ISO/IEC 17025, accredited by an accrediting body that is signatory to the ILAC and/or APLAC MRAs.

The only procedure you should need is one that says to send the equipment to an accredited calibration provider.

Here are a couple:

http://www.iasonline.org

http://www.a2la.org

Or sent me an off-line note and I can provide some contacts of labs to talk to.

Hope this helps.

Hershal