Using Prepared In-House Reference Materials (RM) for Equipment Calibration & Verifica

S

suka_batang

#1
Due to unavailability and cost of certified reference material (CRM), our laboratory decide to prepare and use in-house reference material (RM) as calibration and verification standards for calibrating/validating our instrument/equipment especially in GC/HPLC/IC.

However,I have some problem when we need to comply with ISO17025

1. Are we require to perform the correction/compensation (actual amount) on the assay/concentration amount of the in-house standards?

2. If yes, there are any tools/methods/templates that more simple & practical which I can use in determine the compensated amount.

3.Then, are the in-house standards also require to have certificate of analysis (COA) and how to report the raw data and result of the compensated amount and what the format the report?

Thanks to all in assist me in this stuff, I'm really need your help.

Thanks
:truce:
 
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Stijloor

Staff member
Super Moderator
#2
Re: Using Prepared In-House Reference Materials (RM) for Equipment Calibration & Veri

Due to unavailability and cost of certified reference material (CRM), our laboratory decide to prepare and use in-house reference material (RM) as calibration and verification standards for calibrating/validating our instrument/equipment especially in GC/HPLC/IC.

However,I have some problem when we need to comply with ISO17025

1. Are we require to perform the correction/compensation (actual amount) on the assay/concentration amount of the in-house standards?

2. If yes, there are any tools/methods/templates that more simple & practical which I can use in determine the compensated amount.

3. Then, are the in-house standards also require to have certificate of analysis (COA) and how to report the raw data and result of the compensated amount and what the format the report?

Thanks to all in assist me in this stuff, I'm really need your help.

Thanks
:truce:
Can someone help with this?

Thank you!!

Stijloor.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Re: Using Prepared In-House Reference Materials (RM) for Equipment Calibration & Veri

What is the source of your RM? Is it a NMI-certified material? That is the real key for traceability.

For equipment, that can often be calibrated by an accredited lab, which in this case I certainly suggest.

Those two will help with your traceability. After that, everything can be negotiated with your AB.
 

LUV-d-4UM

Quite Involved in Discussions
#4
Re: Using Prepared In-House Reference Materials (RM) for Equipment Calibration & Veri

My suggestion is for you to send your Prepared In-House to a lab that is ISO17025 accredited and have them include a +/- tolerance of their test results. Also ask the lab what standards do they use to test your product? Once you have this information, you now have a reference material for calibration verification.
 
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