ISO 17025 - Expert Advice Community

Applicability of 17025 to GMP analytical laboratory

The question is about the applicability of 17025 to our operations. We are a GMP analytical laboratory that conducts lot release testing for pharmaceutical and/or biological products used in clinical trials and eventually for commercial.  We abide by 21CFR11.  

We only test these medicines. We do not manufacture. 

Does ISO 17025 apply to our operations?

Conceding ISO 17025 certificate

After finishing all the documentation, which institution concedes the iso 17025 certificate?

Difference between technical and control of records of ISO 17025:2017

Is it possible for the company's internal lab to get ISO accreditation?

We are a food safety company that is providing sanitation systems to customers. We have an internal lab and want to get accredited. Is it possible for the company's internal lab to get ISO accreditation?

Distance between people in calibration lab

People checking in the calibration lab
What should be the distance between and from which standard can I learn it?

Difference between ISO EN 17025 and ISO IEC 17025

Can you tell me the difference between Just wondered what the difference was between ISO EN 17025 and ISO IEC 17025. I have seen on a laboratory website that they are working towards the ISO/EN 17025 but I can't find any information about this.

How long we should retain measurement system records?

Sampling (clause 7.3)

We are aluminium curtain walls, doors and windows performance testing lab. we do mock up test for the system we are going to install at site. We make a closed chamber and do the air and water test by applying pressure difference. Is sampling clause applicable to us?

We only follow ASTM/AAMA standards only. so can we consider the verification, validation and measurement uncertainty not applicable to us.

Root cause analysis

in our laboratory we find a difficulty in root cause analysis when the result of iis sample is unsatisfactory, due to delay of result report around 3 months, so we can not investigate the error happened at testing time. what is your advice to avoid this problem and make the root cause investigation easy?
thank you

Calibration of laboratory equipment

I'm implementing ISO 17025 in my laboratory. *** company. When I'm writing verification and calibration methods, I'm not able to distinguish the difference between intern and extern? When have I to do an intern calibration? When have I to sent my equipments for calibration to an extern laboratory?

The measuring apparatus has to be linked to the SI system, so if my analyzer is calibrated by an accredited laboratory, I can virtually do all my calibration on my own?