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ISO 17025 Certification Requirements

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Guest user Created:   Feb 16, 2022 Last commented:   Feb 21, 2022

ISO 17025 Certification Requirements

Hi there, I am interested in finding out what the requirements are for calibrating/ running standards on a GCMS are for ISO certification?
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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Feb 21, 2022

For a test method to be included in your scope as an ISO 17025 testing laboratory there are a number of technical requirements required. This includes ensuring the validity of results (clause 7.7) by monitoring an already validated method with the use of suitable checks. One of these is the use of reference material for quality control checks for your instrument and method. The requirement is that you can ensure metrological traceability, meaning all measuring equipment and the reference material must be certified.

Regarding the range – the QC checks must cover the calibration range / range of testing for each batch. As far as how often you should  plan a QC check, it depends on the risk, including the stability of the instrument. I suggest you engage with your supplier of your GCMS for assistance on best recommended practice.

For more information, have a look at

The article: What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? at https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/
The ISO 17025 toolkit document template: Equipment and Calibration Procedure at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure/
The ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement Results available from https://ilac.org/publications-and-resources/

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