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ISO 17025 implementation

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Guest user Created:   Apr 15, 2020 Last commented:   Apr 16, 2020

ISO 17025 implementation

Please can you clarify the document " ANNEX 2 OF THE OMCL NETWORK GUIDELINE “QUALIFICATION OF EQUIPMENT” QUALIFICATION OF GC EQUIPMENT " we have our SOP and we have read all documents and checked our SOP regarding to the documents but we cannot decid if there is major differences?

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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 Apr 16, 2020

ISO 17025 clause 6.4 covers requirements for Equipment; where the requirement is that equipment should be suitable, maintained and monitored to ensure a laboratory produces consistently valid results. It is important to know what is required of specific equipment to ensure suitable performance. In all cases mandatory specifications, regulations or guidelines should be followed; if applicable for your sector.

The document you refer to, is an Annex of the document “Qualification of Equipment”, published for European Union (EU) Official medicines control laboratories (OMCL). Such laboratories support quality control regulations for medicinal products.
I cannot tell by your question which sector your laboratory supports and whether the document your refer to is prescribed as mandatory by a regulatory body or your accreditation body; or just a guideline you are using to meet ISO 17025 requirements. Either way, if you have assessed your processes thoroughly against ISO 17025 requirements as well as the OMCL Annex, and there are no gaps; then surely you are meeting requirements ?

The following may be of interest

Article What does ISO 17025:2017 require for laboratory measurement equipment and related procedures? https://advisera.com/17025academy/blog/2019/07/25/iso-17025-measurement-requirements-of-the-standard/
The ISO 17025 toolkit or ISO 17025 document template: Equipment and Calibration Procedure and associated appendices: List of Laboratory Equipment, Calibrated Equipment Record, Calibration Record and Equipment Maintenance Record, available at https://advisera.com/17025academy/documentation/equipment-and-calibration-procedure//
 

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Apr 15, 2020

Apr 16, 2020