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Lab exchanging anonymized samples for studies

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Guest user Created:   May 30, 2023 Last commented:   Jun 02, 2023

Lab exchanging anonymized samples for studies

What are the ISO regulations for internal/external lab exchanging anonymised samples for comparison studies?

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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 Jun 02, 2023

What you are referring to relates to the requirement of ISO 17025 clause 7.7 to ensure the validity of results. Internal quality control can include, for example, the laboratory or quality manager submitting control samples as unknown test samples. This is listed as clause 7.7.1 g, retesting of retained items. Simply ensure the samples are processed as routine samples and monitor the results against expected results. When it comes to exchanging samples externally for quality control purposes, ensure best practices are followed and the approach to statistical evaluation and performance criteria are agreed to in advance. This is listed as clause 7.7.2b,  participation in interlaboratory comparisons other than proficiency testing. In both cases, clause 7.7.3 states the requirement to analyze data and if the results are not within the pre-defined criteria, the laboratory must take corrective action.

For more information see the response to another question at https://community.advisera.com/topic/clause-7-7-7-7-1/ and the Advisera Toolkit  Quality Assurance Procedure at https://advisera.com/17025academy/documentation/quality-assurance-procedure/

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May 30, 2023

Jun 02, 2023

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