Tools, Technologies and Training for Healthcare Laboratories

Q & A on ISO and QC: Are Mean Rules Mandatory?

Posted by Sten Westgard, MS

Recently, a user submitted a question about the mandatory use of the 10x rule on chemistry analytes as mandated by ISO 15189 through NABL:

"Specific criteria of accreditation of NABL India (for ISO 15189) say that 10x should be considered as a violation for clinical chemistry  and Immunoassay parameters. However we understand that Westgard rules consider it as a warning only. Please advise."

So, the central question is, does ISO 15189 mandate the use of the 10x control rule?

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Quality Indicators can be dangerous to your health

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New Book: Quality Control for Qualitative Tests, Paulo Pereira, PhD

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A dearth of data in published papers

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EFLM database: 78 steps forward, 272 steps back

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