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  Decision Rule Conformity Reporting (7.8.6 & 7.8.7)

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  ensuring the validity of rsults (IQC ILC) (7.7)

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  ISO/IEC 13485:2016

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  ISO/IEC 17025:2017

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  ISO/IEC 2200:2018

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  Personal Competence (6.2)

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  Risk Management (8.5)

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  Uncertainty (7.6)

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  Validation & Verification (Cause: 7.2.2, 7.2.1.5)

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