Iso 15378 Key Pointspdf Free ((free)) Guide

No more arbitrary AQLs (Acceptable Quality Limits). ISO 15378 requires a statistically justified sampling plan for each critical attribute, linked to patient safety risk.

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: It uses the same high-level structure as ISO 9001 for general quality management. GMP Requirements : It embeds specific Good Manufacturing Practice (GMP) No more arbitrary AQLs (Acceptable Quality Limits)