Maps to
FDA QMSR (Part 820): §820.250
ISO 13485: ISO 13485 §8.4
Requirement text
The organization shall determine, collect, and analyze appropriate data to demonstrate QMS suitability and effectiveness.
Atomic constraints
- •Data analysis procedures must be documented
- •Statistical techniques must be identified
- •Trend analysis must be performed
- •Results must feed into management review
Evidence signals
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FILE_EXISTS
(Data.*Analysis|Statistical|Trend.*Analysis|Quality.*Metric|Quality.*Dashboard)
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CONTENT_MATCH
Does this document describe data analysis procedures, statistical methods, or quality trend analysis?
Audit defense
Data analysis for our QMS is performed per [your document ID]. Quality data including complaints, NCRs, process metrics, and audit findings is systematically collected, analyzed using defined statistical techniques, and reported to management review per ISO 13485 8.4.