Maps to
QMSR / ISO 13485: §820.250
ISO 13485: §8.4
Requirement text
The organization shall determine, collect, and analyze appropriate data to demonstrate QMS suitability and effectiveness.
What changed
Part 820.250 explicitly required documented procedures for identifying valid statistical techniques needed for verifying the acceptability of process capability and product characteristics, and required that sampling plans be written and based on a valid statistical rationale. ISO 13485 clause 8.4 takes a different approach: rather than mandating statistical techniques specifically, it requires the organization to determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to identify where continual improvement can be made.
ISO 13485 clause 8.4 specifies that data analysis must include data generated from monitoring and measurement activities and from other relevant sources, and must provide information on: feedback (8.2.1), conformity to product requirements (8.2.6), characteristics and trends of processes and products including opportunities for preventive action (8.5.3), and suppliers (7.4). This enumeration of required data analysis inputs is more explicit than Part 820.250, which focused on statistical methodology rather than defining what data must be analyzed.
The shift is from "use valid statistics" (Part 820.250) to "analyze the right data to demonstrate QMS effectiveness" (ISO 13485 8.4). Organizations that built strong statistical process control programs under Part 820 may actually need to broaden their data analysis scope to include the softer quality data inputs ISO 13485 requires, while organizations that had minimal statistical programs under Part 820 now have explicit data analysis requirements they may not have previously met.
The FDA preamble noted that the shift to ISO 13485's data analysis framework does not diminish the expectation for appropriate statistical techniques; rather, it places statistical analysis within a broader data-driven quality management framework. Organizations should maintain statistical rigor while expanding the scope of data they analyze.
Atomic constraints
- •Data analysis procedures must be documented
- •Statistical techniques must be identified
- •Trend analysis must be performed
- •Results must feed into management review
Common gaps
Ignoring 'negative' trends
majorThe QMS doesn't define 'triggers' for when a trend of minor issues becomes a 'systemic' issue requiring a CAPA. ISO 13485 §8.4 requires identifying opportunities for corrective action.
Data Analysis Limited to Statistical Process Control
moderateISO 13485 clause 8.4 requires analysis of data from feedback, product conformity, process trends, and supplier performance. Many Part 820-era organizations have strong SPC programs but do not systematically analyze complaint trends, audit finding patterns, or supplier quality data as required inputs to their data analysis process.
No Documented Data Analysis Procedure
moderateISO 13485 requires documented procedures for data analysis. Some organizations perform ad hoc analyses for management review but lack a formal procedure defining what data is collected, how often it is analyzed, what methods are used, and how results are reported and acted upon.
Data Analysis Results Not Driving Preventive Action
moderateISO 13485 explicitly requires that data analysis identify opportunities for preventive action (linking to 8.5.3). Many organizations perform trend analysis for management review reporting but do not have a formal mechanism for data analysis findings to trigger preventive actions before nonconformities occur.
No formal trend analysis records
moderateData is collected (e.g., in a spreadsheet) but no 'Trend Report' is produced and reviewed by management. ISO 13485 §8.4 requires records of the results of analysis.
Evidence signals
- •
FILE_EXISTS
(Data.*Analysis|Statistical|Trend.*Analysis|Quality.*Metric|Quality.*Dashboard)
- •
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.