FDA Quality Management System Regulation (QMSR) QMSR-ISO13485-Sec8: Measurement, analysis and improvement (ISO 13485:2016 Section 8)

ISO 13485:2016 Section 8 - the MEASUREMENT + ANALYSIS + IMPROVEMENT framework. (8.1) GENERAL - planning + monitoring + measurement + analysis + improvement processes; (8.2) MONITORING + MEASUREMENT (8.2.1 FEEDBACK from production + post-production + complaint handling; 8.2.2 COMPLAINT HANDLING; 8.2.3 REPORTING TO REGULATORY AUTHORITIES; 8.2.4 INTERNAL AUDIT; 8.2.5 MONITORING + MEASUREMENT OF PROCESSES; 8.2.6 MONITORING + MEASUREMENT OF PRODUCT); (8.3) CONTROL OF NONCONFORMING PRODUCT - identification + documentation + segregation + evaluation + disposition + records; corrective actions where nonconforming product is detected after delivery (CORRECTIONS AND REMOVALS); (8.4) ANALYSIS OF DATA - feedback + customer satisfaction + product conformity + process performance + suppliers + improvement opportunities + outcomes; (8.5) IMPROVEMENT (8.5.1 GENERAL; 8.5.2 CORRECTIVE ACTION - identify cause + evaluate need + determine + implement + verify - the CAPA Corrective Action; 8.5.3 PREVENTIVE ACTION - the CAPA Preventive Action). The CAPA system under §8.5.2 + 8.5.3 is the central improvement mechanism + the most-inspected area in FDA medical-device audits.