CAPA
Skill packages tagged with “CAPA”
CAPA Report
Corrective and Preventive Action reports for audit non-conformities. Enforces 5 Whys root cause analysis and a future Effectiveness Check date (ISO 9001 / ISO 13485).
ISO 27001 Monitoring, Measurement & Evaluation
Draft and validate the Clause 9.1 report (PDCA 'Check'): KPIs that measure control effectiveness, executive insight from raw data, and CAPA linkage for every failed control.
MDevSPICE Software Problem Resolution Process
Document and evidence the software problem resolution process per IEC 62304 and MDevSPICE: problem reporting, analysis, root cause, corrective action, and link to maintenance and CAPA.