Skills and MCP tagged “qms”

quality-documentation-manager Alireza Rezvani skill This skill manages document control workflows for medical device QMS under ISO 13485 and 21 CFR Part 11. It helps set up numbering conventions, approval flows, and change control. Claude Code 803installs capa-officer Alireza Rezvani skill Runs CAPA investigations for a medical device QMS: root cause analysis, corrective action planning, effectiveness verification. Useful when you are working a nonconformance or an audit finding. Claude Code 795installs quality-manager-qms-iso13485 Alireza Rezvani skill Guides ISO 13485:2016 quality management system work for medical device organizations. Use it to plan QMS implementation, prepare internal audits, and manage document control. Claude Code 784installs qms-audit-expert Alireza Rezvani skill Guides ISO 13485 internal audits for medical device quality management systems. Useful when planning audit schedules, evaluating nonconformities, and preparing for external inspections. Claude Code 747installs