by affaan-m
quality-nonconformance is a regulated-manufacturing skill for NCR intake, root cause analysis, CAPA, SPC interpretation, and final disposition. Use it for Compliance Review, supplier quality issues, and evidence-based decisions where traceability, risk, and audit-ready judgment matter.
by alirezarezvani
qms-audit-expert is an ISO 13485 internal audit skill for medical device QMS teams. It supports risk-based audit planning, clause checklists, nonconformity classification, CAPA verification, external audit prep, and schedule optimization using included references and a Python tool.
by alirezarezvani
fda-qsr-audit-prep is a Compliance Review skill for FDA medical-device QSR audit readiness. Use it to pressure-test complaint files, MDR decisions, CAPA links, process validation, Form 483 responses, and QMSR transition evidence with six inspection-style questions.
