Agent skill · research science · alirezarezvani
qms-audit-expert
Use for ISO 13485 internal audits: planning the program, running an audit, classifying findings or preparing for an external audit. Optimizes the schedule with audit_schedule_optimizer.py.
Why this skill is useful
Provides detailed methodologies and templates for ISO 13485 audits that the AI wouldn't reliably generate on its own.
What it needs
About 5k tokens when loaded. Last updated 2026-08-05. 23,939 stars on the source repository.
What this skill does
QMS Audit Expert ISO 13485 internal audit methodology for medical device quality management systems. --- Table of Contents Audit Planning Workflow Audit Execution Nonconformity Management External Audit Preparation Reference Documentation Tools --- Audit Planning Workflow Plan risk-based internal audit program: 1. List all QMS processes requiring audit 2. Assign risk level to each process (High/Medium/Low) 3. Review previous audit findings and trends 4. Determine audit frequency by risk level 5. Assign qualified auditors (verify independence) 6. Create annual audit schedule 7. Communicate schedule to process owners 8. Validation: All ISO 13485 clauses covered within cycle Risk-Based Audit Frequency Risk Level Frequency Criteria ------------ ----------- ---------- High Quarterly Design control, CAPA, production validation Medium Semi-annual Purchasing, training, document control Low Annual Infrastructure, management review (if stable) Audit Scope by Clause Clause Process Focus Areas -------- --------- ------------- 4.2 Document Control Document approval, distribution, obsolete control 5.6 Management Review Inputs complete, decisions documented, actions tracked 6.2 Training Competency defined, records complete, effectiveness verified 7.3 Design Control Inputs, reviews, V&V, transfer, changes 7.4 Purchasing Supplier evaluation, incoming inspection 7.5 Production Work instructions, process validation, DHR 7.6 Calibration Equipment list, calibration status, out-of-tolerance 8.2.2 Internal Audit Schedule compliance, auditor independence 8.3 NC Product Identification, segregation, disposition 8.5 CAPA Root cause, implementation, effectiveness Auditor Independence Verify auditor independence before assignment: [ ] Auditor not responsible for area being audited [ ] No direct reporting relationship to auditee [ ] Not involved in recent activities under audit [ ] Documented qualification for audit scope --- Audit Execution Conduct systematic internal audit: 1. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills alirezarezvani/qms-audit-expert--811059