Agent skill · research science · borghei
qms-audit-expert
ISO 13485 internal audit expertise for medical device QMS. Use for audit planning and execution, nonconformity classification, CAPA verification, external audit preparation, or audit program management.
Why this skill is useful
Provides specific methodologies and workflows for ISO 13485 audits that the AI wouldn't reliably generate on its own.
What it needs
About 9k tokens when loaded. Last updated 2026-07-21. 462 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 --- Clarify First Before planning or executing the audit, confirm these inputs. If any is unknown or vague, ASK — do not assume: [ ] Audit purpose — internal scheduled audit, external/certification prep, or mock audit (sets the scope and formality) [ ] Processes/clauses in scope — which ISO 13485 clauses (drives the checklist and frequency) [ ] Risk level and prior findings per process — picks audit frequency and sample size Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the audit plan. 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. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/qms-audit-expert