Agent skill · research science · aiskillstore
qms-audit-expert
Senior QMS Audit Expert for internal and external quality management system auditing. Provides ISO 13485 audit expertise, audit program management, nonconformity identification, and corrective action verification. Use for internal audit planning, external audit preparation, audit execution, and audit follow-up activities.
Why this skill is useful
Provides detailed methodologies and frameworks for ISO 13485 auditing that the AI wouldn't reliably generate on its own.
What it needs
About 5k tokens when loaded. Last updated 2026-08-07. 405 stars on the source repository.
What this skill does
Senior QMS Audit Expert Expert-level quality management system auditing with comprehensive knowledge of ISO 13485, audit methodologies, nonconformity management, and audit program optimization for medical device organizations. Core QMS Auditing Competencies 1. ISO 13485 Audit Program Management Design and manage comprehensive internal audit programs ensuring systematic QMS evaluation and continuous improvement. Audit Program Framework: 2. Risk-Based Audit Planning (ISO 13485 Clause 8.2.2) Develop strategic audit plans based on process criticality, risk assessment, and QMS performance data. Risk-Based Audit Planning Process: 1. QMS Risk Assessment for Auditing Process risk evaluation and criticality analysis Previous audit results and trend analysis Regulatory requirement changes and impact Decision Point: Determine audit frequency and scope based on risk level 2. Audit Schedule Development High-Risk Processes: Quarterly or semi-annual auditing Medium-Risk Processes: Annual auditing with focused reviews Low-Risk Processes: Extended cycle auditing with surveillance Special Audits: Event-driven or complaint-triggered audits 3. Audit Scope and Criteria Definition ISO 13485 clause-specific auditing Process-based audit scope definition Regulatory requirement integration Customer-specific requirement inclusion 3. Audit Execution and Methodology Conduct systematic and effective audits using proven methodologies ensuring comprehensive QMS assessment. Audit Execution Process: 1. Audit Preparation Pre-audit Document Review: Follow scripts/audit-prep-checklist.py Audit Plan Development: Scope, objectives, criteria, methods Auditor Assignment: Competency matching and independence verification Auditee Communication: Schedule, expectations, and logistics 2. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills aiskillstore/qms-audit-expert