Does it support risk-based auditing?

Absolutely. It includes logic to generate audit schedules that prioritize high-risk processes like design control, CAPA, and production validation.

Is it compliant with ISO 13485:2016?

The skill is modeled directly on ISO 13485:2016 requirements, covering all major clauses including document control, purchasing, and design history files.

Can it help with external audit preparation?

Yes, it includes a readiness checklist and mock audit protocols to prepare for certification body or regulatory inspections.

What is the QMS Audit Expert skill?

It is a specialized capability for Claude Code designed to help medical device companies conduct internal audits following ISO 13485:2016 standards.

How does it classify nonconformities?

The skill uses a systematic decision tree to categorize findings as Major, Minor, or Observations based on systematic failure, product safety impact, and frequency.

QMS Audit Expert

Name: QMS Audit Expert
Author: zhangzhang-111-i

byzhangzhang-111-i

0•

Security & Testing

Streamlines ISO 13485 internal audits for medical device quality management systems with risk-based planning and finding classification.

The QMS Audit Expert skill provides a comprehensive framework for conducting internal audits according to ISO 13485:2016 standards. It assists quality managers and auditors in planning risk-based audit schedules, executing systematic inspections, classifying nonconformities (Major, Minor, or Observations), and preparing for external regulatory audits. By integrating specific clause requirements and audit checklists, this skill ensures that medical device manufacturers maintain a compliant and effective quality management system while streamlining the CAPA (Corrective and Preventive Action) verification process.

Key Features

01Risk-based audit program planning and automated scheduling

02Structured evidence collection and standardized finding templates

03Automated nonconformity classification based on severity and frequency

04Comprehensive ISO 13485:2016 clause-specific audit checklists

050 GitHub stars

06External audit readiness assessment and mock audit protocols

Use Cases

01Preparing for an upcoming ISO 13485 certification or regulatory audit

02Documenting and classifying audit findings during a live QMS inspection

03Planning an annual internal audit schedule based on process risk levels

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 qms-audit-expert

For use in Claude.ai and ChatGPT

Key Features

01Risk-based audit program planning and automated scheduling

02Structured evidence collection and standardized finding templates

03Automated nonconformity classification based on severity and frequency

04Comprehensive ISO 13485:2016 clause-specific audit checklists

050 GitHub stars

06External audit readiness assessment and mock audit protocols

Use Cases

01Preparing for an upcoming ISO 13485 certification or regulatory audit

02Documenting and classifying audit findings during a live QMS inspection

03Planning an annual internal audit schedule based on process risk levels

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 qms-audit-expert

For use in Claude.ai and ChatGPT