Does this skill support risk-based auditing?

Absolutely. It includes an Audit Schedule Optimizer that assigns audit frequencies (Quarterly, Semi-annual, or Annual) based on the risk level of the specific QMS process.

What documentation does it produce?

It helps generate audit plans, standardized finding reports with objective evidence, and optimized audit schedules in both human-readable and JSON formats.

How do I prepare for an external audit using this tool?

The skill provides an external audit readiness checklist and a mock audit protocol to simulate actual inspection conditions, helping you identify and close gaps before regulators arrive.

How does this skill help with ISO 13485 compliance?

It provides a clause-by-clause methodology for auditing medical device quality systems, covering everything from design controls (7.3) to CAPA (8.5), ensuring all regulatory requirements are met.

Can it help categorize audit findings?

Yes, the skill includes a built-in classification decision tree to help users determine if a finding is a Major nonconformity, a Minor nonconformity, or an Observation based on systemic impact and risk.

QMS Audit Expert

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

byzhangzhang-111-i

0•

生産性とワークフロー

Streamlines ISO 13485 internal audits for medical device quality management systems through automated planning, risk-based scheduling, and nonconformity classification.

The QMS Audit Expert skill provides a specialized framework for conducting and managing ISO 13485:2016 internal audits within medical device environments. It enables users to design risk-based audit programs, generate clause-specific checklists, and systematically classify findings into Major or Minor nonconformities. By guiding the user through evidence collection, finding documentation, and CAPA (Corrective and Preventive Action) integration, this skill ensures that QMS processes remain compliant and ready for external regulatory inspections or certification body audits.

主な機能

01Automated audit schedule generation based on process criticality

02Clause-by-clause audit methodology for ISO 13485 compliance

030 GitHub stars

04Standardized nonconformity classification and finding templates

05External audit readiness protocols and mock audit checklists

06Risk-based audit frequency optimization and program planning

ユースケース

01Generating a risk-prioritized annual internal audit schedule for a medical device manufacturer

02Preparing internal teams for external MDSAP or Notified Body inspections with mock audit simulations

03Classifying audit findings and drafting objective evidence reports for CAPA initiation

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

主な機能

01Automated audit schedule generation based on process criticality

02Clause-by-clause audit methodology for ISO 13485 compliance

030 GitHub stars

04Standardized nonconformity classification and finding templates

05External audit readiness protocols and mock audit checklists

06Risk-based audit frequency optimization and program planning

ユースケース

01Generating a risk-prioritized annual internal audit schedule for a medical device manufacturer

02Preparing internal teams for external MDSAP or Notified Body inspections with mock audit simulations

03Classifying audit findings and drafting objective evidence reports for CAPA initiation

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