qms-audit-expert

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.

Install with Tessl CLI

npx tessl i github:alirezarezvani/claude-skills --skill qms-audit-expert

What are skills?

Review — 100%

Does it follow best practices?

Validation — 10 / 11 Passed

Validation for skill structure

SKILL.md

Review

Evals

Evaluation results

100%

14%

Annual Internal Audit Program Planning

Risk-based audit schedule generation

Criteria

Without context

With context

Script invocation

40%

100%

JSON input file

62%

100%

Correct JSON schema

100%

High-risk processes identified

100%

Medium-risk processes identified

62%

100%

Correct frequency mapping

100%

All ISO 13485 clauses covered

100%

JSON output format

100%

Auditor independence criteria

100%

Audit program metrics

75%

100%

Previous findings considered

100%

Audit dates included

100%

Without context: $0.5442 · 2m 30s · 14 turns · 15 in / 10,163 out tokens

With context: $0.6425 · 2m 8s · 22 turns · 23 in / 7,247 out tokens

99%

Internal Audit Report — Finding Documentation and Classification

Finding documentation and nonconformity classification

Criteria

Without context

With context

Requirement/Evidence/Gap format

100%

Specific clause references

100%

Objective evidence in Evidence field

100%

Correct Major classification

100%

Correct Minor classification

100%

Correct Observation classification

100%

Decision tree applied

87%

CAPA timeline for Major

100%

CAPA timeline for Minor

100%

No corrective actions in finding

100%

Neutral language used

100%

Findings not combined

100%

Finding log produced

100%

Without context: $0.3071 · 1m 45s · 9 turns · 10 in / 5,951 out tokens

With context: $0.4462 · 1m 56s · 15 turns · 16 in / 6,273 out tokens

88%

CAPA Management and Finding Closure

CAPA root cause analysis and finding closure

Criteria

Without context

With context

5-Why or Fishbone for Major

100%

Immediate cause for Minor

87%

100%

Major closure checklist

75%

91%

Closure only after CAPA verified

100%

Closure record template

100%

Evidence references in closure

100%

87%

Major CAPA timeline

25%

62%

Effectiveness verification method

100%

Verification timing for Major

83%

NC-YYYY-XXX finding ID format

100%

Finding log updated

100%

Management review metrics

33%

Without context: $0.4271 · 2m 16s · 13 turns · 14 in / 7,953 out tokens

With context: $0.6734 · 3m 3s · 23 turns · 308 in / 9,346 out tokens

Evaluated: 3 days ago
Agent: Claude Code

Table of Contents

Annual Internal Audit Program Planning Internal Audit Report — Finding Documentation and Classification CAPA Management and Finding Closure

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