ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.
SkillScore78Maintained
Automatic
◆QA & Test Engineering pack
Last verified 8/20/2026
What it changes
Passed 18 of 23 test cases with the skill, and 12 of 23 without it.
Without skill52%
With skill78%
Checks it passed that the model alone missed
Include --output json in the command.
Include --interactive in the command.
Include --audit-type system in the command.
and 4 more in the full report
6 fixed12 passed either way5 still failing0 broke
Pass-rate lift
+26 pp
Tokens
+86%
Agent turns
0%
Response time
-1%
Model gemini-3.6-flashMeasured 8/20/2026v118 of 23 cases passed with skill
Tokens, turns and time describe resource use, not a dollar price.
See it in action
One of 6 test cases the skill fixed. Same model, same prompt, with and without the skill.
1 of 6
Prompt
We want to launch the QMS audit checklist Python script in interactive terminal mode. Just draft it: provide the exact command line invocation.
What was checked, without and with the skill
Checked
Without skill
With skill
Include --interactive in the command.
Missed
Passed
case-17 · gemini-3.6-flash · 8/20/2026 · answers are capped and redacted
What's inside
The instructions your model reads when the skill loads.
SKILL.md84 lines8 filesincludes scripts
Quality Manager - QMS ISO 13485 Specialist
ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations. Covers the full lifecycle from gap analysis through certification, plus the FDA QMSR transition (effective Feb 2026), digital/electronic QMS, and AI-enabled device considerations.
Core Capabilities
QMS implementation — gap analysis, Quality Manual (Clause 4.2.2), the 6 mandatory documented procedures, four-tier document hierarchy, certification readiness
Cross-framework integration — FDA QMSR, 21 CFR Part 11 / EU Annex 11, ISO 42001 (AI), remote/hybrid audits, cybersecurity-driven CAPA
When to Use
Building an ISO 13485:2016 QMS from scratch or remediating gaps
Preparing for or transitioning to the FDA QMSR
Establishing document control, internal audit, validation, or supplier programs
Modernizing to a digital/electronic QMS (Part 11 / Annex 11)
Integrating AI-enabled device or cybersecurity requirements into the QMS
Clarify First
Before building or assessing the QMS, confirm these inputs. If any is unknown or vague, ASK — do not assume:
Task — QMS implementation/gap analysis, internal audit, process validation, or supplier qualification (picks the workflow and script)
Standard scope — ISO 13485 only, FDA QMSR transition, or digital QMS (Part 11 / Annex 11) (determines which requirements and retained FDA items apply)
Certification stage — building from scratch, remediating gaps, or certification readiness (sets the depth)
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 deliverable.
Quick Start
# Generate an ISO 13485 audit checklist (clause, process, or full system)
python scripts/qms_audit_checklist.py --clause 7.3
python scripts/qms_audit_checklist.py --process design-control
python scripts/qms_audit_checklist.py --audit-type system --output json
python scripts/qms_audit_checklist.py --interactive
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when
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