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iso-13485-certification

A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS. Use when you need to perform a documentation gap analysis, draft or update a Quality Manual, create required procedures/work instructions, build Medical Device Files (MDF), interpret ISO 13485 clauses, or identify missing documents for certification (often triggered by ISO 13485, QMS certification, FDA QMSR, EU MDR, or quality system documentation requests).

92100Total Score
Core Capability
88 / 100
Functional Suitability
11 / 12
Reliability
10 / 12
Performance & Context
8 / 8
Agent Usability
14 / 16
Human Usability
8 / 8
Security
10 / 12
Maintainability
10 / 12
Agent-Specific
17 / 20
Medical Task
20 / 20 Passed
99A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS. Use when you need to perform a documentation gap analysis, draft or update a Quality Manual, create required procedures/work instructions, build Medical Device Files (MDF), interpret ISO 13485 clauses, or identify missing documents for certification (often triggered by ISO 13485, QMS certification, FDA QMSR, EU MDR, or quality system documentation requests)
4/4
95A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS. Use when you need to perform a documentation gap analysis, draft or update a Quality Manual, create required procedures/work instructions, build Medical Device Files (MDF), interpret ISO 13485 clauses, or identify missing documents for certification (often triggered by ISO 13485, QMS certification, FDA QMSR, EU MDR, or quality system documentation requests)
4/4
93Automated documentation gap analysis via scripts/gap_analyzer.py to detect missing/covered QMS documents
4/4
93Clause-by-clause ISO 13485 reference guidance using references/iso-13485-requirements.md
4/4
93End-to-end case for Automated documentation gap analysis via scripts/gap_analyzer.py to detect missing/covered QMS documents
4/4

Veto GatesRequired pass for any deployment consideration

Skill Veto✓ All 4 gates passed
✓
Operational Stability
System remains stable across varied inputs and edge cases
PASS
✓
Structural Consistency
Output structure conforms to expected skill contract format
PASS
✓
Result Determinism
Equivalent inputs produce semantically equivalent outputs
PASS
✓
System Security
No prompt injection, data leakage, or unsafe tool use detected
PASS

Core Capability88 / 100 — 8 Categories

Functional Suitability
Related legacy finding for iso-13485-certification: Improve stress-case output rigor. Stress and boundary scenarios show weaker consistency
11 / 12
92%
Reliability
Reliability was softened by the legacy issue 'Improve stress-case output rigor'. Stress and boundary scenarios show weaker consistency
10 / 12
83%
Performance & Context
Performance context reached full score in the archived evaluation.
8 / 8
100%
Agent Usability
A modest deduction remained in agent usability for iso-13485-certification in the archived review.
14 / 16
88%
Human Usability
No point loss was recorded for human usability in the legacy audit.
8 / 8
100%
Security
The legacy audit deducted points for iso-13485-certification in security.
10 / 12
83%
Maintainability
The legacy audit deducted points for iso-13485-certification in maintainability.
10 / 12
83%
Agent-Specific
Agent specific was softened by the legacy issue 'Improve stress-case output rigor'. Stress and boundary scenarios show weaker consistency
17 / 20
85%
Core Capability Total88 / 100

Medical TaskExecution Average: 94.6 / 100 — Assertions: 20/20 Passed

99
Canonical
A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS. Use when you need to perform a documentation gap analysis, draft or update a Quality Manual, create required procedures/work instructions, build Medical Device Files (MDF), interpret ISO 13485 clauses, or identify missing documents for certification (often triggered by ISO 13485, QMS certification, FDA QMSR, EU MDR, or quality system documentation requests)
4/4 ✓
95
Variant A
A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS. Use when you need to perform a documentation gap analysis, draft or update a Quality Manual, create required procedures/work instructions, build Medical Device Files (MDF), interpret ISO 13485 clauses, or identify missing documents for certification (often triggered by ISO 13485, QMS certification, FDA QMSR, EU MDR, or quality system documentation requests)
4/4 ✓
93
Edge
Automated documentation gap analysis via scripts/gap_analyzer.py to detect missing/covered QMS documents
4/4 ✓
93
Variant B
Clause-by-clause ISO 13485 reference guidance using references/iso-13485-requirements.md
4/4 ✓
93
Stress
End-to-end case for Automated documentation gap analysis via scripts/gap_analyzer.py to detect missing/covered QMS documents
4/4 ✓
99
Canonical✅ Pass
A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS. Use when you need to perform a documentation gap analysis, draft or update a Quality Manual, create required procedures/work instructions, build Medical Device Files (MDF), interpret ISO 13485 clauses, or identify missing documents for certification (often triggered by ISO 13485, QMS certification, FDA QMSR, EU MDR, or quality system documentation requests)

The A toolkit for preparing ISO 13485:2016 certification documentation... scenario completed within the documented A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS boundary.

Basic 38/40|Specialized 60/60|Total 99/100
✅A1The iso-13485-certification output structure matches the documented deliverable
✅A2The script execution path completed successfully for the documented case
✅A3The output stays fully within the documented skill boundary
✅A4The response quality is acceptable for the documented path
Pass rate: 4 / 4
95
Variant A✅ Pass
A toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS. Use when you need to perform a documentation gap analysis, draft or update a Quality Manual, create required procedures/work instructions, build Medical Device Files (MDF), interpret ISO 13485 clauses, or identify missing documents for certification (often triggered by ISO 13485, QMS certification, FDA QMSR, EU MDR, or quality system documentation requests)

The archived evaluation treated A toolkit for preparing ISO 13485:2016 certification documentation... as a clean in-scope run.

Basic 36/40|Specialized 59/60|Total 95/100
✅A1The iso-13485-certification output structure matches the documented deliverable
✅A2The script execution path completed successfully for the documented case
✅A3The output stays fully within the documented skill boundary
✅A4The response quality is acceptable for the documented path
Pass rate: 4 / 4
93
Edge✅ Pass
Automated documentation gap analysis via scripts/gap_analyzer.py to detect missing/covered QMS documents

Automated documentation gap analysis via scripts/gap_analyzer.py to... remained well-aligned with the documented contract in the preserved audit.

Basic 35/40|Specialized 58/60|Total 93/100
✅A1The iso-13485-certification output structure matches the documented deliverable
✅A2The script execution path completed successfully for the documented case
✅A3The output stays fully within the documented skill boundary
✅A4The response quality is acceptable for the documented path
Pass rate: 4 / 4
93
Variant B✅ Pass
Clause-by-clause ISO 13485 reference guidance using references/iso-13485-requirements.md

Clause-by-clause ISO 13485 reference guidance using... remained well-aligned with the documented contract in the preserved audit.

Basic 34/40|Specialized 59/60|Total 93/100
✅A1The iso-13485-certification output structure matches the documented deliverable
✅A2The script execution path completed successfully for the documented case
✅A3The output stays fully within the documented skill boundary
✅A4The response quality is acceptable for the documented path
Pass rate: 4 / 4
93
Stress✅ Pass
End-to-end case for Automated documentation gap analysis via scripts/gap_analyzer.py to detect missing/covered QMS documents

End-to-end case for Automated documentation gap analysis via... remained well-aligned with the documented contract in the preserved audit.

Basic 31/40|Specialized 60/60|Total 93/100
✅A1The iso-13485-certification output structure matches the documented deliverable
✅A2The script execution path completed successfully for the documented case
✅A3The output stays fully within the documented skill boundary
✅A4The response quality is acceptable for the documented path
Pass rate: 4 / 4
Medical Task Total94.6 / 100

Key Strengths

  • Primary routing is Other with execution mode B
  • Static quality score is 88/100 and dynamic average is 81.6/100
  • Assertions and command execution outcomes are recorded per input for human review
  • Execution verification summary: Script verification 1/1; adjustment=5. gap_analyzer.py: OK