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iso-13485-certification

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 users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.

71

Quality

88%

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SecuritybySnyk

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SKILL.md
Quality
Evals
Security

Quality

Content

77%

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

The body is well-structured and actionable with concrete commands, templates, and validation checklists, but it is over-long and inlines material already present in the reference bundle, hurting token efficiency and progressive disclosure.

Suggestions

Move the '31 Required Documented Procedures' list, 'Key Regulatory Requirements', and 'Document Retention' sections into the existing references and replace them with one-line pointers, since mandatory-documents.md already covers this material.

Trim redundancy between 'Core Workflow', 'Common Scenarios', and 'Getting Started' — consolidate the repeated priority/phase ordering into a single authoritative list and cross-reference it.

Reduce the step-by-step scenario walkthroughs to the unique guidance per scenario rather than restating the shared process each time.

DimensionReasoningScore

Conciseness

The ~670-line body is mostly efficient and contains genuine domain knowledge, but it is padded with redundancy (the priority order, scenarios, and 'Getting Started' re-summarize the same steps) and inline content that duplicates the reference files, so it could be tightened.

2 / 3

Actionability

Provides a concrete executable command (`python scripts/gap_analyzer.py --docs-dir <path> --output gap-report.json`), specific template and reference paths, explicit placeholder lists, and verbatim good-vs-poor justification examples that are copy-paste ready.

3 / 3

Workflow Clarity

Multi-step processes are clearly sequenced (five core workflow phases, numbered scenarios) with explicit validation checkpoints such as the Quality Manual validation checklist and the pre-audit checklist.

3 / 3

Progressive Disclosure

References are one level deep, clearly signaled, and all referenced bundle files exist, but substantial content that belongs in references is inlined in SKILL.md (e.g., the full 31-procedure list mirrors mandatory-documents.md, plus regulatory and retention details), so organization could be better.

2 / 3

Total

10

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12

Passed

Description

100%

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

The description is third-person, concise, and clearly states both capabilities and explicit trigger conditions with natural domain terminology. It is among the strongest examples in the rubric's reference set.

DimensionReasoningScore

Specificity

Lists multiple concrete actions enumerated as (1) gap analysis, (2) Quality Manuals, (3) procedures and work instructions, (4) Medical Device Files, (5) understanding requirements, and (6) identifying missing documentation, matching the 'lists multiple specific concrete actions' anchor.

3 / 3

Completeness

Explicitly answers both what (the six documentation tasks) and when via two explicit 'Use when...' / 'Also use when...' trigger clauses, matching the top anchor.

3 / 3

Trigger Term Quality

Includes natural terms a user in this domain would say — 'ISO 13485', 'medical device regulations', 'QMS certification', 'FDA QMSR', 'EU MDR', 'quality system documentation' — giving good coverage rather than technical jargon.

3 / 3

Distinctiveness Conflict Risk

The niche is narrow and specific (ISO 13485 medical-device QMS certification) with distinct triggers, making conflict with other skills unlikely.

3 / 3

Total

12

/

12

Passed

Validation

81%

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation13 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

skill_md_line_count

SKILL.md is long (678 lines); consider splitting into references/ and linking

Warning

metadata_version

'metadata.version' is missing

Warning

referenced_paths_exist

Referenced path issues: 5 deeper-than-1-level

Warning

Total

13

/

16

Passed

Repository
foryourhealth111-pixel/Vibe-Skills
Reviewed

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