iso-13485-certification

Prepare and structurally review ISO 13485 QMS scope, controlled documentation, and local evidence manifests. Use for ISO 13485 certification-readiness documentation or for separating related FDA QMSR, MDSAP, and EU MDR/IVDR evidence boundaries; not for legal applicability, compliance, or certification decisions.

Quality

92%

Does it follow best practices?

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Adds up to 20 points to the overall score

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Securityby

Passed

No findings from the security scan

Quality

Content

84%

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

Highly actionable, well-structured content with executable commands and explicit validation checkpoints across an eight-step workflow. Progressive disclosure is clean — all references are one level deep and resolve to real bundle files; the only minor weakness is some verbosity in boundary and prose sections.

Suggestions

Tighten the 'Non-negotiable boundary' and per-step prose to remove repetition that assumes less competence than needed, improving token efficiency.

Consider moving the long enumerations (e.g. Step 4 review list) into a reference file referenced from SKILL.md to keep the body leaner while preserving detail.

Dimension	Reasoning	Score
Conciseness	Mostly efficient and free of obvious concept padding, but the boundary/copyright sections and the per-step prose add length that assumes less competence than needed; some enumerations could be tightened without losing clarity.	2 / 3
Actionability	Provides complete, executable CLI invocations with real flags and relative paths (e.g. 'python3 scripts/validate_scope_intake.py assets/templates/scope-intake-template.json'), and concrete field lists for each check — copy-paste ready.	3 / 3
Workflow Clarity	An eight-step sequence with explicit validation checkpoints (fail-closed templates, exit-code semantics, blocked-closure rules) and clear feedback guidance for error recovery in batch/evidence operations.	3 / 3
Progressive Disclosure	SKILL.md is a well-organized overview with one-level-deep references to verified files (references/.md, assets/templates/, scripts/*.py), each clearly signaled and listed in dedicated Templates/References sections; all referenced paths resolve to real bundle files.	3 / 3
	Total	11 / 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.

A strong, specific description with concrete actions, natural trigger terms, and explicit what/when guidance plus a clear out-of-scope clause. It is distinguishable from neighboring skills and uses correct third-person voice.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete actions — 'Prepare and structurally review ISO 13485 QMS scope, controlled documentation, and local evidence manifests' — naming specific artifact types rather than vague verbs.	3 / 3
Completeness	Explicitly answers what ('Prepare and structurally review...scope, controlled documentation, and local evidence manifests') and when ('Use for ISO 13485 certification-readiness documentation or for separating related FDA QMSR, MDSAP, and EU MDR/IVDR evidence boundaries'), with a clear negative-scope trigger.	3 / 3
Trigger Term Quality	Covers natural terms a user would say — 'ISO 13485', 'certification-readiness documentation', 'FDA QMSR', 'MDSAP', 'EU MDR/IVDR' — with good coverage of common phrasings.	3 / 3
Distinctiveness Conflict Risk	Narrow niche — ISO 13485 certification-readiness documentation with explicit 'not for legal applicability, compliance, or certification decisions' boundaries — unlikely to trigger for unrelated skills.	3 / 3
	Total	12 / 12 Passed

Validation

87%

Warnings & errors only

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

Validation — 14 / 16 Passed

Validation for skill structure

Criteria	Description	Result
allowed_tools_field	'allowed-tools' contains unusual tool name(s)	Warning
referenced_paths_exist	Referenced path issues: 16 deeper-than-1-level	Warning

	Total	14 / 16 Passed

Repository: K-Dense-AI/scientific-agent-skills
Path: skills/iso-13485-certification/SKILL.md
Commit: 757b63b

Reviewed: about 12 hours ago

Table of Contents

Discovery Implementation Validation

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