iso-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).

Quality

78%

Does it follow best practices?

Run evals on this skill

Adds up to 20 points to the overall score

View guide

Securityby

Passed

No findings from the security scan

Fix and improve this skill with Tessl

tessl review fix ./scientific-skills/Other/iso-13485-certification/SKILL.md

Quality

Content

61%Weight 40%Scale 1-5

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

A well-structured, mostly actionable skill body that makes good use of a real bundle with one-level-deep references. It would improve by trimming inlined reference material, adding an explicit validation gate to the drafting workflow, and giving executable guidance for procedure drafting.

Suggestions

Move the MDF content model and procedure-customization parameter lists into a reference file, keeping SKILL.md as a lean overview that links to them.

Add an explicit validation/verification step to the drafting workflow (e.g., 'After drafting, run references/gap-analysis-checklist.md to confirm clause coverage before finalizing').

Provide a concrete, executable example for drafting a procedure from a template rather than only listing template paths.

Dimension	Reasoning	Score
Conciseness	Mostly efficient, but the 'Implementation Details' sections inline reference-style material (the MDF 9-item content model, procedure-customization parameter list, L1–L4 documentation hierarchy) that reads as domain reference content rather than lean skill instruction and could be tightened or moved to references.	3 / 5
Actionability	Provides a copy-paste-ready bash invocation of scripts/gap_analyzer.py with concrete flags and points to specific template/reference paths; the document-drafting steps, however, only point to files without executable examples, leaving minor gaps.	4 / 5
Workflow Clarity	A clear numbered workflow exists (run analyzer → review report → read clause guidance → draft manual → draft procedures → checklist assessment), but there is no explicit validation/verification gate for generated compliance documents; the checklist is listed as a step rather than framed as a 'verify before finalizing' checkpoint.	3 / 5
Progressive Disclosure	Real bundle files (4 references, 1 script, 3 templates) are all referenced one level deep with clear navigation, but some content that belongs in references (MDF model, procedure parameters) is inlined in SKILL.md — a minor organization gap.	4 / 5
	Total	14 / 20 Passed

Description

95%Weight 40%Scale 1-5

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 that clearly states capabilities and trigger conditions with comprehensive natural keywords. The only issue is second-person voice ('you need to'), which per the rubric reduces the specificity score by one point.

Suggestions

Rewrite in third person ('Use when preparing ISO 13485:2016 certification documentation...' instead of 'Use when you need to...') to recover the specificity penalty.

Dimension	Reasoning	Score
Specificity	Lists multiple concrete actions ('documentation gap analysis', 'draft or update a Quality Manual', 'create required procedures/work instructions', 'build Medical Device Files (MDF)', 'interpret ISO 13485 clauses', 'identify missing documents') matching the comprehensive anchor, but the second-person phrasing 'Use when you need to' triggers the mandated 1-point specificity reduction.	4 / 5
Completeness	Explicitly answers both what ('toolkit for preparing ISO 13485:2016 certification documentation for medical device QMS') and when ('Use when you need to... often triggered by...') with concrete trigger phrases.	5 / 5
Trigger Term Quality	Comprehensive natural-language triggers with synonyms ('ISO 13485', 'QMS certification', 'FDA QMSR', 'EU MDR', 'quality system documentation requests') that users would naturally say when needing this skill.	5 / 5
Distinctiveness Conflict Risk	Occupies a clear niche (medical-device QMS certification) with highly specific triggers, making conflict with other skills minimal.	5 / 5
	Total	19 / 20 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
frontmatter_unknown_keys	Unknown frontmatter key(s) found; consider removing or moving to metadata	Warning
referenced_paths_exist	Referenced path issues: 4 deeper-than-1-level	Warning

	Total	14 / 16 Passed

Repository: aipoch/medical-research-skills
Path: scientific-skills/Other/iso-13485-certification/SKILL.md
Commit: f5ef65b

Reviewed: ~15 hours ago

Table of Contents

Discovery Implementation Validation

Is this your skill?

If you maintain this skill, you can claim it as your own. Once claimed, you can manage eval scenarios, bundle related skills, attach documentation or rules, and ensure cross-agent compatibility.