iso-standards-readiness

iso-standards-readiness is a skill for Claude Code from K-Dense-AI/scientific-agent-skills. It costs 145 tokens per session (3,838 once invoked), scanned A, original, MIT.

A preparation and review workflow for evidence related to four standards: ISO 13485 for medical-device quality systems, ISO 14971 for device risk management, ISO/IEC 17025 for testing and calibration laboratories, and ISO 15189 for medical laboratories.

In plain words
What is it for?
Use it to structure readiness evidence, controlled documents, implementation records, and review materials for a named standard and a human assessment.
Why use it?
It helps organize documents, records, traceability, and declared scope before qualified people review readiness. It does not certify, accredit, audit, or decide legal or regulatory compliance.

Skill for Claude Code

Written for Claude Code: allowed-tools in frontmatter.

Good fit Use it to structure readiness evidence, controlled documents, implementation records, and review materials for a named standard and a human assessment.

Compare 6 skills from other repositories ↓
Install with agentmods
npx agentmods add skills/k-dense-ai/scientific-agent-skills/iso-standards-readiness
About the project

Scientific Agent Skills is a collection of reusable procedures that give AI agents capabilities for scientific research across areas such as biology, chemistry, medicine, and drug discovery. It is used by researchers and by people building AI scientist workflows with compatible coding agents. The catalogue contains many of the project's skills and supporting instructions.

K-Dense-AI/scientific-agent-skills · 44,469 stars · on GitHub · arxiv.org

Install

Getting it into your agent

One page per mod, every tool's command on it. A separate URL per tool would split the same page into five that compete with each other.

Any agent
npx skills add K-Dense-AI/scientific-agent-skills --skill iso-standards-readiness
Clone the repo
git clone --depth 1 https://github.com/K-Dense-AI/scientific-agent-skills

Made for: Claude Code.

Wrote this? Show the measurements

A badge with what this costs and how it scanned, read live from this page, so it follows the numbers instead of freezing them. Markdown for a README, HTML for a documentation site or a project page.

agentmods badge for iso-standards-readiness

README.md
[![agentmods](https://agentmods.dev/badge/skills/k-dense-ai/scientific-agent-skills/iso-standards-readiness/github.svg)](https://agentmods.dev/skills/k-dense-ai/scientific-agent-skills/iso-standards-readiness)
Your own site
<a href="https://agentmods.dev/skills/k-dense-ai/scientific-agent-skills/iso-standards-readiness"><img src="https://agentmods.dev/badge/skills/k-dense-ai/scientific-agent-skills/iso-standards-readiness/github.svg" alt="Measured on agentmods" height="20"></a>

Or the 80×15 button, for a site that already has a row of RSS and ATOM ones. Only the verdict fits; the numbers stay here.

agentmods 80×15 button for iso-standards-readiness

Your own site · 80×15
<a href="https://agentmods.dev/skills/k-dense-ai/scientific-agent-skills/iso-standards-readiness"><img src="https://agentmods.dev/badge/skills/k-dense-ai/scientific-agent-skills/iso-standards-readiness.svg" alt="Reviewed on agentmods" width="80" height="20"></a>
Per session 145 Skills are progressive disclosure: only the name and description are preloaded; the body loads when the skill is used.
When invoked 3,838 The whole file, excluding the scripts and references it only reads on demand.
Security scan A 0 findings. A grade says what 26 rules found in the file — not that it is safe. Third-party audits
  • Socket pass 3 Sept 2026
  • Snyk pass 3 Sept 2026
  • NVIDIA SkillSpector pass 7 Sept 2026
How audits are shown
Origin original No closer match found in the catalogue.
Token cost

What it costs to keep this loaded

Counted locally with the o200k_base tokenizer, which is exact for GPT models; Claude uses its own tokenizer and its counts differ. Treat this as one consistent yardstick across the catalogue rather than a bill. Prices are per million input tokens.

ModelPer sessionOnce invoked
Fable 5.1 $0.00145 $0.03838
Opus 5 $0.00072 $0.01919
Sonnet 5 $0.00029 $0.00768
Haiku 4.5 $0.00015 $0.00384

Measured 9d ago against content hash ea63a36e5d43, method: parsed. Prices are Anthropic first-party input rates as of 2026-09-12, from the pricing page.

Security

Grade A, and why

iso-standards-readiness scanned grade A with 0 findings against 26 rules in 11 categories — prompt injection, anti-refusal, data exfiltration, privilege escalation, supply chain, agent snooping, system-prompt leakage, SSRF and excessive agency — measured 9d ago.

The scan reads SKILL.md. This mod also ships 10 executable files (scripts/_catalog.py, scripts/_common.py, scripts/audit_document_records.py, …), listed below but not scanned — reading those needs a real analyzer, not pattern matching.

A static scan of the body, not an audit. Every finding is printed with the line that produced it so you can judge whether it matters here. A mod is markdown that instructs an agent; that is exactly why what it instructs is worth reading.

Nothing flagged

None of the 26 patterns this scan looks for appear in this file: no shell pipes, no recursive deletes, no credential paths, no hidden text, no instruction-override or anti-refusal phrasing, no agent-config snooping. That is not a guarantee, it is the absence of the things that are checkable.

Origin

Copies of this mod

1 near-identical copy found in the catalogue:

skills/iso-standards-readiness/SKILL.md · 370 lines

How it starts

The opening of the file, as written. The whole thing — 370 lines — stays where its author put it; the contents beside it link to each section on GitHub.

ISO Standards Readiness Evidence Preparation

Purpose

Use this skill to organize declared scope, controlled documents, implementation records, traceability, and readiness evidence for substantive human review against a named standard. It summarizes process workflows and provides deterministic local checks. It contains no clause text and performs no audit.

This is a router. SKILL.md holds the boundary, the lane discipline, the shared workflow, and the CLI contract. Per-standard depth lives in references/.

Non-negotiable boundary

This skill cannot:

  • certify or accredit anything, issue or validate a certificate, accreditation schedule, or licence, or promise an audit, assessment, or inspection result;
  • determine legal/regulatory applicability, device classification, reportability, conformity route, product authorization, market access, licensure, personnel qualification, or compliance;
  • replace authorized management, the management representative, laboratory director, quality manager, authorized signatory, RA/QA, legal counsel, regulatory/competent authorities, a notified body, an MDSAP Auditing Organization, an accreditation body, an assessor, or a certification body;
  • validate a method, compute or approve measurement uncertainty, establish metrological traceability, set risk-acceptability criteria, or judge whether a risk, decision rule, or reference interval is fit for purpose; or
  • infer implementation, competence, conformity, compliance, or readiness from a template, checklist, filename, keyword, document count, percentage, or script result.

Always label outputs draft evidence-preparation material for authorized human review. Preserve unresolved decisions as blockers rather than resolving them.

ISO and IEC standards are copyrighted. Obtain each standard from ISO, IEC, an ISO national member, or another authorized source. Do not retrieve, paste, reproduce, or generate clause text. Summarize the organization's own process and cite the controlled authorized copy. See ISO copyright. Accreditation-body, CAP, and scheme checklists that quote requirements are separately licensed — keep them out of shared repositories and prompts too.

Read the full file on GitHub · 370 lines

Files

What ships with it

31 files beside SKILL.md in the same directory: the scripts, references and assets a skill reads on demand. Not counted in the per-session cost; read them before you install if any of them is executable.

Changes

What this file has done since we first saw it

Hashed on every crawl. A supply-chain change to an agent config is a question of when, not whether, so the history is kept rather than the latest state alone.

  1. 9d ago Changed · +17 lines ea63a36e5d43
  2. 13d ago First seen · 353 lines · 145 tokens per session scan A a08ce20a9aea

Subscribe to this mod's changes

iso-standards-readiness is a skill published in the GitHub repository K-Dense-AI/scientific-agent-skills (44,469 stars, last pushed yesterday), licensed MIT. It adds 145 tokens to every session and 3,838 once invoked, about $0.0007 per session on Opus 5. A static security scan graded it A with 0 findings. No closer match exists in the catalogue, so it is treated as the original; first seen 2026-08-30.

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