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ISO Standards Readiness Evidence Prep

Organizes ISO 13485, 14971, 17025 and 15189 readiness records for human review; no audits or certifications

Source Download skill
Repository
K-Dense-AI/scientific-agent-skills
Stars
55,780
Licence
MIT
Files
15 files

What it does

Once installed, the agent helps organize a company's own documents, scope statements, traceability links, CAPA records, supplier controls and local evidence lists for ISO management-system and lab-competence standards such as ISO 13485, ISO 14971, ISO/IEC 17025 and ISO 15189. It uses bundled templates and reference notes, and can run small local checks that verify files are structured correctly. It is explicitly designed to prepare draft material for qualified people to review. It does not decide whether anything complies, is certified, or is accredited, and it contains no copyrighted standard clause text.

Great for

  • Quality managers preparing organized draft evidence folders before a human-led review
  • Regulatory or QA staff who need templates for document registers, CAPA records and traceability matrices
  • Students learning how ISO certification and laboratory accreditation differ

Skip it if

  • Anyone expecting a compliance, certification, or accreditation decision: the skill explicitly cannot make these, and outputs can look complete while meaning nothing without expert review
  • Labs or companies relying on it to set risk-acceptability criteria, validate methods, or compute measurement uncertainty: these are excluded from its scope
  • Users needing the actual standard text: the skill deliberately contains no clause text and requires obtaining standards from ISO or authorized sources

Try asking

  • “Use the ISO 13485 readiness workflow to build a document register and traceability matrix for my device QMS”
  • “Prepare a scope-intake template for our ISO/IEC 17025 calibration laboratory”
  • “Create a CAPA record draft and a supplier controls checklist for human QA review”
  • “Explain the difference between ISO 15189 accreditation and CLIA certification for our lab”
Step-by-step guide: how to use ISO Standards Readiness Evidence PrepInstall, first run, examples, tips and FAQs

Install in 3 steps

  1. 1

    Download the skill

    The ZIP contains the 15 original files, the MIT licence and an attribution note.

    iso-standards-readiness.zip
  2. 2

    Add it to your agent

    Claude Code (all projects)

    mkdir -p ~/.claude/skills && unzip iso-standards-readiness.zip -d ~/.claude/skills/

    Claude Code / Agent SDK (this project only)

    mkdir -p .claude/skills && unzip iso-standards-readiness.zip -d .claude/skills/

    Claude apps (web/desktop): Settings → Capabilities → Skills → Upload skill, and choose the ZIP.

  3. 3

    Ask for the task

    No special command needed — the agent reads the skill's description and loads it when your request matches. Try one of the prompts above.

Get better results

  • Read the relevant reference file for your standard before asking for evidence preparation, since each standard has its own vocabulary and lane
  • Keep standard text and accreditation-body checklists out of prompts and shared repos, as the skill itself advises for copyright reasons
  • Treat every output as a draft and have authorized staff (quality manager, RA/QA, notified body or accreditation body as relevant) make all decisions

What's inside

  • assets/templates/capa-record-template.json
  • assets/templates/document-register-template.json
  • assets/templates/evidence-manifest-template.json
  • assets/templates/laboratory-scope-intake-template.json
  • assets/templates/medical-laboratory-scope-intake-template.json
  • assets/templates/procedures/CAPA-procedure-template.md
  • assets/templates/procedures/document-control-procedure-template.md
  • assets/templates/qmsr-transition-template.json
  • assets/templates/quality-manual-template.md
  • assets/templates/scope-intake-template.json
  • assets/templates/supplier-controls-template.json
  • assets/templates/traceability-matrix-template.json
  • references/assurance-lanes.md
  • references/evidence-architecture.md
  • SKILL.md

Redistributed unmodified from K-Dense-AI/scientific-agent-skills under the MIT licence. The assessment was drafted with AI from the skill's files on 2026-10-29. Skills can instruct your agent to run code — read SKILL.md and any scripts before installing.