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iso-standards-readiness

Organizes and structurally validates readiness evidence for ISO 13485, 14971, 17025, and 15189 standards.

41.1k|3.8k|Updated Oct 19, 2025
Search Tags:#quality management#evidence validation#ISO 13485#ISO 14971#accreditation#iso 15189#iso 17025
One-click install
npx skills add https://github.com/K-Dense-AI/scientific-agent-skills --skill iso-standards-readiness
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: iso-standards-readiness
Source: https://github.com/K-Dense-AI/scientific-agent-skills/tree/main/skills/iso-standards-readiness
Command: npx skills add https://github.com/K-Dense-AI/scientific-agent-skills --skill iso-standards-readiness

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill includes scripts (resource) and references (resource) and assets (resource) components.

What problem does it solve?

Preparing evidence for ISO management-system certification or laboratory accreditation is error-prone: teams confuse certification with accreditation, mix up FDA QMSR, CLIA, MDSAP, and EU MDR/IVDR lanes, and mistake document counts for implementation. This Skill organizes declared scope, controlled documents, risk files, traceability, CAPA, and supplier controls into bounded local evidence manifests for authorized human review, without reproducing copyrighted clause text or making compliance decisions.

Core Features & Use Cases

  • Deterministic local checks: Python standard-library CLIs validate scope intake, document registers, CAPA records, traceability matrices, supplier controls, QMSR transition evidence, and evidence manifests with fail-closed structural findings.
  • Per-standard profiles and references: Dedicated reference files cover ISO 13485, ISO 14971, ISO/IEC 17025, and ISO 15189, plus assurance-lane separation, a dated source ledger, and evidence architecture guidance.
  • Use Case: A quality manager preparing for an ISO/IEC 17025 accreditation assessment copies the laboratory scope-intake template, fills it with controlled organizational evidence, runs the validation and gap-analysis scripts, and hands the resulting draft evidence review to the laboratory director for authorized assessment.

Quick Start

Ask the agent to prepare an ISO 17025 accreditation-readiness evidence manifest from your controlled document export and run the bundled validation and gap-analysis checks against it.

Frequently Asked Questions about iso-standards-readiness

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I prepare ISO 17025 accreditation readiness evidence?▼

Copy the laboratory scope-intake template, complete it with controlled organizational evidence, then run validate_scope_intake.py with --standard iso-17025. Follow with validate_evidence_manifest.py and gap_analyzer.py against your controlled export to produce a draft evidence review for authorized human assessment.

What is the difference between ISO certification and laboratory accreditation?▼

Organizations and management systems are certified by certification bodies, while laboratories are accredited by accreditation bodies for a defined technical scope. ISO 13485 is a certification lane; ISO/IEC 17025 and ISO 15189 are accreditation lanes, and phrases like "ISO 17025 certified" are category errors.

Does this skill determine ISO compliance or certification readiness?▼

No. The bundled scripts perform structural evidence checks only and never determine legal applicability, compliance, conformity, certification, or accreditation. A zero-finding exit code means the supplied fields passed deterministic checks, not that any standard is satisfied.

Does ISO 13485 certification exempt a manufacturer from FDA inspection?▼

No. ISO 13485 certification never displaces FDA inspection, and FDA does not issue ISO 13485 certificates. Since 2026-02-02 the QMSR is effective and FDA uses Compliance Program 7382.850 rather than the retired QSIT.

What Python dependencies do the ISO readiness check scripts require?▼

None beyond the standard library. All bundled CLIs use only Python 3.11+ standard-library modules, perform no network requests, and validate bounded local JSON and Markdown files with symlink, duplicate-key, and size-limit protections.

Why does the evidence manifest validator reject my input file?▼

Inputs are rejected for symbolic links, duplicate JSON keys, non-finite numbers, excessive size or nesting, unsafe paths, or an unlisted --standard value, all exiting with code 2. Templates intentionally fail closed until placeholders are replaced with controlled organizational evidence.

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