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ISO Standards Readiness

Structures and locally verifies readiness evidence for ISO 13485, 14971, 17025 and 15189 without touching copyrighted clause text.

Docs & OfficeAdvanced★ 33,030⑂ 3,248AI score 8/10Last updated: Aug 9, 2026

What it does

Organizes readiness evidence for human review against named standards: ISO 13485 medical device QMS, ISO 14971 device risk management, ISO/IEC 17025 testing and calibration labs, and ISO 15189 medical laboratories.

  • Structures declared scope, controlled-document registers, risk-management files, traceability, CAPA and external-provider controls
  • Keeps assurance lanes separate: certification vs. accreditation vs. FDA QMSR inspection vs. CLIA vs. MDSAP vs. EU MDR/IVDR
  • Ships stdlib-only Python CLIs (no network, no credentials) for scope intake validation, document/record audit, traceability, CAPA, supplier controls, evidence manifests and domain gap analysis
  • Maintains a dated source ledger so time-sensitive statements (current editions, QMSR effective date, accreditation recognition changes) are grounded

Hard boundary: it never certifies, accredits, determines legal applicability, or computes a compliance score. All output is labeled draft evidence-preparation material, and no ISO clause text is included or generated.

Who it's for

  • QA/RA staff and management representatives at medical device manufacturers
  • Quality managers and lab directors preparing for ISO 17025 / ISO 15189 accreditation
  • Consultants doing pre-audit document and record gap sweeps
  • Regulatory teams that must not blur certification, accreditation and inspection evidence

Examples

  1. ISO 13485 audit prep: copy the scope intake template outside the skill, fill it with controlled evidence, run validate_scope_intake.py --standard iso-13485, then chain the document register, traceability and CAPA checks; undetermined items stay as HUMAN_DECISION_REQUIRED blockers.
  2. Lab accreditation packet: validate a bounded evidence manifest with --standard iso-17025 --verify-files, then produce a domain-level gap report with gap_analyzer.py (domains not listed come back not-assessed, not "N/A").
  3. US device lane check: run check_qmsr_transition.py to surface obsolete QSR/QSIT references, pre-effective-date records and prohibited certificate-equivalence claims before an FDA inspection.

· · · Install guide · · ·

Install in the Claude app (no terminal)
  1. Download the ZIP with the button below.
  2. In Claude, open Settings → Capabilities and turn on 'Code execution and file creation'. (one time)
  3. Go to Customize → Skills → + → 'Upload a skill' and upload the ZIP.
↓ Download ZIP
Install in Claude Code

Let Claude do it — paste this into Claude Code

Install the skill I found on Claude Skill Mart.
Copy the skills/iso-standards-readiness folder from the GitHub repo K-Dense-AI/scientific-agent-skills into my ~/.claude/skills/iso-standards-readiness/.
When it's done, tell me in one line what this skill can do.

Install with a command instead

git clone https://github.com/K-Dense-AI/scientific-agent-skills.git /tmp/sci-skills && mkdir -p ~/.claude/skills && cp -r /tmp/sci-skills/skills/iso-standards-readiness ~/.claude/skills/

⚠ This is a third-party skill. Check the source repository before installing.

  1. Open a terminal and go to a scratch directory.
  2. Clone the repository: git clone https://github.com/K-Dense-AI/scientific-agent-skills.git
  3. Create the skills directory: mkdir -p ~/.claude/skills
  4. Copy just this skill: cp -r scientific-agent-skills/skills/iso-standards-readiness ~/.claude/skills/
  5. Confirm Python 3.11 or newer: python3 --version
  6. Restart Claude Code and ask something like "Help me prepare ISO 13485 readiness evidence for a certification lane".
  7. Always copy templates outside the skill folder before filling them with real controlled records — never edit a distributed template into a purported approved record.
View source on GitHub ↗License: MIT