iso-standards-readiness
Prepares and structurally reviews readiness evidence for ISO management-system and laboratory-competence standards - ISO 13485 medical device QMS, ISO 14971 device risk management, ISO/IEC 17025 testing and calibration laboratories, and ISO 15189 medical laboratories. Use when organizing declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, external-provider controls, or bounded local evidence manifests, and when separating ISO certification from laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP, and EU MDR/IVDR evidence
npx skills add K-Dense-AI/scientific-agent-skills --skill iso-standards-readiness --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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; -
- Purpose
- Non-negotiable boundary
- ISO and IEC copyright
- Standards covered
- Current baseline (read the ledger before any time-sensitive statement)
- Keep the assurance lanes separate
- Core workflow
- Step 1: Declare the standard, purpose, and authorized owners
- Step 2: Freeze source/version evidence
- Step 3: Inventory controlled documents and records
- Step 4: Review process implementation
- Step 5: Run the focused checks that apply to the lane
- Step 6: Address lane-specific regulator evidence separately
- Step 7: Assemble a bounded readiness manifest
assets/templates/scope-intake-template.json --standard iso-13485 assets/templates/document-register-template.json assets/templates/traceability-matrix-template.json assets/templates/capa-record-template.json assets/templates/supplier-controls-template.json assets/templates/qmsr-transition-template.json
What does the iso-standards-readiness skill do?
Prepares and structurally reviews readiness evidence for ISO management-system and laboratory-competence standards - ISO 13485 medical device QMS, ISO 14971 device risk management, ISO/IEC 17025 testing and calibration laboratories, and ISO 15189 medical laboratories. Use when organizing declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, external-provider controls, or bounded local evidence manifests, and when separating ISO certification from laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP, and EU MDR/IVDR evidence
How do I install it?
Run `npx skills add K-Dense-AI/scientific-agent-skills --skill iso-standards-readiness --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From K-Dense-AI/scientific-agent-skills, a repository with 32,619 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.