Agent skill · research science · k-dense-ai
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 boundaries. Not for legal applicability, compliance, certification, or accreditation decisions; contains no clause text.
Why this skill is useful
Provides structured workflows and local checks for ISO standards readiness that the AI wouldn't reliably generate on its own.
What it needs
About 8k tokens when loaded. Last updated 2026-08-03. 32,849 stars on the source repository.
What this skill does
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 copyright 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. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills k-dense-ai/iso-standards-readiness