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.
git clone --depth 1 https://github.com/K-Dense-AI/scientific-agent-skills /tmp/iso-standards-readiness && cp -r /tmp/iso-standards-readiness/skills/iso-standards-readiness ~/.claude/skills/iso-standards-readinessSKILL.md
# 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](https://www.iso.org/standards.html), IEC, an ISO national member, or another authorized source. Do not retrieve, paste, reproduce, or generate clause text. Summarize the organization's own process and cite the controlled authorized copy. See [ISO copyright](https://www.iso.org/copyright.html). Accreditation-body, CAP, and scheme checklists that quote requirements are separately licensed — keep them out of shared repositories and prompts too. ## Standards covered Read the reference file for the standard in play **before** preparing evidence. Each one carries its own current edition, lane, domain vocabulary, and failure modes. | Standard | Profile key | Lane | Reference | | --- | --- | --- | --- | | ISO 13485 medical device QMS | `iso-13485` | Certification | `references/iso-13485.md` | | ISO 14971 device risk management | `iso-14971` | No lane of its own | `references/iso-14971.md` | | ISO/IEC 17025 testing and calibration laboratories | `iso-17025` | Accreditation | `references/iso-17025.md` | | ISO 15189 medical laboratories | `iso-15189` | Accreditation | `references/iso-15189.md` | A standard absent from this table is out of scope for the bundled checks. Do not repurpose a profile for a standard it does not name — a domain vocabulary borrowed from a different standard produces a report that looks complete and means nothing. ## Current baseline (read the ledger before any time-sensitive statement) - **ISO 13485:2016** Edition 3, confirmed after its 2025 systematic review. **EN ISO 13485:2016/A11:2021** is a European amendment, not an ISO international "Amendment 1:2021." - **ISO 14971:2019** Edition 3, confirmed in 2025, with **ISO/TR 24971:2020** as its informative guidance companion. There is no ISO 14971 certificate. - **ISO/IEC 17025:2017** Edition 3 remains current; no successor edition identified. - **ISO 15189:2022** Edition 4 replaced the 2012 edition, absorbed the POCT requirements formerly in ISO 22870, and its accreditation transition closed in **December 2025** — implemented, not upcoming. - **FDA QMSR** effective and enforced since **2026-02-02**; Part 820 is titled *Quality Management System Regulation*; QSIT is retired in favour of Compliance Program **7382.850**. - **MDSAP** current Audit Approach is **MDSAP AU P0002.010**, version date **2026-02-02**. - **Accreditation recognition:** Global Accreditation Cooperation Incorporated commenced full operations **2026-01-01**, replacing ILAC and IAF, with its own MRA; former IAF MLA / ILAC MRA outputs stay recognized during the transition. - **EU:** use current consolidated MDR/IVDR texts, current OJEU harmonised-standard decisions, current MDCG guidance, and the product-specific conformity route. Read `references/source-ledger.md` before making any time-sensitive statement. It records provenance limitations, including which entries still need confirmation against the ISO catalogue. ## Keep the assurance lanes separate Lane confusion, not missing documents, causes most substantive errors here. Certification, accreditation, regulator inspection, mandatory licensure, regulatory audit programmes, and product conformity assessment are decided by different bodies against different bases, and none substitutes for another. Two rules that are violated constantly: - Organizations are **certified**; laboratories are **accredited**. "ISO 17025 certified" and "ISO 15189 certified" are category errors. - A certificate never displaces a regulator. ISO 13485 certification does not exempt anyone from FDA inspection, and ISO 15189 accreditation does not satisfy CLIA. Read `references/assurance-lanes.md` for the full lane table, scope-statement limits, and the titling rule. ## Core workflow ### Step 1: Declare the standard, purpose, and authorized owners Name the standard(s), the lane(s) the work supports, and the owners: management representative or laboratory director, quality owner, legal/applicability owner, process or technical owners, approvers, and escalation route. A lane is a declared input, never an inference. ```bash PYTHONDONTWRITEBYTECODE=1 python3 scripts
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