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.

SKILL.md holds the boundary, lane discipline, shared evidence workflow, and CLI contract. Per-standard preparation details live 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. Summarize the organization's own process and cite the controlled authorized copy. See ISO copyright. 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.

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. Its proposed successor ISO/AWI TS 24971-1 is under development, not a published replacement or a new normative basis.
• 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 P0002.011, version date 2026-08-03.
• Accreditation recognition: Global Accreditation Cooperation Incorporated commenced full operations 2026-01-01, replacing ILAC and IAF, with its own MRA;

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