/iso-standards-readiness

name: iso-standards-readiness
description: 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.
license: MIT
compatibility: Python 3.11+; bundled CLIs use only the standard library and bounded local JSON/Markdown files, with no network access or credentials.
allowed-tools: Read Write Bash Glob
metadata:
  version: "1.1"
  skill-author: K-Dense Inc.
  supersedes: iso-13485-certification
  last-reviewed: "2026-07-26"

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 error