---

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, 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.

| 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.

PYTHONDONTWRITEBYTECODE=1 python3 scripts/validate_scope_intake.py \
  assets/templates/scope-intake-template.json --standard iso-13485

Use the matching template and profile:

| Profile | Template | | --- | --- | | iso-13485, iso-14971 | assets/templates/scope-intake-template.json | | iso-17025 | assets/templates/laboratory-scope-intake-template.json | | iso-15189 | assets/templates/medical-laboratory-scope-intake-template.json |

--standard defaults to iso-13485. Every distributed template intentionally fails closed; copy it outside the skill and complete it with controlled organizational evidence. Undetermined applicability raises HUMAN_DECISION_REQUIRED — leave it as a blocker.

Step 2: Freeze source/version evidence

For every standard, regulation, guidance, scheme document, audit model, and product source, record publisher, official title, edition/version/date, authorized location, access and currency-review dates, scope/applicability owner, impact assessment, status, evidence, and approval.

Do not use search snippets as controlled requirements. Do not silently update an incorporated edition when a publisher releases a new one — FDA incorporated a specific ISO 13485 edition, and a later ISO or EN publication does not change it.

Step 3: Inventory controlled documents and records

Do not count named procedures or scan keywords. Build an explicit register linking documents, records, source versions, owners, approvals, effective dates, retention bases, training, and change records.

PYTHONDONTWRITEBYTECODE=1 python3 scripts/audit_document_records.py \
  assets/templates/document-register-template.json

This check is standard-agnostic. Read references/evidence-architecture.md for the evidence architecture.

Step 4: Review process implementation

Assess controlled procedures and sampled records across the domains your profile declares — the per-standard reference file lists them. Each item needs owner, status, evidence IDs, source/version, approval, and open-gap links.

A procedure describing an activity is not evidence the activity happened. Sample records in every domain you report on, and state what you sampled and what you did not.

Step 5: Run the focused checks that apply to the lane

Device lanes (iso-13485, iso-14971) — risk/design/production/post-market chain:

PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_traceability.py \
  assets/templates/traceability-matrix-template.json

All standards — corrective action and effectiveness:

PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_capa.py \
  assets/templates/capa-record-template.json

All standards — suppliers and externally provided products and services, including calibration providers, reference-material suppliers, and referral or subcontracted laboratories:

PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_supplier_controls.py \
  assets/templates/supplier-controls-template.json

Pending or ineffective CAPA effectiveness evidence blocks closure. Critical supplier controls stay blocked until risk-based controls and approvals are evidenced.

Note that check_traceability.py concerns design and risk traceability, not metrological traceability — the words collide and it is the wrong tool for laboratory work.

Step 6: Address lane-specific regulator evidence separately

For the US device lane only:

PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_qmsr_transition.py \
  assets/templates/qmsr-transition-template.json

Review current Part 820/FDA source basis, supplemental provisions, obsolete QSR/QSIT references, pre-effective-date records, inspection-accessible management/quality/ supplier-audit records, current inspection-process training, complaint and servicing records, labeling/packaging controls, supplier/software/change evidence, and prohibited certificate-equivalence claims. Do not build an old-820-to-ISO clause map as the current control framework.

Laboratory lanes have no equivalent bundled check. CLIA, licensure, and national inspection evidence stays with the authorized compliance owner; see references/iso-15189.md.

Step 7: Assemble a bounded readiness manifest

Copy the evidence template outside the skill. Use relative paths to local .json, .md, or .markdown evidence only, and one declared lane purpose per manifest.

PYTHONDONTWRITEBYTECODE=1 python3 scripts/validate_evidence_manifest.py \
  /path/to/evidence-manifest.json \
  --standard iso-17025 \
  --base-dir /path/to/controlled-export \
  --verify-files \
  --output /path/to/manifest-report.json

Then generate a domain-level gap view against the same profile:

PYTHONDONTWRITEBYTECODE=1 python3 scripts/gap_analyzer.py \
  /path/to/evidence-manifest.json \
  --standard iso-17025 \
  --base-dir /path/to/controlled-export \
  --verify-files \
  --output /path/to/gap-report.json

T