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; 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 catalogue confirmation, published versus draft documents, and the remaining EU source-retrieval limitations. The bundled report basis_date is this skill release's research baseline, not the organization's review date or a freshness guarantee.

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:

--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

For a calibration supplier, link the purchased measurand, range, method, and location to the provider's dated accreditation scope and applicable calibration and measurement capability, using the current Global ACI-TECH-1-009 (M) policy basis (successor to ILAC P14; see the source ledger). Capture the actual certificate's reported uncertainty separately; a scope CMC is not automatically the uncertainty of the delivered calibration. Leave any coverage or suitability judgment to the authorized technical owner.

Pending or ineffective CAPA effectiveness evidence blocks closure. High-risk 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

The analyzer uses explicit manifest labels. It does not infer evidence from filenames, keywords, or proprietary standard text, and does not calculate a compliance score. A domain absent from expected_domains is reported not-assessed, which is not a not-applicable determination. Entry-level structural findings, including a requested hash mismatch, prevent an evidence-present-for-human-review domain label. Always read the report-level findings too; domain labels do not establish file authenticity or substantive adequacy.

Read references/gap-analysis-checklist.md for the fail-closed review questions.

Step 8: Human review and controlled handoff

Present:

• declared standard, scope, assurance lane(s), and unresolved applicability decisions;
• the exact source/version baseline;
• evidence sampled and the limitations of that sample;
• structural findings grouped by process and risk;
• actions, change, and CAPA owners with dates;
• approval state; and
• the authorized party responsible for the next decision.

Never title the result "certificate," "accreditation," "compliance report," "audit pass," "deemed status," or "ready for inspection." A suitable title is Draft evidence review for authorized human assessment, naming the lane it was prepared for.

CLI behavior and safety

All bundled CLIs:

• use the Python standard library only;
• perform no network requests;
• accept bounded local JSON; optional evidence verification accepts only bounded local JSON/Markdown;
• reject symbolic-link inputs, duplicate JSON keys, non-finite numbers, excessive size/nesting/items, and unsafe evidence paths;
• refuse an unlisted --standard value rather than falling back to a default;
• use no dynamic evaluation, executable deserialization, pickle, or shell execution;
• refuse to overwrite reports unless --force is explicit; and
• produce deterministic sorted JSON.

Treat the manifest itself as a controlled organizational record. An optional SHA-256 comparison detects a local file mismatch only; it does not establish provenance, authenticity, adequacy, or trust in a user-supplied manifest. Values in JSON local_path and evidence.location fields refer to the user's controlled export, not to bundled skill resources; unresolved placeholders must never be opened.

Exit codes:

• 0: no structural finding for the supplied fields; not a compliance, conformity, competence, or accreditation result;
• 1: structural/evidence gaps found;
• 2: invalid or unsafe input/output, including an unlisted standard.

Run python3 scripts/<name>.py --help for each interface.

Templates

Scope intake, per profile:

• assets/templates/scope-intake-template.json — device lifecycle
• assets/templates/laboratory-scope-intake-template.json — testing/calibration
• assets/templates/medical-laboratory-scope-intake-template.json — examinations

Shared registers and records:

• assets/templates/document-register-template.json
• assets/templates/capa-record-template.json
• assets/templates/traceability-matrix-template.json
• assets/templates/supplier-controls-template.json
• assets/templates/evidence-manifest-template.json
• assets/templates/qmsr-transition-template.json — US device lane only

Management-system documentation:

• assets/templates/quality-manual-template.md
• assets/templates/procedures/CAPA-procedure-template.md
• assets/templates/procedures/document-control-procedure-template.md

Every template is deliberately draft/pending, uses placeholders, and includes owner/status/evidence/approval fields. Copy and control it; never edit a distributed template into a purported approved record.

References

Shared:

• references/assurance-lanes.md — what each lane decides, and the titling rule
• references/source-ledger.md — dated authoritative source baseline and provenance limitations
• references/evidence-architecture.md — documentation and record architecture
• references/gap-analysis-checklist.md — fail-closed evidence review questions
• references/quality-manual-guide.md — controlled manual development

Per standard:

• references/iso-13485.md — device QMS process/evidence framework, QMSR, MDSAP, EU
• references/iso-14971.md — risk-management chain and the missing-link failure modes
• references/iso-17025.md — laboratory competence, traceability, uncertainty, and decision rules
• references/iso-15189.md — medical laboratories, POCT, reporting, and the CLIA lane