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 sc

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. 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. 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: All standards — corrective action and effectiveness: All standards — suppliers and externally provided products and services, including calibration providers, reference material suppliers, and referral or subcontracted laboratories: 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: 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. Then generate a domain level gap view against the same profile: 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. 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 int

iso-standards-readiness