@pikaa-ai/pikaa 0.2.5 → 0.3.0

package/skills/iso-standards-readiness/references/quality-manual-guide.md

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+# Quality Manual Development Guide
+
+Research basis: **2026-07-23**, extended **2026-07-26** for laboratory lanes. This guide
+explains an evidence-controlled authoring process. It does not reproduce standard text
+or prescribe a universal manual format.
+
+The authoring process applies to any management-system documentation this skill covers.
+Where it says "QMS scope," a laboratory's equivalent is the **scope of laboratory
+activities** — per location and per method or examination — and a laboratory manual
+should point to the accredited scope schedule rather than restate it. Read
+`references/iso-17025.md` or `references/iso-15189.md` alongside this guide.
+
+## Boundary and copyright
+
+A quality manual template cannot establish an effective QMS, conformity,
+certification, FDA compliance, MDSAP acceptance, EU conformity, or legal
+applicability. It cannot replace authorized management, RA/QA, legal, notified-body,
+regulatory-authority, MDSAP Auditing Organization, or certification-body decisions.
+
+ISO publications are copyrighted. Obtain ISO 13485 from
+[ISO](https://www.iso.org/standard/59752.html), a national member, or an authorized
+source. Do not paste standard text into the manual. Summarize the organization's
+actual processes and reference its controlled authorized copy.
+
+## Purpose of a manual
+
+A useful manual or equivalent policy architecture:
+
+- identifies the approved QMS scope;
+- identifies controlled processes and their interactions;
+- states governance, authorities, and responsibilities;
+- explains the documentation/evidence hierarchy;
+- points to organization-specific controlled procedures and records; and
+- distinguishes the applicable standard, regulatory, audit, and product sources.
+
+The manual should be the length and structure needed for the organization. Page count,
+a fixed procedure list, or mirroring standard headings does not prove adequacy.
+
+## Development workflow
+
+### 1. Establish an authorized source baseline
+
+Create a controlled source ledger before drafting. At minimum record:
+
+- ISO 13485:2016, Edition 3, and authorized location;
+- the applicable EN adoption/amendment/corrigendum if European harmonisation is
+  being used;
+- current FDA QMSR/eCFR sources if U.S. operations are in declared scope;
+- current MDSAP Audit Approach if MDSAP is in declared scope;
+- current consolidated MDR or IVDR, OJEU harmonised-standard decisions, and relevant
+  MDCG guidance if EU work is in declared scope;
+- ISO 14971/EN A11 and product-specific standards where applicable; and
+- current product/jurisdictional regulations and guidance.
+
+For each source, capture publisher, title, edition/version/date, official URL or
+authorized location, access date, owner, currency-review date, impact assessment,
+status, and approval.
+
+### 2. Freeze purpose and scope
+
+Record:
+
+- legal entities and sites;
+- product types/families and controlled intended-use references;
+- lifecycle activities performed at each site;
+- outsourced processes and interfaces;
+- markets being considered;
+- organizational and physical boundaries;
+- assurance purpose (ISO certification, FDA, MDSAP, EU, internal); and
+- limitations and unresolved applicability decisions.
+
+Do not let an agent decide applicability. `Undetermined` remains a blocker until an
+authorized human approves a decision and rationale.
+
+### 3. Map actual process interactions
+
+Interview accountable process owners and inspect actual records. Build a process map
+from the organization's work—not from copied standard headings.
+
+For each process record:
+
+- inputs and outputs;
+- owner, authority, delegate, and escalation;
+- controlled procedure/system;
+- implementation records;
+- interfaces to risk and change control;
+- measures and review method;
+- source/version basis;
+- status and approval.
+
+Include management, support, product lifecycle, assurance, feedback, and improvement
+processes. Show how complaints/postmarket data update risk, design, production,
+suppliers, CAPA, and management review.
+
+### 4. Build a controlled cross-reference
+
+Create a matrix that links manual statements to:
+
+- controlled procedure IDs and revisions;
+- forms and record series;
+- product/device/technical files;
+- risk and traceability evidence;
+- system/software validation;
+- process owners and approvals;
+- source/version criteria; and
+- open gaps/change/CAPA records.
+
+Do not describe a referenced document as effective until its approval, effective date,
+training, and availability are evidenced.
+
+### 5. Draft policy-level content
+
+Use the fail-closed template in
+`assets/templates/quality-manual-template.md`. Keep statements factual and
+organization-specific:
+
+- “The approved process is defined in `<controlled ID/revision>`.”
+- “Evidence is retained in `<controlled record series/location>`.”
+- “`<role>` owns the decision, with approval in `<record ID>`.”
+- “Applicability remains undetermined pending `<authorized review>`.”
+
+Avoid:
+
+- “The organization is compliant” or “audit ready”;
+- “This template satisfies ISO/FDA/EU requirements”;
+- generic quality policies presented as approved;
+- fixed timelines or retention periods without source/risk basis;
+- unsupported “not applicable” statements;
+- old QSR clause maps presented as current QMSR; and
+- claims that an ISO certificate covers FDA, MDSAP, or EU product conformity.
+
+### 6. Review against evidence
+
+Perform independent review in two directions:
+
+1. **Manual to evidence:** every material statement points to a current controlled
+   source, procedure, owner, and record set.
+2. **Evidence to manual:** sampled implementation records match the described scope,
+   roles, interactions, and controls.
+
+Sample across products, sites, shifts/time periods, suppliers, systems, changes, and
+risk as justified. Record limitations and open gaps.
+
+### 7. Approve, train, release, and maintain
+
+Before release:
+
+- resolve placeholders;
+- obtain technical, RA/QA, document-control, and authorized management approvals;
+- complete source and applicability reviews;
+- close or formally control open document/process gaps;
+- approve process map and cross-reference;
+- complete affected-person training;
+- verify controlled point-of-use access;
+- assign effective date and obsolete prior revisions; and
+- record maintenance/currency-review triggers.
+
+Review when products, sites, roles, processes, suppliers, systems, standards,
+regulations, audit programs, certificates, or postmarket evidence change—not only on
+an arbitrary calendar date.
+
+## Suggested content architecture
+
+### Controlled-document front matter
+
+Include document ID, revision, owner, status, effective date, confidentiality,
+controlled location, change record, superseded revision, reviewers, approvers, dates,
+and approval evidence.
+
+### Purpose, limits, and definitions
+
+State the intended organizational use and hard boundaries. Use definitions from
+approved organizational and regulatory sources; do not copy protected standard text.
+
+### QMS scope and applicability
+
+State entities, sites, products, activities, outsourced processes, and interfaces.
+Reference the approved scope/applicability intake. List unresolved decisions as
+blockers.
+
+### Source/version basis
+
+Identify exact ISO, FDA, MDSAP, EU, and product sources separately. Include owner and
+currency-review controls.
+
+### Governance and roles
+
+Describe top-management authority, authorized management representative, RA/QA,
+process owners, document/record control, release authorities, audit independence,
+complaint/reportability roles, CAPA/change approval, delegates, and escalation.
+
+### Process architecture
+
+At a policy level, describe and cross-reference:
+
+- document/record/external-source control;
+- risk management;
+- design/development and transfer/change;
+- suppliers and outsourced processes;
+- production, service, acceptance/release, and traceability;
+- process/equipment/test/software validation;
+- feedback, complaints, postmarket, and vigilance;
+- nonconformity, CAPA, and effectiveness;
+- internal audit and management review;
+- competence/training; and
+- integrated change control.
+
+### Product evidence architecture
+
+Explain how product/family files point to requirements, specifications, risk,
+design, validation, production, release, distribution, clinical/performance,
+postmarket, complaint, vigilance, and change evidence. Preserve jurisdiction-specific
+records rather than claiming one file concept replaces another.
+
+### Appendices
+
+Use controlled appendices or references for:
+
+- procedure/record index;
+- source ledger;
+- scope/product/site register;
+- organization chart/authorities;
+- process interaction map;
+- risk-design-production-postmarket traceability matrix;
+- supplier/outsourced-process register;
+- validation/software inventory;
+- open gap/change/CAPA register; and
+- certificate/audit scope and status register.
+
+## Regime-specific cautions
+
+### FDA QMSR
+
+QMSR became effective **2026-02-02**. Describe current Part 820 and relevant FDA
+processes; do not present the former QSR/QSIT structure as current. Link to current
+[21 CFR Part 820](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820)
+and [Compliance Program 7382.850](https://www.fda.gov/media/80195/download?attachment).
+An ISO certificate does not exempt a manufacturer from FDA inspection.
+
+### MDSAP
+
+Reference current **MDSAP AU P0002.010** (2026-02-02) and declared participating
+jurisdictions. Do not describe an ISO-only audit as MDSAP or an FDA inspection as
+using the MDSAP plan.
+
+### EU MDR/IVDR
+
+Reference the current consolidated regulation, applicable conformity-assessment
+route, technical documentation, postmarket/vigilance, economic-operator, and
+notified-body evidence separately. Verify notified-body designation scope in NANDO.
+MDCG guidance is nonbinding and must be version-controlled.
+
+### Certification and accreditation
+
+Record the certification body's scope and, if accredited certification is sought, the
+accreditation scope relevant to ISO 13485 technical areas. This does not establish
+notified-body designation or product conformity.
+
+For a laboratory, the manual describes a system that an accreditation body assesses —
+the laboratory is accredited, not certified, and the manual must not say otherwise.
+Record the accreditation body, the scope schedule reference, authorized signatories and
+what each may sign, and the rules for using accreditation symbols and endorsement
+wording. Verify current recognition-arrangement phrasing before reproducing it: Global
+Accreditation Cooperation Incorporated replaced ILAC and IAF on 2026-01-01, so legacy
+"ILAC MRA" or "IAF MLA" wording may be transitional rather than current.
+
+## Review questions
+
+- Does the scope match actual sites, products, and activities?
+- Are all applicability decisions owned and approved by authorized humans?
+- Does every statement link to current controlled evidence?
+- Are records sampled, not just procedures listed?
+- Are risk, design, production, suppliers, validation/software, and postmarket
+  connected?
+- Are complaint/vigilance and CAPA decisions owned by authorized roles?
+- Do changes link to validation, training, source/version, and product impacts?
+- Are ISO, FDA, MDSAP, EU, and product-specific claims clearly separated?
+- Are certificate, notified-body, and accreditation scopes accurately bounded?
+- Does the manual avoid compliance, conformity, certification, and readiness claims?
+
+Use `scripts/gap_analyzer.py` and `scripts/validate_evidence_manifest.py` only to
+identify structural gaps before substantive human review.

package/skills/iso-standards-readiness/references/source-ledger.md

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+# Official Source Ledger
+
+**Baseline research date:** 2026-07-23 — device lanes (ISO 13485, ISO 14971, FDA
+QMSR, MDSAP, EU MDR/IVDR), established with targeted `parallel-cli search` and
+`parallel-cli extract` against official publishers and regulator/program sites.
+
+**Extension research date:** 2026-07-26 — laboratory lanes (ISO/IEC 17025,
+ISO 15189), ISO/TR 24971, and accreditation-scheme documents, established with web
+search against official publishers, accreditation bodies, and CMS.
+
+**Purpose:** version baseline for this skill; not legal advice, an applicability
+decision, certification or accreditation criteria, or a substitute for controlled
+source copies.
+
+**Provenance limitation on the 2026-07-26 additions.** `iso.org` returned HTTP 403
+to automated fetching during that research, so the ISO catalogue metadata below was
+taken from search-result summaries and from accreditation-body and ILAC pages rather
+than read directly off the ISO catalogue page. Entries carrying that limitation are
+marked **[confirm on iso.org]**. Confirm each against the linked official page, or an
+authorized copy, before relying on an edition, date, or stage.
+
+Recheck every source before operational use. Web pages and consolidated texts can
+change after the research date.
+
+## ISO standards and copyright
+
+### ISO 13485:2016
+
+- Official page:
+  [ISO 13485:2016](https://www.iso.org/standard/59752.html)
+- Verified metadata: Edition 3; publication date 2016-03; stage 90.93
+  (confirmed); 2025 systematic review closed 2025-06-05 and confirmation recorded
+  2025-10-31.
+- Use: identifies the current international edition and lifecycle status.
+- Limitation: the ISO page is not the complete normative text. Obtain an authorized
+  copy.
+
+### EN ISO 13485:2016/A11:2021 distinction
+
+- Current Commission index:
+  [Harmonised standards](https://health.ec.europa.eu/medical-devices-topics-interest/harmonised-standards_en)
+- Current MDR decision:
+  [Consolidated Decision (EU) 2021/1182, 2026-06-17](https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02021D1182-20260617)
+- IVDR amendment decision:
+  [Decision (EU) 2022/729](https://eur-lex.europa.eu/eli/dec_impl/2022/729/oj)
+- Verified fact: current EU lists include EN ISO 13485:2016, AC:2018, and
+  A11:2021. A11:2021 is a European EN amendment, not an ISO international
+  “Amendment 1:2021.”
+- Limitation: verify the latest OJEU citation and the exact requirements for which
+  presumption of conformity is claimed; use of harmonised standards is not a blanket
+  product-conformity decision.
+
+### ISO 14971:2019 and European A11
+
+- Official page:
+  [ISO 14971:2019](https://www.iso.org/standard/72704.html)
+- Verified metadata: Edition 3; publication 2019-12; reviewed and confirmed in 2025.
+- EU source:
+  [Decision (EU) 2022/757](https://eur-lex.europa.eu/eli/dec_impl/2022/757/oj/eng)
+- Verified fact: EN ISO 14971:2019/A11:2021 is cited for MDR and, through the
+  corresponding IVDR decision, IVDR support. A11 is European; it does not change the
+  international ISO 14971 normative part.
+- Limitation: risk-management evidence remains product- and jurisdiction-specific.
+
+### ISO/TR 24971:2020
+
+- Official page:
+  [ISO/TR 24971:2020](https://www.iso.org/standard/74437.html)
+- Verified metadata: Edition 2; guidance companion to ISO 14971:2019, with the same
+  clause structure and numbering. **[confirm on iso.org]**
+- Verified status: a Technical Report. Its guidance is informative, not normative, and
+  conformity is claimed to ISO 14971, never to ISO/TR 24971.
+- Limitation: a TR cannot be used to relax or reinterpret a normative requirement.
+  Record which guidance the organization adopted and why.
+
+### ISO/IEC 17025:2017
+
+- Official page:
+  [ISO/IEC 17025:2017](https://www.iso.org/standard/66912.html)
+- Landing page:
+  [ISO/IEC 17025 — Testing and calibration laboratories](https://www.iso.org/ISO-IEC-17025-testing-and-calibration-laboratories.html)
+- Verified metadata: Edition 3; published 2017; no successor edition identified at the
+  research date. **[confirm on iso.org]**
+- Use: identifies the current edition for laboratory competence work.
+- Limitation: ISO/IEC 17025 is an accreditation standard, not a certification scheme
+  and not a product standard. Accreditation is granted by an accreditation body for a
+  defined scope of laboratory activities; nothing in this skill grants or predicts it.
+
+### ISO 15189:2022
+
+- Official page:
+  [ISO 15189:2022](https://www.iso.org/standard/76677.html)
+- ILAC announcement:
+  [ISO 15189:2022 for medical labs published](https://ilac.org/latest_ilac_news/iso-151892022-for-medical-labs-published/)
+- Verified metadata: Edition 4; published December 2022; cancels and replaces
+  ISO 15189:2012. **[confirm on iso.org]**
+- Verified structural facts: the 2022 edition aligns structurally with
+  ISO/IEC 17025:2017 and incorporates point-of-care testing requirements previously
+  held in ISO 22870. Do not cite ISO 22870 as a separate current POCT basis without
+  confirming its status.
+- Verified transition: the ILAC-agreed transition period for accredited medical
+  laboratories ran to **December 2025**. Treat the 2022 edition as implemented, not
+  upcoming; a 2012-based quality system is out of date, not "in transition."
+- Limitation: accreditation scope is per laboratory, per location, and per
+  examination. It is not organization-wide and not equivalent to licensure.
+
+### ISO copyright
+
+- Official page: [ISO copyright](https://www.iso.org/copyright.html)
+- Verified fact: ISO publications are copyright protected; unauthorized copying,
+  scanning, or distribution is prohibited, and reproduction requires permission.
+- Operational rule: this skill summarizes processes and bibliographic metadata only.
+  Do not paste or generate copyrighted clause text.
+
+## United States: FDA QMSR
+
+### Final rule
+
+- Source:
+  [Medical Devices; Quality System Regulation Amendments](https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments)
+- Citation/date: 89 FR 7496; published 2024-02-02.
+- Verified effective date: **2026-02-02**.
+- Verified boundary: ISO certification does not exempt a manufacturer from FDA
+  inspection; FDA does not issue ISO 13485 certificates.
+- Correction:
+  [2024 correction](https://www.federalregister.gov/documents/2024/10/15/2024-23701/medical-devices-quality-system-regulation-amendments-correction).
+- Later source:
+  [2025 QMSR technical amendments](https://www.federalregister.gov/documents/2025/12/04/2025-21955/medical-devices-quality-management-system-regulation-technical-amendments).
+  Use the current eCFR rather than reconstructing current requirements from the
+  original final rule alone.
+
+### FDA QMSR landing page
+
+- Source:
+  [Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr)
+- Page update: 2026-02-02.
+- Verified current state: QMSR became effective 2026-02-02; it incorporates
+  ISO 13485:2016 and ISO 9000:2015 Clause 3 by reference, with FDA provisions and
+  other applicable FDA requirements controlling as stated in the regulation.
+- Verified inspection transition: FDA stopped using QSIT and began the inspection
+  process in Compliance Program 7382.850 on 2026-02-02.
+
+### Current eCFR
+
+- Source:
+  [21 CFR Part 820](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820)
+- Verified current title: *Quality Management System Regulation*.
+- Verified current structure: Subpart A contains current general provisions; Subpart B
+  contains supplemental provisions; remaining legacy subparts are reserved.
+- Verified incorporation: ISO 13485:2016(E), Third edition, March 1, 2016, and
+  ISO 9000:2015 Clause 3.
+- Operational rule: use the current eCFR and linked current regulations. Do not use
+  the former QSR section structure as a current requirements map.
+- Limitation: eCFR is continuously updated and authoritative but unofficial; consult
+  official CFR/Federal Register publications when legal status matters.
+
+### FDA QMSR FAQ
+
+- Source:
+  [QMSR Frequently Asked Questions](https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions)
+- Page update: 2026-02-02.
+- Verified implementation status: FDA began enforcing QMSR on the effective date.
+- Verified records point: FDA investigators may review QMS records created before
+  2026-02-02. The former exemption for management-review, quality-audit, and
+  supplier-audit reports was not retained.
+- Verified boundary: FDA QMSR inspections do not follow the MDSAP audit plan; an
+  ISO certificate does not replace or prevent FDA inspection.
+- Verified access: FDA points to ANSI read-only IBR access for incorporated standards.
+
+### Current inspection program
+
+- Source:
+  [Inspection of Medical Device Manufacturers Compliance Program 7382.850](https://www.fda.gov/media/80195/download?attachment)
+- Effective date: 2026-02-02.
+- Verified use: current FDA inspection process aligned to QMSR; QSIT and the
+  superseded device inspection programs are no longer used.
+- Supplemental education:
+  [April 2026 FDA town hall](https://www.fda.gov/medical-devices/medical-devices-news-and-events/town-hall-fdas-quality-management-system-regulation-qmsr-medical-device-risk-based-inspections).
+- Limitation: prepare evidence for actual applicable FDA requirements; this skill
+  does not predict inspection scope, classification, or enforcement outcome.
+
+## MDSAP and IMDRF
+
+### Current MDSAP Audit Approach
+
+- Source:
+  [MDSAP Audit Approach](https://www.mdsap.global/documents/library/audit-approach)
+- Current document: **MDSAP AU P0002.010**.
+- Version date: **2026-02-02**.
+- Verified high-level model: process-based regulatory audit by recognized Auditing
+  Organizations, with four primary process areas, supporting purchasing linkages, a
+  risk-management foundation, jurisdiction-specific requirements, and a three-year
+  audit cycle.
+- Superseded baseline observed during research: FDA-hosted P0002.009 dated
+  2024-08-06. Use the current MDSAP.global library instead.
+
+### MDSAP program and IMDRF foundation
+
+- Current program site:
+  [MDSAP.global](https://www.mdsap.global/)
+- IMDRF background:
+  [IMDRF MDSAP working group](https://www.imdrf.org/working-groups/medical-device-single-audit-program-mdsap)
+- FDA program page:
+  [Medical Device Single Audit Program](https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap)
+- Verified status: IMDRF development work moved to implementation; current MDSAP
+  documents are managed on MDSAP.global.
+- Boundary: an MDSAP audit is not generic ISO certification, an FDA inspection plan,
+  or EU notified-body conformity assessment.
+
+## European Union: MDR, IVDR, and MDCG
+
+### MDR
+
+- Source:
+  [Regulation (EU) 2017/745, consolidated 2026-01-01](https://eur-lex.europa.eu/eli/reg/2017/745/2026-01-01/eng)
+- Verified status as of research: consolidated version dated 2026-01-01.
+- Relevant scope for this skill: manufacturer QMS, technical documentation,
+  conformity assessment, notified bodies, postmarket surveillance, vigilance, and
+  market surveillance.
+- Limitation: consolidated texts are documentation tools; authentic acts are those
+  published in the Official Journal.
+
+### IVDR
+
+- Source:
+  [Regulation (EU) 2017/746, consolidated 2025-01-10](https://eur-lex.europa.eu/eli/reg/2017/746/2025-01-10/eng)
+- Verified status as of research: 2025-01-10 was the current consolidated version.
+- Relevant scope for this skill: IVD QMS, technical/performance documentation,
+  conformity assessment, notified bodies, postmarket surveillance, vigilance, and
+  market surveillance.
+- Limitation: transitional provisions and device-specific deadlines require current,
+  authorized analysis; this skill does not calculate them.
+
+### MDCG guidance
+
+- Source:
+  [MDCG endorsed documents and other guidance](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en)
+- Verified legal status: MDCG guidance is not legally binding; it expresses a common
+  implementation understanding and is regularly revised or archived.
+- Relevant current item:
+  [MDCG 2025-10, post-market surveillance](https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdf),
+  published December 2025.
+- Other items must be selected by device, role, transition, and conformity route.
+
+## Notified bodies, certification, and accreditation
+
+### EU notified bodies
+
+- Commission overview:
+  [Notified bodies for medical devices](https://health.ec.europa.eu/medical-devices-topics-interest/notified-bodies-medical-devices_en)
+- Official list:
+  [NANDO](https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies)
+- Verified boundary: Member States designate and notify bodies for defined
+  legislation, conformity-assessment tasks, and product/designation codes. NANDO
+  lists the current notified scope.
+- Operational rule: verify legislation, annex/task, and designation-code scope.
+  Accreditation or ISO certification alone is not notified-body designation.
+
+### ISO 13485 certification-body accreditation
+
+- Current Global ACI documents:
+  [Global ACI document library](https://global-aci.org/en/global_aci-documents/)
+- Current cross-reference:
+  [Global ACI–IAF/ILAC table, version 1.2, 2026-06-10](https://sys.global-aci.org/uploads/documents/Global_ACI_IAF_and_ILAC_Document_Cross-Reference_Table_10_June_20262.pdf)
+- Carried document:
+  [IAF MD 9:2023 Issue 5](https://sys.global-aci.org/uploads/documents/IAF_MD9_Issue_5_20112023.pdf)
+- Verified transition: Global Accreditation Cooperation Incorporated began full
+  operations on 2026-01-01, replacing IAF/ILAC operational functions. The
+  2026-06-10 table showed successor Global ACI documents for former MD 8/MD 9 as
+  in process while the prior documents remained in the current library.
+- Verified boundary: MD 9 concerns bodies auditing/certifying management systems to
+  ISO 13485 under ISO/IEC 17021-1. It does not establish product conformity,
+  notified-body designation, regulatory applicability, or market authorization.
+
+### Accreditation: GLOBAC and the recognition arrangement
+
+- Launch announcement:
+  [Global Accreditation Cooperation Incorporated launch](https://iaf.nu/en/news/global-accreditation-cooperation-incorporated-launch-unifies-international-accreditation-organisations-and-strengthens-worldwide-trust/)
+- Transition guidance:
+  [Specifying use of GLOBAC accreditation](https://ilac.org/latest_ilac_news/iaf-and-ilac-release-information-on-specifying-use-of-globac-accreditation/)
+- Verified transition: Global Accreditation Cooperation Incorporated commenced full
+  operations on **2026-01-01**, bringing together the former ILAC and IAF and
+  launching its own Multilateral Recognition Arrangement. Certificates and accredited
+  results issued under the former IAF MLA / ILAC MRA continue to be recognized during
+  the transition.
+- Operational rule: check the *current* recognition-arrangement wording, logo rules,
+  and document designations before reproducing any accreditation claim in a document.
+  Legacy "ILAC MRA" / "IAF MLA" phrasing may be transitional rather than current.
+- Boundary: recognition arrangements concern accreditation bodies. They do not make an
+  accredited result a regulatory approval or a product conformity decision.
+
+### Accreditation: traceability and decision-rule policy
+
+- Policy series:
+  [ILAC policy series (P documents)](https://ilac.org/publications-and-resources/ilac-policy-series/)
+- Metrological traceability: **ILAC P10:07/2020**, implementation date July 2021,
+  revised to reflect ISO/IEC 17025:2017.
+- Decision rules and statements of conformity: **ILAC G8:09/2019**; JCGM 106:2012 /
+  ISO/IEC Guide 98-4 is the companion metrological basis.
+- Limitation and open item: no GLOBAC renumbering of the P/G series was identified at
+  the research date, and the ILAC designations above were still in use. Confirm the
+  current designation and issue before citing either document in a controlled
+  procedure — this is the most likely item in this ledger to have moved.
+- Boundary: a stated decision rule is a documented rule for declaring conformity
+  against a specification. It is not a compliance determination, and this skill does
+  not evaluate whether a chosen rule is fit for a customer's purpose.
+
+### United States medical laboratories: CLIA is a separate lane
+
+- CMS program page:
+  [Clinical Laboratory Improvement Amendments (CLIA)](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments)
+- Accreditation and exemption page:
+  [CLIA accreditation and testing](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/accreditation-exemptions)
+- Approved accreditation organizations:
+  [Specialty/subspecialty information for approved AOs](https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf)
+- Verified facts: CLIA certification by CMS is mandatory before a US laboratory may
+  accept human specimens for testing. CMS approves a limited set of accreditation
+  organizations whose standards must meet or exceed CLIA requirements; approval is
+  reapplied for every six years or more often. Seven approved AOs were reported at the
+  research date — read the current AO list rather than repeating that count.
+- Verified boundary: **ISO 15189 accreditation does not satisfy CLIA and cannot
+  replace a CLIA-based accreditation for a US laboratory.** Deemed status flows only
+  from a CMS-approved accreditation organization's program, not from ISO 15189 itself.
+- Program note: the CAP 15189 program is layered on top of CAP Laboratory
+  Accreditation Program accreditation rather than offered as a standalone substitute.
+  See [CAP 15189](https://www.cap.org/laboratory-improvement/accreditation/cap-15189-accreditation-program);
+  confirm current program prerequisites with CAP.
+- Operational rule: never present an ISO 15189 readiness output as CLIA compliance,
+  deemed status, licensure, or an inspection result. Keep the CLIA decision with the
+  authorized laboratory director and compliance owner.
+
+## Research queries used
+
+Parallel searches/extracts covered:
+
+- ISO 13485 edition, review/confirmation, and amendment metadata;
+- ISO versus EN A11:2021 distinction and current EU citations;
+- FDA final rule, QMSR page/FAQ, eCFR Part 820, and Compliance Program 7382.850;
+- current MDSAP/IMDRF program and Audit Approach version;
+- current MDR/IVDR consolidated versions and MDCG guidance;
+- ISO 14971 and EN A11 status;
+- NANDO/notified-body designation boundaries; and
+- the 2026 Global ACI transition and current MD 8/MD 9 documents.
+
+The 2026-07-26 extension searched:
+
+- ISO/IEC 17025 revision status and whether a successor edition exists;
+- ISO 15189 edition, POCT consolidation, and the ILAC transition deadline;
+- ISO/TR 24971 edition and its status relative to ISO 14971;
+- the GLOBAC launch date, its MRA, and transitional recognition wording;
+- ILAC P10 and ILAC G8 current issues; and
+- CMS CLIA certification, approved accreditation organizations, and whether
+  ISO 15189 confers deemed status.
+
+No Parallel research JSON was saved in the repository. Several 2026-07-26 results came
+from secondary summaries of ISO catalogue pages because `iso.org` refused automated
+access; those entries are marked **[confirm on iso.org]** above.