@pikaa-ai/pikaa 0.3.1 → 0.3.4

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

@@ -1,282 +0,0 @@
-# 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

@@ -1,357 +0,0 @@
-# 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.