📄 / / profiles / r-and-d / raw_evidence / scientific-agent-skills / skills / iso-standards-readiness / references / source-ledger.md

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
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
Current MDR decision: Consolidated Decision (EU) 2021/1182, 2026-06-17
IVDR amendment decision: Decision (EU) 2022/729
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
Verified metadata: Edition 3; publication 2019-12; reviewed and confirmed in 2025.
EU source: Decision (EU) 2022/757
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
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
Landing page: ISO/IEC 17025 — Testing and calibration laboratories
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
ILAC announcement: ISO 15189:2022 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
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
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.
Later source: 2025 QMSR 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)
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
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
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
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.
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
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
IMDRF background: IMDRF MDSAP working group
FDA program page: Medical Device Single Audit Program
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
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
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
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, 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
Official list: NANDO
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
Current cross-reference: Global ACI–IAF/ILAC table, version 1.2, 2026-06-10
Carried document: IAF MD 9:2023 Issue 5
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
Transition guidance: 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)
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)
Accreditation and exemption page: CLIA accreditation and testing
Approved accreditation organizations: Specialty/subspecialty information for approved AOs
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; 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.