EU AI Act vs NIST AI RMF: reusing RMF work as EU evidence
A provider established outside the Union holds a record set built under NIST AI RMF 1.0Published, a published voluntary framework, and asks how much of it counts under Regulation (EU) 2024/1689. For a high-risk system under Art. 6(2), the records are tested against the risk management system of Art. 9 and the quality management system of Art. 17 from the Annex III application date Deferred. This page maps each RMF function to the elements it answers, lists the elements with no counterpart, and shows how the traceability matrix records the result.
Where this starts
The company is established in the United States or another third country, holds no EU entity and sells its system into the Union. Art. 2(1)(a) of Regulation (EU) 2024/1689 applies the provider obligations irrespective of establishment, Art. 2(1)(c) applies them where the output is used in the Union, and Art. 22(1) requires a provider of a high-risk system established in a third country to appoint an authorised representative in the Union, who under Art. 22(3)(b) keeps the technical documentation at the disposal of the authorities. The role, the territorial scope and the Annex III match are recorded under PR-CLS v1.0 as a technical assessment for discussion with counsel; the hub for providers outside the Union holds the full obligation set with its dates. The question this page answers is the one that follows the classification: which of the existing framework records count as Art. 9 and Art. 17 evidence, and what has to be produced fresh.
NIST AI RMF 1.0Published is NIST AI 100-1, which its own text describes as intended to be voluntary, rights-preserving, non-sector-specific and use-case agnostic. It organises AI risk management in four functions, Govern, Map, Measure and Manage, with 19 categories and 72 subcategories, each stated as an outcome such as "risk tolerances are determined and documented", and it fixes no test procedure, no threshold and no record format. In the source hierarchy this site applies where the Act sets no threshold, the framework sits at the fifth level: after a harmonised standard cited in the Official Journal, of which none exists as of the anchor date, so no presumption of conformity is available to any provider; after a JTC 21 draft named with its stage, which is prEN 18228Enquiry at enquiry stage for Art. 9 and prEN 18286Published, a published European standard not cited in the Official Journal, for Art. 17; after an ISO/IEC standard, which is ISO/IEC 23894:2023Published for the risk management process and ISO/IEC 42001:2023Published for the management-system clauses; and after a Commission guideline or code of practice. Below the framework sits only the provider's justified state of the art.
The unit of record differs between the two texts, and the difference decides what is reusable. An RMF subcategory is met when an organisation-level record exists; an Art. 9 element is met by a record per system, per version and per hazard, and an Art. 17(1) aspect by a written procedure plus the records the procedure names. A Measure record answers Art. 9(8) only where it names the system version tested, the metric, the threshold recorded before the run and the reason the threshold fits the intended purpose. The mapping below is therefore recorded row by row in the gap register of PR-17-QMS v1.0 and in the traceability matrix, never assumed from the presence of a function.
RMF records with an Art. 9 or Art. 17 counterpart
| RMF record | Element answered | What the record supplies | What the element still needs |
|---|---|---|---|
| GOVERN 1.1: legal and regulatory requirements understood, managed and documented | Art. 17(1)(a): strategy for regulatory compliance | The register of regulatory requirements the provider tracks | The conformity assessment procedure named, and a modification management procedure with a substantial-modification decision per released version under Art. 43(4) |
| GOVERN 1.5: periodic review of the risk management process planned, with its frequency and roles | Art. 9(2): regular and systematic review of the risk management system | The review trigger, the frequency and the roles | A record of each review carried out on the system under review |
| GOVERN 2.1 and 2.3: roles, responsibilities and lines of communication documented; executive leadership responsible for AI risk decisions | Art. 17(1)(m): accountability framework | The responsibilities of management and staff by role | Coverage of every aspect in Art. 17(1) points (a) to (m) by a named role |
| GOVERN 4.3 and MANAGE 4.3: practices for incident identification; incident processes followed and documented | Art. 17(1)(i): serious incident reporting under Art. 73 | The internal incident path and the incident record | The market surveillance authority as addressee and the Art. 73 timeframes |
| MAP 1.1: intended purposes and prospective deployment settings documented | Art. 9(2)(a): risks identified under the intended purpose | The intended purpose and the settings the hazard register starts from | One hazard entry per known and reasonably foreseeable risk to health, safety or fundamental rights |
| MAP 1.5: organisational risk tolerances determined and documented | Art. 9(5): residual risk judged acceptable | The tolerance the acceptance criteria derive from | An acceptance criterion per hazard and for the overall residual risk, recorded before testing, with its rationale |
| MAP 5.1: likelihood and magnitude of each identified impact documented | Art. 9(2)(b): risks estimated and evaluated | The estimation and evaluation method applied per impact | Estimation and evaluation per hazard under reasonably foreseeable misuse conditions |
| MEASURE 1.1: metrics selected for the mapped risks, unmeasured risks documented | Art. 9(8): prior defined metrics | The metric selection rationale | A probabilistic threshold per metric, recorded before the run, with the reason it fits the intended purpose |
| MEASURE 2.1 and 2.3: test sets, metrics and tools documented; criteria measured for conditions similar to deployment | Art. 9(6): consistent performance for the intended purpose | The test records with test set and metric | A result per operating condition recorded in the risk management file, tied to the version tested |
| MEASURE 2.6: residual negative risk does not exceed the risk tolerance; the system fails safely | Art. 9(5): residual risk compared with the acceptance criterion | The residual risk value against the organisation's tolerance | The comparison per hazard and overall against the criterion recorded for that hazard |
| MEASURE 3.1 and MANAGE 4.1: risks tracked from performance in deployed contexts; post-deployment monitoring plans implemented | Art. 9(2)(c): post-market data evaluated; Art. 17(1)(h): post-market monitoring system under Art. 72 | The monitoring plan and the tracking record | The plan content Art. 72(3) names, and the risk evaluation entry each analysis changed |
| MANAGE 1.2 and 1.3: treatment prioritised; responses planned and documented with mitigate, transfer, avoid or accept as options | Art. 9(2)(d), 9(5)(a) and 9(5)(b): targeted risk management measures | The measure adopted per risk | The Art. 9(5) order, elimination or reduction by design first, then mitigation and control, then deployer information; transfer is not an Art. 9 option |
| MANAGE 1.4: negative residual risks to downstream acquirers and end users documented | Art. 9(5)(c): information to deployers under Art. 13 | The residual risk statement passed downstream | The technical knowledge and training expected of the deployer and the presumable context of use |
Elements with no RMF counterpart
| Element | What the file needs | Opened by |
|---|---|---|
| Art. 9(3) | A statement per risk of whether design, development or adequate technical information can reasonably mitigate or eliminate it | PR-17-QMS step 25 |
| Art. 9(4) | The interaction analysis between the measures taken under Art. 10 to Art. 15 and the balance chosen | PR-17-QMS step 35 |
| Art. 9(7) | The plan and conditions for testing in real-world conditions under Art. 60, where used | PR-17-QMS step 24 |
| Art. 9(8) | A full test run on the identified system version before placing on the market or putting into service | PR-17-QMS step 29 |
| Art. 9(9) | The consideration of adverse impact on persons under the age of 18 and other vulnerable groups, with its outcome | PR-17-QMS step 33 |
| Art. 9(10) | The mapping to a risk management procedure under other Union law, where combined | PR-17-QMS step 24 |
| Art. 17(1)(b) and (c) | Design verification records traced to design inputs, and quality control records for the current release | PR-17-QMS steps 11 and 12 |
| Art. 17(1)(d) | The frequency of examination, test and validation before, during and after development | PR-17-QMS steps 13 and 14 |
| Art. 17(1)(e) | The list of applied standards and the statement of means for each Chapter III Section 2 requirement not covered by a harmonised standard, of which none exists as of the anchor date | PR-17-QMS step 15 |
| Art. 17(1)(f) | Data management records across acquisition, labelling, storage and retention for the training, validation and testing sets | PR-17-QMS step 16 |
| Art. 17(1)(j) | The procedure for communication with national competent authorities and notified bodies | PR-17-QMS step 20 |
| Art. 17(1)(k) | Record-keeping for the period Art. 18 sets, with a retrieval test on the current and one earlier version | PR-17-QMS step 21 |
| Art. 17(2) and 17(3) | The proportionality rationale and, where used, the mapping to a sectoral quality management system | PR-17-QMS steps 4 and 5 |
How the traceability matrix records the mapping
The matrix specified on the deliverables page carries one row per element of the Art. 9 and Art. 17 obligation records: the element, its kind, the protocol step that checks it, the evidence record, its location in the technical file and a status. For a framework record set, the evidence column holds the RMF subcategory and the document id and version of the record, and the status reads Ready where the record answers the element in full, Draft where the record answers in part and the additions named in the table above are still open, and Missing where no counterpart exists. Each Art. 9 row locates its evidence in Annex IV section 5, the section that Art. 11(1) requires for the description of the risk management system. The coverage summary per article and the change log keyed to system versions are the two sections a reviewer reads first, since a Measure record for one version says nothing about the next. The browser traceability matrix template generates the row set and the ids for the role and tier entered; the deliverable adds the coverage summary and the change log.
| Id | Element | Kind | Checked by | Evidence | Status |
|---|---|---|---|---|---|
| TM-9-06 | Art. 9(5): acceptance criterion per hazard and overall, recorded before testing | document | PR-17-QMS step 26 | MAP 1.5 risk tolerance statement RT-3 v2; criteria per hazard open | Draft |
| TM-9-08 | Art. 9(8): prior defined metrics and probabilistic thresholds | document | PR-17-QMS step 29 | MEASURE 1.1 metric selection memo MS-2 v1; thresholds and their reasons open | Draft |
| TM-9-04 | Art. 9(4): interaction analysis between the Art. 10 to Art. 15 measures | document | PR-17-QMS step 35 | No RMF record | Missing |
| TM-17-13 | Art. 17(1)(m): accountability framework by role for each Art. 17(1) aspect | document | PR-17-QMS step 23 | GOVERN 2.1 responsibility chart G-7 v4 | Ready |
The sequence
The work runs in the order below: the role and the classification first, then the inventory and the clause map, then the checks against each article, then the matrix and the file.
Record the provider role, the territorial scope and the Annex III match for each function of the system.
Record Role determination record, territorial scope record and Annex III matching record per function
[Regulation (EU) 2024/1689, Art. 2(1)(a) and (c), Art. 3(3) and Art. 6(2); PR-CLS steps 8 to 13]
Inventory each Govern, Map, Measure and Manage record with its subcategory, version and owner role.
Record Document inventory with the RMF function, subcategory, document id, version and owner role per record
[NIST AI RMF 1.0, published, Core categories and subcategories; PR-17-QMS step 2]
Map each Art. 17(1) aspect and Art. 9 paragraph to its standard clause and its RMF subcategory.
Record Clause map with one row per Art. 17(1) aspect and Art. 9 paragraph, the standard clauses and the RMF subcategory
[prEN 18286, published, Annex ZA mapping to the Act; PR-17-QMS step 3]
Check each Art. 17(1) aspect as a document and as sampled records against the mapped RMF record.
Record Gap register rows (a) to (m), each marked conforms, partial or gap, with the RMF record as the evidence id
[Regulation (EU) 2024/1689, Art. 17(1)(a) to (m); PR-17-QMS steps 9 to 23]
Review the risk management file against each Art. 9 paragraph, with the Map and Measure records as evidence.
Record Risk management system review record with the hazard register check, the acceptance-criteria record and the prior-definition check
[Regulation (EU) 2024/1689, Art. 9(1) to 9(10); PR-17-QMS steps 24 to 36]
Record the provider's justification for each acceptance criterion and threshold that no published document sets.
Record Element-evidence record: element, value set by the provider, justification, source consulted
[Regulation (EU) 2024/1689, Art. 9(5) and 9(8); PR-17-QMS step 38]
Assign each element with no RMF counterpart a corrective action, an owner role and the closing evidence.
Record Corrective-action plan rows: gap row id, action, owner role, closing evidence
[prEN 18286, published, clause on nonconformity and corrective action; PR-17-QMS step 40]
Build the traceability matrix with one row per element and the RMF record or the gap as evidence.
Record Obligation to test to evidence traceability matrix with the RMF record or the gap in the evidence column and a status per row
[PR-11-DOC step 43]
Place the risk management description in Annex IV section 5 and give the file to the authorised representative.
Record Annex IV section 5 draft and the copy of the technical documentation held by the authorised representative
[Regulation (EU) 2024/1689, Art. 11(1), Annex IV section 5 and Art. 22(3)(b)]
Evidence this situation ends with
| Artifact | Answers | Produced by |
|---|---|---|
| Hazard register with intended purpose and reasonably foreseeable misuse conditions (Art. 9(2)(a) and (b)) | Art. 9(2)(a) and 9(2)(b): one entry per risk, with the misuse conditions the Map records lack | the provider |
| Residual risk acceptance record per hazard and overall (Art. 9(5)) | Art. 9(5): the criterion per hazard derived from the MAP 1.5 tolerance, recorded before testing, with its rationale | the provider |
| Prior defined metrics and probabilistic thresholds declaration (Art. 9(8)) | Art. 9(8): the threshold per MEASURE 1.1 metric, recorded before the run, with the reason it fits the intended purpose | the provider |
| Applied technical specifications and standards list with the Section 2 coverage statement (Art. 17(1)(e)) | Art. 17(1)(e): each standard applied with its stage, and the means used for each Section 2 requirement | the provider |
| Accountability framework with management and staff responsibilities (Art. 17(1)(m)) | Art. 17(1)(m): the GOVERN 2.1 responsibilities extended to every Art. 17(1) aspect | the provider |
| QMS gap analysis report (PR-17-QMS output) | Art. 17(1)(a) to (m): each aspect marked conforms, partial or gap, with the RMF record sampled as evidence | PR-17-QMS v1.0 |
| Risk management system review record (PR-17-QMS output) | Art. 9(1) to 9(10): the coverage tables and the residual risk comparison against the provider's criteria | PR-17-QMS v1.0 |
| Obligation to test to evidence traceability matrix | Art. 9 and Art. 17: one row per element with the RMF record or the gap, the technical file location and the status | PR-11-DOC v1.0 |
Each artifact follows a specification with a synthetic sample on the deliverables page: the gap analysis report and the review record follow the findings register specification, the matrix follows the traceability matrix specification, and the provider's own records follow the register or checklist specification where the protocol names one.
If nothing is done
A framework record set offered as it stands leaves the Art. 9 file without an acceptance criterion per hazard and without prior defined thresholds, and the Art. 17 system without a named conformity assessment procedure, a statement of means and a reporting path to the market surveillance authority; each of those sits in the provider obligations of Art. 16, which include the Chapter III Section 2 requirements and the quality management system under Art. 17. Under Art. 79(2) the market surveillance authority evaluates the system and, where it finds that the requirements are not met, requires the provider to take corrective action, to withdraw the system or to recall it within a period the authority sets; for a provider outside the Union the request reaches the authorised representative, which under Art. 22(4) terminates the mandate and informs the authority when it considers that the provider acts contrary to its obligations. A finding against Art. 16 falls in the penalty tier of Art. 99(4), with the amount in a given case set by the national authority under the Art. 99(7) criteria. The provider's action is corrective action under Art. 20 on its own initiative, and the gap analysis above supplies the record set that Art. 21(1) requires the provider to produce on a reasoned request.
Services, guides and tools for this situation
The QMS gap analysis runs PR-17-QMS v1.0 over the framework records against Art. 17 and Art. 9, within the limits stated on what we cannot do; the classification and readiness assessment produces the role, scope and classification records that open the sequence.
- Guides
- ICP hubs
Questions
What is the NIST AI RMF?
The NIST AI Risk Management Framework, NIST AI 100-1, is a published framework described in its own text as voluntary, rights-preserving, non-sector-specific and use-case agnostic. The framework organises AI risk management in four functions, Govern, Map, Measure and Manage, with 19 categories and 72 subcategories. The framework sets no test procedure and no threshold. Under Regulation (EU) 2024/1689 the framework is evidence of structure only, and no presumption of conformity follows from it, since no harmonised standard is cited in the Official Journal as of the anchor date.
What documentation does the NIST AI RMF ask for?
Most subcategories of NIST AI 100-1 end in documented or in place: MAP 1.1 the intended purpose and deployment settings, MAP 1.5 the risk tolerance, MEASURE 2.1 the test sets, metrics and tools, and MANAGE 1.4 the residual risks passed downstream. The framework fixes no document format and no record per system version. Under Art. 9 and Art. 17 of Regulation (EU) 2024/1689 such a record counts where a traceability matrix row ties it to a paragraph, a version and a status and names the open additions.
Every inquiry receives a reply within 24 hours. Scope and availability are discussed per request.