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ObligationUpcomingv1.0.0

Article 17: quality management system

The documented quality system through which a high-risk AI provider structurally assures compliance.

The official source remains authoritative. This is general information about obligations and not legal advice. See this object on the map

Address and citation

This object has an address of its own that is never renamed or reused. Store the identifier in your own file, not the title or the link.

Identifier
praxikon:eu:ai-act:obligation:article-17-quality-management
Payload hash (sha256)
7d04f5f23729c5c48f26262f0e266c680dce5753d12543479b1ea672bbe1c6e9

Citation line

Praxikon, "Article 17: quality management system", praxikon:eu:ai-act:obligation:article-17-quality-management@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-08-14T00:00:00.000Z, sha256 7d04f5f23729c5c48f26262f0e266c680dce5753d12543479b1ea672bbe1c6e9
Version
1.0.0
Legal time (effective_at)
27 July 2026
Knowledge time (known_at)
8 August 2026
Closed on
Not closed
Application date
2 December 2027
Topics
high-risk-requirements

Review status: Placed against the official source (8 August 2026). Next check due by 4 February 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

Who must act and who is affected

On an obligation the addressee is recorded separately from the party that is merely affected. That difference decides who a supervisory authority addresses and who has work to do without the duty resting on them.

Duty holder

Affected actor

Not recorded on this object.

Oversight

Not recorded on this object.

Evidence owner

What this object links to

Every relation appears below as a path: from the source with its locator, through the conditions and exceptions of the object carrying the relation, to the consequence. A locator belongs to a statement in the data and not to a relation, so the source is the source anchor of the carrying object.

Who carries the duty

1 of 1 shown

The duty rests on this role. A supervisory authority addresses this role when it is not met.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places high-risk AI systems on the market or puts them into service.
    • ExceptionProviders already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Who owns the evidence

1 of 1 shown

This duty holder creates, maintains and can produce the evidence.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places high-risk AI systems on the market or puts them into service.
    • ExceptionProviders already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What has to be done

1 of 1 shown

This is what concretely has to be done under the obligation.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places high-risk AI systems on the market or puts them into service.
    • ExceptionProviders already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What has to be recorded

1 of 1 shown

This is what has to be in the file to show that the action was carried out.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places high-risk AI systems on the market or puts them into service.
    • ExceptionProviders already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

    • EvidenceQMS documentation

      praxikon:eu:ai-act:evidence:article-17-quality-management-record

What keeps it in place

1 of 1 shown

This is what keeps compliance in place over time, periodic or event-driven.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places high-risk AI systems on the market or puts them into service.
    • ExceptionProviders already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

Public tools

1 of 1 shown

This is the public route a reader can actually use.

  1. Source

    Official fact on this object, with its locator.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    • Condition | allThe provider places high-risk AI systems on the market or puts them into service.
    • ExceptionProviders already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Consequence

What points at this object

Objects hanging off this obligation

7 of 7 shown

The object belongs to this obligation. The source line it hangs off sits there.

  1. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Set up an AI quality management system

    Consequence

  2. Source

    Official fact on this object, with its locator.

    • CEN-CENELEC JTC 21: European standards under standardisation request M/613

      Locator: EN 18286:2026, CEN/CLC/JTC 21 under standardisation request M/613

      praxikon:eu:ai-act:source:cen-cenelec-jtc21

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: First European AI Act standard approved

    Consequence

  3. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Internal audit cycle

    Consequence

  4. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: QMS documentation

    Consequence

    • EvidenceQMS documentation

      praxikon:eu:ai-act:evidence:article-17-quality-management-record

  5. Source

    Official fact on this object, with its locator.

    • CEN-CENELEC JTC 21: European standards under standardisation request M/613

      Locator: EN 18286:2026, CEN/CLC/JTC 21 under standardisation request M/613

      praxikon:eu:ai-act:source:cen-cenelec-jtc21

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17; Article 40

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allRelevant to providers of high-risk AI systems, who must have a quality management system in place by 2 December 2027 (Annex III standalone) or 2 August 2028 (Annex I embedded in regulated products).
    • ExceptionAccording to that same coverage statement the standard does not cover Article 17(2) to (4) or Article 72; those obligations must be substantiated independently.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Relation recorded on: EN 18286:2026: quality management system for EU AI Act regulatory purposes

    Consequence

  6. Source

    Official fact on this object, with its locator.

    • CEN-CENELEC JTC 21: European standards under standardisation request M/613

      Locator: EN ISO/IEC 42001:2026, European adoption via CEN-CENELEC

      praxikon:eu:ai-act:source:cen-cenelec-jtc21

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17; Article 40

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    Via

    • Condition | allUsable by both providers and deployers seeking to structure AI governance organisation-wide.
    • ExceptionCertification against ISO/IEC 42001 replaces no AI Act obligation and does not shift the burden of proof.

    As long as this exception is not ruled out, the outcome stays conditional and you have to establish it yourself.

    Relation recorded on: EN ISO/IEC 42001: artificial intelligence management system

    Consequence

  7. Source

    This object carries no official fact of its own. The source line below sits on the obligation it hangs off; the link itself is recorded editorially.

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1)-(3)

      praxikon:eu:ai-act:source:reg-eu-2024-1689

      Open official source

    • Digital Omnibus on AI 2026/1744

      Locator: Amended Article 113 application dates

      praxikon:eu:ai-act:source:reg-eu-2026-1744

      Open official source

    Via

    No condition or exception recorded on this object.

    Relation recorded on: Full text of Article 17

    Consequence

What this object states

Official fact

Attributable to a named primary source, with a locator. Where they differ, the official source prevails.

  • Article 17 requires a documented quality management system covering a compliance strategy, design and development procedures, data management, risk management, post-market monitoring, incident reporting and an accountability structure.

  • For the Annex III route this requirement applies from 2 December 2027; for high-risk AI in regulated products (Annex I) from 2 August 2028.

    • Locator: Amended Article 113 application datespraxikon:eu:ai-act:source:reg-eu-2026-1744Open official source

Our interpretation

Our own reading. It can change without the law changing, and it is not the position of a supervisory authority.

  • The QMS is the umbrella over all other provider duties: those with the separate files but no system connecting them fail exactly this article in an audit.

Recommended step

A practical step we consider appropriate. Not an obligation following from the Regulation.

  • Build the QMS not as a separate document but as an index on top of the existing files (risk, data, documentation, monitoring) with owners per procedure.

When this applies

  1. 1The provider places high-risk AI systems on the market or puts them into service.

When this does not apply

  • Providers already under sectoral quality regimes may integrate the AI elements into that existing system; SMEs may implement elements in simplified form.

Referring to this object

Citation block

Copy this reference into your advice, article or file. The identifier, the version and the hash keep the statement findable later, even once the dataset has moved on.

Reference

Praxikon, "Article 17: quality management system",
praxikon:eu:ai-act:obligation:article-17-quality-management@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0 (schema 1.4.0),
effective_at 2026-07-27T00:00:00.000Z, known_at 2026-08-08T00:00:00.000Z,
sha256 7d04f5f23729c5c48f26262f0e266c680dce5753d12543479b1ea672bbe1c6e9,
https://www.praxikon.com/en/verkenner/obligation/article-17-quality-management
(https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-17-quality-management&effective_at=2026-07-27&known_at=2026-08-08&lang=en, accessed 2026-08-25)

Short form

praxikon:eu:ai-act:obligation:article-17-quality-management@1.0.0 (sha256 7d04f5f2)

BibTeX

@misc{praxikon-eu-ai-act-obligation-article-17-quality-management-1-0-0,
  author       = {{Praxikon}},
  title        = {Article 17: quality management system},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:obligation:article-17-quality-management},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.1.0, schema 1.4.0},
  note         = {effective_at 2026-07-27T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 7d04f5f23729c5c48f26262f0e266c680dce5753d12543479b1ea672bbe1c6e9},
  url          = {https://www.praxikon.com/en/verkenner/obligation/article-17-quality-management},
  urldate      = {2026-08-25},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:obligation:article-17-quality-management@1.0.0",
    "type": "dataset",
    "title": "Article 17: quality management system",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:obligation:article-17-quality-management",
    "URL": "https://www.praxikon.com/en/verkenner/obligation/article-17-quality-management",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          8,
          8
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          8,
          25
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.1.0; schema 1.4.0; effective_at 2026-07-27T00:00:00.000Z; known_at 2026-08-08T00:00:00.000Z; sha256 7d04f5f23729c5c48f26262f0e266c680dce5753d12543479b1ea672bbe1c6e9; retrieved_from https://www.praxikon.com/api/v1/obligations?id=praxikon%3Aeu%3Aai-act%3Aobligation%3Aarticle-17-quality-management&effective_at=2026-07-27&known_at=2026-08-08&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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