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ActionEditorialv1.0.0

Determine and bound the simplification of your quality management system

Test whether you are a microenterprise with no partner or linked enterprises, build the Article 17 system, mark which elements you would want to simplify once the Commission guidelines exist, and keep the nine articles of Article 63(2) expressly outside that simplification.

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:action:article-63-scope-simplified-quality-management
Payload hash (sha256)
64ba2f1ec918638f12ebd8e70d57d6162e4a07a205c05757c576a4b3418cd267

Citation line

Praxikon, "Determine and bound the simplification of your quality management system", praxikon:eu:ai-act:action:article-63-scope-simplified-quality-management@1.0.0, dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0), effective_at 2026-08-08T00:00:00.000Z, known_at 2026-09-06T00:00:00.000Z, sha256 64ba2f1ec918638f12ebd8e70d57d6162e4a07a205c05757c576a4b3418cd267
Version
1.0.0
Legal time (effective_at)
2 August 2026
Knowledge time (known_at)
6 September 2026
Closed on
Not closed
Topics
high-risk-requirements, innovation

Review status: Editorially reviewed (6 September 2026). Next check due by 5 March 2027. The check date is the knowledge date of this version; no later recheck has been recorded.

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.

The obligation this hangs off

1 of 1 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 63(1) and (2)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1); Article 62(2); Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allArises where you are the provider of a high-risk AI system and want to rely on Article 63, and again at every change in the shareholding structure. This action is our construction: Article 63 grants a possibility and places the only literal duty on the Commission.

    Consequence

What this object is about

1 of 1 shown

The object is about this role. Undifferentiated: it does not follow that the duty rests on this role.

  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 63(1) and (2)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1); Article 62(2); Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allArises where you are the provider of a high-risk AI system and want to rely on Article 63, and again at every change in the shareholding structure. This action is our construction: Article 63 grants a possibility and places the only literal duty on the Commission.

    Consequence

What points at this object

Where this action comes from

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 63(1) and (2)

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

      Open official source

    • EU Artificial Intelligence Act 2024/1689

      Locator: Article 17(1); Article 62(2); Article 113, second paragraph

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

      Open official source

    Via

    • Condition | allTwo cumulative conditions. The organisation is an SME, including a start-up, within the meaning of Recommendation 2003/361/EC, and it does not have partner enterprises or linked enterprises within the meaning of that Recommendation. A standalone small enterprise that is not a microenterprise is therefore covered since 27 July 2026. The thresholds and the notions of partner enterprise and linked enterprise sit in that Recommendation and not in this Regulation; anyone relying on this article tests against that text. The benefit touches only the quality management system required by Article 17, and only those elements of it that the Commission designates in its guidelines. Article 63 sits in Chapter VI, which is named in none of the three exceptions in the third paragraph of Article 113; the general date of application in the second paragraph therefore governs, 2 August 2026.
    • ExceptionParagraph 2 expressly provides that paragraph 1 shall not be interpreted as exempting those operators from fulfilling any other requirements or obligations laid down in this Regulation, including those established in Articles 9, 10, 11, 12, 13, 14, 15, 72 and 73. The risk management system, data and data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness and cybersecurity, post-market monitoring and the reporting of serious incidents therefore continue to apply in full.

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

    Relation recorded on: Article 63: derogations for SMEs in the quality management system

    Consequence

When this applies

  1. 1Arises where you are the provider of a high-risk AI system and want to rely on Article 63, and again at every change in the shareholding structure. This action is our construction: Article 63 grants a possibility and places the only literal duty on the Commission.

When this does not apply

No exception recorded on this object.

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, "Determine and bound the simplification of your quality management system",
praxikon:eu:ai-act:action:article-63-scope-simplified-quality-management@1.0.0,
dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0 (schema 1.5.0),
effective_at 2026-08-02T00:00:00.000Z, known_at 2026-09-06T00:00:00.000Z,
sha256 64ba2f1ec918638f12ebd8e70d57d6162e4a07a205c05757c576a4b3418cd267,
https://www.praxikon.com/en/verkenner/action/article-63-scope-simplified-quality-management
(https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aaction%3Aarticle-63-scope-simplified-quality-management&effective_at=2026-08-02&known_at=2026-09-06&lang=en, accessed 2026-09-21)

Short form

praxikon:eu:ai-act:action:article-63-scope-simplified-quality-management@1.0.0 (sha256 64ba2f1e)

BibTeX

@misc{praxikon-eu-ai-act-action-article-63-scope-simplified-quality-management-1-0-0,
  author       = {{Praxikon}},
  title        = {Determine and bound the simplification of your quality management system},
  year         = {2026},
  version      = {1.0.0},
  number       = {praxikon:eu:ai-act:action:article-63-scope-simplified-quality-management},
  howpublished = {AI Act Change \& Evidence Graph, dataset 2.2.0, schema 1.5.0},
  note         = {effective_at 2026-08-02T00:00:00.000Z; known_at 2026-09-06T00:00:00.000Z; sha256 64ba2f1ec918638f12ebd8e70d57d6162e4a07a205c05757c576a4b3418cd267},
  url          = {https://www.praxikon.com/en/verkenner/action/article-63-scope-simplified-quality-management},
  urldate      = {2026-09-21},
  language     = {en}
}

CSL JSON

[
  {
    "id": "praxikon:eu:ai-act:action:article-63-scope-simplified-quality-management@1.0.0",
    "type": "dataset",
    "title": "Determine and bound the simplification of your quality management system",
    "container-title": "AI Act Change & Evidence Graph",
    "publisher": "Praxikon",
    "version": "1.0.0",
    "number": "praxikon:eu:ai-act:action:article-63-scope-simplified-quality-management",
    "URL": "https://www.praxikon.com/en/verkenner/action/article-63-scope-simplified-quality-management",
    "language": "en",
    "issued": {
      "date-parts": [
        [
          2026,
          9,
          6
        ]
      ]
    },
    "accessed": {
      "date-parts": [
        [
          2026,
          9,
          21
        ]
      ]
    },
    "note": "dataset praxikon:sys:registry:dataset:ai-act-implementation-graph 2.2.0; schema 1.5.0; effective_at 2026-08-02T00:00:00.000Z; known_at 2026-09-06T00:00:00.000Z; sha256 64ba2f1ec918638f12ebd8e70d57d6162e4a07a205c05757c576a4b3418cd267; retrieved_from https://www.praxikon.com/api/v1/entities?id=praxikon%3Aeu%3Aai-act%3Aaction%3Aarticle-63-scope-simplified-quality-management&effective_at=2026-08-02&known_at=2026-09-06&lang=en; licence https://www.praxikon.com/nl/legal/terms"
  }
]

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