Annex VI (internal control)
The conformity assessment procedure in which the provider itself verifies (without notified-body involvement) that the quality management system, the technical documentation, and the design-development and post-market monitoring processes are compliant with the Act's requirements. Mandatory for Annex III, points 2 to 8 systems; optional (alongside Annex VII) for Annex III, point 1 systems when harmonised standards are fully applied.
Defined in 2 GAGE programs, which carry 4 distinct definitions of it. The wording above is taught in EU AI Act Implementation Expert.
How each discipline defines it
The same term does different work depending on who is using it. These are the definitions as each program teaches them, unedited.
The conformity assessment procedure in which the provider itself verifies (without notified-body involvement) that the quality management system, the technical documentation, and the design-development and post-market monitoring processes are compliant with the Act's requirements. Mandatory for Annex III, points 2 to 8 systems; optional (alongside Annex VII) for Annex III, point 1 systems when harmonised standards are fully applied.
The internal self-assessment conformity route: the provider checks the system against the requirements, assembles the technical documentation, and signs the declaration without an outside body reviewing it before market. The default for most Annex III high-risk systems.
The conformity assessment procedure that does not involve a notified body. The provider assesses its own system against Section 2 requirements, draws up technical documentation and a QMS, and issues the EU declaration of conformity on its own authority. Required for Annex III points 2 to 8 systems.
The conformity assessment procedure in which the provider itself verifies and documents conformity with Section 2 requirements without third-party notified body involvement. Available for Annex III points 2 to 8 high-risk AI systems when harmonized standards are applied (Article 43(2)).
Where it is taught
The exact lessons this term appears in. The first 7 topics of every program are free with a free account.
- The conformity file: assembling the evidence for the system you shipped in Module 3 · The EU AI Act: The Executive Map, AI Governance: Applied Mastery
- Conformity Assessment Routes (Articles 43 to 47) · Standards and Conformity Assessment, EU AI Act Implementation Expert
- Notified Bodies: Selection and Engagement · Standards and Conformity Assessment, EU AI Act Implementation Expert
- Audit Preparation: Facing the Notified Body · Capstone: The Compliance Portfolio, EU AI Act Implementation Expert
Terms it appears with
Not an alphabetical neighbourhood: these are the terms taught in the same lessons, ranked by how often they appear together.