QM-011MittelAnbieterPräventiv
Verfahren zur Dokumentenlenkung
Anbieter müssen Verfahren zur Dokumentenlenkung einführen, die sicherstellen, dass QMS-Dokumente aktuell, genehmigt, für das zuständige Personal zugänglich und einer Versionskontrolle unterworfen sind, wobei veraltete Dokumente aus der aktiven Nutzung genommen werden.
Artikel:Article 17(1)Article 11(3)
Nachweisbeispiele
- Document control procedure
- Document register with version history
- Obsolete document archive policy
Normen
ISO 42001:2023 §7.5ISO 9001:2015 §7.5
Verwandte Kontrollen
- QM-001Quality Management System EstablishmentArticle 17(1) requires providers of high-risk AI systems to put in place a quality management system that ensures compliance with the requirements of the…
- QM-002Regulatory Compliance StrategyProviders must establish and document a strategy for achieving and maintaining compliance with applicable regulatory requirements, including the EU AI…
- QM-003Design Control ProceduresProviders must implement documented design control procedures that ensure regulatory and performance requirements are systematically incorporated from the…
- QM-004Data Management ProceduresProviders must have documented data management procedures covering the acquisition, preparation, use, and retention of data throughout the AI system…
- QM-005Staff Training and Competency ProceduresArticle 17(1)(d) requires providers to implement procedures for training personnel involved in AI system development, testing, and monitoring, with…
- QM-006Pre-Market Testing and Validation ProceduresProviders must implement documented procedures for pre-market testing and validation of high-risk AI systems, including the metrics to be achieved, the…
Verwandte KI-VO-Begriffe
- Quality Management SystemA documented system that providers of high-risk AI systems must establish, implement, document, and maintain covering: the regulatory compliance strategy, design and development processes, data governance procedures, risk management, post-market monitoring, and incident reporting.
- Technical DocumentationThe documentation that providers of high-risk AI systems must draw up before placing the system on the market, containing all necessary information to assess compliance with the Regulation, including a general description, design specifications, training data information, risk management records, and performance metrics. Content requirements are set out in Annex IV.
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