Kit Anbieter von Hochrisiko-KI (AI Act)

Screen a proposed AI use case: data, affected people, AI Act prohibited/high-risk/transparency questions, tier, reviews

Provider record that an Annex III AI system is not high-risk under Art. 6(3): profiling check, condition relied on, risk reasoning, Art. 49(2) registration

Article 9 risk management for high-risk AI: intended purpose, misuse, criteria, hazards, measures, predefined tests, minors, residual risk, post-market loop

Bias profile per IEEE 7003-2024: bias requirements and boundaries, stakeholders, data representation, risk, fairness metrics, mitigation, monitoring, AI Act Art. 10

Dataset motivation, composition, collection, labelling, uses, distribution, maintenance, privacy and consent

Human oversight: objectives, decision points (in, on, over the loop), approval gates, override and stop, overseer training, automation bias, UI, logs

EU AI Act Art. 13 instructions for use for high-risk AI: intended purpose, accuracy metrics, group performance, oversight measures, logging, deployer checklist

Annex IV technical file for a high-risk AI system: design, data, testing, risk, standards, conformity, monitoring

Article 17 QMS manual for high-risk AI: points (a) to (m), SME and SMC proportionality, Article 63 option, standards status, RACI, records, procedures

Art. 47 and Annex V declaration for a high-risk AI system: conformity route, evidence before signing, eight Annex V items, CE marking

Post-market monitoring plan for a high-risk AI system: data collection, thresholds, reviews, Article 73 incident reporting

AI incident or near miss: classification, Art. 3(49) serious incident test, timeline, harm, evidence, root cause, Art. 73 deadlines, notifications, CAPA