{"answer_id":"praxikon:eu:ai-act:answer:kwaliteitsmanagementsysteem","canonical_page":"https://www.praxikon.com/en/antwoord/kwaliteitsmanagementsysteem","query":"Do we need a quality management system?","lang":"en","view":"full","mode":"scenario","question":"Do we need a quality management system?","situation":"You are the provider of a high-risk AI system and want to know whether you must set up a documented quality system, and what belongs in it.","likely_role":"Provider (you place the system on the market)","note":"The quality management system is the organisational side of conformity: it describes how you structurally assure design, testing, change and oversight, and it is what a conformity assessment examines. An existing ISO quality system can be the basis but does not automatically cover the AI Act requirements.","matched_terms":[],"dataset":{"id":"praxikon:sys:registry:dataset:ai-act-implementation-graph","version":"2.2.0","schema_version":"1.5.0","effective_at":"2026-08-08T00:00:00.000Z","known_at":"2026-09-06T00:00:00.000Z","last_reviewed_at":"2026-08-08T00:00:00.000Z","licence":"https://www.praxikon.com/nl/legal/terms","canonical_url":"https://www.praxikon.com/api/v1/entities"},"obligations":[{"slug":"article-17-quality-management","label":"Article 17: quality management system","summary":"The documented quality system through which a high-risk AI provider structurally assures compliance.","legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","high_risk_regime_from":null,"human_page":"https://www.praxikon.com/en/verplichtingen/article-17-quality-management","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","citations":[{"kind":"official_fact","statement":"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.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"official_fact","statement":"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.","source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"kind":"editorial_interpretation","statement":"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.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"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.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 17(1)-(3)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]},{"slug":"annex-iii-high-risk","label":"Annex III: high-risk AI","summary":"Classification route for standalone high-risk AI systems under Article 6(2) and Annex III.","legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","high_risk_regime_from":null,"human_page":"https://www.praxikon.com/en/verplichtingen/annex-iii-high-risk","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","citations":[{"kind":"official_fact","statement":"The core rules in Chapter III, Sections 1 to 3, for systems under Article 6(2) and Annex III become applicable on 2 December 2027.","source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113, Article 6(2) and Annex III application date","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"kind":"editorial_interpretation","statement":"The later application date does not remove the classification question. An early classification record avoids design and procurement decisions without evidence.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6 and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"Document now the intended purpose, Annex III point, Article 6(3) assessment, profiling and selected registration path.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 6(2)-(4), Article 49 and Annex III","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]},{"slug":"conformity-ce-registration","label":"Articles 43-49: conformity assessment, CE and registration","summary":"The route from assessment to CE marking and EU database registration before market placement of high-risk AI.","legal_status":"applicable","deadline_at":"2026-08-02T00:00:00.000Z","high_risk_regime_from":"2027-12-02T00:00:00.000Z","human_page":"https://www.praxikon.com/en/verplichtingen/conformity-ce-registration","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","citations":[{"kind":"official_fact","statement":"Article 43 governs the conformity assessment, Article 47 the EU declaration of conformity, Article 48 the CE marking and Article 49 the registration in the EU database before market placement or putting into service, including registration of the Article 6(3) assessment.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"official_fact","statement":"This provision is named in none of the three points of Article 113, third paragraph, and therefore falls under the general application date in the second paragraph: 2 August 2026. The move to 2 December 2027 and 2 August 2028 in point (c) concerns only Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5). When a high-risk AI system that this provision addresses can practically exist is a second question: through Article 6(2) and Annex III that is 2 December 2027, and through Article 6(1) and Annex I 2 August 2028. That practical date sits in high_risk_regime_from and not in deadline_at. This is how decision D1 of 6 September 2026 is recorded; see data/ai-act/review/decision-d1-application-dates.json.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 113, second paragraph","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"official_fact","statement":"This provision is named in none of the three points of Article 113, third paragraph, and therefore falls under the general application date in the second paragraph: 2 August 2026. The move to 2 December 2027 and 2 August 2028 in point (c) concerns only Chapter III, Sections 1, 2 and 3, with the exception of Article 6(5). When a high-risk AI system that this provision addresses can practically exist is a second question: through Article 6(2) and Annex III that is 2 December 2027, and through Article 6(1) and Annex I 2 August 2028. That practical date sits in high_risk_regime_from and not in deadline_at. This is how decision D1 of 6 September 2026 is recorded; see data/ai-act/review/decision-d1-application-dates.json.","source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Article 1, point (40)(b), replacing Article 113, third paragraph, point (c)","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"kind":"editorial_interpretation","statement":"For buyers this is the simplest supplier check there is: ask for the declaration of conformity and the registration number. No declaration means the system may not be there by 2 December 2027.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"Plan the conformity route backwards from 2 December 2027: standards selection, assessment, declaration and registration together take months, not weeks.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Articles 43, 47, 48 and 49","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]},{"slug":"article-9-risk-management","label":"Article 9: risk management system","summary":"A continuous, documented risk management system across the entire lifecycle of a high-risk AI system.","legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","high_risk_regime_from":null,"human_page":"https://www.praxikon.com/en/verplichtingen/article-9-risk-management","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","citations":[{"kind":"official_fact","statement":"Article 9 requires a risk management system as a continuous, iterative process across the entire lifecycle, with identification, analysis, evaluation and mitigation of risks to health, safety and fundamental rights, and testing to determine the most appropriate measures.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"official_fact","statement":"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.","source_id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","source_locator":"Amended Article 113 application dates","source_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj"},{"kind":"editorial_interpretation","statement":"This is not a one-off risk analysis but a living process: most organisations have an assessment, but no cycle that reruns on every change. The cycle is what a supervisor will request.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"Start the risk management file now for systems that will become high-risk towards 2 December 2027: today’s design and procurement choices determine tomorrow’s residual risks.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 9(1)-(10)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]},{"slug":"article-16-provider-obligations","label":"Article 16: the twelve duties of a provider of a high-risk AI system","summary":"Article 16 is the summary list of duties for providers: twelve points that route onward to the quality management system, the documentation, the logs, the conformity assessment, the EU declaration of conformity, the CE marking, the registration, corrective actions and accessibility requirements.","legal_status":"upcoming","deadline_at":"2027-12-02T00:00:00.000Z","high_risk_regime_from":null,"human_page":"https://www.praxikon.com/en/verplichtingen/article-16-provider-obligations","api":"https://www.praxikon.com/api/v1/obligations?lang=en","official_source":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","citations":[{"kind":"official_fact","statement":"Article 16 requires providers of high-risk AI systems to do twelve things. They must ensure their systems comply with the requirements of Chapter III, Section 2 (point (a)); indicate on the system or, where that is not possible, on its packaging or accompanying documentation, their name, registered trade name or registered trade mark and the address at which they can be contacted (point (b)); have a quality management system in place complying with Article 17 (point (c)); keep the documentation referred to in Article 18 (point (d)); keep the automatically generated logs referred to in Article 19 when under their control (point (e)); ensure the system undergoes the conformity assessment procedure referred to in Article 43 prior to being placed on the market or put into service (point (f)); draw up an EU declaration of conformity in accordance with Article 47 (point (g)); affix the CE marking in accordance with Article 48 (point (h)); comply with the registration obligations referred to in Article 49(1) (point (i)); take the necessary corrective actions and provide the information required under Article 20 (point (j)); upon a reasoned request of a national competent authority, demonstrate conformity with the requirements of Section 2 (point (k)); and ensure the system complies with the accessibility requirements of Directives (EU) 2016/2102 and (EU) 2019/882 (point (l)).","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 16(a)-(l)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"editorial_interpretation","statement":"Article 16 reads like a table of contents and is therefore often planned as a single roadmap line. It is twelve separate duties with widely differing lead times: building a quality management system takes months, affixing a CE marking takes a day. The bigger trap sits in Article 25(1): anyone who puts their own brand on an existing high-risk system, substantially modifies it, or changes the intended purpose of a non-high-risk system so that it becomes high-risk counts as a provider and inherits all twelve points without ever having built anything. In the branding scenario of point (a) this applies without prejudice to contractual arrangements stipulating that the obligations are otherwise allocated, but you must have made and be able to show those arrangements in advance. In practice this catches parties that white-label AI or apply a general-purpose model to an Annex III use case.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 16(a)-(l)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"},{"kind":"recommended_action","statement":"First determine whether you are a provider or whether Article 25 makes you one, then work out the twelve points as twelve separate work packages with an owner and a date. Start with points (c) and (f), because they set the lead time of the whole track.","source_id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","source_locator":"Article 16(a)-(l)","source_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj"}]}],"conditional":[{"slug":"article-61-informed-consent","id":"praxikon:eu:ai-act:obligation:article-61-informed-consent","label":"Article 61: informed consent of test subjects for testing in real world conditions","status":"possibly_applies","source_locator":"Article 60(4), point (i), with Article 61(1)","addressee":"reader","human_page":"https://www.praxikon.com/en/verplichtingen/article-61-informed-consent"}],"sources":[{"id":"praxikon:eu:ai-act:source:reg-eu-2024-1689","title":"EU Artificial Intelligence Act 2024/1689","publisher":"European Parliament and Council","canonical_url":"https://eur-lex.europa.eu/eli/reg/2024/1689/oj","eli":"http://data.europa.eu/eli/reg/2024/1689/oj","source_version":"original-oj-2024-07-12","verified_at":"2026-08-08T00:00:00.000Z"},{"id":"praxikon:eu:ai-act:source:reg-eu-2026-1744","title":"Digital Omnibus on AI 2026/1744","publisher":"European Parliament and Council","canonical_url":"https://eur-lex.europa.eu/eli/reg/2026/1744/oj","eli":"http://data.europa.eu/eli/reg/2026/1744/oj","source_version":"official-journal-2026-07-24","verified_at":"2026-08-08T00:00:00.000Z"},{"id":"praxikon:eu:ai-act:source:commission-draft-high-risk-classification-guidelines","title":"Draft guidelines on the classification of high-risk AI systems","publisher":"European Commission (AI Office)","canonical_url":"https://digital-strategy.ec.europa.eu/en/library/draft-commission-guidelines-classification-high-risk-ai-systems","eli":null,"source_version":"draft-for-consultation-2026-05-19","verified_at":"2026-08-08T00:00:00.000Z"},{"id":"praxikon:eu:ai-act:source:cen-cenelec-jtc21","title":"CEN-CENELEC JTC 21: European standards under standardisation request M/613","publisher":"CEN-CENELEC JTC 21","canonical_url":"https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/","eli":null,"source_version":"work-programme-checked-2026-08-08","verified_at":"2026-08-08T00:00:00.000Z"}],"first_actions":[{"label":"Set up an AI quality management system","summary":"Describe strategies, procedures and responsibilities for compliance, from design and data to post-market monitoring."},{"label":"Justify the Article 6(3) exception against each individual condition","summary":"Name which of the four Article 6(3) conditions you invoke, with facts, and separately justify why the system poses no significant risk of harm to health, safety or fundamental rights and does not materially influence the outcome of decision making."},{"label":"Complete the conformity route before market placement","summary":"Select the correct assessment procedure, draw up the EU declaration of conformity, affix the CE marking and register in the EU database."}],"evidence":[{"label":"QMS documentation","summary":"The documented quality system with procedures, role assignment and references to the underlying files.","url":null},{"label":"Article 49(2) registration record for the system assessed as not high-risk","summary":"Proof that the system for which you invoke the Article 6(3) exception is registered as Article 49(2) requires, with the registration number linked to the underlying assessment.","url":null},{"label":"Conformity file","summary":"The assessment, EU declaration of conformity, CE marking and registration proof, per system version.","url":null}],"guidance":[{"label":"Annex I lists legislation, not products","statement":"The draft guidelines of 19 May 2026, published for consultation and expressly non-binding, clarify that Annex I AI Act does not list individual products to be classified as high-risk, but Union harmonisation legislation regulating the safety aspects of certain products. Whether an AI system falls within the scope of Annex I therefore depends on whether the system, or the product of which it is a safety component, falls within the material scope of one of the listed legislative acts. According to the draft guidelines the list in Annex I is exhaustive; products can only be added or removed by amending the scope of the harmonisation legislation itself or by adding new harmonisation legislation to Annex I. The draft guidelines also state that through Article 6(1) the AI Act does not itself extend the scope of harmonisation legislation to new or additional products, and that the AI Act does not determine or change the risk profile of a product but builds on the sectoral risk classification. Products mentioned include machinery, toys, lifts, equipment and protective systems for potentially explosive atmospheres, radio equipment, pressure equipment, recreational craft, cableway installations, appliances burning gaseous fuels, medical devices, in vitro diagnostic medical devices, and products in the automotive and aviation sectors.","source_locator":"Draft guidelines Annex I, points (23) to (26)"},{"label":"Section A and Section B of Annex I trigger different requirement sets","statement":"The Commission draft guidelines of 19 May 2026, which are non-binding as long as the final version has not been adopted, draw a distinction that is often missed in practice. AI systems classified as high-risk under Article 6(1) in respect of products covered by the harmonisation legislation in Section A of Annex I are subject to the requirements for high-risk systems in Section 2 of Chapter III AI Act. By contrast, for AI systems classified as high-risk under Article 6(1) in respect of products covered by the harmonisation legislation in Section B of Annex I, only Article 6(1), Articles 102 to 109 and Article 112 AI Act apply. The draft guidelines refer to Article 2(2) AI Act for this. Section A contains harmonisation legislation based on the New Legislative Framework, Section B the other Union harmonisation legislation.","source_locator":"Draft guidelines Annex I, point (60), referring to Article 2(2) AI Act"},{"label":"Two cumulative conditions for high-risk under Annex I","statement":"The European Commission draft guidelines of 19 May 2026, which are expressly non-binding and not final, read Article 6(1) as two cumulative conditions. First, the AI system must be intended to be used as a safety component of a product, or the AI system must itself be a product, covered by the Union harmonisation legislation listed in Annex I. Second, that product, or the AI system itself where it is the product, must be required to undergo a third-party conformity assessment. The draft guidelines state explicitly that not all AI systems that are components of regulated products are high-risk, but only the subset that satisfies both criteria.","source_locator":"Draft guidelines Annex I, points (27) and (21)"},{"label":"The Article 6(3) filter: four exhaustive grounds, to be read narrowly","statement":"According to the non-binding draft guidelines of 19 May 2026 on the classification of high-risk AI, Article 6(3) sets out four grounds on which a provider may exempt a system from high-risk classification: performing a narrow procedural task, improving the result of a previously completed human activity, detecting decision-making patterns or deviations from prior patterns without replacing or influencing the previously completed human assessment absent proper human review, and performing a preparatory task. Paragraph (88) of this draft states these grounds are exhaustive but alternative, that there is no separate independent risk test, and that they must be interpreted narrowly because Article 6(3) is an exception to rules that among other things protect fundamental rights. Paragraph (87) states the filter applies only to systems under Article 6(2) and not to systems under Article 6(1). Paragraph (89) states a system always remains high-risk where it performs profiling. Paragraph (90) adds that the filter does not apply where the system forms part of a complex system whose combined intended purpose or joint outputs materially influence an individual decision, including agentic AI. Paragraphs (113) to (116) of this draft describe that this is a self-assessment by the provider, that Article 6(4) requires documenting the assessment before placing on the market and registering in the Article 71 EU database, and that the assessment must contain at least the intended purpose, why the system falls under Article 6(2), which Article 6(3) condition applies and why, and why the system does not perform profiling. Paragraph (117) of these draft guidelines points to Articles 80 and 99 where an authority finds a system was misclassified as non high-risk to circumvent the rules.","source_locator":"Draft guidelines on high-risk AI classification (19 May 2026), Annex III chapter, sections 2.7, 2.7.1, 2.7.3 and 2.7.4, paragraphs (84) to (90) and (113) to (117)"}],"examples":[{"label":"Candidate recommendation that automatically becomes a decision","situation":"An employer uses a system that ranks applicants and recommends a candidate to hire. In one setup a recruiter weighs that recommendation in their own assessment; in the other the outcome is applied automatically and a candidate is rejected without anyone looking at it.","outcome":"The Commission draft guidelines of 19 May 2026 address this case when determining whether an application falls under Annex III. The document is a consultation version: non-binding and not yet final.","lesson":"Assess a recruitment system on its intended purpose rather than on whether a recruiter reviews the output, because adding or removing human involvement does not change its high-risk classification.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III","provenance":"official"},{"label":"Face comparison at the border gate: verification or identification","situation":"An automated border gate uses biometric facial recognition to compare a traveller’s face with the photo in the passport chip. The same camera could technically also compare against a law-enforcement database, and exactly that difference decides whether this biometrics is high-risk.","outcome":"The Commission draft guidelines of 19 May 2026 state that biometric verification falls outside the high-risk classification: one-to-one comparison of presented biometrics with previously stored biometrics, for the sole purpose of confirming that a person is who they claim to be. Where the same capture is additionally compared against a law-enforcement database, it does become remote biometric identification. The document is a consultation version: non-binding and not yet final.","lesson":"Test your biometric application on purpose rather than technology: the same camera and the same model stay outside the high-risk route as long as the comparison is one-to-one and only confirms identity, and fall inside it as soon as that same capture is also held against a database. Record per application what the comparison runs against, because that single design choice moves the entire regime.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III, paragraph (136)","provenance":"official"},{"label":"A CV filter that ranks applicants","situation":"An employer has an external recruitment system score and rank every incoming application, after which recruiters only review the top twenty percent by hand. The vendor puts the system on the market under its own name, and the employer uses it in its own selection process.","outcome":"The Commission draft guidelines of 19 May 2026 address this case when determining whether an application falls under Annex III. The document is a consultation version: non-binding and not yet final.","lesson":"Recruiters keeping the final say does not help you, because once the system scores or ranks applicants and thereby shapes the shortlist it stays high-risk and no exemption applies.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III","provenance":"official"},{"label":"Application file handling at an educational institution","situation":"An educational institution uses AI for application file handling: indexing, searching, text and speech processing, translation of documents submitted with applications, and extracting, transforming and organising the collected data into a usable format.","outcome":"The Commission draft guidelines of 19 May 2026 address this case when determining whether an application falls under Annex III. The document is a consultation version: non-binding and not yet final.","lesson":"Indexing, searching, translating and reorganising application files remains preparatory work, as long as the system leaves the substantive judgment on the application entirely to the institution.","source_locator":"Draft guidelines on high-risk AI classification, 19 May 2026, annex on Annex III","provenance":"official"}],"standards":[{"label":"EN 18286:2026: quality management system for EU AI Act regulatory purposes","summary":"The first completed European standard under the AI Act standardisation request: the quality management system that Article 17 requires from providers of high-risk AI systems.","statement":"EN 18286:2026 (Artificial intelligence: Quality management system for EU AI Act regulatory purposes) was drafted by CEN/CLC/JTC 21 under standardisation request M/613 and approved by CEN-CENELEC on 12 July 2026. It is the first JTC 21 deliverable to reach publication. According to a published coverage statement accompanying the standard, not yet confirmed by a second independent source, it addresses Article 17(1) points (a) to (m) and Article 11(1) first sentence, and expressly not Article 17(2) to (4) or Article 72. The standard is NOT currently cited in the Official Journal. The Article 40 presumption of conformity only attaches after that citation."},{"label":"EN ISO/IEC 42001: artificial intelligence management system","summary":"The certifiable organisation-level AI management system, a European standard since 2026, but not a harmonised standard under the AI Act.","statement":"ISO/IEC 42001:2023 is the first certifiable international standard for an AI management system, published on 18 December 2023 and structured on the plan-do-check-act cycle. The text was adopted unchanged as EN ISO/IEC 42001:2026, approved by CEN on 13 March 2026, with national implementation by the member standards bodies. This adoption is not a deliverable under standardisation request M/613: the standard is not cited in the Official Journal and therefore confers no presumption of conformity under Article 40. For Article 17, the designated deliverable under M/613 is EN 18286:2026; that standard is likewise not cited in the Official Journal."},{"label":"ISO/IEC 23894: guidance on risk management for AI","summary":"The international guidance for AI-specific risk management, usable as an interim structure while prEN 18228 remains in draft.","statement":"ISO/IEC 23894:2023 (Information technology: Artificial intelligence: Guidance on risk management) was published in February 2023 and is the first international standard dealing specifically with risk management for AI. It is non-prescriptive and built on the ISO 31000 structure. The text was adopted by CEN-CENELEC as EN ISO/IEC 23894:2024. It is not cited in the Official Journal and therefore confers no presumption of conformity under Article 40 of the AI Act. The deliverable intended to do so for Article 9 is prEN 18228."},{"label":"prEN 18228: AI risk management for high-risk systems","summary":"The draft European standard filling in the Article 9 risk management system, built on a product-safety logic rather than an enterprise-risk logic.","statement":"prEN 18228 (AI risk management) is the JTC 21 deliverable under M/613 intended to confer presumption of conformity with Article 9 of the AI Act: the risk management system that providers of high-risk AI systems must establish, implement, document and maintain across the full lifecycle. The public Enquiry ran until 30 July 2026. The standard has not yet been published as an EN and is not cited in the Official Journal. The prEN designation means it is a draft text."}],"definitions":[],"answer_page":"https://www.praxikon.com/en/antwoord/kwaliteitsmanagementsysteem","follow_up_questions":[{"question":"What data requirements does the AI Act set for high-risk AI (Article 10)?","url":"https://www.praxikon.com/en/antwoord/data-eisen-hoog-risico"},{"question":"What does \"reasonably foreseeable misuse\" mean in the AI Act?","url":"https://www.praxikon.com/en/antwoord/redelijkerwijs-te-voorzien-misbruik"},{"question":"How do we monitor our AI system after it goes live?","url":"https://www.praxikon.com/en/antwoord/monitoring-na-livegang"}],"disclaimer":"General interpretation, not legal advice. The official source remains authoritative.","methodology":"https://www.praxikon.com/en/methodologie"}