Daiki logo blue

Unlock AI Excellence with ISO/IEC 42001 Certification

Daiki empowers your team to effortlessly achieve ISO/IEC 42001 compliance, ensuring confident navigation of regulatory requirements

Simplify ISO/IEC 42001 certification with our 
AI solutions

Our solution empowers your team to navigate regulatory requirements with ease, ensuring compliance without unnecessary complexity. Learn more about how Daiki can support your organization’s journey towards ISO/IEC 42001 certification.

Benefits of knowing and using AI

Simplify Certification, Maximize Efficiency

Navigate Regulations with Ease

Guided ISO/IEC 42001 Compliance Journey

Daiki’s platform streamlines the ISO/IEC 42001 certification process, offering clear step-by-step guidance to understand and navigate even the most intricate regulations effortlessly.

Daiki’s dynamic knowledge base and AI Copilot provides immediate answers to your compliance questions, saving you research time and accelerating your product launch.

Enhance Efficiency & Simplify Compliance

Optimize Costs, Enhance Efficiency

Benefit from Daiki’s AI-driven insights to receive cost-effective guidance, reducing reliance on expensive consulting services while maximizing operational efficiency.

Daiki’s AI continuously learns and updates you on evolving regulations, ensuring seamless compliance adaptation, keeping you ahead of the curve.

Daiki evaluates training requirements, customizes questionnaires, and automates record generation, streamlining internal audits and technical documentation creation.

Simplify Documentation & Audit Submission

Effortless Documentation Management

Effortlessly generate, organize, and manage essential documents, ensuring crucial information is readily accessible and up-to-date.

Daiki’s integrated interface enables direct compliance result submissions to international bodies, simplifying the process and instilling confidence.

Accelerate Your Journey to ISO/IEC 42001 Compliance

The Daiki Copilot system addresses all your queries regarding the specific ISO standard, provides templates, and assists in automating documentation and training processes

Daiki AI Co-Pilot

Electronic Quality Management System (eQMS) for establishing, implementing, maintaining, and continually improving an Artificial Intelligence Management System (AIMS)

Electronic Quality Management System for Artificial Intelligence Management System in Daiki

Simplify the audit process and improve your preparation by implementing a structured audit plan. Leverage the various available interfaces to facilitate the audit submission

Audit preparation in Daiki

Integrated versioning, review, and approval processes, along with private team communication through document-specific comments

Documenting in Daiki

Why choose Daiki for ISO/IEC 42001 certification?

Icon Responsible AI Leader

Responsible AI Leader

Daiki was built by a multidisciplinary team of experts. We combine legal, ethical, design, and machine learning expertise to enable responsible AI development.

Icon Beyond Compliance

Beyond Compliance

Our goal is to not just ensure your compliance with 
ISO/IEC 42001 but to also enhance your development process, QMS, and operational efficiency using 
AI technologies.

Icon Acces to AI Tech

Access to AI Tech

Opt for trusted and regulatory-compliant tech stacks, such as Daiki’s Secure Private Large Language Models (LLMs) and Retrieval Augmented Generation (RAG) system.

Ready to streamline your ISO/IEC 42001 certification journey?

Contact Daiki today for a consultation and demo. Let our experts assist you in navigating compliance complexities, freeing you to concentrate on business growth and innovation.

Seeking Assistance
with AI Development

Apply for our AI Pilot Program and explore tailored solutions for your AI development needs.

Experience our Digital
SaaS Product Tour

Let our experts showcase Daiki’s capabilities and walk you through the software. We’re here to address all your inquiries about the product and its application.

Trusted by leading international organizations

“As a physician and data scientist, I believe the collaboration with Daiki is a great win for my projects. In addition to the integrity of the members of Daiki, the company offers an infrastructure that makes large-scale projects possible on an international level. “

Profile picture of Dr. Murat Bilici

University Hospital Basel, Switzerland

Dr. Murat Bilici
Orthopaedic Trauma Surgeon, Data Scientist

Asked Questions

Find answers to frequently asked questions.

What is the purpose of ISO/IEC 42001?

The purpose of ISO/IEC 42001 is to provide a structured framework for establishing, implementing, maintaining, and continually improving an Artificial Intelligence Management System (AIMS) within organizations. It addresses the unique challenges posed by AI technology, including ethical considerations, transparency, and continuous learning. By adhering to ISO/IEC 42001, organizations can manage risks and opportunities associated with AI, ensuring responsible development and use of AI systems throughout their lifecycle.

To learn more, visit the ISO official website.

While ISO/IEC 42001 is not mandatory, there are significant incentives for its adoption, particularly concerning the presumption of conformity under Article 40 of the current draft EU AI Act. This article suggests that high-risk AI systems in conformity with relevant harmonized standards, such as ISO/IEC 42001, will be presumed to meet the requirements outlined in the Act. Although ISO/IEC 42001 remains voluntary, its importance and potential future recognition as the benchmark for AI management systems make proactive adoption advisable for organizations involved in AI development or usage.

Organizations involved in AI development or usage have a responsibility to consider the potential implications of ISO/IEC 42001 adoption, particularly in light of Article 40 of the draft EU AI Act. While ISO/IEC 42001 remains voluntary, organizations should proactively assess the benefits of conformity with this standard, as it may offer presumptive conformity with relevant regulatory requirements. This entails staying informed about emerging standards, evaluating potential regulatory developments, and considering the proactive adoption of ISO/IEC 42001 to ensure responsible AI development and usage practices.

Failing to meet the ISO/IEC 42001 standard may result in various consequences for organizations. Without ISO/IEC 42001 certification, businesses may miss out on the structured approach it provides for establishing, implementing, maintaining, and continually improving an Artificial Intelligence Management System (AIMS). Consequently, organizations may struggle to ensure the responsible development and application of AI systems, which could lead to ethical issues, transparency challenges, and missed opportunities for innovation. Additionally, without ISO/IEC 42001 certification, organizations may face difficulties in showcasing the responsible application of AI, which could impact their reputation and trustworthiness in the market. Moreover, non-compliance with ISO/IEC 42001 may result in increased risks, reduced operational efficiency, and missed cost-saving opportunities. Ultimately, failing to meet the ISO/IEC 42001 standard could hinder organizations’ ability to compete effectively, adapt to changing regulatory landscapes, and demonstrate their commitment to responsible AI development and usage.

ISO/IEC 42001 focuses on establishing and managing Artificial Intelligence Management Systems (AIMS) within organizations, emphasizing responsible AI development and application. In contrast, ISO 23894-2023 provides strategic guidance for managing AI-related risks across all sectors, aligning with established risk management principles. While ISO/IEC 42001 addresses AI-specific management systems, ISO 23894-2023 offers broader risk management guidance applicable to AI-driven activities and business functions. Both standards complement each other, with ISO/IEC 42001 providing a framework for managing AI-specific risks, while ISO 23894-2023 offers guidance on integrating risk management into AI-driven activities and addressing the complexities of the AI lifecycle.

ISO/IEC 42001 and the NIST AI Risk Management Framework (AI RMF) address AI risk management from different angles. ISO/IEC 42001 focuses on establishing and managing AI Management Systems (AIMS) within organizations, emphasizing responsible AI development and compliance with regulations. In contrast, the NIST AI RMF, developed collaboratively with public and private sectors, aims to enhance trustworthiness in AI design, development, and use. While ISO/IEC 42001 offers a structured approach for managing AI risks, the NIST AI RMF provides voluntary guidelines for incorporating trustworthiness into AI-related activities across sectors. Both frameworks promote responsible AI usage but with differing emphases and scopes.

A companion NIST AI RMF Playbook also has been published by NIST.

ISO/IEC 42001 focuses on managing Artificial Intelligence Management Systems (AIMS), emphasizing responsible AI development. In contrast, ISO 27001-2022 centers around Information Security Management Systems (ISMS), safeguarding data integrity and confidentiality. While ISO/IEC 42001 addresses AI-specific risks, ISO 27001-2022 focuses on broader information security concerns. Both certifications offer benefits such as improved risk management and stakeholder confidence, tailored to the organization’s needs and priorities regarding AI and information security.

ISO/IEC 42001 and the EU AI Act serve different yet complementary roles in governing AI. ISO 42001 provides a comprehensive framework for managing AI systems responsibly, emphasizing risk management and governance practices. On the other hand, the EU AI Act proposes regulations specifically targeting AI applications, categorizing them based on risk levels and establishing legal requirements, particularly for high-risk applications.

While ISO/IEC 42001 sets general standards for AI management, the EU AI Act offers more specific guidelines and legal obligations. However, organizations can leverage ISO 42001 compliance to align with the principles and objectives outlined in the EU AI Act. By adhering to ISO/IEC 42001, companies can demonstrate their commitment to responsible AI practices, potentially facilitating compliance with the EU AI Act’s requirements.

In essence, while ISO/IEC 42001 provides a foundation for managing AI systems ethically and efficiently, the EU AI Act offers a regulatory framework to ensure accountability and mitigate risks associated with AI applications. Together, they contribute to fostering trust in AI technologies and promoting their responsible development and use.

ISO offers several standards aimed at reducing risks and optimizing benefits associated with artificial intelligence (AI). These standards include ISO/IEC 22989, which sets forth terminology and fundamental concepts in the AI domain; ISO/IEC 23053, which outlines a framework for describing AI systems leveraging machine learning (ML); and ISO/IEC 23894, which offers guidance on managing AI-related risks within organizations.
In contrast, ISO/IEC 42001 is distinct as a management system standard (MSS).

To learn more, visit the ISO official website.

Any more questions?

Contact us for further information or assistance.

Get started with Daiki

Sign up today for a demo or apply to our pilot program

Daiki Logo

Book Demo Today

Daiki Logo

Apply today

Daiki Logo

Let's talk about responsible AI development

Daiki Logo

Book Demo Today

Daiki Logo

Partner with us

Daiki Logo

Join our waitlist for responsible AI development

Daiki Logo

Join our waitlist for responsible AI development

Daiki Logo

Join our waitlist for responsible AI development

Daiki Logo

Join waitlist for responsible AI development