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With the ratification of the EU Artificial Intelligence Act (AI Act) and the growing momentum of AI regulation worldwide, organizations are now responsible for independently architecting, operationalizing, and validating their compliance frameworks. This regulatory shift imposes additional pressure on enterprises already operating in highly competitive markets. It introduces new layers of complexity and accountability that many organizations, particularly those in complex and highly regulated sectors, may lack the specialized governance structures, risk management protocols, and internal oversight mechanisms necessary to navigate effectively within this emerging compliance landscape.
Beyond the EU Act, companies in regulated industries such as healthcare, finance, defense, and critical infrastructure face increasing concerns around how to safely and effectively deploy AI within their respective domains. ISO/IEC 42001 is designed to streamline and standardize internal assessments, providing a structured framework that is adaptable to regulatory requirements in the EU, Canada, the U.S., and beyond.
As a team of engineers and certified ISO/IEC 42001 Lead Auditors delivering tailored AI solutions across regulated sectors, Lemay.ai now offers ISO/IEC 42001:2023 implementation and certification readiness services.
ISO/IEC 42001:2023 is a global standard for Artificial Intelligence Management Systems (AIMS), providing standard operating procedures for the safe and effective adoption of machine learning systems.
Similar to standardized quality management systems, it provides:
1 Reduction of AI risks through risk assessment and treatment.
2 Performance evaluation of AI systems through monitoring, measurement, and analysis.
Continual improvement and corrective actions are addressed at every level of the organization
Furthermore, ISO 42001 establishes a prescription for appropriate oversight, providing the right amount of flexibility for high-growth startups and quality assurance for large organizations.
For Clients Coming From ISO 9001
For companies already operating a Quality Management System (QMS) under ISO 9001, the new ISO/IEC 42001 offers a natural extension, enabling organizations to align their emerging AI initiatives with existing corporate objectives and quality principles. Specifically, compliance with ISO 42001 provides:
1 Effective management of AI risks and opportunities unique to the organization.
2 A set of established processes for effectively managing concerns related to the trustworthiness of AI systems.
3 Additional processes for managing suppliers, partners, and third parties engaged in provisioning and developing AI systems for the organization.
Designed to align itself with existing quality management systems, ISO 42001 avoids many redundancies in other AI risk management frameworks.
For Clients Coming From ISO 13485
Within the medtech industry, risk-aware decisions influence every part of the design and delivery of medical solutions.
Aligned with the risk management considerations of medical device design, ISO 42001 establishes risk management as a primary consideration for any and all AI development activities. Medical devices augmented with AI software can ensure successful compliance without exposing patients to undue risk.
AI Management Systems apply to:
1 Medical devices embedded with firmware running statistical or deep learning models.
2 Cloud-connected systems with scalable, medically-compliant backends.
3 Pure software plays (such as medical imaging) are being used as medical decision support systems.
With a team of engineers and consultants possessing both deep technical experience and certified as lead auditors, Lemay.ai can provide tailored implementation of ISO 42001 by assessing your present state, identifying the optimal path to certification, and providing a clear set of activities of achieving compliance.
Working with Lemay.ai for ISO/IEC 42001:2023 implementation brings with it the following benefits:
1 Execution of a gap analysis between existing and desired AI/ML systems.
2 Implementation and provisioning of appropriate MLOps pipelines.
3 Generation, customization, and training of all required Standard Operating Procedures (SOPs).
4 Documentation and training for the leadership team, technical experts, and internal auditors.
5 Implementation of desired AI projects in compliance with MLOps pipelines.
6 Internal audit support for certification readiness.
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