Implement ISO 42001 within your organization—Today

Implementing Reliable AI in Regulated Industries

The EU AI Act and ISO/IEC 42001:2023

With the ratification of the EU AI Act, effective compliance mechanisms for the Act’s various obligations are presently left to organizations to design, implement, and evaluate safe and effective AI oversight.

This creates an additional burden in an already competitive market.

In addition to the Act, companies already participating in regulated industries have concerns about how safe and effective AI can be effectively deployed within their respective industries.

As a team of engineers and consultants providing tailored AI solutions across multiple regulated industries, Lemay.ai now offers ISO/IEC 42001:2023 implementation and certification readiness services.

About ISO 42001

ISO/IEC 4 2001:2023—Artificial Intelligence Management Systems is a compliance standard offering standard operating procedures for the safe and effective adoption of machine learning systems.

Similar to standardized quality management systems, it provides:

• Reduction of AI risks through risk assessment and treatment.
• 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 with a quality management system, ISO 42001 presents a mechanism for aligning new AI initiatives with corporate objectives.

Compliance with the standard provides:

• Effective management of AI risks and opportunities unique to the organization.
• A set of established processes for effectively managing concerns related to the trustworthiness of AI systems.
• 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:

• Medical devices embedded with firmware running statistical or deep learning models.
• Cloud-connected systems with scalable, medically-compliant backends.
• Pure software plays (such as medical imaging) are being used as medical decision support systems.

Working With Lemay.ai

With a team of engineers and consultants possessing both deep technical experience and certified as lead auditors, Lemay.ai can provide tailored implementation of ISO42001 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:

• Execution of a gap analysis between existing and desired AI/ML systems.
• Implementation and provisioning of appropriate MLOps pipelines. 
• Generation, customization, and training of all required Standard Operating Procedures (SOPs).
• Documentation and training for the leadership team, technical experts, and internal auditors.
• Implementation of desired AI projects in compliance with MLOps pipelines.
• Internal audit support for certification readiness.

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