Regulatory Compliance
What is Regulatory Compliance?
The process of adhering to laws and regulations relevant to an organisation's operations. Non-compliance can result in fines, legal action, and reputational damage.
Related terms
Frameworks that govern regulatory compliance
What the standards actually require on regulatory compliance
Requirements naming regulatory compliance across 6 standards, quoted from the control text.
Article 15 requires manufacturers to have permanently available within their organisation at least one Person Responsible for Regulatory Compliance (PRRC) with the requisite expertise in the field of in vitro diagnostic medical devices.
IVDR-Art.15 · Person Responsible for Regulatory Compliance (Article 15) →Accountability (Sekinin 責任) is the seventh of 10 Principles per Japan AI Guidelines for Business + addresses organisational governance + clear responsibility allocation + stakeholder engagement + regulatory compliance across AI lifecycle.
JP-AIG-Accountability-Governance-AI-Inventory-Stakeholder-Engagement-Board-Reporting-Tone-at-Top · Japan AI Guidelines Accountability + Governance + AI Inventory + Stakeholder Engagement + Board Reporting + Tone at Top + AI Ethics Committee + DPO + AI Officer + Regulatory Compliance + Multi-Stakeholder →Article 15 requires manufacturers to have permanently available at least one Person Responsible for Regulatory Compliance (PRRC) with the requisite expertise. The PRRC has formal responsibility to ensure: (a) device conformity before release;
MDR-Art.15 · Person Responsible for Regulatory Compliance (Article 15) →ISMAP Cloud Governance establishes the management framework for Cloud Service Providers operating under ISMAP. (1) Information Security Management System (ISMS): based on ISO/IEC 27001:2022 + JIS Q 27001 (Japanese Industrial Standard equivalent) + ISMS-AC Info...
ISMAP-CloudGovernance-ISMS-RiskAssessment-SharedResponsibility-Policy-RegulatoryCompliance-RolesResponsibilities · ISMAP Cloud Governance - ISMS per ISO 27001/JIS Q 27001 + Risk Assessment + Shared Responsibility Model + Cloud Security Policy + Regulatory Compliance + Roles and Responsibilities →Regulatory compliance for cloud services. Control from NIST SP 800-190 framework, domain: NIST SP 800-190: Cloud Governance.
NIST190-04 · Regulatory compliance for cloud services →Operate AI incident reporting + regulatory compliance + public reporting + international cooperation per OECD AI Principles + applicable regulation + voluntary commitment.
OECDAI-8 · AI Incident Reporting, Regulatory Compliance, Public Reporting, and International Cooperation →Questions people ask about regulatory compliance
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