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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.

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) →

The cybersecurity program addresses and supports achievement of applicable legal and regulatory compliance, with people responsible for knowing the obligations.

australian-energy-sector-cyber-security-framework-aescsf::PROGRAM-2i · PROGRAM-2i: Program enables legal and regulatory compliance →

Identify the laws, regulations and contractual obligations that bear on the organization's data, decide how governance monitors compliance in collaboration with risk, audit and legal, and keep the assessment current.

dama-dmbok2-data-management-body-of-knowledge-2nd-edition::DG.2.11 · DG.2.11 Assess regulatory compliance requirements →

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 (Japan)1 control

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 →

The entity is required to set up, keep up to date and document procedures for complying with the legislation, policies, regulatory requirements and directives that apply to it.

nfpa-1600-standard-on-continuity-emergency-and-crisis-management::4.7.2 · 4.7.2 Documented procedures for legal and regulatory compliance →

Questions people ask about 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.
Why is Regulatory Compliance important for compliance?
Regulatory Compliance is a key concept in Compliance. Understanding regulatory compliance helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 1,016 frameworks with 316K cross-framework control mappings.
What concepts are related to Regulatory Compliance?
Key concepts related to Regulatory Compliance include Compliance, Audit. Understanding these interconnected concepts provides a more comprehensive view of Compliance requirements and helps organizations build holistic compliance programs.
Which compliance frameworks address Regulatory Compliance?
Regulatory Compliance appears in the requirement text of EU In Vitro Diagnostic Medical Devices Regulation (IVDR), Australian Energy Sector Cyber Security Framework (AESCSF), DAMA-DMBOK2 - Data Management Body of Knowledge (2nd Edition), EU Medical Devices Regulation (MDR 2017/745), ISMAP (Japan). Across these standards we have identified 7 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about Regulatory Compliance?
Explore our compliance framework pages to see how regulatory compliance applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 1,016 frameworks.

See how Regulatory Compliance applies across compliance frameworks

Our platform maps 1,016 frameworks with 316K cross-framework control mappings. Explore how this concept is addressed across standards.

Written and maintained by Gerard Blokdyk, The Art of Service.