Beyond Compliance: An HRO-Based Governance Framework for ISO 45001-Enabled Safety Strategy in Healthcare

Area of Science:

• Healthcare Management
• Occupational Health and Safety
• Organizational Governance

Background:

• ISO 45001 is often treated as a compliance tool in healthcare, leading to audit-driven behavior.
• This approach can undermine the development of a sustainable safety culture within healthcare organizations.

Purpose of the Study:

• To propose a conceptual framework for repositioning ISO 45001.
• To shift the focus from compliance to strategic governance for improving occupational health and safety (OHS) in healthcare settings.

Main Methods:

• Conceptual paper synthesizing literature from management, safety science, and healthcare.
• Development of a three-layer governance framework operationalizing High-Reliability Organization (HRO) principles.

Main Results:

• A proposed three-layer governance framework: foundational infrastructure, strategic integration mechanisms, and strategic outcomes.
• The framework integrates ISO 45001 clauses with leadership accountability, worker participation, and risk governance.
• Achieving strategic outcomes such as safety culture maturity, workforce well-being, patient safety, and organizational resilience.

Conclusions:

• The proposed framework offers a novel, theoretically grounded model for healthcare.
• It provides a roadmap to move beyond mere certification towards strategic OHS management.
• Enables healthcare leaders to enhance workforce well-being, patient safety, and organizational resilience.