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

This paper proposes a conceptual framework to reposition the ISO 45001 standard from a compliance-driven tool to a strategic governance framework for improving occupational health and safety (OHS) in healthcare.

This is a conceptual paper that synthesizes existing literature from management, safety science, and healthcare. It does not present new empirical data but develops a new theoretical lens for understanding and applying ISO 45001.

The compliance-oriented approach to ISO 45001 in healthcare fosters audit-driven behavior and weakens sustainable safety culture. We propose a three-layer governance framework-(1) Foundational governance infrastructure (ISO 45001 Clauses 4-10), (2) Strategic integration mechanisms (leadership accountability, worker participation, integrated risk governance), and (3) Strategic outcomes (safety culture maturity, workforce well-being, patient safety, and organizational resilience)-that operationalizes High-Reliability Organization (HRO) principles through auditable governance mechanisms.

The paper's novelty lies in offering a practical, theoretically grounded model that bridges the gap between OHS management and strategic governance in healthcare. It provides a roadmap for moving beyond certification to unlock the standard's potential for enhancing workforce well-being, patient safety, and organizational resilience.

The framework offers healthcare leaders, regulators, and accreditation bodies a new way to think about and implement ISO 45001. It provides concrete examples of how to integrate OHS into existing governance structures, address common critiques, and measure the strategic value of safety investments.