Why This Course Matters

Healthcare quality failures are rarely caused by lack of clinical knowledge. They are more often the result of weak systems, unmanaged clinical risks, and unclear leadership accountability.

BS EN 15224:2016 is the recognised healthcare interpretation of ISO 9001:2015, developed to embed patient safety, clinical risk management, outcomes, and ethical practice into healthcare Quality Management Systems.

Course Overview

Healthcare organisations operate in environments where patient safety, clinical effectiveness, and ethical care are critical. Traditional quality management approaches often focus on administrative compliance, leaving gaps in clinical risk management and patient outcomes.

BS EN 15224:2016 provides a healthcare-specific interpretation of ISO 9001:2015, translating generic quality management principles into clinically meaningful systems that prioritise patient safety, quality of care, ethical practice, and risk-based thinking.

This Level 1 Awareness & Foundations course builds leadership understanding and organisational readiness for implementing an effective Healthcare Quality Management System (QMS).

Who Should Attend

• Medical Directors & Chief Medical Officers
• Hospital CEOs & Administrators
• Clinical Leads & Heads of Department
• Quality, Risk & Compliance Officers
• Health Administrators & Managers
• HMOs & Managed Care Leaders
• Regulators, Inspectors & Policy Makers
• Hospital Board Members & Executives

No prior ISO knowledge is required.

What Participants Will Learn

• ISO 9001:2015 principles in a healthcare context
• Purpose and value of BS EN 15224:2016
• Patient safety, clinical risk, and outcomes as QMS priorities
• Leadership responsibilities for clinical governance and ethics
• ISO 9001 certification using BS EN 15224 healthcare interpretation

Course Content Highlights

• Quality Management in Healthcare
• ISO 9001:2015 Overview and High-Level Structure
• BS EN 15224:2016 Explained
• The 11 Quality Characteristics of Healthcare
• Patient Safety & Clinical Risk-Based Thinking
• Leadership, Ethics & Governance
• Certification & Audit Overview

Course Delivery Method

Recorded Self-Tutored (Google Classroom):
• On-demand access
• Short recorded modules
• Self-paced (6–8 hours)
• Defined access period (30 days)

Assessment & Certification

Participants complete a short knowledge quiz and guided exercise.

Award

Certificate of Awareness – BS EN 15224:2016 (Level 1)

Professional Progression Pathway

Level 1 – Awareness & Leadership Understanding
Level 2 – Healthcare QMS Implementation
Level 3 – Internal Audit & Certification Readiness

Key Benefits to Organisations

• Improved leadership understanding of patient safety
• Strong foundation for healthcare QMS implementation
• Better alignment between management and clinical teams
• Clear pathway to ISO 9001 certification
• Enhanced trust from patients, regulators, and partners

Quality in healthcare is not accidental.
It is designed, led, and governed.

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