BS EN 15224:2016

What is BS EN 15224 – Quality management system for healthcare about?  

BS EN 15224 is an international standard that focuses on quality management systems in the healthcare sector. BS EN 15224 specifies requirements for a quality management system when a healthcare organization: 

• Needs to demonstrate its ability to consistently provide healthcare product or service that meets customer and applicable statutory and regulatory requirements 
• Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements, applicable statutory and regulatory requirements and requirements related to the quality aspects 

Who is BS EN 15224 - Quality management system for healthcare? 

BS EN 15224 on quality management systems in the healthcare sector is useful for: 

• Hospital management team 
• Health information managers 
• Health administrators 
• Healthcare facilities  

Why should you use BS EN 15224 - Quality management system for healthcare?  

BS EN 15224 is based on quality management principles. BS EN 15224 includes a statement of each principle, a rationale of why the principle is important for the organization, some examples of benefits associated with the principle and examples of typical actions to improve the organization's performance when applying the principle.  

The adoption of BS EN 15224 is a strategic decision for a healthcare organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.  

The potential benefits to a healthcare organization of implementing a quality management system based on BS EN 15224 are: 

• The ability to consistently provide healthcare products and services that meet customer and applicable statutory and regulatory requirements 
• Facilitating opportunities to enhance customer satisfaction  
• Addressing risks and opportunities associated with its context and objectives 
• The ability to demonstrate conformity to specified quality management system requirements 

BS EN 15224 employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. 

What’s changed since the last update?  

BS EN 15224:2016 supersedes BS EN 15224:2012 which has been withdrawn. BS EN 15224:2016 has been editorially revised.