The adoption of a quality management system 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 based on this standard are:
- ability to consistently provide healthcare products and services that meet customer and applicable statutory and regulatory requirements;
- facilitate opportunities to enhance customer satisfaction;
- address risks and opportunities associated with its context and objectives;
- the ability to demonstrate conformity to specified quality management system requirements
This is a sector specific quality management system standard for healthcare. This standard incorporates EN ISO 9001:2015 and adds interpretations, explanations, examples and additional requirements. The standard also includes aspects related to clinical risk management throughout the planning, operation and control of processes.
In this standard, healthcare includes: primary healthcare, pre-hospital and hospital care, nursing homes, hospices, preventive healthcare, mental health services, dental services, aesthetic centers, physiotherapy, occupational health services, rehabilitation, wellness centers, and pharmacies.
The national standards organizations of the following countries have been bound to implement ISO BS EN 15224:2016 beginning 2017:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom