ISO 9001 is a universal quality management standard adopted by organizations across all industries to standardize and improve the services offered to their customers. It is the most recognized quality management standard at the global level, boasting more than 1.1 million certificates given to organizations in 178 countries.
In the healthcare sector, ISO 9001:2008 was adopted to provide a structure for service provision, compliance improvement, and monitoring for quality assurance. The standard was adopted across the healthcare sector, including care homes and third sector community health service providers, to help in risk management and compliance to statutory requirements whilst maintaining a working partnership with clinical services.
ISO 9001:2015, which an improvement of the former ISO 9001:2008 requires healthcare providers to adjust their quality management systems in response to the changing and more demanding regulatory and statutory framework.
The standard provides the specific requirements for a quality management system that enhances the ability to deliver risk-based and high-quality customer-based services that not only meet patient needs but also comply with legal and statutory requisites.
The major reason for the adoption of ISO 9001 standard in healthcare is to improve quality and enhance patient safety through a quality management system that provides patient-centered care as the core principle of all Health and Social care provision.