ISO 7101 requirements explained: video brief

A quality standard written for healthcare

ISO 7101 is the first international management system standard written specifically for quality in healthcare organisations. Developed by ISO/TC 304, the ISO committee for healthcare organisation management, it sets requirements for a systematic approach to sustainable, high-quality care, and ISO describes it as applicable to providers from small clinics to large hospitals. This short film sets out what it asks for.

The standard requires top management to lead a culture of quality and to build care around people. Respect, compassion, co-production, equity and dignity sit alongside risk identification, patient and workforce safety, documented service delivery, performance monitoring and improvement. In practice it gives a hospital group, a day-surgery centre or a diagnostic clinic one framework for quality across clinical and support services.

Clauses 4 to 10 in a clinical setting

ISO 7101 follows the harmonised structure of the ISO management system standards. Context covers the services, patient groups, interested parties and boundaries the quality system covers. Leadership makes top management accountable for care quality, with a policy, roles and a culture that puts people at the centre. Planning addresses risks and opportunities for patients, staff and services, and sets quality objectives that can be measured. Support provides competent and aware staff, communication, resources and controlled documented information.

Operation covers the planning and control of care and support services, including outsourced services. Performance evaluation monitors and measures care quality, with internal audit and management review, and improvement acts on what those show, including learning from incidents and feedback. The detailed requirements under each heading are checked against the standard itself during a gap analysis. ISO 7101:2023, the first edition, was published in October 2023. It is a requirements standard, assessed and decided by an independent certification body, and the scope of a certificate names the facilities, departments, clinical and support services it covers.

It does not replace hospital accreditation programmes, which run against their own standards, and the two can operate side by side; a small clinic needs a proportionate system, not a hospital-sized manual.