ISO 7101:2023 is the first international consensus standard for healthcare quality management. It gives healthcare organisations a systematic, enduring approach to delivering high-quality care, and applies to organisations of any size or location.
What the standard sets out to do
ISO 7101:2023 helps healthcare organisations:
- Establish a quality-focused culture underpinned by strong leadership
- Deliver people-centred care that emphasises compassion and dignity
- Identify and manage healthcare risks
- Protect the safety of patients and the workforce
- Document and control how services are delivered
- Monitor clinical and non-clinical performance
- Enable continuous quality improvement
Why it matters
The standard brings six headline benefits: a systematic, evidence-based approach to care; better experiences for both patients and professionals; improved service quality; better outcomes through structured processes; a cultural shift that prioritises quality; and the flexibility to apply across diverse types of healthcare provider.
Demonstrating conformity
Organisations can show they meet ISO 7101:2023 in several ways — through self-assessment and internal declaration, confirmation by external stakeholders, third-party validation of a self-declaration, or formal certification by an external assessment body.
In context
ISO 7101:2023 sits within the broader landscape of healthcare quality management and supports the UN Sustainable Development Goals. For organisations already pursuing quality and safety certifications, it complements the wider work ABS supports across the healthcare sector, alongside standards such as ISO 9001.