ISO 7101:2023 — Healthcare Organization Management
The international standard for quality management in healthcare organisations — hospitals, clinics, and health services demonstrating commitment to patient safety and service excellence.
Standard
ISO 7101:2023
Service type
By CAS
Issued under
CAS — own authority
Standards & technical basis
Certified standard
ISO 7101:2023
Certification-body competence
ISO/IEC 17021-1:2015 · ISO/IEC TS 17021-15:2023
CAS audits and certifies to the requirements of ISO/IEC 17021-1:2015 and ISO/IEC TS 17021-15:2023 — which sets the competence requirements for auditing and certification of management systems for quality in healthcare organizations.
Mark & recognition
Issued by CAS under its own authority — carries the CAS mark and does not bear the EGAC or IAF marks.
What it is
ISO 7101:2023 specifies requirements for a management system for quality in healthcare organisations (HOMS). Published in 2023 as the first dedicated international ISO standard for healthcare quality management systems, it addresses patient safety, person-centred care, clinical governance, and regulatory compliance within a structured management system framework aligned with the ISO Harmonized Structure.
Who needs it
Hospitals, clinics, health centres, diagnostic laboratories, dental practices, rehabilitation centres, and other healthcare service providers seeking to demonstrate quality management and patient safety commitment.
Benefits of certification
- International recognition of healthcare quality management
- Structured approach to patient safety and clinical risk management
- Demonstrates commitment to person-centred care
- Supports healthcare regulatory compliance
- Competitive differentiation for healthcare accreditation and contracts
- Integrates with ISO 9001 for comprehensive quality management
Frequently asked questions
Common questions
Is ISO 7101 the same as hospital accreditation?
No. ISO 7101 is a management system standard that can complement hospital accreditation programmes. It provides a structured quality management framework for any healthcare organisation.
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