By CAS
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.
By CAS
ISO 7101:2023
ISO 7101:2023
HOMS
What is Healthcare Organization Management Systems?
ISO 7101:2023 specifies requirements for a management system for quality in healthcare organisations. It addresses the unique aspects of healthcare delivery — patient safety, person-centred care, clinical governance, and regulatory compliance — within a structured management system framework.
Who Is This For?
Hospitals, clinics, health centres, diagnostic laboratories, dental practices, rehabilitation centres, and other healthcare service providers seeking to demonstrate quality management and patient safety commitment.
Key Benefits
- 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
Certification Process
1
Application & Review
Submit your application. CAS reviews your organisation's scope, personnel, sites, and activities to prepare a detailed audit time calculation and formal commercial proposal.
2
Stage 1 — Document Review
On-site or remote review of your management system documentation, readiness assessment, and confirmation of Stage 2 audit scope and plan.
3
Stage 2 — On-site Audit
Full on-site audit of the implemented management system against the standard's requirements. Findings are reported; nonconformities must be closed before certification.
4
Certification Decision
CAS's independent certification committee reviews the audit findings and issues the certificate. The certificate is valid for 3 years.
5
Surveillance & Recertification
Annual surveillance audits (~1/3 of initial audit time) maintain certification. Recertification audit (~2/3 of initial time) is conducted before certificate expiry to renew for a further 3 years.
Frequently Asked Questions
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.
Related Services