ISO 7101:2023 — Gap Analysis
Healthcare Organization Management — Requirements for Patient-Centred Quality HealthcareAbout ISO 7101:2023
ISO 7101:2023 is the first international healthcare quality management system standard, published in October 2023. It addresses gaps in ISO 9001 specific to healthcare — patient safety, equity, person-centeredness, integration of services, and outcomes. It is intended to be sector-specific while complementing ISO 9001, JCI standards, ANCC Magnet and other healthcare quality programmes.
Issuing Body
ISO Technical Committee 304 — Healthcare organization management
Edition
2023
Coverage
Requirements for healthcare organisations seeking to demonstrate ability to consistently provide patient-centred, safe, effective, equitable and timely healthcare.
Typical Users
Hospitals, clinics, surgeries, mental-health services, ambulatory care, long-term care, dental, optometry — any healthcare-delivery organisation.
How to use this tool
1. Work through each clause. For each requirement, choose Compliant, Partial, Non-compliant, or leave as Not assessed.
2. Add notes against any requirement to record evidence, gaps, or corrective actions.
3. Click Save progress — data is stored locally in your browser, never uploaded.
4. Export the report as TXT, CSV, JSON or print to PDF for your audit file.
Note: This tool is a guided self-assessment. It does not replace a third-party audit and the authoritative version of the standard must be obtained from the issuing body.
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