Healthcare Quality Management
Management systems standard for quality in healthcare organisations. Specifies requirements enabling healthcare organisations to consistently provide safe, effective, and person-centred care.
ISO 7101 is the first ISO management system standard developed specifically for healthcare organisations. It specifies requirements for quality management enabling hospitals, clinics, and other care providers to consistently deliver safe, effective, and person-centred healthcare.
The standard addresses healthcare-specific challenges including clinical governance, patient safety culture, incident learning, and workforce competence — going beyond generic QMS requirements to address the unique nature of healthcare service delivery.
ACI-certified ISO 7101 auditors develop competency in assessing healthcare quality management systems, evaluating patient safety programmes, and reviewing clinical governance structures.
Attend an ACI-Approved Training Provider (ATP) course for your chosen grade level. ACI-approved courses are aligned to the examination syllabus for ISO 7101.
Examinations are administered exclusively through ACI Approved Training Providers. Foundation and Internal Auditor examinations require 70% to pass; Lead Auditor requires 65%.
Submit your application through the ACI portal with your examination result, training certificate, and relevant audit experience log. Upon approval you receive your ACI Card ID and digital certificate.
Available Grades for ISO 7101
All six ACI auditor grades are available for this scheme. Each grade has defined competence, experience, and examination requirements.
Entry-level certification for those beginning their auditing career. Suitable for individuals who have completed foundation training but have limited audit experience.
For auditors who have completed Internal Auditor training and have begun accumulating audit experience under supervision or in an internal audit role.
Full auditor grade for practitioners with demonstrated audit experience. Recognised as a competent independent auditor of management systems.
Senior grade for experienced auditors capable of leading audit teams and managing full audit programmes. The most widely recognised auditor grade internationally.
Advanced grade for highly experienced auditors demonstrating sustained performance in complex audit environments and contributions to the auditing profession.
The highest ACI designation, awarded to individuals who have made an exceptional contribution to the management system auditing profession and to the ACI community.
Find an Approved Training Provider, sit the examination, and submit your application to ACI.