ISO 7101:2023 Certification
Certify how your hospital, clinic, or healthcare network manages quality — patient safety, clinical effectiveness, and people-centred care — against the first international standard written specifically for healthcare organisations.
ISO 7101:2023 is a genuinely new standard — the first international standard written specifically for healthcare quality management, published by ISO in August 2023. Because it’s so new, accreditation programmes for certifying against it are still being rolled out by national accreditation bodies worldwide (several, including UKAS, are running pilot schemes as of this writing). We’ll confirm our current accreditation position for this specific standard before your engagement begins, alongside our standing EGAC accreditation across our established ISO management system scopes.
Quality built for how healthcare actually works
ISO 7101:2023, Healthcare organization management — Management systems for quality in healthcare organizations, gives hospitals, clinics, and healthcare networks a management system framework built specifically for their sector, rather than a generic quality standard retrofitted onto clinical care.
It covers clinical governance, patient safety, infection prevention, ethics and informed consent, discharge planning, and workforce wellbeing — with a strong emphasis on people-centred care, equity, and continuous learning from incidents rather than blame.
For healthcare leaders facing workforce shortages, resource pressure, and rising patient volumes, it provides a structured way to demonstrate that quality and safety are governed systematically, not held together by individual clinicians’ effort.
Hospitals
General and specialist hospitals of any size or ownership structure.
Clinics & outpatient centres
Standalone clinics and multi-specialty outpatient facilities.
Healthcare networks
Multi-site groups seeking a consistent quality standard across facilities.
Diagnostic & specialty centres
Imaging, dialysis, and other specialty care providers.
Public health facilities
Government-run facilities under pressure to demonstrate governance.
Private healthcare providers
Private hospitals and groups differentiating on quality and safety.
What certification changes on the ground
Better patient safety
Systematic risk assessment and incident learning reduce preventable harm.
Improved clinical effectiveness
Structured quality objectives and outcome monitoring drive consistent care.
Cost & resource efficiency
Better governance reduces waste and improves use of scarce resources.
Stronger workforce wellbeing
Clearer processes and leadership accountability support staff retention.
Strengthened reputation
Independent certification builds trust with patients, insurers, and regulators.
Equity & people-centred care
Bakes cultural competency and equity into everyday care delivery.
Our certification process
A structured audit pathway from application to certificate issuance, and beyond.
Application & contract review
We scope your certification boundary — sites, services, and clinical departments — and confirm audit duration and pricing.
Documentation review
Your healthcare quality policy, strategic objectives, and QMS documentation are reviewed against ISO 7101:2023.
Stage 1 audit
An on-site readiness assessment confirming your quality management system is implemented and prepared for the certification audit.
Stage 2 audit
Full evaluation of implementation and effectiveness across clinical governance, patient safety, and care delivery processes.
Certification decision
An independent technical committee, including relevant clinical expertise, reviews audit findings ahead of the certification decision.
Certificate issuance
Your ISO 7101:2023 certificate is issued, valid for three years under our current accreditation scope for the standard.
Surveillance & recertification
Annual surveillance audits maintain certification; a recertification audit renews it at the three-year mark.
What your system needs in place
These form the baseline our auditors assess against during Stage 1 and Stage 2.
- 01A healthcare quality policy and strategic objectives
- 02Risk-based assessment of clinical and non-clinical activities
- 03Documented processes for infection control and ethics/consent
- 04Discharge planning and continuity of care procedures
- 05Internal audits and patient experience measurement
- 06Clinical outcome monitoring systems
- 07Incident reporting and organisational learning systems
- 08Top management and clinical leadership accountability
Independent, methodical, Nigerian-based
Accredited by the Egyptian Accreditation Council (EGAC), a full IAF/GAC Multilateral Recognition Arrangement signatory, across our established ISO management system scopes.
Certification, compliance, and consultancy across ISO management system standards, alongside AML/due diligence and cybersecurity advisory.
Supported by affiliated entities Ecora Consulting Limited and Primose Technologies Ltd for wider advisory and technical capability.
Headquartered at 27A Alternative Drive, Chevron, Lekki, Lagos — serving clients across Nigeria and the wider African market.
“Healthcare quality shouldn’t depend on which clinician is on shift. ISO 7101 gives hospitals a system for it — and we’ll always be upfront about exactly what our certification does and doesn’t cover for a standard this new.”
IEMA Standards LtdReady to certify your healthcare quality management system?
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