ISO 7101
Healthcare quality management focused on patient safety.
ISO 7101 is one of the newest standards in the family, built specifically for healthcare providers rather than adapted from a generic quality framework. It centres on patient safety and clinical governance — how care decisions are made, how risk to patients is identified and reduced, and how a healthcare organisation learns from incidents instead of burying them. The standard also addresses workforce wellbeing and organisational culture as direct contributors to care quality, reflecting the reality that patient outcomes depend on more than clinical protocols alone.
How It Works
Tell us about your organisation and its scope — we review fit against the standard and respond with a clear, itemised quotation.
A documentation and readiness review confirming your management system is designed to meet the standard before any on-site assessment begins.
An on-site (or remote, where permitted) assessment of how the system actually operates in practice, checked against every applicable clause.
A reviewer who was not part of the audit team evaluates the findings and makes the certification decision — the impartiality safeguard behind every certificate we issue.
Your certificate is issued with a QR code for instant online verification, valid for three years subject to annual surveillance audits.
Indicative, not exhaustive — your auditor confirms the exact list for your scope during Stage 1.
A ISO 7101:2023 certificate is valid for three years from the date of issue, subject to annual surveillance audits that confirm the management system is still being maintained — not a one-time snapshot. Recertification before the three-year expiry keeps the certificate (and the QR-code verification behind it) current.