What this helps you do.
- Healthcare organisations developing a quality management system.
- Providers reviewing readiness or planning the transition of an existing system.
Scope of the review
- Agreed requirements of ISO 9001:2026 or ISO 7101:2023, as applicable.
- Leadership, process ownership, risk, documented arrangements and performance review.
- Internal audit, corrective actions and evidence of continual improvement.
How it works
- Set the standard
Confirm the edition, organisational boundary and objectives of the review.
- Understand processes
Map how the system operates and the records it produces.
- Review readiness
Compare selected evidence with the agreed requirements and record gaps.
- Plan improvement
Assign priorities and identify what needs demonstrating before external assessment.
What you receive
- A scoped readiness and gap review.
- An implementation plan with evidence priorities.
- Recommendations for internal review and management oversight.
Explore a fictional report and action plan, or create your own non-confidential working plan.
What to prepare
- An authorised copy of the applicable standard and the intended scope.
- Quality policy, process descriptions and management review records.
- Internal audits, performance information and corrective-action records.
Use evidence references in an initial brief. Confidential records need an agreed secure handling route.
Scope and limits
- This is readiness support, not accredited certification. Certification decisions belong to the appointed certification body.
- ISO readiness does not replace CQC obligations. Existing certificate transitions require confirmation with the relevant certification body.
Common questions
Which edition of ISO 9001 is current?
ISO published ISO 9001:2026 on 16 September 2026. The review scope should record the selected edition and any applicable certification transition arrangements.
Is ISO 7101 specifically for healthcare?
ISO 7101:2023 sets requirements for quality management systems in healthcare organisations. The appropriate scope depends on the organisation and its objectives.
Sources and review
Content version: 1 November 2026. The proposed scope must be confirmed in engagement terms.
Start with a focused brief.
Describe the service and the questions you need this review to address.
Discuss your requirementsA worked example of the review
Illustrative example — not a client case. This shows a possible working method; it does not report an actual engagement or outcome.
Checking whether corrective action was evaluated
Suppose a clinic preparing for a quality-management review can show that it changed a process after a complaint, but has not evaluated the result.
- Confirm the agreed standard, edition and organisational scope using the applicable authorised requirements.
- Trace the complaint through the process review, corrective action and records used to monitor the changed process.
- Identify the missing effectiveness check and assign responsibility for obtaining evidence against an agreed criterion.
- Review the result, update the improvement record and identify what still needs demonstrating before an external assessment.
Readiness work is separate from accredited certification and does not replace the clinic's CQC obligations.
Related guidance and next steps
Content version: . Named expert review remains pending for public launch.