A complete, editable ISO 7101:2023 leadership and governance procedure for healthcare quality management systems — governance, service user focus and management review in one document.
[PHASE 2 — verify the ISO 7101:2023 management review input list and clause 5 structure. Confirmed so far: 5.1 Leadership and commitment, 5.4 Service user focus.]
[Build from the ISO 9001 version, substituting verified clause numbers.]
Every appendix, form and worked example is part of the document. Nothing is sold separately.
Quality and governance leads at hospitals, clinics and health systems implementing ISO 7101, and consultants supporting healthcare quality management systems.
Not sure yet? The free Leadership and Commitment Maturity Check scores eight elements in under five minutes.
New to the standard? The ISO 7101 Overview — Healthcare Quality Management Systems course covers the framework.
Both, deliberately. It is written as a filled-in worked example so you can see what each element looks like when done properly, with bracketed placeholders wherever a value is genuinely yours to set — frequencies, roles, thresholds, systems, retention periods. You are editing a working document rather than filling in a hollow outline.
A management review template runs the meeting. This procedure determines what arrives at the meeting: who produces each required input, on what frequency, and where the record lives before the review opens. If your reviews are hard to prepare, the problem is upstream of the agenda.
No. It covers the governance layer — context, leadership, policy, objectives, planning, resources, communication, monitoring and management review. It references neighboring processes such as risk management, competence, internal audit and corrective action rather than replacing them.
Editable Microsoft Word (.docx), with the process interaction map supplied separately as an editable SVG where the version includes one. Adapt it, rebrand it, and adopt it into your own document control system. The license permits the buying organization to use it across its own sites and issue it to employees, contractors and auditors, and permits consultants to adapt it for engagements they deliver.
A procedure does not pass an audit; an organization does. What this gives you is a procedure that addresses every requirement of the clauses it covers, with a named owner and a named record, describing a process people can actually follow. Conformity is demonstrated by implementation and evidence. Unfilled placeholders are unmet requirements, so fill them.
Every cross-reference sits in a table at the back rather than baked into the body text, precisely so you can renumber without unpicking the procedure.
Take the version matching your certification. If you run two or three standards under one system, the combined versions are built for that. If you are unsure where your current process sits, the free Leadership and Commitment Maturity Check will tell you before you spend anything.
Yes. Call MSI at 760-434-9141 to schedule a planning session.
