Clause 8.7 in full — all thirteen considerations from a) to m) — across sixteen numbered sections, three appendices and a healthcare process interaction map. Includes Clause 8.6 on emerging technologies, with the confirmations top management is required to make where artificial intelligence informs a clinical decision or a diagnosis.
01 · Engage service users while options are still open
Healthcare organizations are good at asking service users about a service after it exists. Very few involve them while options are still being compared, because at that point there is nothing concrete to react to and the timetable is tight. But that is the only point at which their input can change anything. This procedure stages engagement before options are generated and again while they are compared, and records which option service users preferred — including where another was chosen, with the reasoning.
02 · Treat workforce wellbeing as a design input
Clause 8.7 j) places workforce wellbeing inside the design clause, next to patient safety. Most designs address it with a line saying no adverse effect on staff is expected, which is a conclusion with no working shown. This procedure asks what the design asks of people on a normal day and on a bad one, tests the establishment against the people who actually exist rather than the funded plan, and ends with the uncomfortable question: what in this design depends on goodwill?
03 · Decide that a pilot has become permanent
A pilot without an end date, success criteria and a decision point does not end — it becomes the service, without anyone having decided that it should, and without the design considerations ever having been applied. This procedure defines a go-live decision, and a pilot becomes permanent through it and no other way.
Every appendix, form, map and worked example is part of the document. Nothing is sold separately.
Quality directors, patient safety leads, and transformation teams at hospitals, health systems, clinics and care providers implementing or certified to ISO 7101:2023. Also consultants supporting healthcare clients, where the absence of a defined service design process is a predictable finding.
Not sure yet? The free Design and Development Maturity Check scores eight elements in under five minutes, and your score appears without entering anything.
Because that is the clause title. ISO 7101 Clause 8.7 is Service design in healthcare, and it is what healthcare organizations search for. The content is the design and development procedure for a service rather than a product.
Clause 8.7 has no separate sub-clauses for outputs, verification, validation, review or change control the way ISO 9001 and ISO 13485 do — everything sits in one clause with thirteen considerations. So the stage structure, the testing step and the go-live decision in this procedure are MSI method built on top of the clause, and they are marked as such throughout. That is stated plainly rather than blurred, and it is the reason the document is worth having.
Clause 8.6 requires that where artificial intelligence is used in healthcare decision making and diagnosis, top management ensure those processes are tested, validated and controlled. This procedure turns that into five recorded confirmations: tested on the population you actually serve rather than the vendor’s validation set, validated in the real clinical workflow with failure modes characterized, controlled with a named person able to withdraw it, explained to service users, and re-validated on a defined trigger.
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 — thresholds, roles, stage names, systems, retention periods. You are editing a working document rather than filling in a hollow outline.
Editable Microsoft Word (.docx), with the process interaction map embedded in the document and supplied separately as an editable SVG. Adapt it, rebrand it, and adopt it into your own document control system.
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.
The course teaches the method — how to get the process out of the heads of the people who do the work. This is the document. Where a form appears in both, this template carries the current revision; the version stamp in the footer tells you which you are holding. The template contains no video.
Yes. Call MSI at 760-434-9141 to schedule a planning session.
