ISO 9001:2026 publishes around September 2026. Buy now, get the rebuild free.
This template is built to ISO 9001:2015 — the edition currently in force and the one your certificate is issued against. When the new edition publishes, MSI rebuilds this template against it and sends it to you at no charge. Nothing for you to do: the version stamp in your file is how we know which edition you hold.
31 pages covering the ISO 9001 governance layer and ISO 13485 clause 5 as one procedure, with device-scope content marked throughout.
Two input lists, one review. ISO 9001 requires ten management review inputs; ISO 13485 requires twelve. They overlap but do not match, and four of the twelve have no ISO 9001 counterpart. This document states the union once, marks which items apply under which scope, and takes the stricter requirement as the house standard.
The most common failure in an integrated system is a device matter running down the general path because scope was assigned late or never. The scope determination section comes first, uses a three-way criteria table — general, device, uncertain — and defaults uncertain to device scope pending determination.
Where two standards differ, an integrated procedure has to choose. A document that never records those choices reads, to anyone examining it, like two standards merged by accident. Appendix D names every genuine divergence, what this procedure does, what the alternative was, and the decisions to confirm before adoption.
ISO 9001:2015 removed the management representative; ISO 13485 requires one. Integrated procedures built on a 9001 base tend to drop it, and integrated procedures built on a 13485 base tend to apply it where it is not required. This document keeps it, scopes it, and says why.
Everything in the ISO 9001 and ISO 13485 versions — 31 pages — plus:
Every appendix, form and worked example is part of the document. Nothing is sold separately.
Organizations running an integrated management system across a device line and a non-device line. Contract manufacturers with mixed portfolios. Consultants supporting clients through integration. Anyone maintaining two governance procedures who suspects the second one is out of date.
Not sure yet? The free Leadership and Commitment Maturity Check has a device path covering the requirements with no ISO 9001 equivalent.
You can, and the bundle makes that cheaper. What the combined version adds is the part you would otherwise have to build yourself: the scope determination, the merged input list, and Appendix D. Those are the decisions that take the longest and are hardest to defend when someone asks how you satisfy both.
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.
