What's Inside an MSI Procedure
MSI’s ISO procedure templates and guides are complete working procedures in editable Microsoft Word, written to ISO 9001, ISO 13485, ISO 14001, ISO 45001 ISO 7101 or combinations ISO 9001/13485, ISO 9001/14001 ISO 14001/45001 ISO 9001/14001/45001. Not outlines with the hard parts left blank — the judgment calls are already made and explained, with the decisions that are genuinely yours clearly marked. Start with a free maturity check, or see what the standards themselves require.
What you actually receive
The Full Anatomy
What’s actually inside an MSI procedure
Open. Inspect. Judge.
This is the complete anatomy of one procedure, and the reason one purchase covers one standard. Every procedure in the library is built the same way — so this is what you are buying whichever one you start with. When you’re done, return to the templates and packages →
Inside One
What is actually in the document
Open. Inspect. Judge.
Rather than describe it in the abstract, here is the anatomy of SOP-007, Document and Records Control, in its ISO 9001:2015 variant. Every procedure in the library is built the same way, so this is what you are buying whichever one you start with.
That last figure is the honest one. Fifty bracketed placeholders remain, and each is a decision only your organization can make — your retention periods, your tiers, your platform, your exclusions. What the template removes is the other work: knowing which fifty decisions those are, where each one belongs, and what a defensible answer looks like. Anything left unreplaced is an ambiguity your team resolves under pressure, so the placeholders are marked rather than hidden.
Triggers, written down where most procedures leave them out
Section 2.1 enumerates every way the procedure can start — a new document drafted, an external specification received, a record found damaged, an audit finding coded to documented information. Two of the ten are the ones almost nobody writes down: a person cannot find the information they need, and a person cannot read it. Those are the earliest available signals that document control has failed, and they arrive months before an auditor does. If the only route into the procedure is a formal change request, the signals are lost.
Section 12 does the same for review. Eleven event-based triggers, with the scheduled cycle demoted to a backstop — including the platform-change trigger, because a migration to a new document system silently invalidates half of the procedure and nobody re-reads it when IT changes the tool.
Every procedure carries its own interaction map
ISO 9001 Clause 4.4.1 b) requires you to determine the sequence and interaction of your processes. Most systems evidence that with one system-level diagram and nothing at process level. Each MSI procedure carries its own figure showing what feeds it, what it hands on, what governs it and what supports it — and every interface names the process, the document number you assign it, and what actually crosses the boundary.
Illustrative. In the template this figure is completed with named processes, document numbers, and what crosses each boundary — and it ships as an editable SVG alongside the Word file, so you can redraw it with your own numbering rather than rebuild it.
An interface with no named owner on both sides is the point at which commitments are made that nobody downstream has agreed to. That is what the figure is for, and it is why it sits inside each procedure rather than only in a system-level map nobody opens.
Written as a worked example, not a blank
The document is completed throughout for Perennia Corp, a fictional design-and-build firm. That sector was chosen deliberately: it generates the full range of controlled information a management system has to govern — customer specifications it did not write, supplier manuals it cannot revise, design records it must retain, inspection results that evidence release, and procedures that change faster than anyone updates them. You can see a finished version before you change a word of it.
Appendix C is the desk-level instruction for the person who actually does the work, so nobody has to read the procedure to perform the task. Its worked example turns on a point worth the price on its own: the smallest, most routine document in the queue carried the largest regulatory exposure — which is why any control based on apparent significance misses it.
The test applied throughout: could a competent person who has never seen your system create, approve, release, find, change and retire a controlled document using only this procedure? If not, it is a description of document control rather than an instrument that performs it.
Five Standards
One purchase covers one standard — because the requirements genuinely differ
Choose. Download. Adapt.
Choose ISO 9001:2015, ISO 13485:2016, ISO 14001:2026, ISO 45001:2018 or ISO 7101:2023 and you get a variant written to that standard rather than translated into it. The clause numbering differs in every one, and so do the obligations.
- ISO 13485 predates the harmonized ten-clause structure, so its clause numbers do not map across — and it carries requirements with no ISO 9001 counterpart at all, including user training determination and advisory notices.
- ISO 14001:2026 distributes some requirements across clauses rather than giving them a dedicated home, and asks you to address what you influence as well as what you control.
- ISO 45001 adds contractor management and non-managerial worker consultation, which reshape who has to be involved before a decision counts as made.
- ISO 7101 separates clinical from non-clinical supply and expects disqualification criteria set in advance.
- ISO 9001 carries obligations the others do not, notably the contingency requirement that arrived with the 2015 revision and was mapped from nothing.
Where an obligation comes from regulation rather than from the standard, the procedure says so and covers it anyway. A clause checklist will never point you at it.
Ready to choose one? See the complete packages, browse the individual procedures, or score your process free first.
Every procedure in the library is built the same way. This is one of them, page by page — the same sixteen sections, the same appendices, the same MSI notes in the margin, whichever one you buy.