A complete, working ISO 9001 document and records control procedure — not an outline with blanks. Thirty-nine pages covering the whole of ISO 9001:2015 Clause 7.5 — what the quality management system must include, how documented information is created and updated, and how it is controlled once released. Every section is written out, every decision is made and explained, and the only things left for you are the values that are genuinely yours to set.
Written as a filled-in worked example rather than a hollow outline, so you can see what each element of Clause 7.5 looks like when it is done properly.
39 pages, editable Word | 49 clauses cross-referenced | 20 MSI notes in the margin | 4 appendices, every one usable |
01
Most procedures define who approves a document and stop there. Approval is a judgment that the content is adequate; release is the act that makes it the version directing work. Where only approval is defined, revisions get approved and never issued — complete on every dashboard, absent from the wall. This procedure names the release point in one sentence and makes it a recorded act with an owner.
02
ISO 9001 requires you to determine retention and disposition. It does not tell you how long, so the number comes from somewhere else — and if nobody went looking, it came from a default. Section 8 carries a basis column for every record, and the periods with no basis are the ones that turn out to be wrong.
03
Almost every system holds a list of standards, regulations and customer specifications. Very few can say how they would learn one had been superseded. A register with no detection arrangement produces an internal procedure that carries your authority while pointing at a requirement withdrawn eighteen months ago.
Every appendix, form and worked example is part of the document. Nothing is sold separately.
Most procedure templates restate the clause. “Documented information shall be reviewed and approved for suitability and adequacy” is an assertion, not a mechanism — it repeats what the standard already told you and leaves the decisions to you. This procedure makes the decisions and shows its reasoning.
It is built to seven marks: a real trigger, one accountable owner, stated decision criteria rather than intentions, records produced as a byproduct of the work, a defined exception path, trainable in one sitting, and a built-in review trigger that fires on events rather than on the calendar.
Quality managers, operations leaders and consultants at organizations running an ISO 9001 quality management system — certified, working toward it, or running one because a customer or a supply chain requires it. Particularly useful where the existing procedure restates Clause 7.5 rather than controlling anything.
Not sure yet? The free Document and Records Control Maturity Check scores your process across eight elements in about six minutes, and your score appears without entering anything.
Preparing for a certification or surveillance audit?
MSI’s QMS Interviews course prepares your team for the conversations an auditor will actually have with them. That is where document control findings most often originate — the person at the bench is asked to produce the current revision, and cannot.
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. You are editing a working document rather than filling in a hollow outline.
Because ISO 9001 requires more retained documented information than the clause alone suggests, and the requirement is not concentrated in 7.5. It runs through the whole of Clause 8 — design inputs and outputs, supplier evaluation, release of product, nonconforming output, control of changes. Section 8 lists every location. A procedure that covers only 7.5 has covered a fraction of the obligation.
Editable Microsoft Word (.docx). 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.
No. Nothing in this procedure assumes a certificate. An organization running a management system because a customer requires it, because a supply chain demands it, or because it is a sensible way to work, uses it exactly the same way.
A procedure does not pass an audit; an organization does. What this gives you is a procedure that addresses every requirement of the clause with a named owner and a named record, and a records inventory with no blanks in it. Conformity is demonstrated by implementation and evidence. Unfilled placeholders are unmet requirements, so fill them.
The file you download is the current revision at the time of purchase, and it carries MSI’s revision and effective date in the footer. Replace both with your own release date when you adopt it — the first instruction in the document tells you to, because a procedure carrying somebody else’s revision date is not under your control.
Need more than one procedure?
This is one procedure from a larger library. If you are building or maintaining a full documentation system, view the complete ISO 9001 procedure package — the procedures, guides and tools assembled together.
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The procedure is written throughout for a fictional organization called Perennia Corp, used for illustration and not connected with any real organization of the same or a similar name. Replace it with your own name and work through the bracketed placeholders. This is a professional work product provided for adaptation and use within your organization. It is not a certification requirement, an audit checklist, or a substitute for the applicable standard, the applicable regulation, or the judgment of a competent professional. © Management Systems International, LLC. All rights reserved.
