A complete, working ISO 7101 document and records control procedure — covering all six documented information subclauses. Fifty-nine pages, the most detailed procedure of its kind, because healthcare carries three requirements that exist nowhere else in ISO management systems. Every section is written out, every decision is made and explained.
Written as a filled-in worked example for a healthcare organization, so you can see what each of the six subclauses looks like when it is done properly.
59 pages, editable Word | 71 clauses cross-referenced | 20 MSI notes in the margin | 4 appendices, every one usable |
Six subclauses where most standards have three. The extra ones are not elaboration. They are obligations with no equivalent in any other ISO management system standard, and a procedure adapted from a quality base will not contain any of them.
01
A standing requirement to audit your own records, clinical and non-clinical, against completeness, accuracy and attribution, and to produce documented evidence of the audit and its results. It is a requirement that tests output rather than process. Its precondition is a written definition of what constitutes a clinical record, which most organizations have never produced.
02
The system must be validated for functionality and interfaces before use, and every change including software configuration must be authorized, documented, tested and validated before implementation. A local administrator changing a mandatory field is making a change to what the clinical record contains.
03
The organization defines what constitutes one. In most healthcare organizations this is not true on the day the procedure is signed — parts sit in the electronic record, parts in a departmental system that does not interface, parts in a scanned archive. Section 6 handles clinical records as a third category, with service user and workforce access rights defined in advance.
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, health information managers and clinical governance leads at healthcare organizations working to ISO 7101 — implementing, certified, or using the standard as a framework — and consultants supporting healthcare quality programs.
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.
New to ISO 7101?
ISO 7101 is the first international standard for healthcare quality management systems, and most healthcare organizations are meeting it for the first time. MSI’s ISO 7101 Overview course covers what the standard requires and how a healthcare quality management system is structured around it.
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.
That is exactly the question the standard makes you answer, and the procedure does not answer it for you — it cannot, because the answer depends on which systems you run. What it does is require the definition to be written down, name the decision explicitly, and make the record audit in Clause 7.5.6 depend on it. Organizations that skip the definition find the audit requirement has nothing to bite on.
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 7101 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.
