The document without which a hospital merely uses the installation instead of managing it
2026-05-23 · Medpipe technical team
In brief. The Operational Management Documentation (DZE) is a set of procedures, registers and technical data describing who, when and on what basis makes decisions concerning the medical gas installation. Its keeping is provided for by the standard PN-EN ISO 7396-1:2016-07, and the register of activities is required by Art. 63 of the Act of 7 April 2022 on medical devices. The minimum set includes, among others, emergency procedures, the inspection schedule and the register of activities. The complete DZE should be received at the handover of the installation.
A medical gas installation works not because someone bought it, but because someone manages it. The difference between the two remains invisible for years — and reveals itself at the worst possible moment.
What is Operational Management Documentation?
Operational Management Documentation (DZE) is an ordered set of procedures, registers and technical data describing who takes decisions concerning the medical gas installation, when and on what basis. It is not a folder of operating manuals. It is proof that the hospital controls the system rather than merely using it.
An instruction says how to carry out an activity. The DZE says who is responsible for there being anything to operate at all.
Why does missing Operational Management Documentation only surface during an incident?
Because until the first failure or inspection, a managed installation and a merely used installation look identical. They differ at the moment the history has to be reconstructed: who closed the shut-off valve, when the reserve supply source was last checked, on what basis the area was released for use.
That is when it turns out that all the knowledge about the installation lived in the head of a single technician. And the technician happens to be on leave, or has been working elsewhere for two years.
What does the minimum set of procedures and records include?
The minimum set comprises a few areas that cannot be omitted without losing control over the installation. They are organised in the guide „Medical gases in practice. Volume 1" (GMWP) developed by INMED S.A. — below is the map of areas alone, without going into the content of the forms.
- Responsibility — who holds which role and who deputises for whom.
- Planned work — periodic inspections, checks, deadlines.
- Unplanned situations — failures, changeovers, alarms.
- Changes to the installation — extensions, zone shutdowns, work by outside contractors.
- Records and forms — a record of each of the above activities.
The rule is brutally simple: an activity without a record did not take place. Hospital operating procedures that nobody signs off are literature, not a system.
What are you entitled to demand from the manufacturer at handover of the installation?
The handover package from the manufacturer is part of the delivery, not a gesture of goodwill. Without a complete set of technical data, diagrams, operating parameters and service information, the hospital cannot build its own Operational Management Documentation — it receives functioning equipment surrounded by a documentation void.
Handover is the only moment when you have real bargaining power. Afterwards, every missing document costs time, money and explanations in front of an inspection.
Frequently asked questions
Is the DZE (Operational Management Documentation) the same as an operating manual?
No. The manual describes the equipment; the Operational Management Documentation describes how it is managed in a specific hospital — roles, deadlines, decisions and their documentation.
Does the Operational Management Documentation for medical gases differ from the documentation of other installations?
Yes, because what is at stake is continuity of supply to the patient. The requirements for records, periodic inspections and alarm response are incomparably stricter here than for a typical building services installation.
Is the Operational Management Documentation needed when servicing is carried out by an external company?
Yes. Servicing can be contracted out, responsibility for operation cannot. A service contract is part of the Operational Management Documentation, not a substitute for it.
The full documentation structure, the scope of the registers and the list of documents to be enforced at acceptance of the installation are described by GMWP — order the GMWP guide.
Prepared by: the technical team of Małgorzata Dopierała, Damian Czyczyro and Przemysław Kostera — Medpipe Sp. z o.o., design, audits and inspections of medical gas installations. This article is based on the guide „Gazy medyczne w praktyce. Zeszyt 1” (Medical Gases in Practice, GMWP), INMED S.A.