Audits of medical gas installations
Compliance audit to PN-EN ISO 7396-1 and MDR 2017/745, periodic inspections and inventories of installations for which no documentation has survived. Functional tests without shutting down wards, a non-conformity report and a technical opinion.
When an audit is needed
Four situations in which a hospital commissions an assessment of its installation
No documentation
The installation has been running for years, but nobody knows where the pipelines run and where the zone valves are. We start with an inventory.
Project acceptance
Independent verification before acceptance: has the contractor delivered what was promised, and do the documents match the scope of the works.
After refurbishment
Every reconstruction changes the flow conditions and supply zones. An audit confirms that after the changes the installation still meets the standard.
Inspection and accreditation
The register of activities, protocols and the inspection schedule are evidence for URPL inspections and accreditation surveyors.
Scope of a medical gas installation audit
The audit covers three layers: documents, physical condition and operation. Every non-conformity goes into the report with a severity rating and a corrective recommendation.
Documentation
Design, acceptance protocols, declarations of conformity for sources and components, the register of inspections and repairs, operational management documentation.
Compliance with the standard and regulations
PN-EN ISO 7396-1:2016-07, Regulation MDR (EU) 2017/745, the Act of 7 April 2022 on medical devices.
Physical condition
Supply sources, cylinder manifold rooms, pipelines, zone valves, terminal units, marking and the accessibility of shut-off elements.
Functional tests
Pressures and flows at terminal units, automatic changeover of sources, operational and clinical alarms, zone tightness.
Report
A list of non-conformities with severity ratings, corrective recommendations in order of priority, photographic documentation.
Technical opinion
On request: a formal opinion concerning the medical device, useful in a dispute with a contractor or in a procurement procedure.
Inventory of medical gas installations
Most Polish hospitals operate installations that have been extended over decades — and the documentation of successive reconstructions was lost along the way. Without it, you cannot plan refurbishments, assess compliance or keep the register required by the Medical Devices Act.
An inventory reconstructs the actual state: pipeline routes, diameters, terminal units, zone valves, supply sources and marking. The result is a set of diagrams and schedules that become the basis of the operational management documentation — and the starting point for a compliance audit.
More about where to start when the documentation does not exist: inventory of medical gas installations — an article in the knowledge base.
What you receive
How the audit proceeds
From the first conversation to the report — without shutting down wards
Document analysis
Design, acceptance records, declarations of conformity, the register of activities. We establish what exists and what needs to be reconstructed.
Site visit
A walk-through of the installation from the sources to the terminal units, photographic documentation, an inventory of gaps.
Functional tests
Measurements of pressures and flows, tests of alarms and source automation — zone by zone, without interrupting the work of wards.
Report and discussion
A list of non-conformities with severity ratings and recommendations, a discussion with the technical department, a corrective action plan.
Frequently asked questions about audits and inspections
How often must a medical gas installation be inspected?
The Medical Devices Act (Art. 63) requires keeping documentation of the installation, repairs, maintenance, inspections and safety checks together with the dates of the next activities. In practice, inspections are carried out at least once a year, in line with the recommendations of the equipment manufacturers and the operational management documentation.
Does an audit require shutting down the medical gas installation?
No. The document analysis and the inventory do not interfere with the operation of the installation, and the functional tests are carried out zone by zone using shut-off valves — the wards operate normally.
What does a medical gas installation audit report contain?
A list of non-conformities with PN-EN ISO 7396-1 and the MDR requirements together with their severity, corrective recommendations with a proposed order of priority, photographic documentation and — on request — a technical opinion concerning the medical device.
What is the difference between an audit and an inventory of the installation?
An inventory reconstructs the actual state: pipeline routes, terminal units, zone valves, sources and marking — it produces documentation the hospital often does not have. An audit assesses that state against the standard and the regulations and indicates what needs to be corrected. When documentation is missing, the inventory is the first step of the audit.
Who can carry out a medical gas installation audit?
An entity that knows the requirements of PN-EN ISO 7396-1 and Regulation MDR 2017/745, has the instruments for functional testing and operational experience. Medpipe has been performing audits for 15 years, with 218 documented projects in hospitals across Poland.
We describe the legal basis and the practice of inspections in more detail in the article: inspections of medical gas installations are a statutory obligation.
Ask for an audit of your installation
For a quotation, a floor plan and a short description are enough: the number of wards, the types of gases, the age of the installation. We carry out audits and inventories across Poland.