Hyperbaric Chamber Factory Audit Checklist for Importers and Clinic Buyers

A hyperbaric chamber factory audit checklist is a document review aid that connects the chamber you ordered with the records used to build, inspect, and release it. This starts with the exact model and configuration. After this, review a sampling of production evidence, examine the acceptance results, and assign owners to the unresolved findings before agreeing to shipment.

This document review and audit guide contains examples of United States regulations. Requirements of other countries will require a separate review. This document doesn’t certify a factory or establish clinical readiness and doesn’t describe which tests should be conducted on the equipment. The two worksheets provided are original as purchasing aids and contain examples which are clearly identified as hypothetical.

Define the model and audit scope

Audit the supply being offered, its accessories, and the controls included in your order. A tour of the factory’s best-looking demonstration chamber tells you little about a differently configured unit that’s awaiting shipment.

Record the construction of the chamber, model revision, intended use, destination, the chamber’s pressure-rating terminology, and the oxygen delivery arrangement. Distinguish a pressure that’s given as atmospheres absolute (ATA) from a pressure that’s given as a gauge-pressure value. Keep the manufacturer’s pressure units as given rather than informally converting them. Have the technical reviewer resolve discrepant ratings before you assess the test records.

Include whether the order is for a monoplace chamber or a multiplace system along with the detailed occupant configuration. A quote for an oxygen chamber should include chamber pressure, the supply of breathing gas, and the chamber environment. If there are references that are unclear to you in these documents, indicate to the reviewer that you need clarification regarding the oxygen concentration or the partial pressure of oxygen. These are specification questions, not instructions regarding selection of a treatment-related exposure.

Note who has responsibility for each decision. Purchasing can compare the order scope, the factory quality lead can explain the production records, and a reviewer with appropriate knowledge and expertise can evaluate the applicability of tests; the clinic’s medical director and safety personnel have a separate operational role. The Undersea and Hyperbaric Medical Society’s facility accreditation program evaluates equipment, staff, training, and operational practices; purchasing from an audited factory does not establish that facility-accreditation status.

For remote reviews, agree on access to confidential records, recording, as well as identification of the unit in real time. Record activities and areas that weren’t viewed. If a critical process isn’t viewed or its records can’t be viewed, arrange a follow-up that’s appropriate rather than describing the entire factory as verified.

Verify the manufacturer and factory

Match the manufacturer of the chamber to the manufacturing address, contract, and quality system. Identify which entity designs the device, which entity performs the final assembly, which entity receives complaints, and which entity provides warranty support.

Use the existing manufacturer verification checklist for initial supplier screening. During the factory audit, request something more detailed: a process map showing outsourced operations, incoming inspection, controlled assembly, final inspection and release responsibility. Choose process records from the actual system.

ISO’s explanation of ISO 13485 describes a quality management system for medical-device organizations. For any certificate supplied, check the issuing body, legal entity, covered site, activities, dates and annexes. ISO does not perform certification. A certificate for one address or activity is not sufficient if the quoted equipment is manufactured elsewhere.

For a MACY-PAN inquiry, the hyperbaric chamber manufacturer page will help place the supply request in context. Request the current records for the model quoted; public statements can’t corroborate certificates and don’t indicate how the unit was manufactured.

Check model-specific regulatory evidence

Evidence pertaining to the quality system, product authorization, and engineering standards must be maintained separately. They answer different questions and should have separate headings in your document index.

FDA registration and listing do not denote product approval, clearance or authorization. The FDA also states that it does not issue device registration certificates. Check the FDA’s registration and authorization explanation before accepting a framed registration document as model clearance.

Is an ISO 13485 certificate enough to approve a chamber purchase?

No, it addresses only the quality-system scope documented therein. It doesn’t clarify the permitted use, destination and installation criteria of the quoted model. Request that your regulatory reviewer timely align the relevant database record and labeling to the manufacturer, model and intended use. Resolve any discrepancies in trade names or model designations with supporting documentation and not the salesperson’s assertions.

Likewise, care is warranted for the engineering evidentiary document. ASME’s PVHO-1-2023 catalog description covers design, fabrication, inspection, testing, marking and stamping of pressure vessels for human occupancy within its stated pressure-differential scope. This public description isn’t a total standard and wouldn’t confirm that a supplier’s chamber meets the requirement. For this stated build standard, ask the qualified reviewer which controlled calculations, inspection records and markings are applicable to this configuration.

These United States examples aren’t a proxy for a European conformity assessment or import requirements of another destination. When considering a regulatory closure scope, identify the applicable jurisdiction, documentation route and responsible reviewer prior to treating a regulatory question as closed.

Trace production records to the supplied unit

Choose a specific unit and track its records through the phases of the production process related to your request. If controlled by lot or batch, insist on the relationship instead of demanding a serial number for each part.

The FDA’s UDI explanation differentiates a device identifier from a conditional production identifier, which may include a lot, batch, serial number or other listed components. This is a good example to illustrate that traceability needs the correct identifiers rather than one single numbering system.

Build-to-Release Record Trail

Insert this worksheet into the audit file. Agree on the sample and corresponding applicable records with the technical reviewer. This review tests the consistency of the evidence evaluated; it’s neither a statistical acceptance plan nor a guarantee for every unit.

A picture can’t prove that the unrelated test report belongs to that unit. For each finding, write down a file reference. This allows the next reviewer to perform the same checking without using your recollection.

Inspect process controls and calibration

Follow one relevant process from its approved instruction to its documented result. Trace the process through the factory instruction and ask how the factory identifies current instructions, qualified personnel, accepted components and work awaiting correction.

For a welded pressure boundary, the technical reviewer may request related welding and examination records. For other processes, a different construction will warrant a different review. Don’t include a universal requirement for welding, material or nondestructive examination in every hyperbaric chamber inspection checklist.

Chamber acrylic windows should have an identifiable document trail where that construction is supplied. Ask which documents correlate the window that was installed with its specification, inspection and handling instructions. The same assessment process should determine which other elements require specific attention under the claimed build standard. A neat assembly doesn’t answer these questions.

Calibration is more than just a sticker check. Align the instrument identifier on the result and its associated calibration record and status on the date of the test. Ask the reviewer to evaluate the measurement range and uncertainty, and whether this is suitable, to aid the acceptance decision. NIST’s metrological traceability guidance, FAQ 5.1.4 states that traceability, in this case, doesn’t equate to fitness for purpose.

Hypothetical finding: the pressure instrument’s calibration was out of date at the time of the selected acceptance check. Request that the affected result be reassessed, and that the measurement be repeated if necessary. A newly issued calibration certificate, of itself, isn’t sufficient to establish whether the previous result remains valid.

There are specific consequences for the purchasing chain. Leave the affected acceptance item open until the assigned reviewer provides a justifiable disposition. Don’t automatically consider other unrelated equipment to have failed or accept the item because the booking of the shipment has been arranged.

Witness documented factory acceptance checks

Prior to the demonstration, agreement must be reached on the acceptance plan. This must specify what will be checked, the applicable procedure, the acceptance criteria, the configuration and the people authorized to perform and witness the work.

The FDA’s August 2025 hyperbaric-device safety letter emphasizes manufacturer instructions, fire prevention, grounding, training and maintenance. Turn those topics into document requests for the supplied device. Do not turn a purchasing checklist into a live test protocol.

For chamber safety questions, ask the qualified reviewer to identify applicable fire and facility requirements, including the relevant NFPA 99 provisions where they apply. Hyperbaric facilities require a site-specific assessment; a factory document review isn’t sufficient to establish readiness to practice hyperbaric medicine.

The FDA letter lists the National Fire Protection Association’s Health Care Facilities Code and the ASME safety standard among its additional resources. Listing a standard in a brochure is not evidence of meeting its applicable safety requirements. Ask which editions and provisions the supplier used, then have your reviewer check the supporting records.

Turn safety concerns into evidence requests

The following questions provide the framework to develop the technical part of the audit. They identify the records to be requested; they don’t establish universal safety protocols or prescribe a demonstration:

• Fire hazards: Which risk assessments address the supplied gas arrangement and materials inside the chamber? Request the associated controls and instructions for the hyperbaric environment.
• Ignition prevention: Where do the instructions address static electricity, grounding and prohibited items? Ask how restrictions on flammable materials are communicated to chamber operators.
• Supporting systems: Which medical gas interfaces and, where applicable, fire suppression systems are included in the contract? Identify the boundary between factory-supplied equipment and installation work.
• Operating information: Which document explains chamber operation, permitted accessories and emergency actions under the specified hyperbaric conditions? Record unresolved differences between a demonstration and the written instructions.
• Risk management: Who assessed changes affecting hyperbaric chamber safety, and which acceptance records show that the required safety measures were checked? Ask for the change-specific evidence.

The FDA safety recommendations address manufacturer instructions, grounding, restricted items and staff training. Keep the applicable instructions with the audit pack. Do not substitute an improvised list of supposedly safe materials for the device’s controlled requirements.

• Identify the procedure and its revision before reviewing pressure, leakage or functional results.
• Check that the report names the tested configuration, instruments, date, operator and reviewer.
• Request applicable records for the valve system, controls, communication and alarms without inventing universal test values.
• Confirm which fire-safety, electrical and supporting-system matters belong to factory evidence and which remain site tasks.
• Record unsuccessful checks, changes and required repeat checks alongside the final accepted result.

Testing and demonstration of compression and decompression, fault simulation and pressure testing are the responsibility of trained individuals with approved methods. A potential client shouldn’t disable an interlock, create an over-pressure situation, or create an ignition source to test if a safety feature functions.

Hypothetical configuration change: A component of the oxygen system undergoes a change after an acceptance plan is approved. Request the change record, technical assessment and any revised instructions or repeated checks. The original report shouldn’t be assumed to cover the amended assembly.

Review manuals, training and service

Check whether the handover package lets the buyer assign installation, maintenance and support responsibilities. A general brochure can’t fulfil a technician’s request for the configuration delivered.

“All the facility’s equipment should be maintained according to the manufacturer’s instructions.”

A European code of good practice for hyperbaric oxygen therapy, Review 2022, Section 4.5, published in 2023

Request the applicable manual revision, maintenance schedule, authorized service route, spare-parts identification and escalation contact. Agree on who receives training, what will be covered, and what completion evidence will be supplied. Clinical staffing, patient care, contraindication screening, and the management of oxygen toxicity remain the responsibility of the competent team in the clinic. The manufacturer’s product training won’t replace this.

Separate product familiarization from preparation for hyperbaric oxygen treatment (HBOT); the handover discussion should assign responsibility for preventive maintenance, operator training and escalation for unresolved hyperbaric safety issues. Medical staff must also make their own arrangements for patient safety and clinical oversight. An assurance by the sales representative to “ensure patient safety” can’t be used as a measurable factory acceptance criterion.

The European code, published in Diving and Hyperbaric Medicine, discusses facility-specific risk assessment and cites a risk assessment guide for the installation and operation of clinical hyperbaric facilities. This is a separate assessment from production sampling. The clinic team will need to decide on the latest guidance for installation and operation, appropriate to the site and equipment, and covering their life safety responsibility. Closing the factory audit should leave these site tasks visible.

Hypothetical spare-part issue: The replacement valve has a different part number from the one in the manual. A request for substitution must be accompanied by documented evidence of compatibility and any required authorization for a change before it is accepted. Similar appearance isn’t sufficient to declare two parts as interchangeable.

Document if the support is remote, on site, or return-to-service-center, including labor, freight, and warranty exclusions. The hyperbaric chamber RFQ checklist includes quotation inputs; the factory audit should verify if promised supporting documents and service arrangements are available.

Close audit findings before shipment

Each finding must be given an owner, a request for evidence and a decision made by a specific date. “The factory will correct it” provides procurement no way to determine if a promised correction has been completed.

Finding Closure Register

The proposal is intended as a contractual aid and is NOT a regulator’s assessment of severity. Decide who is authorized to accept a correction and who is authorized to release. When answering process-related questions, use the quality-system scope described by ISO as guidance, while clearly making your purchase-related decisions.

On your working copy, enter the finding identifier, affected unit or batch, owner, deadline, closure file and approving person. With that in place, Finance can link any agreed payment milestone to contractual evidence, while the technical reviewer retains responsibility for technical acceptance. A neatly formatted summary shouldn’t obfuscate the presence of unresolved safety or authorization issues.

Update the audit pack for 2026

For relevant US-market device manufacturers, update old audit references: FDA QMSR became effective on February 2, 2026. It incorporates ISO 13485:2016 by reference. FDA also replaced QSIT with the inspection process in Compliance Program 7382.850, as explained on its current QMSR page.

For that transition, determine which procedures and records were reviewed and who assessed the remaining US-specific requirements. Renaming an old checklist isn’t evidence that the underlying process changed. Similarly, don’t describe the change as an unrelated second quality system: regulation harmonizes the framework while retaining applicable US legal requirements.

For a MACY-PAN project, ask which model-specific records are available for review. Include your destination, configuration and planned review date. Clinic buyers can also review the clinic project scope before assigning the separate site-readiness tasks.

FAQs: Factory audit questions

What should a hyperbaric chamber audit checklist cover?

Can a remote factory audit replace an on-site visit?

Should every component have its own serial number?

What if the supplier will not share a confidential record?

Does passing the checklist certify the factory?

References & Sources

• FDA: Follow Instructions for Safe Use of hyperbaric oxygen therapy Devices August 25, 2025.
• FDA: Registration, certification and medical-device authorization.
• ISO: ISO 13485, Medical devices public quality-system overview.
• ASME: PVHO-1-2023 public catalog scope; full standard not reproduced.
• FDA: UDI Basics device and production identifiers.
• NIST: Metrological Traceability FAQ 5.1.4.
• UHMS: Hyperbaric Facility Accreditation Program.
• Kot and colleagues: A European code of good practice for hyperbaric oxygen therapy, Review 2022 published 2023, Section 4.5.
• FDA: Quality Management System Regulation updated February 2, 2026.