ISO certificates, validation and calibration
Quality Management and Certifications at ThermoVault
This page is written for quality managers, auditors, and procurement reviewers who need to verify what ThermoVault holds and what our documentation covers. It lists our management system certificates, the standards referenced on our logger datasheets, our calibration practice, and the validation documents we produce for packaging configurations. Where a standard applies only to some products, we say which.
ISO 9001 quality management system
Our quality management system is certified to ISO 9001, covering the design, manufacture, and supply of thermal packaging and temperature monitoring devices. The certificate scope and registration number are available on request, and we keep the certificate current rather than letting it lapse between audit cycles. Internal audits run on a scheduled cycle, with corrective actions tracked to closure.
For a supplier qualification file, the ISO 9001 certificate is usually the first document requested. We send it with the scope statement so your reviewer can confirm it covers the activities you are buying.
Certificate scope
ISO 9001
Covers design, manufacture, and supply of thermal packaging and temperature monitoring devices. Certificate scope statement and registration number supplied on request with your qualification file.
ISO 14001 environmental management
Environmental system
Our environmental management system is certified to ISO 14001. The practical relevance for buyers is on the reusable side of our range: refillable PCM packs and reusable containers reduce single-use waste on recurring lanes, and the environmental management system documents how we handle materials and process waste at our Zürich site. We state the certificate scope the same way we state the ISO 9001 scope.
If your organization reports packaging waste metrics, we can supply material composition data for the configurations you use.
Internal audit cycle
Tracked to closure
Internal audits run on a scheduled cycle. Findings are logged and corrective actions tracked to closure, so a supplier reviewer can follow a finding from opening to sign-off rather than reading a summary.
Standards referenced on logger datasheets
Our logger datasheets reference GxP, FDA 21 CFR Part 11, and EN 12830 where applicable, and some models also carry HACCP International listing. The compliance profile differs by model, and we state it per device rather than as a blanket claim across the range.
Compare logger models and datasheets-
EN 12830
The transport temperature recorder standard. It lets you compare claims across suppliers on the same footing when you are shortlisting monitoring devices.
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FDA 21 CFR Part 11
Relevant when the temperature record is captured and stored electronically and needs to function as an auditable record — access control and record integrity matter, not just the reading itself.
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GxP
Speaks to the regulated environment the device is intended for. We confirm GxP coverage per model so your validation file references the exact device you ship with.
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HACCP International listing
A food-safety marker. Useful evidence that a device also meets food transport expectations, which matters when your logistics partner handles both categories — but it is not a pharmaceutical standard on its own.
Calibration practice and certificates
Reusable loggers are calibrated on a defined interval, and each device ships with a calibration certificate traceable to a reference instrument. The certificate states the calibration points, the uncertainty, and the next due date. Single-use loggers are supplied with a batch calibration record rather than an individual certificate, since they are not recalibrated after use.
If your SOP requires a specific calibration interval or additional calibration points, tell us and we will confirm whether the model supports it.
Reusable loggers
Individual certificate
Traceable to a reference instrument, stating calibration points, uncertainty, and next due date. Filed against the device serial in your asset register.
Single-use loggers
Batch calibration record
Supplied per batch because these devices are not recalibrated after use. The record identifies the batch your shipment was drawn from.
Your SOP
Interval on request
Tell us the interval or the extra calibration points your procedure needs and we confirm whether the model supports them before you commit.
Container qualification reports
Every catalog container configuration ships with a qualification report covering its stated temperature range and hold duration at a defined ambient profile. The report includes the test setup, the payload mass, the ambient conditions, and the resulting temperature curves.
Lane-specific qualification, where your route or payload differs from the catalog case, is produced separately. Reusable containers carry a re-qualification interval stated in the report, and we notify fleet customers when a container is due.
Thermal mapping documentation
Thermal mapping identifies where temperature varies inside a loaded container, which is how you decide where to place the payload and the logger. Our mapping documentation shows the warm and cold points inside each catalog configuration under the stated test conditions. That information feeds directly into packing instructions and into the placement rules in your SOP.
If your lane has an unusual ambient profile, a lane-specific mapping study is the right document, and we quote it separately.
Catalog configurations
Warm and cold points shown
Mapping for every catalog container configuration under the stated test conditions, so packing instructions can cite the same document your auditors read.
Lane-specific studies
Quoted separately
When your route or ambient profile differs from the catalog case, we scope a dedicated study rather than stretching the standard one.
Regulatory alignment in Europe
European transport expectations for pharmaceuticals trace back to EU GDP principles, and MHRA guidance is a common benchmark that quality teams cite when writing transport validation. Our documentation is structured to support those expectations: qualified packaging, calibrated monitoring, and records that survive an audit. We update the documentation set when the underlying guidance changes.
We do not issue regulatory approvals. We supply the evidence your qualified person needs to demonstrate compliance, and we say plainly which document supports which expectation.
Audit support and document requests
If you are running a supplier audit, we can provide the ISO certificates, the quality manual summary, the logger datasheets, calibration certificates, and sample qualification reports in one package. For on-site audits, we schedule a date and confirm the scope in advance so the right people are available.
Requests for documents under an NDA are handled the same way, with the confidentiality terms agreed before anything is sent.
Change control and customer notification
When a material, a component, or a production process changes in a way that affects a qualified configuration, we notify affected customers and issue an updated qualification report where needed. That notification is part of the quality system, not an optional courtesy. Customers running regulated lanes usually need it for their own change control records.
If your SOP requires advance notice of a specific duration, tell us and we will note it on your account.
Quality team
ThermoVault Pharma Logistics AG, Industriestrasse 42, 8304 Wallisellen, Switzerland. Monday to Friday, 08:00–17:30 (CET).
Questions quality reviewers ask us
Which standards apply to your data loggers? Open
Models in our range reference GxP, FDA 21 CFR Part 11, and EN 12830 where applicable, and some carry HACCP International listing. The profile differs by model, so we confirm the exact standards for the device you select rather than claiming a blanket certification.
Do reusable loggers come with calibration certificates? Open
Yes. Reusable loggers ship with a calibration certificate traceable to a reference instrument, stating the calibration points, uncertainty, and next due date. Single-use loggers come with a batch calibration record.
Can you support a supplier audit? Open
Yes. We provide the ISO certificates, quality documentation, datasheets, calibration certificates, and sample qualification reports in one package, and we schedule on-site audits with the scope confirmed in advance.
How do you handle changes that affect a qualified configuration? Open
When a material, component, or process change affects a qualified configuration, we notify affected customers and issue an updated qualification report where needed. If your SOP requires a specific notice period, we record it on your account.
Send us your supplier qualification checklist
Tell us which standards, calibration intervals, or qualification documents your review covers and we will assemble the matching package — ISO certificates, quality manual summary, logger datasheets, calibration certificates, and sample qualification reports.