Certifications and Quality System
We are committed to maintaining the highest standards of quality and safety in the transport of temperature-sensitive pharmaceuticals. Our certifications reflect our dedication to compliance, reliability, and excellence. Here, you will find a comprehensive list of our certifications, showcasing our adherence to global standards and our commitment to delivering trusted solutions.
ISO 9001:2015 Certification
Envirotainer and all of our sites received ISO 9001:2015 certification in 2025 for the local rental provision of prepared passive temperature-controlled containers and global management through partnered service centers. ISO 9001 is the globally recognized standard for Quality Management Systems (QMS), enabling us to manage processes effectively, meet customer expectations, and continually improve performance.
Quality System Overview
Quality Unit
We employ 7 dedicated employees within the Quality & Regulatory Management department. Their core activities include:
Compliance Monitoring: conducting independent audits, quality system monitoring, and analysis of safety and quality data.
Quality Support: managing quality documentation, coordination of root cause analysis, coordination of external audits, subcontractor approvals, and certifying staff authorizations.
Quality Control
Certifying staff conduct inspections and reviews to authorize the release of new production items and repaired spare parts, as well as Unit Load Devices (ULDs) following maintenance.
Designated personnel within R&D and Production carry out in-process fault analysis and correction during container design and manufacturing. They also manage investigations into non-conformances.
A dedicated Field Quality function, supports the organization by addressing product care issues, driving process improvements, issuing work orders to service and repair stations, and conducting non-conformance investigations.
ULD Certifications
Our ULD Solutions
Envirotainer's ULD solutions are meticulously designed to protect life-saving medicines throughout the supply chain. Our commitment to safety extends to every individual involved in handling our containers. To ensure the highest standards, our ULDs have earned approval from both the European Union Aviation Safety Agency (EASA) and the Federal Aviation Administration (FAA) for air transportation.
Our ULD Stations
Envirotainer owns and operates six repair stations (AMS, ATL, Rosersberg, SIN, ICN, DUB), all accredited by relevant aviation authorities to issue maintenance, modifications, and repair certificates for our ULD solutions.
| Accreditation | |||
|---|---|---|---|
| EASA Part 145 | FAA CFR 14 Part 145 | Singapore SAR-145 | |
| Amsterdam (AMS) | Yes | Yes | |
| Atlanta (ATL) | Yes | Yes | |
| Rosersberg | Yes | Yes | |
| Singapore (SIN) | Yes | Yes | Yes |
| Incheon (ICN) | Yes | Yes | |
| Dublin | Yes | Yes | |
Design, Maintenance, and Production Certifications
We hold the below certications:
• Design Organization Approval (DOA) granted by EASA
• Production Organization Approval (POA) granted by the Swedish Transport Agency (on behalf of EASA)
• Maintenance Organization Approval (MOA) granted by the FAA, CAAS and the Swedish Transport Agency (on behalf of EASA).
These certifications, earned through rigorous audits of our processes, personnel, and facilities, authorizes us to design, maintain, repair, and manufacture ULD solutions for the transportation of temperature-sensitive biopharmaceuticals by air.
Global Compliance Standards
EU: Basic Regulation (EU) 2018/1139, (EU) No 748/2012, (EC) No 1321/2014.
US: CFR 14 Part 145, US/EU BASA, US/Singapore BASA.
Singapore: Singapore Airworthiness Requirements Part-145.
Advanced Passive Certifications
Our Advanced Passive Solutions
Our Advanced Passive solutions are engineered to safeguard temperature-sensitive, life-saving medicines throughout the global supply chain. Our unwavering commitment to quality and reliability ensures that every step of the journey meets the highest standards. To reinforce trust and compliance, our Advanced Passive solutions meet stringent industry requirements and are qualified for use in pharmaceutical logistics worldwide.
Our Advanced Passive Stations
Envirotainer owns and operates six advanced passive stations (FRA, ICN, LHR, MVD, PHL 1 & 2), which are all ISO 9001 certified.
| ISO 9001 Certified | |
| Frankfurt (FRA) | Yes |
| Incheon (ICN) | Yes |
| London (LHR) | Yes |
| Philadelphia (PHL 1 & PHL 2) | Yes |
| Uruguay (MVD) | Yes |