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.
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 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 | Canada TCCA CAR 573 | Singapore SAR-145 | |
| Amsterdam (AMS) | Yes | Yes | Yes | |
| Atlanta (ATL) | Yes | Yes | ||
| Rosersberg | Yes | Yes | Yes | |
| Singapore (SIN) | Yes | Yes | Yes | |
| Incheon (ICN) | Yes | Yes | ||
| Dublin | Yes | Yes | Yes | |
Design, Maintenance, and Production Certifications
We hold Design Organization Approval (DOA), Maintenance Organization Approval (MOA), and Production Organization Approval (POA) granted by the Swedish Transport Agency (on behalf of EASA) and FAA. This certification, 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.
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, root cause analysis, coordination of external audits, subcontractor approvals, and certifying staff authorizations.
Quality Control
Manufacturing & R&D: In-process fault analysis and rectification by Certifying Staff in manufacturing and Compliance Engineers in R&D.
Network Excellence: Provides support for product care, process development, work orders to service and repair stations, and non-conformance investigations.
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.
Canada: TCCA CAR 573, Canada/EU BASA.
Singapore: Singapore Airworthiness Requirements Part-145.
ISO 9001:2015 Certification
Our Maidstone office received ISO 9001:2015 certification in 2022 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.