ISO 13485

ISO 14001

ISO 45001

ISO 9001

AS/EN 9100

EcoVadis Bronze

Engineered with Precision. Certified to Excel.

At Advanex Europe, our dedication to quality goes beyond manufacturing—it's ingrained in our processes, people, and performance. We deliver precision-engineered components you can trust, backed by rigorous certifications, environmental standards, and continual innovation.

Certifications That Matter

  • ISO 9001 – Quality Management
    We uphold worldwide best practices in quality assurance, ensuring your components meet the highest performance benchmarks.

  • ISO 14001 – Environmental Management
    Sustainability underpins our operations, from eco-conscious production to responsible resource use.

  • ISO 13485 – Medical Device Quality
    Our Southwell site is certified to this globally recognized standard, reinforcing our capability to serve highly regulated medical and pharmaceutical industries.

  • AS9100 / AS9100 Rev D – Aerospace Quality Standard
    Certified to the latest aerospace quality standard, we ensure unmatched precision and safety in aerospace applications, especially for our KATO® Advanes inserts.

Cleanroom & Compliance Excellence

  • ISO Class 7 (J Class 10,000) Clean Rooms
    Our controlled clean environments meet strict cleanliness standards—critical for medical, aerospace, and sensitive electronic manufacturing.

  • In-House Machinery & Verification Protocol
    Automation is central to our strategy. We design, build, and rigorously validate bespoke production equipment under CE marking. All machinery follows a structured verification process—Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Process Qualification (PQ)—ensuring compliance with ISO 9001.

Recognitions & Sustainability Leadership

  • EcoVadis Bronze Medal for Sustainability
    Our UK (Southwell, Bilborough) and Czech facilities earned this strong EcoVadis rating for commitment to ESG performance. Plans are underway to achieve Silver—placing us among the top 25% of sustainable firms globally.

Why Compliance Makes a Difference

Benefit What It Means for You
Reliability & Safety Certified processes ensure every part meets rigorous, traceable standards.
Regulated Industry Readiness Equipped to serve aerospace, medical, automotive, and other regulated sectors.
Clean & Controlled Manufacturing Cleanroom environments uphold component purity and performance.
Continuous Improvement Recognitions like EcoVadis and Ricoh attest to our culture of ongoing excellence.