Accreditations & Certifications
Our current certifications
Independently certified and kept current through regular surveillance audits. Download any certificate below, or request the full set for your supplier records.
ISO 13485
2016 – Quality management for medical devices
The standard medical-device OEMs require of their supply chain. Governs how we design, mould and control parts destined for regulated medical use.
ISO 9001
2015 – Quality management systems
The foundation the whole business runs on: documented processes, continual improvement and consistent output across every project, medical or industrial.
ISO 14001
2015 – Environmental management systems
How we measure and reduce the environmental impact of moulding – from material use and energy to waste – so your supply chain stands up to scrutiny.
What this means for your project
Full traceability
Batch-level traceability and documented controls mean every part can be tracked back through its production history – essential for medical and regulated work.
Audited, repeatable process
Our systems are independently audited on an ongoing basis, so the quality you approve on the first run is the quality you get on the ten-thousandth.
Smoother supplier approval
Recognised certifications shorten your own supplier onboarding and audits – the evidence your quality and procurement teams need is ready to file.
Class5 & 7 Cleanroom moulding
Validated moulding environment for Medical Devices, Biotech, Pharmaceutical, Micro-moulding and Microfluidics.
Accreditation FAQs
Are your certificates current?
Yes. All three certifications are maintained through regular surveillance audits by our certification body. Each certificate on this page shows its issue and expiry date, and we keep the downloadable PDFs updated as they’re renewed.
Can I get copies for our supplier approval records?
Absolutely. You can download each certificate as a PDF above, or request the full set and we’ll send current copies directly for your quality and procurement files.
Does ISO 13485 mean Biplas is a registered medical device manufacturer?
ISO 13485:2016 certifies that our quality management system meets the requirements for organisations manufacturing within the medical-device supply chain. Your finished-device registration and regulatory responsibilities remain with you as the device owner — but you’re working with a supplier whose QMS is built and audited for medical work.
Building a regulated or
precision part? Let’s talk.
Speak to our team about your project and how our certified processes support your
compliance from first sketch to final batch.
