Quality & compliance
Quality is decided before the assay runs
Continuous quality improvement is part of the DNA of every JTC Diagnostics employee. Our certified quality system governs every stage from incoming material to final release.
Our standards
Certified, traceable, documented
Partners in regulated markets need more than a good product — they need the evidence that goes with it.
ISO 13485 quality management
Manufacturing operates under a certified ISO 13485 quality management system, with documented procedures covering every stage from incoming material to release.
Full donor-to-product traceability
Every lot is traceable back to its source material, supported by comprehensive batch records and certificates of analysis.
Ethical sourcing
All human bio-materials are collected under informed consent and strict ethical sourcing protocols, with complete documentation available to customers.
Comprehensive QC testing
Viral marker screening, sterile 0.22 µm filtration where specified, stability programmes and analyte target verification are applied as standard.
Regulatory support
We supply the compliance documentation partners need for their own regulatory submissions and audits, and support customer and notified-body inspections.
Lot-to-lot consistency
Defined pooling strategies and process controls deliver the reproducibility that calibrator and control manufacturing depends on.
Controlled manufacturing
Defined processes, controlled environments, released by specialists
Filling, labelling and release testing follow written procedures under our ISO 13485 quality management system, with environmental monitoring and documented in-process controls at each step.
Documentation
What ships with every lot
Complete records arrive with the material, not weeks later — keeping your own audit and submission timelines intact.
Certificate of analysis
Batch and traceability records
Viral marker screening results
Stability and storage guidance
Need our compliance documentation?
Tell us which materials and markets are involved and we will send the relevant quality and regulatory documents.