NOKE LAB Achieves ISO 13485:2016 Medical Device Certification

NOKE LAB Achieves ISO 13485:2016 Medical Device Certification

Quality management certification expands our capabilities to serve pharmaceutical and clinical laboratories with medical-grade consumables.

Certification Achievement

NOKE LAB is pleased to announce that we have successfully achieved ISO 13485:2016 certification for our quality management system. This internationally recognized standard demonstrates our commitment to consistent quality in the manufacture of medical device components.

Scope of Certification

The certification covers the design, development, and manufacture of chromatography consumables for use in clinical and pharmaceutical applications, including:

  • Autosampler vials and closures
  • Syringe filters
  • SPE columns and cartridges
  • Custom OEM components

Benefits for Customers

This certification enables us to better serve pharmaceutical and clinical laboratory customers who require suppliers with robust quality management systems meeting regulatory expectations.

Ongoing Commitment

ISO 13485 certification joins our existing ISO 9001 and GMP certifications, reflecting our ongoing commitment to quality excellence across all operations.