Accreditations & ISO Standards
Our analytical testing methods, calibration metrology, and data security are independently audited and accredited according to rigorous international standards.
HKAS Lab #0842
Hong Kong Accreditation Service • HKSAR GovernmentAccredited under the Hong Kong Laboratory Accreditation Scheme (HOKLAS) for chemical, chromatographic (HPLC), and mass spectrometric testing in pharmaceutical and biological materials.
ISO/IEC 17025:2017
Competence of Testing & Calibration LaboratoriesThe supreme international benchmark for testing laboratory technical competence, ensuring method validation, measurement uncertainty calculation, and NIST-traceable reference calibrations.
ISO 15189:2022
Medical & Clinical Laboratory QualityStringent quality and competence requirements governing biological specimen handling, chain-of-custody, and clinical-grade chemical diagnostics.
ISO/IEC 27001:2022
Bureau Veritas UKAS Certified ISMSCertified Information Security Management System protecting client test records, raw chromatography sequences, and certificate databases against tampering, unauthorized access, and data breaches.
ILAC-MRA: Worldwide Recognition of Zenith Test Reports
Through HOKLAS's signatory status to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC-MRA), test reports and Certificates of Analysis issued by Zenith BioChemical Laboratories HK are officially recognized by accreditation bodies in over 100 economies globally.
This mutual recognition encompasses major international jurisdictions including the United States (A2LA, NVLAP), the United Kingdom (UKAS), the European Union (EA signatories), Australia (NATA), Canada (SCC), Japan (IAJapan), and Singapore (SAC-SINGLAS). Researchers and pharmaceutical developers can submit Zenith analytical reports directly to international regulatory dossiers with full confidence in cross-border validity.
Continuous Quality Assurance Protocols
Maintaining accreditation requires continuous empirical validation, blind round testing, and independent surveillance.
Annual Proficiency Testing (PT)
Participation in international external quality assessment rounds (e.g. LGC Standards, FAPAS, EDQM) to benchmark instrument accuracy against global reference labs.
Method Validation (ICH Q2(R2))
Every chromatographic SOP is fully validated for specificity, linearity ($R^2 > 0.999$), range, precision (RSD < 1.0%), and limit of detection (LOD).
Dual-Chemist Peer Audit
100% of analytical sequences require independent recalculation and sign-off by a secondary certified QA officer prior to client distribution.
Accredited Testing at Science Park
Receive official HOKLAS & ISO 17025 accredited Certificates of Analysis with full raw chromatograms and cryptographic verification.