Accreditations & ISO Standards
Our analytical testing methods, calibration metrology, and data security are independently audited and accredited according to rigorous international standards across Europe, Asia-Pacific, and Latin America.
DIN EN ISO/IEC 17025:2017
Deutsche Akkreditierungsstelle • Frankfurt FacilityAccredited under Germany's national accreditation body (DAkkS) for high-resolution UHPLC chromatography, Orbitrap mass spectrometry, and metrological reference standards at our Frankfurt European Hub.
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.
ABNT NBR ISO/IEC 17025
Coordenação Geral de Acreditação • São Paulo HubAccredited and aligned under INMETRO's General Coordination for Accreditation (CGCRE) for bio-safety testing, heavy metals screening (ICP-MS), and peptide purity verification in South America.
ISO 15189:2022
Medical & Clinical Laboratory QualityStringent quality and competence requirements governing biological specimen handling, chain-of-custody, and clinical-grade chemical diagnostics across our global network.
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: Tripartite Worldwide Recognition of Zenith Test Reports
Through our tripartite signatory status under DAkkS (Germany / European EA), HKAS (Hong Kong / APAC MRA), and CGCRE/INMETRO (Brazil / IAAC), test reports and Certificates of Analysis issued by Zenith BioChemical Laboratories are officially recognized by accreditation bodies in over 100 economies worldwide under the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC-MRA).
This tripartite mutual recognition encompasses major international jurisdictions including the European Union (EA signatories), the United States (A2LA, NVLAP), the United Kingdom (UKAS), Australia (NATA), Canada (SCC), Japan (IAJapan), Brazil (INMETRO), and Singapore (SAC-SINGLAS). Researchers and pharmaceutical developers can submit Zenith analytical reports directly to international regulatory dossiers with complete confidence in cross-border validity.
Continuous Quality Assurance Protocols
Maintaining accreditation across Germany, Hong Kong, and Brazil 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 Across Germany, Hong Kong & Brazil
Receive official DAkkS, HOKLAS & INMETRO aligned ISO 17025 accredited Certificates of Analysis with full raw chromatograms and cryptographic verification.