Compliance frameworks, security audits, and quality certifications this company maintains.
Agilent's global manufacturing sites — including Santa Clara, Waldbronn Germany, and Penang Malaysia — are ISO 9001:2015 certified, ensuring that Agilent's instrument design, manufacturing, and service delivery processes meet international quality management standards expected by pharmaceutical and regulated lab customers.
Agilent holds ISO 13485 certification for its Diagnostics & Genomics division, covering the design and manufacture of in vitro diagnostic (IVD) reagents, FISH probes, and companion diagnostic products supplied to clinical pathology labs that require medical device quality management system compliance.
Agilent's OpenLAB CDS and MassHunter software platforms are designed and validated to comply with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures, enabling pharmaceutical and biotech customers to use Agilent data systems in GMP-regulated analytical environments.
Agilent supports EU GMP Annex 11 computerized systems compliance through its OpenLAB CDS validation documentation, audit trail functionality, and data integrity controls — critical for Agilent pharmaceutical customers submitting to EMA and conducting clinical trials in the European Union.
Environmental
ISO 14001:2015
CertifiedAgilent Technologies operates under ISO 14001:2015 environmental management certification across its major manufacturing facilities, reflecting Agilent's commitment to reducing chemical waste, energy consumption, and greenhouse gas emissions associated with analytical instrument production.
Environmental
RoHS / REACH
CompliantAgilent ensures all instruments and reagents sold in the EU comply with RoHS restrictions on hazardous substances and REACH chemical registration requirements, providing safety data sheets and substance declarations to support customer supply chain compliance programs.
Agilent complies with U.S. International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR) for export of dual-use analytical instruments and technologies, maintaining an export compliance program that covers GC, LC/MS, and spectroscopy products shipped to controlled-country customers.
Agilent's cloud-hosted OpenLAB CDS Enterprise and CrossLab Connect remote monitoring platform are audited under SOC 2 Type II to verify controls over security, availability, and confidentiality of customer laboratory data — a requirement for pharmaceutical companies using SaaS-based lab informatics.
Safety
OSHA Process Safety
CompliantAgilent's manufacturing sites that handle high-pressure gas systems and compressed gas cylinders comply with OSHA Process Safety Management (29 CFR 1910.119) standards, ensuring safe handling of industrial gases used in instrument testing and calibration at Agilent's California and Delaware facilities.
Regulatory
CLIA Compliance
CompliantAgilent's in vitro diagnostic products sold for use in U.S. clinical laboratories are designed to support customer compliance with the Clinical Laboratory Improvement Amendments (CLIA), covering diagnostic test performance standards for sensitivity, specificity, and reportable range that clinical lab customers must demonstrate to CMS.