Compliance frameworks, security audits, and quality certifications this company maintains.
Thermo Fisher's global manufacturing sites — spanning Waltham MA, Asheville NC, Lenexa KS, Paisley UK, and Singapore — are ISO 9001:2015 certified, ensuring that instrument design, reagent manufacturing, and service delivery meet international quality standards expected by pharmaceutical, clinical, and industrial laboratory customers.
Thermo Fisher's Specialty Diagnostics and Applied Biosystems divisions hold ISO 13485 certification for medical device quality management, covering in vitro diagnostic reagents, clinical immunoassay kits, and companion diagnostic NGS assays — required for CE-IVD marking and FDA 510(k) submissions.
Thermo Fisher's Chromeleon CDS, Xcalibur, and Thermo Scientific SampleManager LIMS platforms are designed for 21 CFR Part 11 compliance, enabling pharmaceutical customers to use Thermo Fisher software systems in GMP-regulated analytical and manufacturing environments with audit trails, electronic signatures, and data integrity controls.
Regulatory
cGMP (21 CFR Parts 210/211)
CompliantThermo Fisher's Pharma Services Group (Patheon CDMO) operates its drug substance and drug product manufacturing facilities under FDA current Good Manufacturing Practice (cGMP) regulations per 21 CFR Parts 210 and 211, supporting pharmaceutical customers in producing clinical and commercial biologic and small molecule medicines.
Environmental
ISO 14001:2015
CertifiedThermo Fisher operates under ISO 14001:2015 environmental management certification across major manufacturing and distribution operations, supporting its Science for Sustainability commitments to reduce Scope 1 and 2 greenhouse gas emissions 50% by 2030 and achieve net-zero operations by 2050.
Thermo Fisher's cloud-hosted SampleManager LIMS, Thermo Fisher Connect, and ScienceCloud platforms are audited under SOC 2 Type II, providing pharmaceutical and clinical laboratory customers with independent assurance of data security, availability, and confidentiality controls for cloud-based laboratory data management.
Thermo Fisher maintains an export compliance program covering ITAR and EAR regulations for controlled dual-use instruments including electron microscopes, mass spectrometers, and ion beam systems that may require export licenses for controlled-country sales, ensuring compliance across 150+ country distribution footprint.
Thermo Fisher's clinical diagnostics products — including transplant diagnostics, allergy immunoassay kits, and Ion Torrent Genexus companion diagnostics — are designed to support customer compliance with CLIA requirements for diagnostic accuracy, precision, and quality control in accredited clinical laboratory environments.
Regulatory
ICH Q10 Pharmaceutical Quality
CompliantThermo Fisher's Pharma Services Group CDMO operations and instrument portfolio support customer ICH Q10 pharmaceutical quality system implementation, with manufacturing procedures, deviation management, and CAPA systems aligned to ICH Q10 expectations for process performance and product quality monitoring.
Environmental
RoHS / REACH
CompliantAll Thermo Fisher instruments and reagents sold in the European Union comply with RoHS restrictions on hazardous substances and REACH chemical substance registration requirements, with substance declaration processes managed through Thermo Fisher's global product compliance program.