Quality & Certifications
Quality & Certifications
Our commitment to quality is embedded in every product we manufacture. ISO 13485 certified, cGMP compliant, and backed by over 40 years of manufacturing excellence.
At Enzo Life Sciences, quality is not just a department — it is a company-wide commitment that guides every aspect of our operations, from raw material sourcing to final product release. Our quality management system ensures that every product meets or exceeds the expectations of our customers in the research, clinical, and pharmaceutical markets.
Our Certifications
Recognized quality standards across our operations
ISO 13485:2016
Certified quality management system for the design and manufacture of medical devices and in-vitro diagnostic products. Independently audited and renewed annually.
cGMP Compliance
Current Good Manufacturing Practice compliance for pharmaceutical-grade reagents and diagnostic components. Full traceability from raw materials to finished products.
CE Marking
Select IVD products carry CE marking for compliance with European In-Vitro Diagnostic Directive (IVDD) requirements for sale and distribution in the European Union.
Quality Metrics
Quality Control Process
Quality Assurance Framework
- Documented change control procedures for all product and process modifications
- CAPA (Corrective and Preventive Action) system for continuous improvement
- Supplier qualification and monitoring program
- Equipment calibration and maintenance schedules
- Environmental monitoring for controlled manufacturing areas
- Employee training and competency assessment programs
- Internal audit program with regular management review
- Customer complaint handling and trend analysis
Product Guarantee
Questions About Quality?
Our quality assurance team is available to answer questions about certifications, compliance, and product specifications.