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Serving Life Sciences since 1973
At Biowest USA, quality is built into every stage of our manufacturing process, from the raw materials we source to the consumables we use, delivering a final product of exceptional quality.
We are committed to the highest standards and guarantee quality, traceability and premium service.
Our success is built on competitive pricing, global sourcing, full traceability, and a fully integrated in-house service from sourcing to delivery.
Using specialized equipment, detailed SOPs and audits, we ensure quality control at every stage and low intra-lot variation.
Our Certifications
All documentation is available in both printed and digital formats. Use the dropdown below to find and access the documents you need.
ISO 9001 Certification
Biowest USA’s production facilities are certified to ISO 9001:2015, demonstrating our commitment to consistent quality management across our manufacturing processes.
Our quality system supports controlled production, traceability, documentation, and continuous improvement. Our products also comply with applicable USDA and regulatory requirements governing animal by-products and derived materials not intended for human consumption.
We work closely with our customers to meet additional quality, regulatory, and documentation requirements specific to their applications.
ISO 13485 Certification
Biowest USA’s production facilities are certified to ISO 13485:2016, supporting rigorous quality management and traceability for products manufactured within a controlled life-science production environment.
Our processes are designed to maintain documented controls throughout production and quality assurance. Our products also comply with applicable USDA and regulatory requirements governing animal by-products and derived materials not intended for human consumption.
Where required, we work with customers to meet additional quality, regulatory, and documentation requirements specific to their applications.