CST Certifications

Cell Signaling Technology (CST) is ISO 9001:2015 and ISO 13485:2016 certified for the manufacture and distribution of antibodies, assay kits, and companion products. These certifications attest to the rigor of CST’s Quality Management Systems (QMS) and commitment to achieving the highest standards of quality and applicable regulatory compliance in the manufacturing of antibody reagents, including reagent lot-to-lot reproducibility, supply chain continuity, and manufacturing excellence.

We welcome on-site audits by our industrial partners, and are committed to strict confidentiality and a spirit of mutual cooperation in our business collaborations.

These certifications mean:

• Quality Management Systems (QMS) Alignment: Formally validates CST’s QMS against globally recognized standards, facilitating the use of CST reagents in clinical research applications.
• Streamlined Qualification: Simplifies supplier qualification and regulatory compliance, reducing barriers for customers seeking to use CST products in commercial applications.
• Reduced Risk: Enables progression beyond biomarker discovery by certifying that CST’s QMS meets regulatory requirements for documented reproducibility, confirmed traceability, and supply continuity.

The combination of CST’s rigorous product validation standards and ISO 13485 certification empowers customers with high-quality research reagents for critical translation, diagnostic, and clinical applications.