ISO 13485:2016 Certified: Does Your Single-Use Integrator Really Need It?

In recent years, the bioprocessing industry has seen a steady rise in companies offering single-use assembly services. The question for consumers is: How do I select the right one for my needs? One often overlooked criterion is the manufacturer’s quality management system. As single-use technology advances toward direct patient applications, partnering with manufacturers prepared for this trend is increasingly critical. The rise of cell and gene therapeutic manufacturing underscores the need for competent suppliers equipped to meet stringent market demands.

At WHK BioSystems, we pride ourselves on adhering to the highest standards in the industry. Our ISO 13485:2016 certified QMS, originally designed for medical device manufacturing, ensures that we follow stringent procedural guidelines across all operations, including supply chain management, regulatory compliance, and manufacturing processes. This certification emphasizes process validation and product traceability, guaranteeing the quality and reliability of our products.

To maintain compliance, we subject our operations to regular, comprehensive on-site audits by 3rd party ISO accredited organizations. These multi-day audits scrutinize every aspect of our processes, ensuring strict adherence to ISO standards. This rigorous oversight ensures that our products meet the highest quality benchmarks, providing our clients with peace of mind.

ISO 13485:2016 certification not only guarantees superior product quality but also offers significant cost savings by reducing supplier management costs. This includes minimizing audit findings and enhancing supply chain efficiency. Additionally, manufacturers like WHK, operating under this certification, hold their supply chain partners to the same high standards. This ensures that all raw materials used in our products are thoroughly qualified, mitigating any risk of drug product contamination.

When choosing a single-use assembly supplier for your critical fluid handling needs, consider the importance of an ISO 13485:2016 certification. At WHK BioSystems, our commitment to excellence and stringent quality controls makes us the leading choice for reliable, high-quality single-use solutions.