Quality Systems

Quality Systems

All SeraCare facilities are ISO 13485-certified and comply with cGMP regulations. Every process is documented and records are maintained according to these regulations. Our products are completely traceable from sourcing, through processing, to delivery — providing a high level of confidence, quality, and safety.

Quality Policy

As a developer and manufacturer of quality control products, diagnostic components, biological products, and services for diagnostic, therapeutic, drug discovery, and research organizations, SeraCare commits to meet or exceed our customers’ needs and expectations, maintain an effective quality management system, and meet regulatory requirements for the products and services we provide.

We ensure our customers’ continued satisfaction by:

  • Optimizing our internal resources
  • Building equal partnerships with our suppliers
  • Encouraging employee empowerment and development
  • Fostering an environment of continuous improvement and innovation

Registration and Certification Information

FDA Blood Establishment Registration (Massachusetts #1270029)

FDA Medical Device Establishment Registration (Massachusetts #3007088335, Maryland #3003610890)

ISO 13485: 2016 Certification (Massachusetts FM 572228,  Maryland FM 735301)

ISO 13485: 2016 MDSAP Certification (MDSAP 689354)

EC 1069/2009 and EU 142/2011 Approval

(Massachusetts #MA-TEC-0003; Maryland #MD-TEC-0002)

Massachusetts Board of Pharmacy License (Massachusetts #WD463)