For over 30 years, we have dedicated ourselves to helping IVD developers and clinical laboratories ensure the quality of their assays. So when the opportunity arose to enhance our own quality standards, we jumped on it.
Heather M. Buckley, VP, Quality & Regulatory Affairs
We are happy to announce that SeraCare has achieved certification to ISO 13485:2016, “Medical Devices – Quality management systems – Requirements for regulatory purposes.” As we announced earlier this year, in order to focus on continuous improvement and customer satisfaction, we made the decision not to seek certification to ISO 9001:2015 due to significant changes to this standard for applicability to service-based organizations. ISO 13485:2016 continues to focus on quality management system requirements for organizations that provide medical devices; as well as expanded global alignment of regulatory requirements; enhancement of requirements for a risk-based quality management system; more detailed validation, verification, and design requirements; additional requirements for supplier management; and focus on continuous improvement and customer satisfaction. In preparation for our certification, we made several enhancements to these systems which better align us with the standard itself and the expectations of our customers. Through implementation of this standard, our systems are stronger, which translates to an even higher level of quality of the products and services that we provide, allowing us to meet current and expanding needs.
We know that you depend on the quality of your controls and reference materials. That's why we continue to invest in our quality management systems, to allow your focus to remain on the quality of your diagnostic results. To learn more about SeraCare’s QC products and services, click here.