Quality Systems

FUJIFILM Irvine Scientific strives to be the top performer for its clients across all business units and to build relationships of trust with its customers.

FUJIFILM Irvine Scientific establishes, reviews, and communicates our quality objectives throughout our organization to assure understanding, continuing suitability, and to maintain the effectiveness of the Quality Management System (QMS).

FUJIFILM Irvine Scientific’s QMS is committed to comply with the requirements applicable to the markets it serves.

As worldwide cell culture media providers, FUJIFILM Irvine Scientific is regulated and adheres to both ISO and FDA regulations with dual manufacturing facilities in California, USA and Tokyo, Japan. Leveraging our extensive experience as producers of cell culture media (for the industrial bioprocess, medical, and diagnostic markets, and industrial scale manufacturing capacity) and our compliance with ISO and FDA regulations for medical devices, we can provide customers with unique capabilities and support.

Our quality system principles start with a clear understanding that a robust Raw Material Program provides a gateway of assurance for lot-to-lot consistency in finished goods. The critical parameters built into our program incorporate the idea that the management of the Raw Material Program and the supply chain is the foundation for high quality products.


Quality Audits

Please contact us at ISAudits@irvinesci.com for On-site Audit inquiries, audit correspondence & submitting audit report & responses:

Downloads:

ISO 13485:2016 Certification