We are happy to announce that SGS Fimko is now able to provide FINAS accredited ISO 13485:2016 certification services to in vitro diagnostic (IVD) industry, after successfully extending our ISO 13485:2016 scope also to cover IVD technical areas. *)
We are currently thriving towards designation for the IVDR (EU) 2017/746 Notified Body status and are preparing for the upcoming Joint Assessment on the early 2024.
We are now also able to offer FINAS accredited Information Security Management System (ISMS) certification according to ISO/IEC 27001:2022.
Our full accreditation scope can be seen at FINAS website SGS Fimko Oy (finas.fi)
*) SGS Fimko Oy is a certification body (S009) accredited by FINAS Finnish Accreditation Service according to the requirement of SFS-EN ISO/IEC 17021-1:2015.
About SGS
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.