This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The latest version of this standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996). The current ISO 13485 edition was published on 1 March 2016. ISO 13485 is structured similarly to ISO 9001: 2000 and is actually 90% the same as the general standard for quality management systems..
 

VF .g8ZG[XG, :8Fg0"0 GL U]6JTF jIJ:YF5G 5|6F,L DF8[ GL VFJxISTFVMG[ :5Q8 SZ[ K[P HIF\ ;\:YF G[ TALAL p5SZ6M VG[ ;\A\lWT ;[JFVM 5|NFG SZJFGL T[GL 1FDTF NXF"JJF GL H~Z CMI K[P H[ ;TT U|FCS VG[ ,FU] lGIDGSFZL VFJxISTF 5]6" SZ[ K[P VF WMZ6 G]\ GJLGTD ;\:SZ6 VUFp GF N:TFJ[HM GF :TZ[ NXF"JJFDF\ VFJ[ K[P