ISO 13485 Key Differences
Although ISO 13485 is based on ISO 9001, a manufacturer that is compliant with this standard cannot also claim compliance with ISO 9001 due to the significant differences between those two standards. This system was written to meet the regulatory requirements of the medical devices industry and so it does not place the same amount of significance on customer satisfaction and continuous improvement found in ISO 9001.
NSAI has a subsidiary office in the USA (NSAI Inc.) and is accredited with ANAB (ANSI-ASQ National Accreditation Board) and SCC (Standards Council of Canada). This means that at NSAI you can gain ISO 13485 Certification under CMDCAS (Canadian Medical Devices Conformity Assessment System) and thus gain entry into the Canadian market. NSAI can also help you gain entry to the European market (with CE marking) and the Japanese market (with JPAL – Japanese Medical Device Certification)