What is ISO 13485 Certification?
ISO 13485 Certification is the standard for a Quality Management System ("QMS") for the structure and production of Medical Devices. Certification to the standard requires an association's quality management system (QMS) to pass an outsider Medical Device Single Audit Program, or "MDSAP" Audit. Generally: ISO 13485 Certification = ISO 9001 + Additional Medical Device Requirements. While ISO 13485 Certification stays an independent report, it lines up with ISO 9001 Certification. (Truly, 2008, not 2015.) This is on the grounds that it doesn't follow the elevated level structure (Annex L) of the most recent variant of ISO 9001 Certification (which is 9001:2015). Likewise, the documentation and wellbeing necessities are a lot more noteworthy under ISO 13485 Certification, while ISO 9001 Certification puts center around consumer loyalty and continuous improvement. A couple of insights regarding ISO 13485 Certification: ISO 13485 Certificatio...