11/1/2023 0 Comments Iso 13485![]() ISO 13485 is intended to help medical device manufacturers (and others in the industry) create a Quality Management System (QMS) that ensures quality and safety of finished products. “ISO 13485:2016 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.” In this post, we’ll take a look at the basics of ISO 13485 to help you decide whether it’s worth pursuing this certification. ![]() ISO 13485 for Medical Device Quality Management Systems is growing in popularity, with the number of certified facilities jumping 13% from 2015 to 2016.īut how is ISO 13485 different from ISO 9001 for Quality Management, and who should certify?
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