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What is iso 13485 in plain english10/5/2023 The standard provides a step-by-step framework for creating a QMS and/or evaluating gaps in your current system in terms of monitoring and controlling processes. 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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