September 22, 2016
EN ISO 13485 - Medical devices Quality management system –
is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry.
EN ISO 13485 reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market.
What is an EN ISO 13485 Quality Management System?
EN ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. EN ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While EN ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. It is more prescriptive in nature and requires a more thoroughly documented quality management system.
EN ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
EN ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. EN ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives.