ISO 13485 is an international standard for the design, manufacture and distribution of medical devices. ISO 13485:2016 is the latest version by ISO, published in 24 july 2003. This standard is based on the ISO 9001:2008 process model approach.
ISO 13485 is process based approach which define, implement, and improve effectives of quality management system that they expected by customers and regulatory requirements. The main aim of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems.
ISO 13485:2016 Certification is closely aligned to other management standards such as ISO 9001, ISO 14001 and OHSAS 18001 providing a great opportunity for integration and synergy with other quality systems.
The main internal benefits of 13485 standard is that it indicate a preventive approach to assuring medical device quality which the process inspection and rejection are done at the end of the manufacturing line
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