ISO 13485 :2016 Medical Device Quality Management System

ISO 13485:2016 (Quality Management System for Medical Devices) ISO 13485:2016 , based on the ISO 9001:2008 Certification process model, suggests that the application and management of a system of processes is an effective way to ensure good quality management. All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization.

The standard strongly infers that clients should consider using ISO 9001:2008 to ensure understanding of the Process Model, definitions and other items of concern, too.

The standard combines generally recognized key elements to ensure food safety along the food chain, including:

ISO 13485 Certification – Benefits

The benefits of an ISO 13485:2016 Certification compliant quality management system to the many of companies worldwide include:

• Recognition by regulators around the world of ISO 13485:2016 as a good basis for addressing medical device design and manufacturing regulatory requirements


• Controlled consistency of manufactured products


• Managed productivity and efficiency, controlling costs


• Competitive advantage and increased marketing and sales opportunities.


• Improved customer perception of the organization’s image, culture and performance.


• Improved communications, morale and job satisfaction – staff understand what is expected of them and each other