ISO 13485:2016 Medical devices — Quality management systems

Updated: Oct 26, 2020



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.

ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of PDCA (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.


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.

Maintaining regulatory compliance by being ISO 13485 certified Company

The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations, and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

What are the benefits of being certified to ISO 13485:2016?

ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

  • Outline how to review and improve processes

  • Increase efficiency, cut costs and monitor performance

  • Demonstrate that you produce safer medical devices

  • Meet regulatory requirements and customer expectations