What is the difference between ISO 9001 2015 and ISO 13485 2016 ?

ISO 9001:2015 is a widely recognized quality management standard that applies to all organizations that are interested in improving their quality management systems. It is focused on ensuring that an organization's processes and procedures are aligned with the requirements of ISO 9001:2015 and that the organization achieves continuous improvement.

On the other hand, ISO 13485:2016 is a specifically designed standard for organizations involved in the design, development, production, installation, and servicing of medical devices. It is based on ISO 9001:2015 and has additional specific requirements for the medical device industry. The primary focus of ISO 13485:2016 is to meet regulatory requirements and ensure the safety and effectiveness of medical devices. It covers the entire life cycle of a medical device, including design control, risk management, traceability, validation, and verification.

In summary, ISO 13485:2016 is a medical device specific standard that builds on the ISO 9001:2015 standard and adds additional requirements for the medical device industry. Compliance with ISO 13485:2016 demonstrates the organization's commitment to quality in the medical device industry.