What is the difference between ISO 9001 and 2015 ?

ISO 9001 and ISO 13485:2016 are both quality management standards that organizations can use to establish and maintain effective quality management systems. However, they have different scopes and requirements.

ISO 9001 is a global standard that provides a framework for organizations to manage their quality processes and achieve customer satisfaction. It is applicable to all types of organizations, regardless of their industry or size. ISO 9001:2015 provides a revised framework for ISO 9001 that includes several key changes and enhancements.

ISO 13485:2016, on the other hand, is a standard specifically designed 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.

Key differences between ISO 9001:2015 and ISO 13485:2016 include the scope, requirements, and focus. ISO 9001:2015 is a broader standard that covers all types of organizations, while ISO 13485:2016 is a more specialized standard focused specifically on the medical device industry.

Both ISO 9001:2015 and ISO 13485:2016 are important standards that organizations can use to improve their quality management systems and achieve customer satisfaction. Compliance with these standards can demonstrate an organization's commitment to quality in the medical device industry.