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

ISO 13485:2016 and ISO 9001:2015 are both international standards that define quality management systems for medical devices.ISO 13485:2016 is a standard that focuses on quality management systems for medical devices, while ISO 9001:2015 is a standard that focuses on quality management systems in general industry.ISO 13485:2016 is a more specific standard that addresses the unique requirements of medical devices, such as ensuring the safety and quality of medical devices and meeting regulatory requirements.

ISO 9001:2015, on the other hand, is a more general standard that provides guidance for organizations to improve their overall quality management systems. It is applicable to a wide range of industries and organizations, including medical devices.

Differences in Scope:

ISO 13485:2016 is a more specific standard that focuses on the quality management systems for medical devices. It has a more limited scope than ISO 9001:2015, which is a more general standard.

ISO 13485:2016 is designed to meet the specific needs of medical device manufacturers, including ensuring the safety and quality of medical devices, and meeting regulatory requirements. It provides guidance on how to establish, maintain, and continually improve the quality management system for medical devices.

ISO 9001:2015, on the other hand, is a more general standard that provides guidance for organizations to improve their overall quality management systems. It is applicable to a wide range of industries and organizations, including medical devices.

ISO 9001:2015 is designed to help organizations improve their overall quality management systems, including the processes and procedures that are used to ensure the consistency and integrity of their products and services.

Conclusion:

In conclusion, ISO 13485:2016 and ISO 9001:2015 are both international standards that define quality management systems. Although they both focus on managing quality within an organization, there are significant differences between them. ISO 13485:2016 is a more specific standard that is designed specifically for medical devices, while ISO 9001:2015 is a more general standard that is applicable to a wide range of industries and organizations.

ISO 13485:2016 is more focused on ensuring the safety and quality of medical devices and meeting regulatory requirements, while ISO 9001:2015 is more focused on improving overall quality management systems and ensuring consistency and integrity in products and services.

Therefore, businesses should carefully consider the specific requirements of their medical device industry when choosing between ISO 13485:2016 and ISO 9001:2015 for their quality management systems.