Application of integrated ISO 9001 and ISO 13485

While ISO 13485:2016 will give to the medical device manufacturer standard to be in complainace with necessary requirements to prove that medical device is produced in safe manner, ISO 9001 will give a more detailed view into management process, especially to business risks and defining the context and strategy of the organization.

Implementing both standards can affect to better management of the whole company. However, some customers are requiring explicitly ISO 9001. 

For more information what are ISO 13485 structure and requirements, please read the article on the following link:
ISO 13485 structure and requirements https://advisera.com/13485academy/what-is-iso-13485/

For more information, please read the following article: What is ISO 9001? https://advisera.com/9001academy/what-is-iso-9001/