Some Information regarding ISO 13485 and ISO 9001

Yes, the manufacturing of surgical masks must lie under the scope of ISO 13485.

There is a difference between ISO 9001:2015 and ISO 13485:2016, and by implementing the ISO 9001 not all requirements for the manufacturing of medical devices will be fulfilled. It is not a question of preference, but what the legal regulations are and what requirements must be met in order for a medical device to comply with its regulations. ISO 13485:2016 is a standard that is specific for Manufacturers of medical devices (Medical devices — Quality management systems — Requirements for regulatory purposes). Besides that, on the web pages of the European Commission are stated which standards are applicable for all types of medical devices:  https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en 

On that list, which has around 300 standards, only ISO 13485:2015 is the standard for the quality management system.

For more information on this topic, please see the following articles:

• Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• How to get ISO 13485 certified? - https://advisera.com/13485academy/iso-13485-certification/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/