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Some Information regarding ISO 13485 and ISO 9001

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Guest user Created:   Aug 12, 2020 Last commented:   Aug 20, 2020

Some Information regarding ISO 13485 and ISO 9001

I am working in a manufacturing company of surgical masks in Dubai I want to know does Manufacturing of Surgical Masks lie under the ISO 13485 scope? and If We implement ISO 9001 in our company, does we require to implement ISO 13485 in the company or is it same..

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Aug 20, 2020

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:

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