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Implementing ISO 9001 alongside ISO 13485

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Guest user Created:   Feb 05, 2021 Last commented:   Feb 08, 2021

Implementing ISO 9001 alongside ISO 13485

We are designing a system to transport medicine by drone. We understand we need to have ISO 13485 certification. Do we also need to have an ISO 9001 certification or is 13485 a superset of 9001? Thanks.

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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 Feb 08, 2021

No, you do not need ISO 9001:2015 certification. 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 13485:2016 is the standard for the quality management system. 

For more information please read the following articles:

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Feb 05, 2021

Feb 08, 2021