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Number of procedures required by ISO 13485:2016

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Guest user Created:   Sep 10, 2020 Last commented:   Sep 11, 2020

Number of procedures required by ISO 13485:2016

How many procedures are required by ISO 13485:2016?

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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 Sep 11, 2020

The number of procedures depends on the type of your medical device. Requirements in the standard are prepared for all types of medical devices, so not all requirements are applicable for each medical device. 

On the following link, you can find the list of mandatory documents from ISO 13485 https://advisera.com/13485academy/blog/2017/01/18/list-of-mandatory-documents-required-by-iso-134852016/

Of course, if you do not have certain processes (for example sterilization, or your product is not software), then there is no need to prepare and have those documents in your quality management system.

Furthermore, I would like to point out that these are mandatory documents and definitely some additional documents can be necessary (for example: some policies, organizational charts, some plans and so on). 

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Sep 10, 2020

Sep 11, 2020