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Gap analysis for ISO 13485

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Guest user Created:   Sep 01, 2020 Last commented:   Sep 01, 2020

Gap analysis for ISO 13485

We have ISO9001:2015 is there an analysis of the extra requirements to achieve ISO13485:2016?
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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.

Expert
Kristina Zvonar Brkić Sep 01, 2020

ISO 13485:2016 is the international standard requirement for a medical device manufacturing quality management system. ISO 13485:2016 standard is based on the requirements of ISO 9001:2008. ISO 13485 includes the entire ISO 9001:2008 standard with additional requirements included in blue italics text. One major distinction of ISO 13485 is that it is intended to also be required for regulatory purposes as well as a non-statutory requirement for a quality management system. 

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

Also, the following articles can be helpful in understanding the ISO 13485:2016:

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