Gap analysis for ISO 13485

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:

• Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

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

• 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/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/