Guest user Created: Mar 29, 2017 Last commented: Mar 29, 2017

ISO 27001 ISMS into ISO 13485 QMS

If an organization already has an ISO 13485 QMS, and is considering ISO 27001 compliance, is there a best practice that recommends integration of an ISMS into the QMS, or is it better for the ISMS and QMS to be separate?

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Rhand Leal Mar 29, 2017

Answer: If the system's scopes have sufficient overlap, considering their integration it is a good option to optimize organization's efforts and resources. Additionally all ISO management systems published after 2012 have the same general structure, and this make integrating them a lot of easier.

This article will provide you further explanation about integrated management systems:
- How to implement integrated management systems https://advisera.com/articles/how-to-implement-integrated-management-systems/

These materials will also help you regarding integrated management systems:
- Book Secure & Simple: A Small-Business Guide to Implementing ISO 27001 On Your Own https://advisera.com/books/secure-and-simple-a-small-business-guide-to-implementing-iso-27001-on-your-own/
- Free webinar – ISO 27001 implementatio n: How to make it easier using ISO 9001 https://advisera.com/27001academy/webinar/iso-27001-implementation-make-easier-using-iso-9001-free-webinar-demand/ This webinar can give you insights that can be applied to ISO 13485.

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Mar 29, 2017

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