Guest user Created: Mar 26, 2020 Last commented: Mar 30, 2020

ISO 13485 and ISO 9001

I am in the process of implementing ISO 13485 using the templates from Advisera. Our parent company is also implementing ISO 9001:2015 at the same time. The global procedures of 9001 seem to overlap with the global procedures of 13485 (i.e. Quality Policy, etc). My question is in regards to implementing both of these certifications simultaneously, while avoiding double work. Do you have any suggestions on what parts of ISO 13485 overlap with ISO 9001 and visa versa? What takes precedence?

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Kristina Zvonar Brkić Mar 30, 2020

Basic aspects of Quality management systems in ISO 9001 and ISO 13485 are very similar: documentation control, internal audits, corrective actions, management of non.conforming products, management review. From medical devices point of view, ISO 13485: 2016 is more important.

To understand better what are similarities and differences between these two standards, please read an article on the following link: Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/

On this link you can find several white papers about the planning process for implementation od ISO 13485, project proposal and similar: https://advisera.com/13485academy/free-downloads/

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Mar 26, 2020

Mar 30, 2020

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