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IS ISO 13485:2016 latest version?

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Guest user Created:   Jul 20, 2020 Last commented:   Jul 20, 2020

IS ISO 13485:2016 latest version?

Would you say, ISO 13485:2016 is this latest version, isn't it? Exclusion clauses are 6,7,& 8?

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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 Jul 20, 2020

Yes, so far ISO 13485:2016 is the latest version. There is an explanation on the web page of the ISO organization that this standard was reviewed and confirmed in 2020, and that this version ISO 13485:2016 remains valid.

You can see it on this link: https://www.iso.org/standard/59752.html 

In section 1. Scope of this standard, it is stated that if any requirement from Clause 6, 7, and 8 is not applicable, the organization does not need to include that requirement in the quality management system.

Here you can find the Checklist of ISO 13485:2016 Implementation steps: https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

Also, you may find useful our ISO 13485:2016 documentation toolkit: https://advisera.com/13485academy/iso-13485-documentation-toolkit/

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Jul 20, 2020

Jul 20, 2020