Guest user Created: Apr 16, 2020 Last commented: Apr 17, 2020

ISO 13485 implementation

My company plans to implement ISO 13485 on the base of the Quality Pharmaceutical System(GDP). Could you advise please which first steps have to be for that implementation?

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Kristina Zvonar Brkić Apr 17, 2020

It is best to make a GAP analysis between your current Quality Pharmaceutical System and requirements from ISO 13485:2016.

For that step, the following documents can be helpful:

Checklist of Mandatory Documentation Required by ISO 13485:2016 https://info.advisera.com/13485academy/free-download/checklist-of-mandatory-documentation-required-by-iso-134852016

Clause-by-clause explanation of ISO 13485:2016 https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485

Diagram of ISO 13485:2016 Implementation Process https://info.advisera.com/13485academy/free-download/diagram-of-iso-134852016-implementation-process

Project Checklist for ISO 13485:2016 Implementation https://info.advisera.com/13485academy/free-download/project-checklist-for-iso-13485-2016-implementation

You can schedule a free 30-minute consultation with our ISO 13485 expert who can provide you with more information on how to proceed: https://advisera.com/13485academy/free-consultation/

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Apr 16, 2020

Apr 17, 2020

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