Jun 26, 2023

Audit Checklist for Risk Management as per ISO 14971 (generated by ChatGPT)

This article provides an audit checklist for evaluating the risk management process according to ISO 14971. ChatGPT prepared the checklist.

This article provides an audit checklist for evaluating the risk management process according to ISO 14971. ChatGPT prepared the checklist.

The following audit checklist has been prepared by ChatGPT, as described in my article, 'How to Create Audit Checklists with ChatGPT.' This checklist is based on ISO 14971:2019, the relevant standard for Risk Management of Medical Devices and Combination Products.

A downloadable PDF version can be found below the table.

Chapter 1: Audit Checklist as per ISO 14971:2019



Chapter 2: Audit Checklist for Download


Torsten Kneuss is an engineer near Berlin with 25+ years in the pharmaceutical industry, specializing in packaging, medical devices, and combination products. 

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