> For the complete documentation index, see [llms.txt](https://documentations.seclea.com/fda-ai-based-samd/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://documentations.seclea.com/fda-ai-based-samd/managing-samd-lifecycle-support-process-record-keeping-rk/rk07-quality-control-process-of-off-the-shelf-components.md).

# RK07 - Quality Control Process of Off-the-Shelf Components

Specify how the Quality Control Process for the Pre-existing AI/ML components developed either by the organisation, open source community or third-party vendor were evaluated before incorporating into the SaMD. Detail or upload a document detailing the evaluation of the Quality Control Process of the pre-existing AI/ML components that are incorporated as part of the AI/ML based SaMD.