ISO/IEC 42001 is titled “Information technology – Artificial intelligence – Management system.” The first medical device manufacturers have set out to be certified according to this standard. But are the efforts required to do so justified? Does ISO/IEC 42001 help to meet the requirements of the AI Act? This article provides answers.
DetailsDocument control is a documented procedure that specifies how documents are created, reviewed, approved, labeled, distributed, and updated. Organizations certified according to ISO 9001 or ISO 13485 are obliged to document control.
DetailsThe QM manual is the top document in the document pyramid of the QM system. It is an entry point for employees and auditors to get a quick overview of the QM system. In this article, you will learn when you need a QM manual, its objectives, and what it should contain.
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