Read the white paper written by MD101 and its experts on Artificial Intelligence and Impact of ISO 42001 on an ISO 13485-compliant QMS.
Extract
Context of the organization according to ISO 42001 and ISO 9001
As with ISO 9001, ISO 42001 requires you to define the context and issues of the interested parties. This requirement is not present in ISO 13485.
It is necessary to clarify the issues and stakeholders involved in order to distinguish between the expectations of these parties. In particular, it is necessary to distinguish between:
- Regulatory requirements for a MD manufacturer and regulatory requirements relating to AI,
- The expectations of the respective authorities and other entities that interact with the AI system developer.
This work is required by ISO 42001 but not by ISO 13485. At least, it is not required by the current version of ISO 13485, which does not respect the HLS structure.
Editors
MD101 Consulting : Sébastien FERRET, Lysiane LETURQUE, Cyrille MICHAUD, Thomas NICOLAÏ, Léonore WAXIN
HERMEDIQUAL : Johann BONAMI
AQ et AR : Daniel DECRUPPE
ISOMED Conseil : Carine GRELAIT
QUAREG Consulting : Rita HALABI
Concept et Pragmatisme : Guy PERNET
CAP ISO : Stéphanie RÉAU
CILLEO : Alain ROBLET
AILANE : Benoît ROUSSEAU
