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(146)
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Moreover, in light of the very small size of some operators and in order to
ensure proportionality regarding costs of innovation, it is appropriate to allow
microenterprises to fulfil one of the most costly obligations, namely to establish
a quality management system, in a simplified manner which would reduce the
administrative burden and the costs for those enterprises without affecting the level of
protection and the need for compliance with the requirements for high-risk AI systems. The
Commission should develop guidelines to specify the elements of the quality management system to
be fulfilled in this simplified manner by microenterprises.
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