ISO13485 - 5.1 Management commitment
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5.1 Management commitment
Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources
NOTE For the purposes of this International Standard, statutory requirements are limited to the safety and performance of the medical device only.
