https://wiki.dirkjanswagerman.nl/index.php?action=history&feed=atom&title=ISO13485_-_Responsibility_and_authority 2026-10-25T12:19:58Z Revision history for this page on the wiki MediaWiki 1.34.2 https://wiki.dirkjanswagerman.nl/index.php?title=ISO13485_-_Responsibility_and_authority&diff=3224&oldid=prev 2020-08-25T09:46:05Z

<p>Created page with &quot;&#039;&#039;&#039;Responsibility and authority&#039;&#039;&#039; Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization. Top ma...&quot;</p> <p><b>New page</b></p><div>&#039;&#039;&#039;Responsibility and authority&#039;&#039;&#039;<br /> <br /> Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.<br /> <br /> Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the &#039;&#039;&#039;&#039;independence&#039;&#039;&#039;&#039;&#039; and authority necessary to perform these tasks.<br /> <br /> NOTE National or regional regulations might require the nomination of specific persons as responsible for activities<br /> related to monitoring experience from the post-production stage and reporting adverse events (see 8.2.1 and 8.5.1).<br /> [[Category:quality]]<br /> <br /> [[Category:ISO13485]]</div>

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