The organization shall document a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard and applicable regulatory requirements.<br><br>The organization shall establish, implement and maintain any requirement, procedure, activity or arrangement required to be documented by this International Standard and applicable regulatory requirements.<br><br>The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirements.<br><br><br>Establishment or change history with dated approval signature by authorized personnel should be included.
正在翻譯中..
