Bs 8004 Clause 7.5.5
Bs 8004 Clause 7.5.5 Act
4 Systemic Requirements4.1Establish a qualitysystem for yourmedical devices. Developa quality management system for medical devices. Implement aquality management system for medical devices. Maintain yourmedical device quality management system.4.2Document yourmedical devicequality system4.2.1 Develop quality managementsystem documents.4.2.2 Prepare quality managementsystem manual.4.2.3 Control qualitymanagement system documents.4.2.4 Maintain qualitymanagement system records.
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