ISO 13485 audit checklist

 An ISO 13485 audit checklist is a tool used by auditors to assess whether an organization’s quality management system (QMS) meets the requirements of the ISO 13485 standard. The ISO 13485 audit checklist covers all aspects of the QMS, from top management commitment to product realization and design control. It also includes guidance on how to conduct an auditor’s review of an organization’s QMS.




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