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  QMS Audit

Process Approach – SIPOC model

bullet-green-arrow-25Collect output evidence of meeting requirements (customer specific)

bullet-green-arrow-25Audit business objectives

bullet-green-arrow-25Check downstream to verify requirements being met

bullet-green-arrow-25Resources available (controlled)

bullet-green-arrow-25Process DO and any documented instructions align

Manufacturing Process Audit

bullet-green-arrow-25All of Above

bullet-green-arrow-25effective implementation of the process risk analysis (such as PFMEA), control plan, and associated documents, product safety