Quality Management System General（质量管理体系总）.pdf

Quality Management System General Audit Date: Requirement: 4.1 and 4.2.2-QMS General Verify Scope Comments/Evidence/Findings: Verify the Exclusions is applicable and j ustified How are the processes in the QMS necessary to meet Comments/Evidence/Findings: customer requirements and improve the QMS identified in the Quality Manual? How are the sequence and interaction of these processes outlined in the Quality Manual? How are procedures included or referenced in the quality Comments/Evidence/Findings: manual? Is there evidence that the system is being reviewed and improved? Site examples of documents that have been modified recently. Document Date Revised Comments/Evidence/Findings: How does the organization check to ensure that appropriate Comments/Evidence/Findings: resources and information are available to ensure the effective operation of the company’s processes? What does the organization monitor to know if things are working well? Is the data being analyzed? How? Is there objective evidence to prove this is happening? What criteria and methods have been determined to ensure Comments/Evidence/Findings: that the operation ad control of processes is effective? What does the company do if processes are not working Comments/Evidence/Findings: well? Is there objective evidence to prove this is happening? (Check CAPA’s) How does the organization handle outsourced product? How Comments/Evidence/Findings: do they define the extent of control that is required of an outsourced supplier? Where is this defined? How do people know? Page 1 of 43 10/28/2011 Requirement: 4.2.1-QMS Documentation Requirements Are all required document