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|4. REQUIREMENTS |Observations/Comments |Results |
|4. Quality Management System || |
|4.1 General Requirements | | |
|Check for documentation of the processes included in the QMS | ||
|Check for information on the relationship and sequence of the | | |
|QMS processes. | | |
|Ask Management if operation andcontrol of processes is | | |
|effective. How do they know if it is effective? | | |
|Ask how they are able to know if resources and information || |
|needed to support processes have been provided. | | |
|Is there any information on the effectiveness of processes? | | |
|How areimprovements made to processes? | | |
|What processes does your organization outsource? How is the | | |
|process controlled? || |
|Additional Questions: | | |
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|4.2 Documentation Requirements | | |
|Is there a list or other means of identifyingother | | |
|documentation required by your QMS? | | |
|Does your quality system documentation include the || |
|documentation required by the standard? | | |
|Quality Policy and Objectives | | |
|Quality Manual...