ISO 13485 audit checklist of general requirements
ISO 13485 audit checklist of general requirements
Clause 4.1
1. Has Organization established, documented, implemented and maintained a QMS and maintained (continually improved) its effectiveness in accordance with ISO 9001/13485? (Questions in section 4.1 are verified throughout the audit).
2. Where has Organization identified the processes needed for the QMS and their application throughout the organization? (See 4.2.2).
3. Were has Organization determined the sequence and interaction of QMS processes? (See 4.2.2).
4. What are the criteria and methods Organization uses to ensure that the operation and control of QMS processes are effective?
5. Has Organization provided resources and information needed to support the operation and monitoring of QMS processes? (See section 6)
6. How does Organization monitor, measure and analyze QMS processes? (See section 
7. How has Organization implemented actions necessary to achieve planned results and maintain the effectiveness (continual improvement) of processes needed for the QMS?
8. Are processes needed for the QMS managed by the organization in accordance with the requirements of ISO 9001:2000?
9. When Organization outsources any process that affects product conformity with requirements, how is control ensured over such processes? (See 7.4)
10. Where is the control of outsourced processes that affect product conformity with requirements identified within the QMS? (See 7.4)
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