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Section 820.1
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Definitions |
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Section 820.3
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Quality system |
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Section 820.5
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Management responsibility |
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Section 820.20
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Quality audit |
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Section 820.22
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Personnel |
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Section 820.25
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Design controls |
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Section 820.30
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Document controls |
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Section 820.40
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Purchasing controls |
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Section 820.50
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Identification |
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Section 820.60
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Traceability |
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Section 820.65
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Production and process controls |
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Section 820.70
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Inspection, measuring, and test equipment |
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Section 820.72
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Process validation |
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Section 820.75
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Receiving, in-process, and finished device acceptance |
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Section 820.80
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Acceptance status |
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Section 820.86
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Nonconforming product |
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Section 820.90
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Corrective and preventive action |
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Section 820.100
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Device labeling |
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Section 820.120
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Device packaging |
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Section 820.130
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Handling |
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Section 820.140
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Storage |
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Section 820.150
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Distribution |
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Section 820.160
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Installation |
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Section 820.170
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General requirements |
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Section 820.180
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Device master record |
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Section 820.181
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Device history record |
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Section 820.184
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Quality system record |
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Section 820.186
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Complaint files |
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Section 820.198
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Servicing |
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Section 820.200
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Statistical techniques |
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Section 820.250
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Scope |