The quality system regulations include a number of specific sections. You can see the titles here, and click the links to read the actual regulations on the FDA website.
Subpart A--General Provisions |
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Scope |
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Definitions |
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Quality system |
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Subpart B--Quality System Requirements |
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Management responsibility |
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Quality audit |
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Personnel |
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Subpart C--Design Controls |
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Design controls |
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Subpart D--Document Controls |
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Document controls |
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Subpart E--Purchasing Controls |
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Purchasing controls |
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Subpart F--Identification and Traceability |
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Identification |
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Traceability |
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Subpart G--Production and Process Controls |
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Production and process controls |
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Inspection, measuring, and test equipment |
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Process validation |
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Subpart H--Acceptance Activities |
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Receiving, in-process, and finished device acceptance |
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Acceptance status |
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Subpart I--Nonconforming Product |
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Nonconforming product |
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Subpart J--Corrective and Preventive Action |
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Corrective and preventive action |
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Subpart K--Labeling and Packaging Control |
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Device labeling |
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Device packaging |
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Subpart L--Handling, Storage, Distribution, and Installation |
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Handling |
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Storage |
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Distribution |
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Installation |
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Subpart M--Records |
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General requirements |
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Device master record |
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Device history record |
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Quality system record |
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Complaint files |
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Subpart N--Servicing |
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Servicing |
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Subpart O--Statistical Techniques |
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Statistical techniques |
Learning Objectives: