Document Control for Cytopathology

Document Control problems are among the most frequently cited in laboratory inspections. As a fundamental component of good laboratory management, the laboratory that develops and maintains a document control system will see collateral benefits throughout the organization. These include process standardization as well as added resources for training and competency assessments. This workbench provides the basic concepts and common elements of an effective Document Control System with specific examples for implementation in Cytopathology.

The objectives for this workbench are:

1. Define common document control elements required by various regulatory organizations.

2. Discuss components of a Document Control System.

3. Provide mechanisms for assessing the effectiveness of a Document Control System.