CLSI GP02-A5-C

The major concepts of document control are presented in a user-friendly format that is easy to read and implement, thanks to the this toolkit. The Toolkit includes the following nine templates with illustrative examples that provide the framework for developing procedures and communicating and organizing information:

• Analytical quantitative procedures;
• Analytical qualitative procedures (e.g., dipstick, slide, immunohematology tests, etc.);
• Pre- and post-nonanalytical processes;
• Analyzer procedures;
• Laboratory information system procedures;
• Master document index (an Excel template is included to facilitate sorting of data);
• Document change request form for approving new documents or changing previously approved documents;
• Comparison of analytic-specific attributes by analyzer type; and
• Analytic attributes for analyzers.

These templates enable one to establish a starting point for creating one’s own laboratory-specific procedure manual. The templates allow the user to enter information into a “boiler plate” file where the parameters are preformatted – headers and footers are set. The user can simply open the template and fill in the blanks.