scope:

This guideline is intended to help laboratories meet QMS requirements for the records portion of quality system essential (QSE) Documents and Records Management. It presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and disposing of laboratory records. This guideline can be used in laboratories worldwide and is intended for use primarily by:

• Medical laboratories

• Blood gas laboratories

• Blood donor and pretransfusion testing laboratories

• Public health laboratories

• Clinical research laboratories

However, because the concepts of records management are generic, this guideline is also applicable to other types of laboratories, including but not limited to:

• Food laboratories

• Environmental laboratories

• Veterinary laboratories

This guideline does not specifically cover management of specimens and clinical materials (eg, pathology blocks and slides, blood and body fluid specimens), which also requires appropriate retention and disposal. However, many of the concepts contained in this guideline could be applied to management of these materials. Refer to CLSI document QMS011 for more information about specimen management. This guideline does not cover the documents portion of QSE Documents and Records Management. Refer to CLSI document QMS0214 for more information on document management.