scope:

This guideline is intended to help laboratories meet quality management system requirements for quality system essential (QSE) Information Management. In addition to discussing the requirements for how data and information are generated and entered into paper-based or electronic recordkeeping systems, this guideline also offers suggestions and examples for meeting the intent of the requirements.

This guideline is applicable to medical laboratories of any size, complexity, or specialty, including point-of-care testing. Because the concepts of information management are generic, this guideline can be used by other types of laboratories, such as public health, research, food, environmental, and veterinary.

This guideline does not provide specific procedures for information management.