CLSI QMS02-A6-2013 (R2018)

Clinical and Laboratory Standards Institute document QMS02-A6-Quality Management System: Development and Management of Laboratory Documents; Approved Guideline-Sixth Edition presents the important components of creating, evaluating, approving, controlling, changing, and retiring documents used in the laboratory environment. This guideline describes the processes needed in a document management system, whether paper-based or electronic. Key features of electronic document management systems are described. Several examples of process and procedure documents for preexamination, examination, and postexamination laboratory activities are included.