“…In the laboratory, we decided to follow the CLSI structure as a framework for our policies, procedures, and processes. We structured those items around the 12 quality system essentials, namely, (1) organization, (2) personnel, (3) facilities and safety, (4) equipment, (5) purchasing and inventory, (6) information management, (7) documents and records, (8) process management, (9) assessments, (10) nonconforming event management, (11) continual improvement, and (12) customer focus. 33 For each quality system essentials category, we first drafted the policies, followed by draft processes or workflows, and then defined the procedures.…”