A cruical part of a functioning laboratory is the lab's quality manual. The quality manaual describes, speicifically, the scope of the activities of the laboratory and establishes documentation for the procedural means by which those actitivies are fufilled. The Quality Manaual provides the all documentaion required to run the laboratory and may include: procedures, policies, forms, and checklists. These activites include: nonconformity, corrective and preventitive action, document control, records management, and internal audit.
A Quality Manaual is important not just for regulatory compliance purposes, but also for creating an objective document that provides instruction for how functions are performed within the laboratory. This eliminates the need for "tribal knowledge" and institutional dependencies on personnel.
