A Quality Management System (QMS) is an organized system that is structured to ensure that laboratory operations provide quality results through quality operations.
The system's structure consists of goals and instructions for all laboratory personnel involved in its implementation and day-to-day operations. All documentation and instructions must be accessible to all laboratory employees, the hospital administrative staff, and all regulatory persons engaged in compliance surveys.
The QMS's documentation most often includes policies, procedures, processes, and forms. These components make up the structural documents that provide guidance and tools for data collection. The specific use of all documents is specified by the persons responsible and accountable for overseeing the laboratory's quality aspects.
A policy is a statement of intent. An overall quality policy is structured to outline quality operations and produce a quality product. It is intended to answer the question, "What is to be done?"
Each Quality System Essential (QSE), defined by CLSI as the components of a Quality Management System, should also have a specific policy that specifies what is to be done and guidelines for the specific personnel who will perform these duties. The policy should also provide tasks to be performed and a general statement regarding who will perform that function.
Processes are activities that must be performed to implement specific policies. There is a minimum of one activity per process. A process is intended to answer the question, "How do we meet the requirement outlined in the policy?" Each process is constructed to provide guidance for what activities and documentation are to be completed as part of it, who will complete each process, and what documentation must be generated as a record of the completed process.
Procedures expand on the processes and provide step-by-step instructions on how to complete each process. A procedure must answer the question, "How is this activity completed?" There should be at least one activity for each process and specific instructions in procedures for each activity.
Forms are created to document the specific activities. A form answers the question, "How is data recorded?" Forms may be used to record data, information, results, and other information related to fulfilling the QSE's. Appropriate staff members complete the forms utilized for completing required procedural activities. Completed documentation becomes a permanent record.
Records are labeled, stored, and retained according to the policy, procedure, and document control system.
