A Quality Management System (QMS) is an organized system that is structured to assure that laboratory operations provide quality results through quality operations.
The structure of the system consists of goals and instructions for all laboratory personnel involved in the implementation and day-to-day operations of the system. All documentation and instructions must be accessible to all laboratory employees as well as the hospital administrative staff and all regulatory persons engaged in compliance surveys.
Documentation that comprises the QMS most often includes documents specifying policies, procedures, processes, and forms. These components make up the structural documents that provide guidance and tools to be used to collect data. Specific use of all documents is specified by the persons responsible and accountable for oversight of the quality aspects of the laboratory.
A policy is a statement of intent. An overall quality policy is structured to provide a statement outlining quality operations and to produce a quality product. A policy is intended to answer the question "What is to be done?"
Each Quality System Essential (QSE), as defined by CLSI as the components to make up a Quality Managment 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 a part of the process, who will complete each process, and documentation that 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 the form of procedures for each activity.
Forms are created for documentation of the specific activities. A form provides the answer to "How is data recorded?" Forms may be used to record data, information, results, and any other information related to fulfillment of the QSE's. Appropriate staff members complete the forms utilized for completion of required procedural activities. Completed documentation becomes a permanent record.
Records are labeled, stored, and retained as outlined in the policy, procedure, and in the document control system.
