As CLSI document QMS 01-05 recommends, 12 quality system essentials (QSEs) should be considered for any QMS program. Table 1 describes the QSEs.
Each laboratory will develop and implement a QMS program suited and structured for the individual laboratory.
Table 1. Description of the Quality System Essentials.| Quality System Essential | Description |
| Organization and Leadership | Leadership responsibilities contribute to the laboratory’s necessary quality to meet regulatory, accreditation, customer, and internal requirements. |
| Customer Focus | Designing work to meet the expectations of the laboratory customers. It also provides customer input to verify the meeting of customer expectations. |
| Facilities and Safety Management | Maintenance and safety programs are needed to provide the laboratory with adequate space, workflow, and environmental conditions to support work practices and staff safety and meet compliance requirements. |
| Personnel Management | Establishing and retaining sufficient qualified personnel to perform all work practices and manage all laboratory activities. |
| Supplier and Inventory Management | Arrangements and agreements with customers and outside vendors for necessary supplies and services are consistently provided. |
| Equipment Management | Sufficient equipment selection, installation, maintenance, and completion of all necessary operating procedures and appropriate documentation of maintenance and operational problems encountered. |
| Process Management | Workflow processes to meet requirements and efficient use of resources. |
| Documents and Records Management | Create, manage, and appropriately retain policy, procedure, and process documents for the QSEs and workflow implementation. |
| Information Management | Management of the information generated and stored in laboratory recordkeeping systems. |
| Nonconforming Event Management | Processes for detecting, documenting, classifying, analyzing, and correcting nonconformances and problems created by them. |
| Assessments | External and internal monitoring and assessments to verify and document that laboratory processes meet requirements and to determine and monitor that these processes are functioning appropriately. |
| Continual Improvement | Processes for identifying opportunities for improvement and developing strategies to continue the improvements. |
