QMS Tools and Resources

Public health and clinical laboratories require a foundation of quality to ensure fidelity in the total testing process. Laboratory operations need to be reliable, tests need to be as accurate as possible, and test results must be promptly delivered. Failures at any step within these systems could result in consequences for patient and population health.

Quality Management Systems (QMS) have been described by the International Organization for Standardization (ISO) and the Clinical Laboratory Standards Institute (CLSI) as “coordinated activities to direct and control an organization with regard to quality.” A QMS investigates the entire laboratory system, and many accreditation programs now require clinical laboratories to develop and follow QMS for their NGS-based tests.

Use of trade names is for identification only and does not imply endorsement by the US Department of Health and Human Services.

Using 12 Quality System Essentials to Build a QMS

CDC and APHL adopted the CLSI 12 QSEs as building blocks for developing a QMS for clinical and public health laboratories performing NGS-based tests.

Assessments

Provides guidance on how internal and external assessments can be used to determine if quality requirements are met. Products and tools for this QSE are currently being developed, and will be presented when available.

Continual Improvement

Provides guidance on how to identify and select opportunities for improvement and how to implement and evaluate the effects of solutions. Products and tools for this QSE are currently being developed, and will be presented when available.

Customer Focus

Guides how laboratories should consider internal and external customer requirements to ensure that processes are designed to meet quality expectations. Products and tools for this QSE are currently being developed, and will be presented when available.

Documents and Records

Provides guidance on how policies and procedures are developed, managed, and maintained. Products and tools for this QSE are currently being developed, and will be presented when available.

Equipment

Provides guidance on how equipment is selected, installed, qualified, maintained, and decommissioned.

Facilities and Safety

Guides the physical requirements of the work environment and considerations for ensuring safety in the workplace. Products and tools for this QSE are currently being developed, and will be presented when available.

Information Management

Provides guidance on how information and data from internal and external sources is managed throughout the laboratory’s workflow. Products and tools for this QSE are currently being developed, and will be presented when available.

Nonconforming Event Management

Provides guidance on how non-conforming events are evaluated and managed to minimize risk. Products and tools for this QSE are currently being developed, and will be presented when available.

Organization

Provides guidance on the roles, responsibilities, and lines of authority. Products and tools for this QSE are currently being developed, and will be presented when available.

Personnel

Provides guidance on ways to ensure that staff are qualified, trained, and competent to perform the Ion.

Process Management

Provides guidance on the way laboratory processes are managed throughout the entire testing lifecycle from sample collection to test result reporting.

Purchasing and Inventory

Provides guidance on how materials and supplies are procured and evaluated for use in the laboratory. Products and tools for this QSE are currently being developed, and will be presented when available.

Contact Us

For more information about the NGS Quality Initiative, contact us at NGSQuality@cdc.gov.

Page last reviewed: February 5, 2020