QMS Tools and Resources

What to know

Clinical and public health laboratory personnel can access free tools and resources to strengthen quality management practices for their next generation sequencing workflows.

A laboratory staff member searching for NGS QI tools on a computer.

Overview

Public health and clinical laboratories require a foundation of quality to ensure fidelity in the total testing process. Failures at any step can impact patient and population health. Find tools to build or enhance your Quality Management System (QMS) on this page.

The International Organization for Standardization (ISO) and the Clinical and Laboratory Standards Institute (CLSI) describe a QMS as "coordinated activities to direct and control an organization with regard to quality." A QMS investigates the entire laboratory system. Many accreditation programs now require clinical laboratories to develop and follow QMS for their NGS-based tests.

The CDC and the Association of Public Health Laboratories (APHL) use the CLSI 12 Quality Systems Essentials (QSEs). These QSEs are used to develop QMS for NGS-based tests in clinical and public health labs.

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

If you encounter an error when downloading, or for other technical issues, contact us at NGSQuality@cdc.gov.

Keep Reading: The Next Generation Sequencing Quality Initiative

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Content Source:
Division of Laboratory Systems (DLS)