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CLSI Releases New Standard on Laboratory Internal Audit Programs

The Clinical and Laboratory Standards Institute (CLSI) has released a new quality management systems standard on laboratory internal audit programs. A laboratory audit program is critical to ensuring laboratories meet applicable requirements for quality system essentials assessments.

QMS15-A—Laboratory Internal Audit Program; Approved Guideline provides guidance for how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement. Whereas an audit program defines the “who,” “what,” “when,” “where,” and “how” of meeting requirements for internal auditing, the audit process describes the details of how to conduct individual laboratory internal audits.

“Don’t just prepare for inspections; be inspection ready at all times,” emphasizes Jennifer Schiffgens,MBA, MT(ASCP), CLS, Chairholder of QMS15-A and Regional Director – Laboratories and Pathology of Sutter Health West Bay Hospitals in San Francisco, California, USA. “Don't be afraid to take an honest look (at your laboratory) in the mirror; in the long run, it will save you time and resources.”  

This document focuses on using a laboratory internal audit program to actualize a laboratory’s commitment to quality. QMS15-A helps laboratories demonstrate good professional practice and continual improvement by identifying problematic processes.  

The new document provides examples that are applicable to laboratories of any size and functional complexity. It is intended for laboratory leaders such as directors, managers, and supervisors, and other individuals associated with laboratories that perform medical testing.

QMS15-A is now available in the CLSI Shop, along with an enlightening on-demand webinar facilitated by QMS15-A Chairholder Jennifer Schiffgens.