Wayne, Pennsylvania, USA—March 2015—The Clinical and Laboratory Standards Institute (CLSI) has published a new document titled Process Management (QMS18-Ed1).This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes.
This new document outlines Process Management, one of the 12 quality system essentials (QSEs) described in CLSI document QMS01, which defines a structured approach to organizing, creating, and maintaining the necessary information for the QSEs. The document describes what laboratories need to do to meet published regulations, accreditation requirements, and international standards for process management and control, and provides suggestions and examples for fulfilling the requirements.
“I think the best feature in QMS18 is a new Project Management Tool Template. You could think of this tool as ‘the Theory of Everything’ for implementing any new or changed process in your laboratory because it covers all the requirements of all 12 QSEs,” notes QMS18 Working Group Chairholder, Lucia M. Berte, MT(ASCP)SBB, DLM; CQA(ASQ), CMQ/OE, of Laboratories Made Better! in Broomfield, Colorado, USA.
QMS18 describes how to use an organized approach for developing, verifying or validating, controlling, and changing laboratory path of workflow processes. By following the guidance in this document, laboratories can reduce or eliminate errors, meet customer expectations, and increase the effectiveness and efficiency of laboratory operations. This document is formatted in an enhanced full-color layout, which presents the information using callout boxes, important notes, and graphics to further comprehension and promote ease of use of the document.
This document is intended for use by administrative and technical personnel who develop, perform, and supervise laboratory processes and procedures; pathologists and laboratory medical directors; regulatory and accreditation organizations; educators; and manufacturers.