CLSI publishes quality management system document
Clinical and Laboratory Standards Institute (CLSI)
The Clinical and Laboratory Standards Institute (CLSI) has published a document entitled 'Quality Management System: A Model for Laboratory Services; Approved Guideline-Fourth Edition (GP26-A4)'.
This document provides a practical model for medical laboratories that is designed to assist with the implementation and maintenance of an effective quality management system (QMS).
To facilitate this objective, GP26 offers a structure for a systematic approach to build quality into the laboratory's processes, to assess the laboratory's performance and to implement quality improvements and can be used with other quality-related documents to design the system foundation necessary to achieve total quality management.
The document combines and replaces the previous edition of the approved guideline, GP26-A3, published in 2004, and the second edition of CLSI document HS01, also published in 2004.
'GP26-A4 categorises existing regulatory and accreditation requirements into universal topics that make it easier for laboratories to design their managerial and technical work to meet those requirements as well as to contribute positively to patient safety,' said Lucia M Berte of Laboratories Made Better in Broomfield, Colorado, and the chairholder of the working group that created the document.
According to the CLSI, an integrated QMS provides an opportunity to deliver consistent, high-quality and cost-effective laboratory services.
If a laboratory implements the QMS model described in this guideline, several key outcomes are enhanced, including the ability to reduce or eliminate error, the likelihood of meeting customer expectations, the practice of more effective and efficient operations, the potential for successful governmental and accreditation assessments and the sustainable attainment of quality objectives.
'This version of GP26 realigns the QSEs [quality system essentials] to more logically follow the implementation of new laboratory processes and test systems and includes any additions or changes to the reference requirements since the previous version,' added Berte.
In addition to reunifying the information about the QSEs with the information about the laboratory's path of workflow, GP26 also provides additional examples of documents and forms that can be used or modified as needed for implementing a QMS in the laboratory.
This guideline is intended for use by laboratory directors, managers, supervisors, quality managers and others responsible for implementing, maintaining and evaluating the laboratory's QMS.
The QMS model described in GP26 can be used in medical laboratories, public health laboratories, research laboratories, veterinary laboratories, food laboratories and environmental laboratories.
By applying the recommendations of GP26, the laboratory can implement a QMS that incorporates international, national, accreditation, local and organisational requirements.
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