Laboratory quality management system world health organization. Manual, for use in all types of analytical laboratories, based on the twelve quality system essentials qse within a quality management system qms. A quality management system qms plans, controls, and improves the elements that impact on the achievement of the desired results by the laboratory and on the satisfaction of the users. Most will be the thoughts and vents of a long time player in the medical laboratory quality from many perspectives, complex and basic laboratories, developed and developing countries, research and new knowledge. Laboratory quality management system handbook pdf download. They are based on both iso 15189 and clsi gp26a3 documents. Clsis 12 quality systems essentials are the building blocks for a quality management system in clinical laboratory. Quality management systems for laboratories and external. Health laboratory management and quality assurance i preface it is apparent that a wellmanaged health laboratory with an appropriate quality assurance program has a major role in enhancing the standard of health service delivery to the community. To this end, xyz laboratory has developed and documented a quality management system to better satisfy the needs of its customers and to improve management of the organization.
A guideline for global application developed through the clinical and laboratory standards institute consensus process. Clinical and laboratory standards institute guideline qms01a quality management. Quality controlquality assurance qcqa can be defined as the set of planned and systematic activities focused on providing confidence that quality requirements will be fulfilled. The quality management system model for laboratory services. In order to achieve this, health laboratories need to strive and achieve international accreditation. This handbook covers topics that are essential for quality management of a public. This handbook covers topics that are essential for quality management of a public health or clinical laboratory.
This handbook is intended to provide a comprehensive reference on laboratory quality management system for all stakeholders in health laboratory processes, from management, to administration, to benchwork laboratorians. The quality system complies with the international standards iso 15189. Reprinted with permission from clinical and laboratory standards institute from. Pdf implementation of the laboratory quality management system.
Laboratory quality management system lab qms has evolved through several. Laboratory quality management system 19 issn 20540930 print, issn 20540949 online for a medical testing and diagnostic laboratory. This laboratory quality management system handbook is intended to provide a comprehensive reference. Xyz laboratory recognizes its responsibility as provider of quality services. A framework for managing this quality system must be established. A quality management system model for laboratory services. At the annual clinical laboratory quality regional meeting held in newport news, virginia, this past september, jean ball, mba, mthhs, mltascpan inspection services manager in the laboratory accreditation program at the college of american pathologists capindicated that gen. This document outlines a comprehensive practical approach to a laboratory quality management system qms by describing how to operationalize the management and technical requirements described in the iso 15189 international standard. It provides a crosswalk of the iso requirements for quality and competence for medical laboratories to the 12 quality system essentials delineated by the. In order to improve the accuracy of results, medical labs around the world have begun adopting iso 15189. A molecular information management system tailored to. Furthermore, it generates an unlimited number of report formats and types for each physician and pathologist. Iso 15189 quality manual for medical testing laboratories. Medical laboratoriesparticular requirements for quality and competence.
Each clinical laboratory must design, develop, document, validate, implement, monitor, and improve its own work processes and management infrastructural elements quality system essentials. The laboratory quality management plan 171 chapter 7 format of the plan there is no required format for a quality management plan. A quality management system qms is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Experience from bugando medical centre clinical laboratory. The clinical and laboratory standards institute clsi is a notforprofit membership organization that brings. The quality management system model for laboratory services, shown in figure 1, below, organizes all laboratory activities into 12 quality system essentials. Implementation of the laboratory quality management system iso 15189. H department of medical laboratory science, faculty of allied health sciences, bayero. The importance of implementing a quality management system. The quality manual is the big daddy of all the documents in the.
These include procedure manuals, maintenance schedules, calibrations, a quality assurance program, training and quality control. The chapters follow the framework developed by clsi and are organized as the 12 quality system essentials. Laboratory systems, and the clinical and laboratory standards institute clsi. Laboratory errors cost in time personnel effort patient outcomes introduction laboratory quality management systemmodule 1 25 25. Pdf guide to iso 9001 quality management systems duration. Pdf improving laboratory quality management system in. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on laboratory quality management system for all stakeholders in health laboratory processes.
Ensures that previously cited deficiencies have been corrected use the following techniques. Quality management system for all stakeholders in health laboratory processes, from management, to administration, to benchwork laboratorians. Quality in medical laboratories can be defined as accuracy, reliability and timeliness of reported results and a qms describes the approach to meet the quality objectives. A quality management system can be described as a set of building blocks needed to control, assure and manage the quality of the laboratorys processes. Requirements for quality management in medical laboratories 7 g. It covers a wide range of matters that influence the quality of a product or service. Implementing a quality management system in the medical. The purpose of this study was to facilitate the establishment of a strategically effective and sustainably standardized document management system by developing methods for document classification and document code standardization in order to improve the quality of laboratory medicine in the medical laboratories of domestic hospitals. The plan may be of the laboratorys own design, or it may follow a reference resource, such as clsi guideline gp22, continuous quality improvement.
Quality system program manual revision 21 dated 5119 see section 20 for procedure number and title page 2 of 41 section i policy and authority statement it is the policy of laboratory testing, incorporated lti, as a material organization, to furnish and perform testing services in nondestructive, mechanical, chemical, metallographic and metrology fields. Since 2002, quality assurance in medical laboratory tests belongs to medical product law rilibaek issued by the german medical association 1971, 1987, 2001, 2008 setting minimum standards for quality assurance in medical laboratories. The clinical and laboratory standards institute clsi has categorized the technical and management iso standards into 12 quality system essentials. It emphasizes the management responsibility to make a.
Laboratory information system psyche systems software. Quality system program manual laboratory testing inc. A quality management system model for laboratory services clsi. This guideline provides a model for medical laboratories to organize the implementation and maintenance of an effective quality management system. Pdf implementation of the laboratory quality management. Integrating five key quality system components,or gp26, application. During an internal audit, the laboratory should assess its quality management system against a recognized set of standards that applies to the quality system prescribed, such as iso 15189. A simple model for a laboratory quality system medical laboratory work is composed of the technical activities that produce laboratory results for patient care and the management activities that support the technical work. Qms for medical laboratories are described in international standards.
Alternatively, if the quality system is created by the institution, then a checklist that focuses on key quality activities as described by the quality. Clsi quality documents hs1a2 a quality management system model for health care describes quality system model, 12 essentials aligns to iso 15189 and parallels iso 9000 applies to all health care systems gp26a3 application of quality management system model for laboratory services describes laboratory application of quality system model. Also, it is a fullfeatured, easily configurable lims system. Westgard qc is proud to announce the publication of a new book, basic quality management systems. Understanding the four components of a quality management system is available as a free pdf download. Basic quality management systems for regulation and accreditation the first part of this book presents a broad perspective of management and technical requirements for laboratory accreditation, with a focus on the plan and process for implementing a quality management system. A qms helps coordinate and direct an organizations activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous. Accurate test results can only be produced if clinical laboratories implement good quality management system that meets international standards. Contains all requirements for a clinical laboratorys quality management system and the technical requirements used as the basis for confirming a clinical. Basic quality management systems essentials for implementing quality management in the medical laboratory. These qses provide a framework to ensure that all laboratory processes are performed correctly and within established guidelines. Economy management economic model may be used to improve business performance of laboratories by removing weaknesses, minimizing threats, using external opportunities and internal strengths. There are different standards that establish requirements for the implementation of a quality management system for laboratories, and a cross comparison between them is shown. Handbook for developing a laboratory quality manual, 1st.
The standard requires medical labs to implement a quality management system. It is part of the dark daily resource center which has a growing library of white papers and other information resources tailored specifically for the needs of laboratory administrators. Among them, international organization for standardization iso 15189 and clinical and laboratory standards institute clsi qms01a4. It provides a crosswalk of the iso requirements for quality and competence for medical laboratories to the 12 quality system.928 351 586 246 678 468 658 1400 1434 198 845 339 1049 1062 1068 275 1051 827 425 580 1095 15 219 456 1478 1317 1515 1556 1050 211 679 1619 1063 1598 941 822 92 715 1027 276 360 977 627 1440