Stepwise implementation of a quality …

1 Stepwise implementation of a quality management system for a health laboratory39 WHO Regional Publications, Eastern Mediterranean SeriesStepwise implementation of a quality management system for a health laboratory39 WHO Regional Publications, Eastern Mediterranean Series World Health Organization 2016 All rights designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.

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3 However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Publications of the World Health Organization can be obtained from Knowledge Sharing and Production, World Health Organization, Regional Office for the Eastern Mediterranean, PO Box 7608, Nasr City, Cairo 11371, Egypt (tel: +202 2670 2535, fax: +202 2670 2492.)

4 Email: Requests for permission to reproduce, in part or in whole, or to translate publications of WHO Regional Office for the Eastern Mediterranean whether for sale or for noncommercial distribution should be addressed to WHO Regional Office for the Eastern Mediterranean, at the above address: email: layout and printing by WHO Regional Office for the Eastern Mediterranean, Cairo, EgyptCover photo shows triage and preparation of patient specimens for processing and examination. WHO/K NahapetyanWHO Library Cataloguing in Publication DataWorld Health Organization.

5 Regional Office for the Eastern MediterraneanStepwise implementation of a quality management system for a health laboratory / World Health Organization. Regional Office for the Eastern Mediterraneanp..- (WHO Regional Publications, Eastern Mediterranean Series; 39)ISBN: 978-92-9022-142-5 ISBN: 978-92-9022-143-2 (online)ISSN: 1020-041X1. Laboratories - standards 2. quality Control 3. Clinical laboratory Services - standards 4. Public Health Practice I. Title II. Regional Office for the Eastern Mediterranean III. Series (NLM Classification: WA 23)ContentsAcknowledgements.

6 71. Introduction ..112. Purpose of the document .. Scope and Target audience .. How to use the document ..143. Essential elements of national quality standards .. Structure and organization .. Facilities and environmental conditions .. Human resources .. laboratory equipment, reagents and consumables .. Examination processes and quality assurance of examination results .. quality management system .. Procurement and supply management .. management and examination of laboratory specimens .. Safety .. laboratory information management .

7 Ethical conduct ..384. Stepwise implementation strategy .. General introduction .. National level .. laboratory level ..42 Glossary ..43 Correlation table ..45 Bibliography ..487 AcknowledgementsAcknowledgementsThis document was developed and edited by the following: S bastien Cognat, WHO Lyon Office, Lyon, FranceFolker Spitzenberger, Deutsche Akkreditierungsstelle GmbH, Berlin, GermanyMohammad Youssef, WHO Lyon Office, Lyon, FranceHumayun Asghar, WHO Regional Office for the Eastern Mediterranean, Cairo, EgyptHala Esmat Tolba, WHO Regional Office for the Eastern Mediterranean, Cairo, EgyptKaren Nahapetyan, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt.

8 The following contributed to development and review of the document: Rainer Haeckel, Deutsche Akkreditierungsstelle GmbH, Berlin, GermanyPanadda Silva, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, ThailandHeinz Zeichhardt, Institut f r Virologie, Berlin, GermanyEvgeniy Gavrillin, WHO Regional Office for Europe, Copenhagen, Denmark Gulam Eshan Sharifi, Central Public Health laboratory , Ministry of Health, Kabul, Afghanistan Bashir Uddin Noormal, Afghanistan National Public Health Institute, Ministry of Health, Kabul, AfghanistanShah Agha Ghulam Rabani.

9 Kabul Medical University, Kabul, AfghanistanMohammad Yousuf Mubarak, Kabul Medical University, Kabul, AfghanistanAmjad Ghanem Zaed Mohamed, Public Health laboratory , Ministry of Health, Manama, Bahrain Nermin Kamal Hasan Saeed, Salmanyia Medical Complex, Ministry of Health, Manama, BahrainAzza Sadiq Eldanasoury, Central Public Health laboratory , Ministry of Health and Population, Cairo, EgyptDina Ramadan Lithy, Central Public Health laboratory , Ministry of Health and Population, Cairo, EgyptNuman Abdul Lateef Abdul Razak, Directorate of Public Health, Ministry of Health, Baghdad, Iraq8 Stepwise implementation of a quality management system for a health laboratoryHassan Yassir Jaber, Department of Technical Affairs, Ministry of Health, Baghdad, IraqMarjan Farzami, Reference Health laboratory , Ministry of Health and Medical Education, Tehran, Islamic Republic of IranNooshafarin Safadel, Reference Health laboratory , Ministry of Health and Medical Education, Tehran.

10 Islamic Republic of IranKatayoon Khodaverdian, Reference Health laboratory , Ministry of Health and Medical Education, Tehran, Islamic Republic of IranRafiq Abdel Rahman Saleh, Central Public Health Laboratories, Ministry of Health, Amman, JordanGaia Al-Wahdani, Central Public Health Laboratories, Ministry of Health, Amman, JordanTarek Al-Sanouri, Central Public Health Laboratories, Ministry of Health, Amman, JordanMohammed El-Khateeb, Faculty of Medicine, University of Jordan, Amman, JordanYousif Bilto, Faculty of Science, University of Jordan, Amman, JordanAla Qutishat, Chemistry and Endocrinology Laboratories, Al-Bashir Hospital, Amman, JordanNadera Eid Al-Shareef, Central Public Health Laboratories, Ministry of Health, Amman, JordanHaifa Ali Isleem, Central Public Health Laboratories, Ministry of Health, Amman, JordanNayef Ismaeel Al Hazaymeh, Jordanian Royal Medical Services, Amman, JordanNuha Yousef Obeid, Jordan University of Science and Technology, Irbid, JordanRanda Salah Yousef.