Laboratory Quality Management System Handbook
LaboratoryQualityManagementSystemHandbook
WHO Library Cataloguing-in-Publication DataLaboratory quality management system: handbook.1.Laboratories — organization and administration. 2. Laboratories — handbooks.3.Laboratories techniques and procedures — standards. 4.Quality control. 5.Manuals.I.World Health Organization.ISBN 978 92 4 154827 4(NLM classification: QY 25) World Health Organization 2011All rights reserved. Publications of the World Health Organization are available on theWHO web site (www.who.int) or can be purchased from WHO Press, World HealthOrganization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: 41 22 791 3264; fax: 41 22 791 4857; e-mail: bookorders@who.int).Requests for permission to reproduce or translate WHO publications – whether for saleor for noncommercial distribution – should be addressed to WHO Press through theWHO web site (http://www.who.int/about/licensing/copyright form/en/index.html).The designations employed and the presentation of the material in this publication donot imply the expression of any opinion whatsoever on the part of the World HealthOrganization concerning the legal status of any country, territory, city or area or of itsauthorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines onmaps represent approximate border lines for which there may not yet be full agreement.The mention of specific companies or of certain manufacturers’ products does not implythat they are endorsed or recommended by the World Health Organization in preferenceto others of a similar nature that are not mentioned. Errors and omissions excepted, thenames of proprietary products are distinguished by initial capital letters.All reasonable precautions have been taken by the World Health Organization to verifythe information contained in this publication. However, the published material is beingdistributed without warranty of any kind, either expressed or implied. The responsibilityfor the interpretation and use of the material lies with the reader. In no event shall theWorld Health Organization be liable for damages arising from its use.Printed in FranceContactsWHO Lyon Office – International Health Regulations Coordination58 avenue Debourg – 69007 Lyon – Franceihrinfo@who.intCDC – National Center for Preparedness, Detection and Control of InfectiousDiseases (NCPDCID)1600 Clifton Road – Atlanta, GA – USAQMS toolkit@CDC.govClinical and Laboratory Standards Institute940 West Valley Road, Suite 1400Wayne, PA 19087 – USAcustomerservice@clsi.orgLaboratory Quality Management System
Table of contentsAcknowledgements .p 4Foreword .p 5Key words .p 61. Introduction to quality .p 71-1: The importance of laboratory quality.p 81-2: Overview of the quality management system .p 91-3: The quality management system model .p 111-4: History of laboratory quality management .p 141-5: International laboratory standards.p 151-6: Summary .p 162. Facilities and safety . p 172-1: Overview .p 182-2: Laboratory design .p 202-3: Geographic or spatial organization .p 212-4: Physical aspects of premises and rooms .p 222-5: Safety management programme .p 232-6: Identification of risks .p 252-7: Personal protective equipment .p 292-8: Emergency management and first aid .p 302-9: Summary .p 323. Equipment . p 333-1: Overview .p 343-2: Selecting and acquiring equipment .p 363-3: Getting equipment ready for service .p 383-4: Implementing an equipment maintenance programme .p 403-5: Troubleshooting, service, repair and retiring equipment .p 423-6: Equipment maintenance documentation .p 443-7: Summary .p 464. Purchasing and inventory . p 474-1: Overview .p 484-2: Purchasing .p 504-3: Implementing an inventory management programme .p 514-4: Quantification .p 524-5: Forms and logs .p 544-6: Receipt and storage of supplies .p 554-7: Monitoring inventory .p 574-8: Summary .p 585. Process control—sample management . p 595-1: Overview .p 605-2: The laboratory handbook.p 615-3: Collection and preservation .p 625-4: Sample processing .p 645-5: Sample storage, retention and disposal .p 665-6: Sample transport .p 675-7: Summary .p 70Laboratory Quality Management System1
6. Process control—introduction to quality control. p 716-1: Introduction .p 727. Process control—quality control for quantitative tests . p 757-1: Overview .p 767-2: Control materials .p 777-3: Establishing the value range for the control material .p 797-4: Graphically representing control ranges .p 847-5: Interpreting quality control data .p 857-6: Using quality control information .p 877-7: Summary .p 888. Process control—quality control for qualitative andsemiquantitative procedures . p 898-1: Overview .p 908-2: Quality control materials .p 928-3: Quality control of stains .p 948-4: Quality control of microbiological media .p 968-5: Summary .p 989. Assessment—audits . p 999-1: Overview . p 1009-2: External audit . p 1039-3: Internal audit . p 1059-4: Internal audit programme . p 1069-5: Actions as result of audit . p 1089-6: Summary . p 10910. Assessment—external quality assessment . p 11110-1: Overview . p 11210-2: Proficiency testing. p 11510-3: Other external quality assessment methods . p 11710-4: Comparison of external quality assessment methods. p 11910-5: Managing external quality assessment in the laboratory . p 12010-6: Summary . p 12211. Assessment—norms and accreditation . p 12311-1: Overview . p 12411-2: International standards and standardization bodies . p 12511-3: National standards and technical guidelines . p 12711-4: Certification and accreditation . p 12911-5: Process of accreditation . p 13211-6: Benefits of accreditation . p 13311-7: Summary . p 13412. Personnel . p 13512-1: Overview . p 13612-2: Recruitment and orientation . p 13812-3: Competency and competency assessment . p 14012-4: Training and continuing education . p 14312-5: Employee performance appraisal . p 14512-6: Personnel records. p 14712-7: Summary . p 1482Laboratory Quality Management System
13. Customer service . p 14913-1: Overview . p 15013-2: The laboratory clients—the customers . p 15213-3: Assessing and monitoring customer satisfaction . p 15513-4: Customer satisfaction surveys . p 15613-5: Summary . p 15814. Occurrence management . p 15914-1: Overview . p 16014-2: Sources and consequences of laboratory error . p 16114-3: Investigation of occurrences. p 16314-4: Rectifying and managing occurrences. p 16414-5: Summary . p 16615. Process improvement . p 16715-1: Continual improvement concept . p 16815-2: Tools for process improvement . p 17015-3: Quality indicators . p 17215-4: Selecting quality indicators . p 17315-5: Implementing process improvement . p 17615-6: Summary . p 17816. Documents and records . p 17916-1: Introduction . p 18016-2: Overview of documents. p 18116-3: The quality manual . p 18416-4: Standard operating procedures (SOPs) . p 18516-5: Document control . p 18816-6: Overview of records . p 19116-7: Storing documents and records . p 19316-8: Summary . p 19417. Information management . p 19517-1: Overview . p 19617-2: Elements of information management . p 19717-3: Manu
management, laboratory sample transport, laboratory purchasing and inventory, laboratory assessment, laboratory customer service, occurrence management, process improvement, quality essentials, laboratory process control, clinical laboratory, ISO 15189. Key words Note: Health laboratories, in this handbook, is a term that is meant to be inclusive
4.2 Quality Management System. The laboratory has a Quality Management System that supports the laboratory management's commitment to good professional practice and to the quality of its testing. 4.3 Document Control. The Laboratory controls all documents that form part of its quality system, such as the
The laboratory quality management system must incorporate all the laboratory . in laboratory handbook. 5.6 Ensuring quality of examination results 5.6.3 Inter-laboratory comparisons The laboratory
Handbook EN (2011): 250. Training-of-trainers course on Laboratory Quality management System for South eastern European Countries Belgrad, Serbia, 14-17 December 2010. Laboratory Quality Management System Training of Trainers in the Caribbean Port of Spain, Trinidad and
maintaining the management infrastructure for a quality laboratory system. Based on CLSI guidelines and the ISO 15189 standard, WHO published a handbook “Laboratory Quality Management System” [16] and tool kit “Laboratory Quality Management Systems Training Toolkit” [17], to guide an
ISO 8402 Quality management and quality assurance – vocabulary ISO 19011 Guidelines for quality and/or environmental management system auditing ISO 9001 Quality management systems – requirements. Laboratory Quality Standards and their Implementation 5 2 Development and
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3. Quality management system 12 3.1 Quality policy 12 3.1.1 Quality levels 12 3.1.1.1 Academic research 12 3.1.1.2 Cooperative research 13 3.1.1.3 Laboratory work of students 13 3.2 Purpose of the quality system 13 3.3 Responsibilities 13 3.4 Structure of the quality management system 13 3.4.1 Quality manual 14
Batch baking is an economical way of having baked goods for the family which will last days. Owning a freezer makes batch baking an even more viable method of cooking as a variety of baked items can be frozen ahead of time and used as required. This is beneficial if you have less time to spend on meal preparation as well as helping to cater for unexpected guests and large numbers. Filling the .
