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Author: Saverio Mannino Publisher: ISBN: 9783031117251 Category : Languages : en Pages : 0
Book Description
This useful and extensive set of guidelines is designed to assist food control laboratories in gainingaccreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements,organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation todistribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers isthe guide for accreditation for food control laboratories. .
Author: Saverio Mannino Publisher: ISBN: 9783031117251 Category : Languages : en Pages : 0
Book Description
This useful and extensive set of guidelines is designed to assist food control laboratories in gainingaccreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements,organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation todistribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers isthe guide for accreditation for food control laboratories. .
Author: World Health Organization Publisher: ISBN: 9789241548274 Category : Laboratories Languages : en Pages : 0
Book Description
Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. 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 was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. 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 bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".
Author: Saverio Mannino Publisher: Springer Nature ISBN: 3031117247 Category : Technology & Engineering Languages : en Pages : 170
Book Description
This useful and extensive set of guidelines is designed to assist food control laboratories in gaining accreditation from an internationally recognized external body, providing all of the necessary information and practices in an easy-to-read, step-by-step fashion. Authored by an experienced consultant for laboratory accreditation in many different countries, with this text food control lab owners now have all of the up-to-date information they need to gain accreditation in a single source. Guidelines for Laboratory Quality Managers covers the essentials for quality management in the food control laboratory, from testing processes to current quality management systems. The ISO standards for accreditation are extensively explored, including managerial requirements, organizational aspects, complaint handling procedures, internal audits, and sampling. An entire section is dedicated to the implementation of managerial and technical requirements from quality control to program monitoring and evaluation. Analysis selection, preparation, and validation is covered extensively, and an entire section is dedicated to basic statistics from data presentation to distribution. Each section comes with helpful tips for lab managers plus definitions and terms. Comprehensive, easy-to-use and up-to-date, Guidelines for Laboratory Quality Managers is the guide for accreditation for food control laboratories.
Author: Candis A. Kinkus Publisher: Demos Medical Publishing ISBN: 1936287455 Category : Business & Economics Languages : en Pages : 192
Book Description
A key issue for every laboratory and individual practitioner is the assessment of risk and current working knowledge of the standards of care established for diagnostic testing via guidelines, major studies and trials. the diagonstic Standards of Care series presents an overview of the key diagnoses in clinical pathology using case examples to illustrate effective analysis of the case in light of current evidence and standards for the problem discussed. In addition to being practical diagnostic guides, these volumes will have a unique emphasis on quality assurance and evidence-based testing pr
Author: Viruti Shivan Publisher: Independently Published ISBN: Category : Medical Languages : en Pages : 0
Book Description
In "Laboratory Quality Manager - The Comprehensive Guide", professionals in the field of laboratory management are introduced to a wide array of essential strategies and techniques necessary for leading a successful laboratory. This in-depth guide covers all aspects of laboratory quality management, from understanding regulatory requirements and maintaining compliance to implementing effective quality control procedures and fostering a culture of continuous improvement. The book dives deep into the role of a Laboratory Quality Manager, highlighting the skills and knowledge required to ensure high standards of laboratory performance. It offers practical advice on handling common challenges, managing a diverse team, and driving innovation in laboratory practices. Additionally, the guide provides valuable insights into the latest industry trends and future directions in laboratory management, preparing readers for the evolving landscape of laboratory science. Please note that this book does not contain any images or illustrations, in compliance with copyright policies, ensuring a focus on high-quality, informative content.
Author: James O. Westgard Publisher: Elsevier Health Sciences ISBN: 032347764X Category : Medical Languages : en Pages : 314
Book Description
This issue of Clinics in Laboratory Medicine entitled “Risk, Error and Uncertainty: Laboratory Quality Management in the Age of Metrology will be guest edited by Sten Westgard, James Westgard, and David Armbruster. The issue will cover a broad range of topics related to management in the laboratory including but not limited to: Metrology Perspectives; Biologic Variation Approach to Daily Laboratory; Clinical Outcome Approach to Goal Setting; Six Sigma Quality Management System; Traceability and Comparability; MU, Risk, and Sigma-metrics at Sunway; and Quality Indicators for the Total Testing Process, among others.
Author: George S. Cembrowski Publisher: ISBN: Category : Pathological laboratories Languages : en Pages : 292
Book Description
Discusses quality control practices in health care laboratories. Will help laboratory directors, managers, supervisors and technologists towards a more quantitative understanding of the performance capabilities of different quality control procedures.
Author: Singer Publisher: CRC Press ISBN: 1498710522 Category : Technology & Engineering Languages : en Pages : 432
Book Description
This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits.
Author: Susan Mahler Zneimer Publisher: John Wiley & Sons ISBN: 1119069777 Category : Science Languages : en Pages : 789
Book Description
Cytogenetic Laboratory Management Cytogenetic Laboratory Management Chromosomal, FISH and Microarray-Based Best Practices and Procedures Cytogenetic Laboratory Management: Chromosomal, FISH and Microarray-Based Best Practices and Procedures is a practical guide that describes how to develop and implement best practice processes and procedures in the genetic laboratory setting. The text first describes good laboratory practices, including quality management, design control of tests, and FDA guidelines for laboratory-developed tests, and preclinical validation study designs. The second focus of the book is on best practices for staffing and training, including cost of testing, staffing requirements, process improvement using Six Sigma techniques, training and competency guidelines, and complete training programs for cytogenetic and molecular genetic technologists. The third part of the text provides stepwise standard operating procedures for chromosomal, FISH and microarray-based tests, including preanalytic, analytic, and postanalytic steps in testing, which are divided into categories by specimen type and test type. All three sections of the book include example worksheets, procedures, and other illustrative examples that can be downloaded from the Wiley website to be used directly without having to develop prototypes in your laboratory. Providing a wealth of information on both laboratory management and molecular and cytogenetic testing, Cytogenetic Laboratory Management will be an essential tool for laboratorians worldwide in the field of laboratory testing and genetic testing in particular. This book gives the essentials of: Developing and implementing good quality management programs in laboratories Understanding design control of tests and preclinical validation studies and reports FDA guidelines for laboratory-developed tests Use of reagents, instruments, and equipment Cost of testing assessment and process improvement using Six Sigma methodology Staffing training and competency objectives Complete training programs for molecular and cytogenetic technologists Standard operating procedures for all components of chromosomal analysis, FISH, and microarray testing of different specimen types This volume is a companion to Cytogenetic Abnormalities: Chromosomal, FISH and Microarray-Based Clinical Reporting. The combined volumes give an expansive approach to performing, reporting, and interpreting cytogenetic laboratory testing and the necessary management practices, staff and testing requirements.
Author: Donnell R. Christian, Jr. Publisher: CRC Press ISBN: 9781420073058 Category : Science Languages : en Pages : 1432
Book Description
In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Laboratory Policies and Processes: Using Templates, Project Management, and Six Sigma provides templates for the various policies, procedures, and forms that should be contained in the quality assurance, operational, and technical manuals of a laboratory seeking accreditation. Templates for the entire project life cycle The book begins with a general introduction and overview of quality assurance and then moves on to cover implementation strategies. It contains best practices and templates for the project management of the design and implementation of the laboratory operational and technical manuals required to establish a quality assurance program. The templates span the entire project life cycle, from initiation, to planning, to execution, to monitoring, and finally, to closure. The book also examines how Six Sigma concepts can be used to optimize laboratories, and contains templates that cover administrative issues, quality assurance, sample control, and health and safety issues. In addition, there is a section of criteria files that relate the individual document templates to specific accreditation criterion. Addresses the standards of ISO 17025 The results of any laboratory examination have the potential to be presented in court and can ultimately affect the life and liberty of the parties involved. Therefore, a stringent quality assurance program, including well-documented policies and a procedure manual, is essential. Ensuring that laboratories meet the standards of ISO 17025, this volume is a critical component of any laboratory’s accreditation process.
Author: Saverio Mannino
Author: Saverio Mannino
Author: World Health Organization
Author: Saverio Mannino
Author: Candis A. Kinkus
Author: Viruti Shivan
Author: James O. Westgard
Author: George S. Cembrowski
Author: Singer
Author: Susan Mahler Zneimer
Author: Donnell R. Christian, Jr.