Implementing Quality in Laboratory Policies and Processes

Implementing Quality in Laboratory Policies and Processes
Author: Donnell R. Christian, Jr.
Publisher: CRC Press
Total Pages: 1434
Release: 2009-11-24
Genre: Science
ISBN: 1420073052

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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 Labora

Laboratory Quality Management System

Laboratory Quality Management System
Author: World Health Organization
Publisher:
Total Pages: 0
Release: 2011
Genre: Laboratories
ISBN: 9789241548274

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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".

The Laboratory Quality Assurance System

The Laboratory Quality Assurance System
Author: Thomas A. Ratliff
Publisher: John Wiley & Sons
Total Pages: 246
Release: 2005-03-11
Genre: Technology & Engineering
ISBN: 0471721662

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Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual: -Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories. -Provides blank forms used in preparing a quality manual. -Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.

Common Sense Implementation Of Qms In The Clinical Laboratory: A Software Guided Approach

Common Sense Implementation Of Qms In The Clinical Laboratory: A Software Guided Approach
Author: Masahiko Amano
Publisher: World Scientific
Total Pages: 274
Release: 2019-10-23
Genre: Medical
ISBN: 981121249X

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This book explains how SaaS works and lists and describes many common misconceptions and pitfalls that laboratories have about implementing Quality Management Systems (QMS). By walking the reader through all ISO 15189 Standards and describing each in detail, we can show how to implement them in common sense and meaningful ways. This book demonstrates to clinical laboratories how to combine the rigor of international standards with the inherent benefits of contemporary cloud-based software systems so that they can involve the entire laboratory in making quality a shared habit.

Iso 17025 2017 Lab Quality Management System

Iso 17025 2017 Lab Quality Management System
Author: Ramesh R Lakhe
Publisher: Educreation Publishing
Total Pages: 298
Release: 2018-12-30
Genre: Education
ISBN:

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Laboratory accreditation has assumed immense importance in recent years because of the need to assure the customer that the laboratory is capable of providing the valid test results reliably. ISO 17025:2017 Lab Quality Management System has become part of the requirement of all the laboratories, small to large. Over the years, ISO 17025:2017 Lab Quality Management System has evolved, as per the laboratory and customer requirements, and has become very important for improving laboratory systems and processes in order to sustain competitive advantages. This book focuses on requirements and key features of ISO 17025:2017 Lab Quality Management System such as risk-based thinking, PDCA approach, process management, and continual improvement. The readers would find it easier to understand the standard requirements and implement these in their work place.

The Forensic Laboratory Handbook Procedures and Practice

The Forensic Laboratory Handbook Procedures and Practice
Author: Ashraf Mozayani
Publisher: Springer Science & Business Media
Total Pages: 604
Release: 2010-12-14
Genre: Medical
ISBN: 1607618729

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Forensic science has come a long way in the past ten years. It is much more in-depth and much broader in scope, and the information gleaned from any evidence yields so much more information than it had in the past because of incredible advances in analytic instruments and crucial procedures at both the crime scene and in the lab. Many practices have gone digital, a concept not even fathomed ten years ago. And from the first collection of evidence to its lab analysis and interpretation to its final presentation in court, ethics has become an overriding guiding principle. That’s why this new edition of this classic handbook is indispensable. The Forensic Laboratory Handbook Procedures and Practice includes thirteen new chapters written by real-life practitioners who are experts in the field. It covers the tried and true topics of fingerprints, trace evidence, chemistry, biology, explosives and arson, forensic anthropology, forensic pathology, forensic documents, firearms and toolmarks. This text also addresses an array of new topics including accreditation, certification, ethics, and how insects and bugs can assist in determining many facts including a margin of time of death. In the attempt to offer a complete and comprehensive analysis The Forensic Laboratory Handbook Procedures and Practice also includes a chapter discussing the design of a laboratory. In addition, each chapter contains educational requirements needed for the discipline it covers. Complete with questions at the end of each chapter, brief author bios and real crime scene photos, this text has risen to greet the many new challenges and issues that face today’s forensic crime practitioners.

Returning Individual Research Results to Participants

Returning Individual Research Results to Participants
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Total Pages: 399
Release: 2018-08-23
Genre: Medical
ISBN: 0309475201

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When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Laboratory Quality Standards and Their Implementation

Laboratory Quality Standards and Their Implementation
Author: WHO Regional Office for South-East Asia
Publisher: World Health Organization
Total Pages: 0
Release: 2011
Genre: Medical
ISBN: 9789290223979

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Establishing and maintaining laboratory quality standards are essential to generate reliable results to support clinical and public health actions. The Laboratory Quality Standardspresent a minimum set of standards that can be readily adapted by countries and applied to laboratories at every level of the health-care system. This book also outlines mechanism to implement them. This book will be of help to national policy-makers as well as regulators in developing national laboratory quality standards. It provides a simple approach to meet the minimum requirements set with the ultimate objective to comply with ISO 15189 in a logical and step-by-step manner.

Quality and Risk Management in the IVF Laboratory

Quality and Risk Management in the IVF Laboratory
Author: Sharon T. Mortimer
Publisher: Cambridge University Press
Total Pages: 241
Release: 2015-03-02
Genre: Medical
ISBN: 1107421284

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Updated edition of this bestselling book, now extended to include quality and risk management in the ART clinic.

A Blueprint for Implementing Best Practice Procedures in a Digital Forensic Laboratory

A Blueprint for Implementing Best Practice Procedures in a Digital Forensic Laboratory
Author: David Lilburn Watson
Publisher: Academic Press
Total Pages: 1074
Release: 2023-11-17
Genre: Law
ISBN: 0128194804

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Digital Forensic Processing and Procedures: Meeting the Requirements of ISO 17020, ISO 17025, ISO 27001 and Best Practice Requirements, Second Edition provides a one-stop shop for a set of procedures that meet international best practices and standards for handling digital evidence during its complete lifecycle. The book includes procedures, forms and software, providing anyone who handles digital evidence with a guide to proper procedures throughout chain of custody--from incident response straight through to analysis in the lab. This book addresses the whole lifecycle of digital evidence. Provides a step-by-step guide on designing, building and using a digital forensic lab Addresses all recent developments in the field Includes international standards and best practices