Laboratory Quality Standards and Their Implementation

Laboratory Quality Standards and Their Implementation PDF

Author: WHO Regional Office for South-East Asia

Publisher: World Health Organization

Published: 2011

Total Pages: 0

ISBN-13: 9789290223979

DOWNLOAD EBOOK →

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.

Laboratory Quality Management System

Laboratory Quality Management System PDF

Author: World Health Organization

Publisher:

Published: 2011

Total Pages: 0

ISBN-13: 9789241548274

DOWNLOAD EBOOK →

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".

Returning Individual Research Results to Participants

Returning Individual Research Results to Participants PDF

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-09-23

Total Pages: 399

ISBN-13: 0309475171

DOWNLOAD EBOOK →

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.

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 PDF

Author: Masahiko Amano

Publisher: World Scientific

Published: 2019-10-23

Total Pages: 274

ISBN-13: 981121249X

DOWNLOAD EBOOK →

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 PDF

Author: Ramesh R Lakhe

Publisher: Educreation Publishing

Published: 2018-12-30

Total Pages: 298

ISBN-13:

DOWNLOAD EBOOK →

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.

Implementing Quality in Laboratory Policies and Processes

Implementing Quality in Laboratory Policies and Processes PDF

Author: Donnell R. Christian, Jr.

Publisher: CRC Press

Published: 2009-11-24

Total Pages: 1434

ISBN-13: 1420073052

DOWNLOAD EBOOK →

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

Implementing ISO/IEC 17025:2017

Implementing ISO/IEC 17025:2017 PDF

Author: Bhavan (Bob) Mehta

Publisher: Quality Press

Published: 2019-02-21

Total Pages: 114

ISBN-13: 1953079105

DOWNLOAD EBOOK →

The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories. AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the development and implementation of effective approaches to quality management, and are recognized blueprints for the establishment of a quality management system (QMS) for many diverse industries. Similar to these recognized QMS standards, ISO/IEC 17025:2017 for laboratory accreditation serves a unique purpose. It is not unusual for laboratories to retain dual certification in ISO 9001:2015 and ISO/IEC 17025:2017. However, ISO/IEC 17025:2017 contains requirements specific to the laboratory environment that are not addressed by ISO 9001:2015. This book highlights those differences between ISO 9001:2015 and ISO/IEC 17025:2017, while providing practical insight and tools needed for laboratories wishing to achieve or sustain accreditation to ISO/IEC 17025:2017. For those currently or formerly accredited to the 2005 version of ISO/IEC 17025, an appendix outlines the changes between the 2005 and 2017 versions of the standard.

Lanterna Rally - Theme by Grace Themes