ISO 17025-2017 Sample Quality Manual for Testing Lab PDF Download
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Author: M. NAVEED
Publisher:
ISBN: 9781791854058
Category :
Languages : en
Pages : 94
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Book Description
This book is specially useful for the laboratories preparing Quality Manual as per ISO 17025-2017 Lab Quality Management System. It includes the index, release authorisation, amendment sheet, explanation of how lab complies with clause requirements, references to procedures and records for each clause as an evidence. The book is also useful to all the professionals associated with laboratory quality management as reference for preparing the lab for accreditation.
Author: M. NAVEED
Publisher:
ISBN: 9781791854058
Category :
Languages : en
Pages : 94
Get Book Here
Book Description
This book is specially useful for the laboratories preparing Quality Manual as per ISO 17025-2017 Lab Quality Management System. It includes the index, release authorisation, amendment sheet, explanation of how lab complies with clause requirements, references to procedures and records for each clause as an evidence. The book is also useful to all the professionals associated with laboratory quality management as reference for preparing the lab for accreditation.
Author: Ramesh R Lakhe
Publisher: Educreation Publishing
ISBN:
Category : Education
Languages : en
Pages : 300
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Book Description
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.
Author: World Health Organization
Publisher:
ISBN: 9789241548274
Category : Laboratories
Languages : en
Pages : 0
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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: Bob Mehta
Publisher:
ISBN: 9781953079091
Category : Laboratories
Languages : en
Pages : 203
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Book Description
Author: United States. Food Safety and Inspection Service. Microbiology Division
Publisher:
ISBN:
Category : Agricultural microbiology
Languages : en
Pages : 556
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Book Description
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241549394
Category : Business & Economics
Languages : en
Pages : 139
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Book Description
The first version of the WHO Malaria microscopy quality assurance manual (2009) was based on recommendations made at a series of informal consultations organized by WHO particularly a bi-regional meeting of the WHO regional offices for South-East Asia and the Western Pacific in April 2005 in Kuala Lumpur Malaysia followed by informal consultations held in March 2006 and February 2008 in Geneva Switzerland. Subsequently extensive consultations among international malaria experts led to consensus and preparation of the manual. This second version of the Manual is based on the recommendations of experts made at a WHO technical consultation in March 2014 in Geneva Switzerland. The aim of the meeting was to review the experiences of national malaria control programmes (NMCPs) national reference laboratories (NRLs) and technical agencies in using the Manual and country experience in order to improve systems for managing the quality of malaria microscopy. This second version takes into account the many years of experience of several agencies in the various aspects of quality assurance (QA) described in the Manual. In particular the sections on assessment of competence in malaria microscopy are based on use of this method by the WHO regional offices for South-East Asia and the Western Pacific in collaboration with the WHO Coordinating Centre for Malaria in Australia and by the WHO Regional Office for Africa in collaboration with Amref Health Africa. The section on setting up and managing an international reference malaria slide bank is based on the work of the WHO Regional Office for the Western Pacific in collaboration with the WHO Coordinating Centre for Malaria Diagnosis in the Philippines. The section on proficiency testing for malaria microscopy is based on work in the WHO Regional Office for Africa in collaboration with the National Institute for Communicable Diseases in South Africa and experience in regional initiatives by Amref Health Africa. The section on slide validation is based on work by Médecins sans Frontières and the section on outreach training and supportive supervision (OTSS) is based on work by the President's Malaria Initiative Malaria Care Project Medical Care Development International and Amref Health Africa. The Manual is designed primarily to assist managers of NMCPs and general laboratory services responsible for malaria control. The information is also applicable to nongovernmental organizations (NGOs) and funding agencies involved in improving quality management systems for malaria microscopy. The Manual is not designed for QA of microscopy in research situations such as in clinical trials of new drugs and vaccines or for monitoring parasite drug resistance. It forms part of a series of WHO documents designed to assist countries in improving the quality of malaria diagnosis in clinical settings including the revised training manuals on Basic malaria microscopy (2010) and the Bench aids for malaria microscopy (2010).
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309475201
Category : Medical
Languages : en
Pages : 399
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Book Description
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.
Author: Milton P. Dentch
Publisher: Quality Press
ISBN: 1951058925
Category : Business & Economics
Languages : en
Pages : 119
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Book Description
The handbook is structured to guide organizations new to ISO 9001 through the process necessary to connect their current practices to the requirements of ISO 9001:2015. For organizations already certified to ISO 9001, it advises how to use your upgrade to ISO 9001:2015 as an opportunity to rebuild your QMS into a helpful asset in managing your business.
Author: Rakesh SHRIVASTAVA
Publisher:
ISBN: 9781980547488
Category :
Languages : en
Pages : 45
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Book Description
ISO 17025:2017 Lab Quality Management system is adopted by laboratories for accreditation and improvement purpose. This book, written by practicing consultants is a diagrammatic representation of requirements of the standard. It is easy to refer, read and understand. The lab personnel, consultants and auditors would find this book useful as a ready reckoner.
Author: Bob Mehta
Publisher: Quality Press
ISBN: 0873899806
Category : Business & Economics
Languages : en
Pages : 114
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Book Description
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.
