Author: Bob Mehta
Publisher:
ISBN: 9781953079091
Category : Laboratories
Languages : en
Pages : 203

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Book Description

Author: Bhavan "Bob" Mehta
Publisher: Quality Press
ISBN: 0873898540
Category : Science
Languages : en
Pages : 225

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Book Description
The purpose of this book is to demystify the requirements delineated within ISO/IEC 17025:2005 while providing a road map for organizations that wish to receive/maintain accreditation for their laboratories. AS9100, ISO 9001, and ISO 13485 are standards that 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 diverse industries. Although similar to these recognized QMS standards, ISO/IEC 17025 serves a unique purpose: laboratory accreditation. It is not unusual for laboratories to retain dual certification to ISO 9001 and ISO/IEC 17025.

Author: Bhavan (Bob) Mehta
Publisher: Quality Press
ISBN: 1953079105
Category : Technology & Engineering
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.

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.

Author: Donnell R. Christian Jr.
Publisher: CRC Press
ISBN: 1420073052
Category : Business & Economics
Languages : en
Pages : 1434

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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 Labora

Author: International Office of Epizootics
Publisher:
ISBN:
Category : Communicable diseases
Languages : en
Pages : 88

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Author: W. Mark Dale
Publisher: CRC Press
ISBN: 1040083676
Category : Business & Economics
Languages : en
Pages : 263

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Book Description
New technologies, including DNA and digital databases that can compare known and questioned exemplars, have transformed forensic science and greatly impacted the investigative process. They have also made the work more complicated. Obtaining proper resources to provide quality and timely forensic services is frequently a challenge for forensic managers, who are often promoted from casework duties and must now learn a whole new set of leadership skills. The interdisciplinary and scientific nature of laboratories requires strong leadership ability to manage complex issues, often in adversarial settings. Forensic Laboratory Management: Applying Business Principles provides laboratory managers with business tools that apply the best science to the best evidence in a manner that increases the efficiency and effectiveness of their management decision making. The authors present a performance model with seven recommendations to implement, illustrating how forensic managers can serve as leaders and strategically improve the operation and management in scientific laboratories. Topics include: Key business metrics and cost–benefit analyses Ethical lapses: why they occur, possible motives, and how problems can be prevented Forensic training, education, and institutes ISO/IEC 17025 accreditation implementation The book includes case studies simulating a working laboratory in which readers can apply business tools with actual data reinforcing discussion concepts. Each chapter also includes a brief review of current literature of the best management theories and practice. The downloadable resources supply two mock trial transcripts and associated case files along with PowerPoint® slides from Dr. George Carmody’s workshop on Forensic DNA Statistics and Dr. Doug Lucas’s presentation on ethics.

Author: Charles H. Moseley
Publisher: Quality Press
ISBN: 1636940080
Category : Business & Economics
Languages : en
Pages : 393

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Book Description
Initially developed as a tool for training lead auditors of nuclear quality systems, the Nuclear Auditing Handbook has also been used as a reference by quality managers who plan quality system audits. It provides detailed material in such aspects as the development, administration, planning, preparation, performance, and reporting of quality system audits in energy-related fields. ASQ's Nuclear Committee of the Energy and Environment Division gathered a team of highly seasoned experts in the nuclear auditing field to expand this new edition's content and bring it current to modern-day best practices and standards. This book introduces updated information about requirements and standards, including the 2019 editions of the American Society of Mechanical Engineers (ASME) NQA-1 Quality Assurance Program Requirements for Nuclear Facility Applications and ASME BPVC Sections I; IV; and VIII, Divisions 1 and 2. The authors and editors have also added helpful tools to aid nuclear auditors, including case studies suitable for training auditors, blank forms for convenient use, and samples of completed forms.

Author: Mark Allen Durivage
Publisher: Quality Press
ISBN: 0873899369
Category : Business & Economics
Languages : en
Pages : 129

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Book Description
For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.

Author:
Publisher:
ISBN:
Category : Delegated legislation
Languages : en
Pages : 340

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Book Description