Implementing ISO/IEC 17025:2005


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.




Implementing ISO/IEC 17025:2017, Second Edition


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.




Implementing ISO/IEC 17025:2017


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.




Forensic Laboratory Management


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.




Quality Control and Assurance


Book Description

Quality control and assurance cover a diverse area of modern life and play, undeniably, an important role. This book brings together a collection of international papers that showcase examples of current research and practice in industry and the medical profession. It is hoped that engineers, researchers and scientists will be assisted in their continuous quest for excelling in qualitative aspects. The Ancient Greek word arete means excellence or virtue and defines the highest qualitative state: a mans effectiveness and skill in goodness (optimum potentiae). Indeed, Ancient Greeks believed that without quality control, specifications are useless and may result to illegitimacy, which in turn may become a threat to society itself.




Validation and Qualification in Analytical Laboratories, Second Edition


Book Description

This Second Edition discusses ways to improve pharmaceutical product quality while achieving compliance with global regulatory standards. With comprehensive step-by-step instructions, practical recommendations, standard operating procedures (SOPs), checklists, templates, and graphics for easy incorporation in a laboratory. This title serves as a complete source to the subject, and explains how to develop and implement a validation strategy for routine, non-routine, and standard analytical methods, covering the entire equipment, hardware, and software qualification process. It also provides guidance on qualification of certified standards, in-house reference materials, and people qualification, as well as internal and third party laboratory audits and inspections.




Implementing Quality in Laboratory Policies and Processes


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







Traceability in Chemical Measurement


Book Description

Metrological traceability of chemical measurement results means the establishment of a relation to metrological stated references through an unbroken chain of comparisons. This volume collects 56 outstanding papers on the topic, mostly published in the period 2000-2003 in the journal "Accreditation and Quality Assurance". They provide the latest understanding, and possibly the rationale why it is important to integrate the concept of metrological traceability including suitable measurement standards such as certified reference materials, into the standard measurement procedures of every analytical laboratory. In addition, this anthology considers the benefits to both the analytical laboratory and the user of the measurement results.