Download or read book Implementing ISO IEC 17025 2005 written by Bhavan "Bob" Mehta and published by Quality Press. This book was released on 2013-04-16 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Implementing ISO IEC 17025 2017 written by Bhavan (Bob) Mehta and published by Quality Press. This book was released on 2019-02-21 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Implementing ISO IEC 17025 2017 Second Edition written by Bob Mehta and published by Quality Press. This book was released on 2019-02-21 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Quality Control and Assurance written by Leo Kounis and published by BoD – Books on Demand. This book was released on 2017-02-22 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Iso Iec 17025 written by Rodrigo Palma and published by Rodrigo Palma. This book was released on 2024-04-28 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The ISO/IEC 17025:2017 standard establishes the requirements for the technical competence, impartiality and quality of testing and calibration laboratories. The objective of this standard is to provide a framework for laboratories to demonstrate their ability to perform reliable and accurate tests and calibrations, and for their results to be internationally accepted. The purpose of implementing ISO/IEC 17025:2017 in a testing or calibration laboratory is to provide a systematic framework for quality management and technical competence, enabling laboratories to demonstrate their ability to perform tests and calibrations. reliable and accurate. The standard establishes requirements for the organizational structure, the management of resources, the testing and calibration process, the handling of the results and the continuous improvement of the quality management system of the laboratory.
Download or read book Implementing Quality in Laboratory Policies and Processes written by Donnell R. Christian, Jr. and published by CRC Press. This book was released on 2009-11-24 with total page 1434 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Iso 17025 2017 Lab Quality Management System written by Ramesh R Lakhe and published by Educreation Publishing. This book was released on 2018-12-30 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book OIE Quality Standard and Guidelines for Veterinary Laboratories written by International Office of Epizootics and published by . This book was released on 2008 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Nuclear Auditing Handbook written by Charles H. Moseley and published by Quality Press. This book was released on 2021-09-01 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Agile Processes in Software Engineering and Extreme Programming written by Giovanni Cantone and published by Springer. This book was released on 2014-06-30 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book contains the refereed proceedings of the 15th International Conference on Agile Software Development, XP 2014, held in Rome, Italy, in May 2014. Because of the wide application of agile approaches in industry, the need for collaboration between academics and practitioners has increased in order to develop the body of knowledge available to support managers, system engineers, and software engineers in their managerial/economic and architectural/project/technical decisions. Year after year, the XP conference has facilitated such improvements and provided evidence on the advantages of agile methodologies by examining the latest theories, practical applications, and implications of agile and lean methods. The 15 full papers, seven short papers, and four experience reports accepted for XP 2014 were selected from 59 submissions and are organized in sections on: agile development, agile challenges and contracting, lessons learned and agile maturity, how to evolve software engineering teaching, methods and metrics, and lean development.
Download or read book Livestock Country Review Poultry Sector Ethiopia written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2019-08-15 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt: The poultry sector continues to grow and industrialize in many parts of the world. An increasing human population, greater purchasing power and urbanization have been strong drivers of growth. A clear division is developing between industrialized production systems of large and medium size feeding into integrated value chains, and extensive production systems supporting livelihoods and supplying local or niche markets. The primary role of the former is to supply cheap and safe food to populations often distant from the source of supply, while the latter acts as a livelihood safety net, often as part of a diverse portfolio of income sources. Understanding how poultry production systems and value chains work is essential in order to develop a country’s poultry sector sustainably. This review for Ethiopia is part of a series of Livestock Country Reviews developed by FAO's Animal Production and Health Division (AGA). The reviews aim to support sustainable and effective development interventions and policy recommendations and contribute to informed decision-making and investments in the poultry sector by: (i) providing information and data about national poultry supply chains (with a special focus on poultry production); (ii) analysing strengths, weaknesses and prospects along the supply chain; and (iii) identifying opportunities for poultry sector development.
Download or read book Digital Forensics Processing and Procedures written by David Lilburn Watson and published by Newnes. This book was released on 2013-08-30 with total page 914 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first digital forensics book that covers the complete lifecycle of digital evidence and the chain of custody. This comprehensive handbook includes international procedures, best practices, compliance, and a companion web site with downloadable forms. Written by world-renowned digital forensics experts, this book is a must for any digital forensics lab. It provides anyone who handles digital evidence with a guide to proper procedure throughout the chain of custody--from incident response through analysis in the lab. A step-by-step guide to designing, building and using a digital forensics lab A comprehensive guide for all roles in a digital forensics laboratory Based on international standards and certifications
Download or read book The Art of Integrating Strategic Planning Process Metrics Risk Mitigation and Auditing written by J.B. Smith and published by Quality Press. This book was released on 2016-03-08 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The authors lessons learnedduring more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, military, aerospace, automotive, and logisticsare condensed in this book to provide reference material to both beginners and seasoned professionals in the development and sustainability of an effective quality and operational system. Experiences shared in this book include the design from ground zero-to-deployment, risk mitigation, and maintenance of quality standards such as ISO 9001, AS9100, ISO/TS 16949, TL 9000, FDA/GMP and C-TPAT standard, and Lean Six Sigma principles. The main focus of this book is to promote the use of the internal auditing tool as a feedback mechanism not only for compliance verification but also for the measurement and enhancement of the systems effectiveness. The catalysts for this goal are: Auditing beyond compliance to include identification of improvement opportunities Use of process metrics as feedback mechanism in the discovery of hidden factories and risks Concepts and models discussed in this book are clearly illustrated using anonymous real-life examples encountered in day-to-day operations. These examples include lessons learned associated with compliance, continuous improvement, and techniques in the conversion of performance metrics as process indicators, savings generators, and risk mitigation. The examples and models are simple and easy to understand accompanied with templates for quick application on the creation of problem statements, root cause analysis methods, and design of action plans with measurement of success. Workshop modules for training the trainers are included in this book with practical hands-on exercises on the different tools associated with problem solving, development of process metrics for risk mitigations and auditing.
Download or read book Integrated Management Systems written by Chad Kymal and published by Quality Press. This book was released on 2015-05-13 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated to the latest standard changes including ISO 9001:2015, ISO 14001:2015, and OHSAS 18001:2016 Includes guidance on integrating Corporate Responsibility and Sustainability Organizations today are implementing stand-alone systems for their Quality Management Systems (ISO 9001, ISO/TS 16949, or AS 9100), Environmental Management System (ISO 14001), Occupational Health & Safety (ISO 18001), and Food Safety Management Systems (FSSC 22000). Stand-alone systems refer to the use of isolated document management structures resulting in the duplication of processes within one site for each of the management standardsQMS, EMS, OHSAS, and FSMS. In other words, the stand-alone systems duplicate training processes, document control, and internal audit processes for each standard within the company. While the confusion and lack of efficiency resulting from this decision may not be readily apparent to the uninitiated, this book will show the reader that there is a tremendous loss of value associated with stand-alone management systems within an organization. This book expands the understanding of an integrated management system (IMS) globally. It not only saves money, but more importantly it contributes to the maintenance and efficiency of business processes and conformance standards such as ISO 9001, AS9100, ISO/TS 16949, ISO 14001, OHSAS 18001, FSSC 22000, or other GFSI Standards.
Download or read book How to Audit ISO 9001 2015 written by Chad Kymal and published by Quality Press. This book was released on 2016-04-04 with total page 161 pages. Available in PDF, EPUB and Kindle. Book excerpt: ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it. This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results. The book includes: An introduction to ISO 9001:2015 An auditing strategy for ISO 9001:2015 How to conduct a Stage 1 audit for ISO 9001:2015 How to conduct a Stage 2 on-site audit for ISO 9001:2015 Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an example of the format for an ISO 9001:2015 conformance checklist.
Download or read book The Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Download or read book How to Establish a Document Control System for Compliance with ISO 9001 2015 ISO 13485 2016 and FDA Requirements written by Stephanie L. Skipper and published by Quality Press. This book was released on 2015-10-14 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations, and a full set of formatted procedures and document templates are available for download to get you off to an even faster start. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.
