Application of Iso/Iec 17025 Technical Requirements in Industrial Laboratories PDF Download
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Author: M. L. Jane Weitzel Publisher: FriesenPress ISBN: 1460210298 Category : Science Languages : en Pages : 81
Book Description
The book introduces the new concepts of target measurement uncertainty and decision rules and explains how to use them to demonstrate a method is fit-for-purpose. As well, they can be used to set the acceptance criteria for a method validation clearly and quantitatively. Examples are given that illustrate the concepts so that the reader can easily apply decision rules and target measurement uncertainty to their methods. The book covers all aspects of method validation from stating the purpose of the method using a Decision Rule, calculating the target measurement uncertainty, deciding the required parameters that need to be included in the method validation, estimating the measurement uncertainty, and setting the acceptance criteria. With this approach the reader will fully understand the method, what its critical control points are and what to control and monitor during routine use. This approach fits in well with the lifecycle approach to analytical methods. The book covers the basics and advanced aspects of method validation so that it is useful for people new to method validation and those with experience. The book is applicable for laboratories in many industries, from mining to pharmaceutical manufacturing to food analysis.
Author: M. L. Jane Weitzel Publisher: FriesenPress ISBN: 1460210298 Category : Science Languages : en Pages : 81
Book Description
The book introduces the new concepts of target measurement uncertainty and decision rules and explains how to use them to demonstrate a method is fit-for-purpose. As well, they can be used to set the acceptance criteria for a method validation clearly and quantitatively. Examples are given that illustrate the concepts so that the reader can easily apply decision rules and target measurement uncertainty to their methods. The book covers all aspects of method validation from stating the purpose of the method using a Decision Rule, calculating the target measurement uncertainty, deciding the required parameters that need to be included in the method validation, estimating the measurement uncertainty, and setting the acceptance criteria. With this approach the reader will fully understand the method, what its critical control points are and what to control and monitor during routine use. This approach fits in well with the lifecycle approach to analytical methods. The book covers the basics and advanced aspects of method validation so that it is useful for people new to method validation and those with experience. The book is applicable for laboratories in many industries, from mining to pharmaceutical manufacturing to food analysis.
Author: Ramesh R Lakhe Publisher: Educreation Publishing ISBN: Category : Education Languages : en Pages : 300
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: Ludwig Huber Publisher: CRC Press ISBN: 9780849382673 Category : Medical Languages : en Pages : 0
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.
Author: Leonard Steinborn Publisher: CRC Press ISBN: 0203026659 Category : Medical Languages : en Pages : 452
Book Description
This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
Author: WHO Regional Office for South-East Asia Publisher: World Health Organization ISBN: 9789290223979 Category : Medical Languages : en Pages : 0
Book Description
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.
Author: Sean Doyle Publisher: Academic Press ISBN: 0128094249 Category : Law Languages : en Pages : 428
Book Description
Forensic science has been under scrutiny for some time, since the release of the NAS report in 2009. The report cited the need for standardized practices and the accreditation of crime labs. No longer can the forensic community take the position that cross-examination in a courtroom will expose weaknesses in methodology and execution. Quality Management in Forensic Science covers a wide spectrum of forensic disciplines, relevant ISO and non-ISO standards, accreditation and quality management systems necessary in any forensic science laboratory. Written by a globally well-respected forensic scientist with decades of experience in the forensic science laboratory and on the stand, as an expert witness who is also a Fellow of both the Royal Society of Chemistry and the Chartered Society of Forensic Sciences. This book will be a must-have resource for all forensic science stakeholders, particularly law enforcement agents and lawyers less familiar with the impact of quality management on the reliability of scientific evidence. - A comprehensive, multidisciplinary reference of scientific practices for use in the forensic laboratory - Coverage from DNA to toxicology, from trace evidence to crime scene and beyond - Extensive review of ISO and non-ISO standards, accreditation, QMS and much more - Written by a foremost forensic scientist with decades of experience in the laboratory and as an expert witness
Author: M. L. Jane Weitzel
Author: M. L. Jane Weitzel
Author: Bob Mehta
Author: International Office of Epizootics
Author: Ramesh R Lakhe
Author: NVLAP (Program : U.S.)
Author: Ludwig Huber
Author: Leonard Steinborn
Author: WHO Regional Office for South-East Asia
Author: British Standards Institution
Author: Sean Doyle