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
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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
Get Book Here
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: Bob Mehta
Publisher:
ISBN: 9781953079091
Category : Laboratories
Languages : en
Pages : 203
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Book Description
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: NVLAP (Program : U.S.)
Publisher:
ISBN:
Category : Testing laboratories
Languages : en
Pages : 524
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Book Description
Author: International Office of Epizootics
Publisher:
ISBN:
Category : Communicable diseases
Languages : en
Pages : 88
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Book Description
Author: Ludwig Huber
Publisher: CRC Press
ISBN: 9780849382673
Category : Medical
Languages : en
Pages : 0
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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: International Atomic Energy Agency
Publisher: IAEA
ISBN:
Category : Medical
Languages : en
Pages : 108
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Book Description
This publication contains information on the implementation of quality assurance and quality control programmes for measuring radioactivity relating to the practice of nuclear medicine, covering standards at both the end user (clinic) and secondary radioactivity standards laboratory levels. It is based on the QA principles in ISO/IEC 17025 which describes requirements that testing and calibration laboratories must meet to demonstrate that they have a quality system in place and are technically competent.
Author: WHO Regional Office for South-East Asia
Publisher: World Health Organization
ISBN: 9789290223979
Category : Medical
Languages : en
Pages : 0
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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: British Standards Institution
Publisher:
ISBN:
Category :
Languages : en
Pages : 14
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Book Description
Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 0203026659
Category : Medical
Languages : en
Pages : 452
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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
