Quality Systems - ISO 17025 and GLP PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download Quality Systems - ISO 17025 and GLP PDF full book. Access full book title Quality Systems - ISO 17025 and GLP by Konstanze Frank. Download full books in PDF and EPUB format.
Author: Konstanze Frank
Publisher: GRIN Verlag
ISBN: 3638394816
Category : Medical
Languages : en
Pages : 15
Get Book Here
Book Description
Essay from the year 2004 in the subject Medicine - Hospital Environment, Clinical Medicine, grade: good, Anglia Ruskin University, language: English, abstract: An accredited laboratory according to ISO/IEC 17025 and a research facility working according to the Organisation for Economic Co-operation and Development Good Laboratory Practice (OECD GLP) series of principles, both facilities perform chemical, analytical and microbiological tests. The main difference is the types of projects that the laboratories deal with. OECD GLP facilities conduct studies for the purpose of testing and assessing chemicals to determine their potential hazards. The GLP principles are a managing tool covering the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Whereas accredited laboratories are testing and calibration laboratories. They operate a quality system, are technically and scientifically competent, and are able to generate technically valid and traceable results. There are many definitions of Quality. One possibility might be to define quality “in terms of customer satisfaction”. As there is no absolute measure hence it should be “management’s task to translate future needs of customers into quality products and services]. Therefore a ‘quality system’ can assist organisations in enhancing customers’ satisfaction. According to Andrew Waddell there are two dimensions of a quality system, a vertical and a horizontal dimension. The requirements of the vertical, i.e. technical, level are covered by ISO 17025 whereas the horizontal, i.e. managing and organisational, concept is detailed in the OECD GLP principles. However, a comparison of both shows overlapping and/or common requirements in these international standards with unique occurrence in the two of them.
Author: Konstanze Frank
Publisher: GRIN Verlag
ISBN: 3638394816
Category : Medical
Languages : en
Pages : 15
Get Book Here
Book Description
Essay from the year 2004 in the subject Medicine - Hospital Environment, Clinical Medicine, grade: good, Anglia Ruskin University, language: English, abstract: An accredited laboratory according to ISO/IEC 17025 and a research facility working according to the Organisation for Economic Co-operation and Development Good Laboratory Practice (OECD GLP) series of principles, both facilities perform chemical, analytical and microbiological tests. The main difference is the types of projects that the laboratories deal with. OECD GLP facilities conduct studies for the purpose of testing and assessing chemicals to determine their potential hazards. The GLP principles are a managing tool covering the organisational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Whereas accredited laboratories are testing and calibration laboratories. They operate a quality system, are technically and scientifically competent, and are able to generate technically valid and traceable results. There are many definitions of Quality. One possibility might be to define quality “in terms of customer satisfaction”. As there is no absolute measure hence it should be “management’s task to translate future needs of customers into quality products and services]. Therefore a ‘quality system’ can assist organisations in enhancing customers’ satisfaction. According to Andrew Waddell there are two dimensions of a quality system, a vertical and a horizontal dimension. The requirements of the vertical, i.e. technical, level are covered by ISO 17025 whereas the horizontal, i.e. managing and organisational, concept is detailed in the OECD GLP principles. However, a comparison of both shows overlapping and/or common requirements in these international standards with unique occurrence in the two of them.
Author: Bernd W. Wenclawiak
Publisher: Springer
ISBN: 3662096218
Category : Science
Languages : en
Pages : 306
Get Book Here
Book Description
Quality Assurance in Chemical Measurement, an advanced EURACHEM textbook, provides in-depth but easy-to-understand coverage for training, teaching and continuing studies. The CD-ROM accompanying the book contains course materials produced by ten experienced specialists, including more than 750 overheads (graphics and text) in ready-to-use PowerPoint® documents in English and German language. The book will serve as an advanced textbook for analytical chemistry students and professionals in industry and service labs and as a reference text and source of course materials for lecturers. The second edition has been completely revised according to the newest legislation.
Author: Elizabeth Prichard
Publisher: John Wiley & Sons
ISBN: 9780470517765
Category : Science
Languages : en
Pages : 316
Get Book Here
Book Description
The issue of quality assurance in the analytical chemistry laboratory has become of great importance in recent years. Quality Assurance in Analytical Chemistry introduces the reader to the whole concept of quality assurance. It discusses how all aspects of chemical analysis, from sampling and method selection to choice of equipment and the taking and reporting of measurements affect the quality of analytical data. Finally, the implementation and use of quality systems are covered.
Author: Ramesh R Lakhe
Publisher: Educreation Publishing
ISBN:
Category : Education
Languages : en
Pages : 300
Get Book Here
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: Allen F. Hirsch
Publisher: Marcel Dekker
ISBN:
Category : Medical
Languages : en
Pages : 248
Get Book Here
Book Description
Author: E.A. Maier
Publisher: Elsevier
ISBN: 0080534880
Category : Science
Languages : en
Pages : 587
Get Book Here
Book Description
The participation in interlaboratory studies and the use of Certified Reference Materials (CRMs) are widely recognised tools for the verification of the accuracy of analytical measurements and they form an integral part of quality control systems used by many laboratories, e.g. in accreditation schemes. As a response to the need to improve the quality of environmental analysis, the European Commission has been active in the past fifteen years, through BCR activity (now renamed Standards, Measurements and Testing Programme) in the organisation of series of interlaboratory studies involving expert laboratories in various analytical fields (inorganic, trace organic and speciation analysis applied to a wide variety of environmental matrices). The BCR and its successor have the task of helping European laboratories to improve the quality of measurements in analytical sectors which are vital for the European Union (biomedical, agriculture, food, environment and industry); these are most often carried out in support of EC regulations, industrial needs, trade, monitoring activities (including environment, agriculture, health and safety) and, more generally, when technical difficulties hamper a good comparability of data among EC laboratories. The collaborative projects carried out so far have placed the BCR in the position of second world CRM producer (after NIST in the USA).Interlaboratory Studies and Certification of Reference Materials for Environmental Analysis gives an account of the importance of reference materials for the quality control of environmental analysis and describes in detail the procedures followed by BCR to prepare environmental reference materials, including aspects related to sampling, stabilization, homogenisation, homogeneity and stability testing, establishment of reference (or certified) values, and use of reference materials. Examples of environmental CRMs produced by BCR within the last 15 years are given, which represent more than 70 CRMs covering different types of materials (plants, biological materials, waters, sediments, soils and sludges, coals, ash and dust materials) certified for a range of chemical parameters (major and trace elements, chemical species, PAHs, PCBs, pesticides and dioxins).The final section of the book describes how to organise improvement schemes for the evaluation method and/or laboratory performance. Examples of interlaboratory studies (learning scheme, proficiency testing and intercomparison in support to prenormative research) are also given.
Author: Michel Jaccard
Publisher: CRC Press
ISBN: 1466573007
Category : Business & Economics
Languages : en
Pages : 450
Get Book Here
Book Description
Quality is a form of management that is composed of the double approach of driving an organization towards excellence, while conforming to established standards and laws. The objective of quality confers advantages to companies: it makes them more resilient to change that can be unexpected or even chaotic; it makes them more competitive by identify
Author: OECD
Publisher: OECD Publishing
ISBN: 9264304797
Category :
Languages : en
Pages : 206
Get Book Here
Book Description
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...
Author: Bob Mehta
Publisher: Quality Press
ISBN: 0873899806
Category : Business & Economics
Languages : en
Pages : 114
Get Book Here
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: Graham Ogg
Publisher: CRC Press
ISBN: 104006163X
Category : Medical
Languages : en
Pages : 229
Get Book Here
Book Description
Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co
