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Qualitatsmanagementsysteme Anforderungen
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Book Synopsis Quality Management System Handbook for Product Development Companies by : Vivek Nanda
Download or read book Quality Management System Handbook for Product Development Companies written by Vivek Nanda and published by CRC Press. This book was released on 2005-01-27 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality Management System Handbook for Product Development Companies describes a systematic approach for quality management and continuous improvement via a formal management system. The approach centers on a high-level process for defining a QMS from essential prerequisites to improvement mechanisms. The book outlines the five major QMS
Book Synopsis Atomic Emission Spectrometry by : Heinz-Gerd Joosten
Download or read book Atomic Emission Spectrometry written by Heinz-Gerd Joosten and published by Walter de Gruyter GmbH & Co KG. This book was released on 2020-03-09 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Atomic Emission Spectrometry is a powerful analytical method which is utilized in academia and industry for quantitative and qualitative elemental analysis. This publication is an excellent guide to the technique, explaining the underlying theory and covering practical measurement applications. Extremely well-written and organized, this book is a beneficial instrument for every scientist or professional working with AES.
Book Synopsis Technical Safety – An Attribute of Quality by : Hubert Keller
Download or read book Technical Safety – An Attribute of Quality written by Hubert Keller and published by Springer. This book was released on 2017-12-28 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on technical safety, means of expanding the current procedures, and making the related risks more predictable. It identifies the ‘hidden commonalities’ of the various technical safety concepts and formulates a corresponding procedure, applicable across disciplines, in a single guideline. The future is now: we constantly face change through science, research and technologies, change through industrial development, and new innovations and complexities. Our society fundamentally depends on technical systems, infrastructures and interconnected smart components, in every corner of the human environment. And these systems bring with them the need for technical safety. The risks of extending what is technically feasible have to be identified and analyzed at an early stage so as to avoid and/or mitigate potential harm by means of appropriate countermeasures. Every technical field interprets technical safety in its own way. However, if a safety concept is to be comprehensively applied, it must be compatible with all technical fields – a challenge this book successfully addresses.
Book Synopsis Calibration compendium by : Peter Jäger
Download or read book Calibration compendium written by Peter Jäger and published by BoD – Books on Demand. This book was released on 2020-01-09 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regular calibration of existing measuring and testing devices is a binding requirement for most areas of the daily environment. This book guides you through the most important standard points of the many applicable standards and explains them with regard to their implementation in everyday life. It lists the most important reference points of the standards such as DIN EN ISO 9001, IATF 16949, ISO / IEC 17025 and other standards on the topic and explains them with practical relevance.
Book Synopsis Public Transport and its Users by : Hans-Liudger Dienel
Download or read book Public Transport and its Users written by Hans-Liudger Dienel and published by Routledge. This book was released on 2017-03-02 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: Public transport is essential to the quality of life of its passengers, both as a means to move around but also to achieve a sustainable environment. However, the passenger's position as a customer is weakened by the dominance of monopolies, regulation and political influence in our public transport systems. This book is one of the first to examine strategies for the representation of user interests in public transport from a variety of perspectives. The authors review approaches to integrating the passengers' views in the planning process and to protecting their interests in operations and customer care across a range of European countries, including Austria, Czech Republic, France, Germany, Italy, the Netherlands, Sweden, Switzerland, the UK and EU policies. The book presents the conclusions of this research and examples of good practice. In this respect it will provide useful guidance for policy makers, stakeholder organizations and planners, as well as transport researchers.
Book Synopsis Praxisbuch Prozessoptimierung by : Ernst Jankulik
Download or read book Praxisbuch Prozessoptimierung written by Ernst Jankulik and published by John Wiley & Sons. This book was released on 2009-06-01 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: Das Buch stellt Modelle für die Messung von Hard- undSoftfacts vor, sowie praxisnahe Beispiele und Lessons Learned ausverschiedenen Branchen. Die Beispiele liefern ein Toolset, aus demman sich Messwerkzeuge und Optimierungsideen für das eigeneUnternehmen heraussuchen kann.
Book Synopsis Quality and risk management in agri-food chains by : Brigitte Petersen
Download or read book Quality and risk management in agri-food chains written by Brigitte Petersen and published by BRILL. This book was released on 2023-09-04 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'An apple a day keeps the doctor away'. While it may be true that a balanced diet is a prerequisite for good health, how good is what we eat and drink every day? And is it actually possible to fulfil every customer desire with the vast array of foodstuffs on offer? BSE, dioxin in eggs, EHEC sprouts: in the light of repeated food safety crises, the issue of quality assurance as well as customer-oriented quality management has become of prime importance for the agri-food industry. This sector features highly complex value-added chains, which means that quality deficiencies or contaminations can quickly lead to far-reaching problems with serious consequences for consumers and businesses. What can be done to reduce this vulnerability to crises? The only solution is to establish systematic methods of quality management which will facilitate the establishment and protection of high standards across companies. This book will show which methods are available and how they can reasonably be used. The authors present an easy-to-read guide which not only includes the most important legal provisions, standards and accreditation and certification procedures, but also develops practical quality assurance strategies and shows how they can be implemented within the agri-food industry.
Book Synopsis The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by : Amiram Daniel
Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-02-21 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA and Global Harmonization Task Force (GHTF) guidance documents.This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization’s QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities. The organization of the guidebook is based on the order of the requirements in the QSReg. For each substantive requirement section there is: A verbatim statement of the QSReg requirement. A description of the comparable requirement in ISO 13485:2003, focusing on any additions to or differences from the requirements contained in the QSReg.Excerpts of the FDA responses to relevant comment groups contained in the Preamble to the QSReg. Excerpts from various FDA guidance documents related to quality management systems. A description of the relevant guidance contained in ISO/TR 14969:2004, focusing on any additions to or differences from the guidance in the Preamble and other FDA guidance documents, and, if useful, excerpts from relevant GHTF guidances. Authors’ notes giving guidance derived from the authors’ sixty years of regulatory compliance experience. This guidance book is meant as a resource to manufacturers of medical devices, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS.
Author :James E. Allen MSPH, PhD, CNHA Publisher :Springer Publishing Company ISBN 13 :9780826102676 Total Pages :628 pages Book Rating :4.1/5 (26 download)
Book Synopsis Nursing Home Federal Requirements by : James E. Allen MSPH, PhD, CNHA
Download or read book Nursing Home Federal Requirements written by James E. Allen MSPH, PhD, CNHA and published by Springer Publishing Company. This book was released on 2010-11-24 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: "[The book] lists all the federal requirements that are evaluated by state surveyors during the annual survey visit to nursing homes and for complaint visits. The exhibit section contains forms used by surveyors to gather data during the survey visit. Visually, the format makes the regulations easy to read. If nursing home staff used the book to prepare for a survey, they would be well prepared." Marcia Flesner, PhD, RN, MHCA University of Missouri-Columbia From Doody's Review The Federal government, together with more than 50 advocacy groups, has spent the past 40 years writing and refining the rules and guidelines in this manual. This book presents the latest federal guidelines and protocols used by federal surveyors in certifying facilities for participation in Medicare and Medicaid funding. It is an essential resource for long-term care facilities to have on hand to be ready for a survey at any time. It provides information straight from CMS's Internet-Only Manual-in print and at your fingertips for easy access. Divided into four accessible and user-friendly parts, this manual includes: Federal requirements and interpretive guidelines Rules for conducting the survey Summary of the requirements for long-term care facilities and surveyors CMS forms commonly used by surveyors This newly updated and revised edition spans every aspect and service of a nursing home and represents the latest requirements to ensure that outstanding quality assurance and risk management programs are in place. New to This Edition: Section on how to use manual Summarization of federal requirements Updated definitions of Medicare and Medicaid Compliance requirements with Title VI of the Civil Rights Act of 1964 SNF/Hospice requirements when SNF serves hospice patients SNF-based home health agencies Life safety code requirements Changes in SNF provider status Surveyor qualifications standards Management of complaints and incidents New medical director guidelines
Book Synopsis QMS Conversion: A Process Approach by : David Hoyle
Download or read book QMS Conversion: A Process Approach written by David Hoyle and published by Elsevier. This book was released on 2012-12-02 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: QMS Conversion: A Process Approach assists organizations in converting their existing quality management systems of documentation into systems of managed processes that deliver business benefits. The 2000 version of ISO 9000 requires a different approach to be taken towards the achievement of quality, an approach that delivers customer satisfaction not simply compliance with documented procedures. By using a process approach to the development of a management system, the significant time and expense invested should be utilized in a way that will help an organization achieve real business benefits through the application of ISO 9000: 2000. The real value of the process approach is its focus on results thereby eliminating activities and procedures that do not add value in the organization's quest to satisfy its customers and other interested parties. Written in a straightforward, non-technical manner, the approach is easily understood and followed by managers or engineers at any level. It allows readers to focus on results rather than functions, activities, procedures or standards. Applying this methodology to the management of quality will give you a distinctive competitive edge over the companies that end the certification process once the requirements have been met. With this book, the reader will be able to: - Recognize the difference between conformance to standard and system performance - Distinguish between procedures and processes and understand what makes the two fundamentally different from one another - Understand the large gap that exists between a procedural approach and a process approach - Comprehend the importance and power of the eight quality management principles - Understand the steps to be taken to convert element-based systems to process-based systems and identify the factors that affect success in the conversion process - Construct a model of the business that identifies the key processes and their interfaces - Establish performance indicators and measurements for each process and produce process flow charts that link together to form a coherent system description - Understand the steps to take to construct a system that fulfills the design criteria - Determine whether the conversion has been successful and identify where further improvement is required Each chapter is structured with a set of learning outcomes that can be accomplished by covering its contents. The chapters follow the sequence of the conversion process and each addresses the change in direction brought about by the ISO 9000: 2000 family of standards. - Achieve real business benefits with ISO 9000:2000 - Focus on results - Provides process modeling and analysis techniques
Book Synopsis Nursing Home Federal Requirements by : James Elmore Allen
Download or read book Nursing Home Federal Requirements written by James Elmore Allen and published by Springer Publishing Company. This book was released on 2006 with total page 670 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designated a Doody's Core Title!. Accessible and user-friendly, this updated edition of Nursing Home Federal Requirements contains information that is essential for nursing home administrators as well as educators and professionals preparing for licensure. It presents the latest federal guidelines and the procedures used by federal surveyors in certifying facilities for participation in Medicare and Medicaid. It is the only text that provides a comprehensive index to nursing home federal requirements. The volume spans every aspect and service of a nursing home, from telephone access and comfortable lighting to urinary incontinence treatment and proper drug storage. Administrators who implement these regulations will ensure that outstanding quality assurance and risk management programs are in place.
Book Synopsis Building Leadership in Project and Network Management by : Hans-Werner Franz
Download or read book Building Leadership in Project and Network Management written by Hans-Werner Franz and published by Springer Science & Business Media. This book was released on 2009-08-14 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt: 1 1. 1 The book The book in your hand is not a scientific book, although it is based just as much on science as on my own experience in consultancy and management. As its title suggests, we want to build a bridge between the leadership that is typical of facilitation techniques and that of pr- ect and network management. Therefore this book does more than p- vide you with insights into the mainly methodical Messages we want to transmit. It will also make suggestions for how to train facilitators, and in the centre of the book you will find a wealth of 40 carefully selected and reality-proof Tools, many of which have never been pre- ously published in English, and in some case have never been published at all. With all of these you will find a presentation of our way of using them. Our sole objective is to offer our views and experience in impr- ing communication for effective co-operation, i. e. we want people who collaborate in some way to find and decide on the best courses of action, then share and implement these decisions better. We want to promote learning by doing, just as well as doing by learning. So this book is for people who in some way are responsible for s- cessful co-operation in projects, in and across organisations or networks of organisations. Action Learning has many fathers (but few mothers) and roots.
Book Synopsis ISO 9001 Quality Management Systems by : Dhanasekharan Natarajan
Download or read book ISO 9001 Quality Management Systems written by Dhanasekharan Natarajan and published by Springer. This book was released on 2017-03-24 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains the requirements of ISO 9001 for establishing quality management system (QMS) for an organization. The requirements are illustrated with examples from industries for understanding the requirements and preparing the documents of QMS with high clarity. Methods of integrating ISO 9001 requirements with enterprise resource planning (ERP) software are presented. The software integrated approach enables process owners to focus on their core tasks of achieving the planned outputs of processes and the software generates quality records automatically.
Book Synopsis Advances in Ergonomic Design of Systems, Products and Processes by : Barbara Deml
Download or read book Advances in Ergonomic Design of Systems, Products and Processes written by Barbara Deml and published by Springer. This book was released on 2016-02-15 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: These proceedings summarize the best papers in each research area represented at the 2015 Annual Meeting of the German Gesellschaft für Arbeitswissenschaft, held at Karlsruhe Institute of Technology (KIT) from February 26-28. The meeting featured more than 160 presentations and 30 posters reflecting the diversity of subject matter in the field of human and industrial engineering.
Book Synopsis Vacuum Technique by : G. Güntherschulze
Download or read book Vacuum Technique written by G. Güntherschulze and published by Elsevier. This book was released on 2017-08-26 with total page 101 pages. Available in PDF, EPUB and Kindle. Book excerpt: Vacuum Technique contains the proceedings of a meeting of the German Society for Vacuum Technique, held at Heidelberg, Germany in September 1962. The compendium is comprised of papers presented during the meeting and discusses the developments and findings of leading experts in the field on various aspects of vacuum techniques and methods. The topics covered include methods of proving the gas tightness of vacuum equipment and components; pumping systems for freeze-drying plants; and sources of surface contamination in vacuum evaporation systems. Engineers and researchers utilizing vacuum technology in research and industry will find the book highly insightful.
Download or read book ISO 9001 written by Itay Abuhav and published by CRC Press. This book was released on 2017-02-17 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: What is risk based thinking? Do you know how to address risks and opportunities? Did you ever analyzed risks? Are you sure it is that what the ISO 9001 expects? What do you really know about knowledge management? Can you identify the types of knowledge in your organization? How do you maintain knowledge? What is awareness in the eyes of the ISO 9001 Standard? Can you tell the relation between awareness and the effectiveness of the QMS? This book explains in details all the new issues and topics required by the ISO 9001:2015 Standard and gives you the tools and tricks to answer the new requirements. Just read and do. The table of contents in the book are identical to the table of contents of the standard so you can orient yourself quite easily and find the specific advice you are looking for.
Book Synopsis Cybersecurity for Connected Medical Devices by : Arnab Ray
Download or read book Cybersecurity for Connected Medical Devices written by Arnab Ray and published by Academic Press. This book was released on 2021-11-09 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: The cybersecurity of connected medical devices is one of the biggest challenges facing healthcare today. The compromise of a medical device can result in severe consequences for both patient health and patient data. Cybersecurity for Connected Medical Devices covers all aspects of medical device cybersecurity, with a focus on cybersecurity capability development and maintenance, system and software threat modeling, secure design of medical devices, vulnerability management, and integrating cybersecurity design aspects into a medical device manufacturer's Quality Management Systems (QMS). This book is geared towards engineers interested in the medical device cybersecurity space, regulatory, quality, and human resources specialists, and organizational leaders interested in building a medical device cybersecurity program. Lays out clear guidelines for how to build a medical device cybersecurity program through the development of capabilities Discusses different regulatory requirements of cybersecurity and how to incorporate them into a Quality Management System Provides a candidate method for system and software threat modelling Provides an overview of cybersecurity risk management for medical devices Presents technical cybersecurity controls for secure design of medical devices Provides an overview of cybersecurity verification and validation for medical devices Presents an approach to logically structure cybersecurity regulatory submissions
