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System Requirements Analysis gives the professional systems engineer the tools to set up a proper and effective analysis of the resources, schedules and parts needed to successfully undertake and complete any large, complex project. This fully revised text offers readers the methods for rationally breaking down a large project into a series of stepwise questions, enabling you to determine a schedule, establish what needs to be procured, how it should be obtained, and what the likely costs in dollars, manpower, and equipment will be to complete the project at hand. System Requirements Analysis is compatible with the full range of popular engineering management tools, from project management to competitive engineering to Six Sigma, and will ensure that a project gets off to a good start before it's too late to make critical planning changes. The book can be used for either self-instruction or in the classroom, offering a wealth of detail about the advantages of requirements analysis to the individual reader or the student group.Written by the authority on systems engineering, a founding member of the International Council on Systems Engineering (INCOSE)Complete overview of the basic principles of starting a system requirements analysis program, including initial specifications to define problems, and parameters of an engineering programCovers various analytical approaches to system requirements, including structural and functional analysis, budget calculations, and risk analysis

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System Requirements Analysis gives the professional systems engineer the tools to set up a proper and effective analysis of the resources, schedules and parts needed to successfully undertake and complete any large, complex project. This fully revised text offers readers the methods for rationally breaking down a large project into a series of stepwise questions, enabling you to determine a schedule, establish what needs to be procured, how it should be obtained, and what the likely costs in dollars, manpower, and equipment will be to complete the project at hand. System Requirements Analysis is compatible with the full range of popular engineering management tools, from project management to competitive engineering to Six Sigma, and will ensure that a project gets off to a good start before it's too late to make critical planning changes. The book can be used for either self-instruction or in the classroom, offering a wealth of detail about the advantages of requirements analysis to the individual reader or the student group.Written by the authority on systems engineering, a founding member of the International Council on Systems Engineering (INCOSE)Complete overview of the basic principles of starting a system requirements analysis program, including initial specifications to define problems, and parameters of an engineering programCovers various analytical approaches to system requirements, including structural and functional analysis, budget calculations, and risk analysis

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.

Good Manufacturing Practices (GMP) for human pharmaceuticals affects every patient taking a medicine. GMP covers all aspects of the manufacturing process, from defining manufacturing processes to systems for recall and investigation of complaints. Consumers expect that each batch of medicines they take will meet quality standards so that they will be safe and effective. GMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. This formal system of controls at a pharmaceutical company, if adequately put into practice, helps to prevent instances of contamination, mix-ups, deviations, failures, and errors. This assures that drug products meet their quality standards. This guidance book is meant as a resource to manufacturers of pharmaceuticals, 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. A companion CD contains dozens of FDA guidance documents as well as international harmonization documents (WHO, PIC/S, and ICH). A check list for cGMP audit is also included based on risk management criteria. An exam complements the material included in the CD.

ISO 9001:2015 specifies requirements for a quality management system when an organization:a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

Book is in Used-VeryGood condition. Pages and cover are clean and intact. Used items may not include supplementary materials such as CDs or access codes. May show signs of minor shelf wear and contain very limited notes and highlighting. 0.8

ISO 9001:2015 specifies requirements for a quality management system when an organization:a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

ISO 45001:2018 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization's OH&S policy, the intended outcomes of an OH&S management system include:a) continual improvement of OH&S performance;b) fulfilment of legal requirements and other requirements;c) achievement of OH&S objectives.ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization's control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.ISO 45001:2018 does not state specific criteria for OH&S performance, nor is it prescriptive about the design of an OH&S management system.ISO 45001:2018 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing.ISO 45001:2018 does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.ISO 45001:2018 can be used in whole or in part to systematically improve occupational health and safety management. However, c

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ISO 45001:2018 specifies requirements for an occupational health and safety (OH&S) management system, and gives guidance for its use, to enable organizations to provide safe and healthy workplaces by preventing work-related injury and ill health, as well as by proactively improving its OH&S performance.ISO 45001:2018 is applicable to any organization that wishes to establish, implement and maintain an OH&S management system to improve occupational health and safety, eliminate hazards and minimize OH&S risks (including system deficiencies), take advantage of OH&S opportunities, and address OH&S management system nonconformities associated with its activities.ISO 45001:2018 helps an organization to achieve the intended outcomes of its OH&S management system. Consistent with the organization's OH&S policy, the intended outcomes of an OH&S management system include:a) continual improvement of OH&S performance;b) fulfilment of legal requirements and other requirements;c) achievement of OH&S objectives.ISO 45001:2018 is applicable to any organization regardless of its size, type and activities. It is applicable to the OH&S risks under the organization's control, taking into account factors such as the context in which the organization operates and the needs and expectations of its workers and other interested parties.ISO 45001:2018 does not state specific criteria for OH&S performance, nor is it prescriptive about the design of an OH&S management system.ISO 45001:2018 enables an organization, through its OH&S management system, to integrate other aspects of health and safety, such as worker wellness/wellbeing.ISO 45001:2018 does not address issues such as product safety, property damage or environmental impacts, beyond the risks to workers and other relevant interested parties.ISO 45001:2018 can be used in whole or in part to systematically improve occupational health and safety management. However, c

Tagline: Project success through realistic requirements

The book presents both the current state of the art in requirements engineering and a systematic method for engineering high-quality requirements, broken down into four parts.  The first part introduces fundamental concepts and principles including the aim and scope of requirements engineering, the products and processes involved, requirements qualities to aim at and flaws to avoid, and the critical role of requirements engineering in system and software engineering. The second part of the book is devoted to system modeling in the specific context of engineering requirements. It presents a multi-view modeling framework that integrates complementary techniques for modeling the system-as-is and the system-to-be. The third part of the book reviews goal-based reasoning techniques to support the various steps of the KAOS method. The fourth part of the book goes beyond requirements engineering to discuss the mapping from goal-oriented requirements to software specifications and to software architecture. Online software will accompany the book and will add value to both classroom and self-study by enabling students to build models and specifications involved in the book’s exercises and case studies, helping them to discover the latest RE technology solutions. Instructor resources such as slides, figures and handouts are available from an accompanying website.

The book presents both the current state of the art in requirements engineering and a systematic method for engineering high-quality requirements, broken down into four parts.  The first part introduces fundamental concepts and principles including the aim and scope of requirements engineering, the products and processes involved, requirements qualities to aim at and flaws to avoid, and the critical role of requirements engineering in system and software engineering. The second part of the book is devoted to system modeling in the specific context of engineering requirements. It presents a multi-view modeling framework that integrates complementary techniques for modeling the system-as-is and the system-to-be. The third part of the book reviews goal-based reasoning techniques to support the various steps of the KAOS method. The fourth part of the book goes beyond requirements engineering to discuss the mapping from goal-oriented requirements to software specifications and to software architecture. Online software will accompany the book and will add value to both classroom and self-study by enabling students to build models and specifications involved in the book’s exercises and case studies, helping them to discover the latest RE technology solutions. Instructor resources such as slides, figures and handouts are available from an accompanying website.

Tagline: Project success through realistic requirements

New! This book is in the same immaculate condition as when it was published 1.74

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Good condition. This is the average used book, that has all pages or leaves present, but may include writing. Book may be ex-library with stamps and stickers. 1.74

Book is in NEW condition. 0.91