Guía de aplicacion de la ISO 9001:2015


Book Description

Las pequeñas empresas son el negocio más grande del mundo. Más del 95 % de emprendimientos en el mundo son pequeños y medianos y muchos países tienen en la mira a las pequeñas y medianas empresas (Pymes) para impulsar el crecimiento económico y el empleo. Por lo tanto, las Normas Internacionales deben ayudar a las Pymes tal y como lo hace con las empresas globales, el gobierno y la sociedad en general. En especial, las Pymes deberían poder participar de las ganancias en eficiencia y eficacia que ofrece la norma ISO 9001. Esta norma, que establece los requisitos para sistemas de gestión de la calidad, está entre las más conocidas e implementadas de la ISO. Se emplea en cerca de 183 países por organizaciones grandes y pequeñas, en los sectores público y privado, por fabricantes y proveedores de servicios, en todos los sectores de actividades.




Guía para la aplicación de ISO 9001 2015


Book Description

Esta publicación tiene como objetivo facilitar la comprensión de la norma ISO 9001:2015. La guía se ha elaborado manteniendo la secuencia de los apartados de la norma, cuyo contenido se reproduce íntegramente. Cada requisito es explicado de una manera sencilla y práctica, incluyendo numerosos ejemplos que intentan mostrar situaciones basadas en la realidad de las organizaciones.




The ISO 9001:2015 Implementation Handbook:


Book Description

The handbook is structured to guide organizations new to ISO 9001 through the process necessary to connect their current practices to the requirements of ISO 9001:2015. For organizations already certified to ISO 9001, it advises how to use your upgrade to ISO 9001:2015 as an opportunity to rebuild your QMS into a helpful asset in managing your business.




Iatf 16949-2016 Plus Iso 9001-2015


Book Description

NEW SECOND EDITION 2018 The SECOND EDITION - IATF 16949:2016 Audit Guide and Checklist provides all the information necessary for an in-depth assessment of your ISO 9001:2015 / IATF 16949:2016 Quality Management System. It was written to help auditors conduct a 'process based' audit and stresses process effectiveness as well as compliance. The evidence-based questions start with top management and follow a generic product through the organization. Following the 14 insightful chapters on such topics as process design, process auditing, PDCA, Turtle Diagrams, Context of the Organization and Systems Integration, you can dive into the evidence-based questions. The Part One audit questions examine the complete systems conformity to the standards along with dozens of Best Practice questions to help you better evaluate the effectiveness of the system. The Part Two questions focus in detail on the effectiveness of each individual process in the organization. This Guide covers every requirement in both ISO 9001 and IATF (some, many more than one time) plus current '2017' Customer Specific Requirements (GM, FORD, FCA, VW, PSA), Core Tools (APQP, FMEA (2018 version), Control Plans, MSA, Process Capability, and PPAP) and CQI requirements (8, 9, 11, 12, 14, 15, 17, 19, 23, 24). The SECOND EDITION - IATF 16949:2016 Audit Guide and Checklist includes: A blend of insightful guidance and practical evidence-based questions that help take your QMS to the next level 584 Assessment Questions, 188 Questions related directly to Customer Specific Requirements, 71 Core Tools Questions 15 Specific CQI Questions 150 valuable notes designed to help auditors understand the intent of specific questions . Help in planning and organizing process audits effectively and documenting the results in a meaningful way. *Additional clarity on System Integration, Context of the Organization, Safety Related Products, and MAQMSR, *2017 - IATF Sanctioned Interpretations and FAQs. Value to organizations that want more than their money's worth from their management systems by driving best practice.




ISO 9001


Book Description

This book covers all of the new ISO 9001 requirements in detail, including examples and demonstrations from various fields and industries. In the practice of industry, the changes will demand from the ISO 9001 standard certified organizations to initiate massive adjustments to their quality management system. The adjustments are to be seen in th




Managing Medical Devices within a Regulatory Framework


Book Description

Managing Medical Devices within a Regulatory Framework helps administrators, designers, manufacturers, clinical engineers, and biomedical support staff to navigate worldwide regulation, carefully consider the parameters for medical equipment patient safety, anticipate problems with equipment, and efficiently manage medical device acquisition budgets throughout the total product life cycle. This contributed book contains perspectives from industry professionals and academics providing a comprehensive look at health technology management (HTM) best practices for medical records management, interoperability between and among devices outside of healthcare, and the dynamics of implementation of new devices. Various chapters advise on how to achieve patient confidentiality compliance for medical devices and their software, discuss legal issues surrounding device use in the hospital environment of care, the impact of device failures on patient safety, methods to advance skillsets for HTM professionals, and resources to assess digital technology. The authors bring forth relevant challenges and demonstrate how management can foster increased clinical and non-clinical collaboration to enhance patient outcomes and the bottom line by translating the regulatory impact on operational requirements. - Covers compliance with FDA and CE regulations, plus EU directives for service and maintenance of medical devices - Provides operational and clinical practice recommendations in regard to regulatory changes for risk management - Discusses best practices for equipment procurement and maintenance - Provides guidance on dealing with the challenge of medical records management and compliance with patient confidentiality using information from medical devices




ISO 9001:2015 Internal Audits Made Easy


Book Description

Implementing the requirements of ISO 9001 can be a daunting task for many organizations. In an attempt to develop a system that will pass the registration audit, we are tempted to establish processes with the primary purpose of conforming to the requirements of ISO 9001. In doing so, however, it is easy to lose sight of the primary intent of the standard: to continually improve the effectiveness of the quality management system (QMS) implemented at our organization. This book is intended to help managers, quality professionals, internal audit coordinators, and internal auditors implement a practical internal audit process that meets the requirements of ISO 9001:2015 while adding significant, measurable value to the organization. The tools, techniques, and step-by-step guidelines provided in this book can also be used by those organizations that have a well-established internal audit process but are looking for easy ways to make that process more effective.




ISO 9001:2000 Quality Management System Design


Book Description

"The book describes the design rules required to document, implement, and demonstrate quality management system effectiveness in compliance with the latest version of the ISO 9000 International Standard. This systematic and engineering approach simplifies the many complexities in maintaining compliance with ISO standards. This hands-on guide is packed with tips and insights the author has garnered from personally designing quality management systems that integrate organizational strategy with quality management. Moreover, the book helps professionals create meaningful documentation and a user-friendly, informative quality manual that together form the core of an effective and responsive quality management system."--Jacket.




CMMI Survival Guide


Book Description

The CMMI provides a framework for process improvement spanning the life cycle of a product or service, from conception through delivery and maintenance. Widely and beneficially adopted around the world, the size and apparent complexity of the framework have nonetheless been daunting to some organizations. That need not be so. With a proper guide to help navigate around unknown dangers, potential pitfalls, and false paths, you too, can realize substantial business value from a successful CMMI implementation. This book is such a guide, full of the real-life examples to ease your way, and written in a lighter style to ease your reading. The CMMI® Survival Guide is an effective resource for multiple readerships. If you are just now considering a process improvement program, with the CMMI among your options, the authors' discussion of relevant issues will enhance your business case right from the start. If you have already decided to implement the CMMI, the authors' practical knowledge will help you make the most of your efforts. Even if you are well into a CMMI implementation, but are lost, stuck, or going around in circles, the authors' valuable advice will help you regain your direction. If you work in a smaller or resource-strapped organization, you will particularly benefit from the authors' description of alternative paths to process improvement–approaches that are more incremental or agile, and less intensive, than you might imagine for a CMMI implementation. The authors draw on their extensive experience working with diverse organizations, and on the CMMI tools, techniques, and templates developed for those organizations. Whatever your background or need, the CMMI® Survival Guide will help you survey the CMMI territory, consult possible road maps, learn from other CMMI explorers, weigh the benefits of hiring a living guide, and even consider whether the trip is right for you.




Industrial System Engineering for Drones


Book Description

Explore a complex mechanical system where electronics and mechanical engineers work together as a cross-functional team. Using a working example, this book is a practical “how to” guide to designing a drone system. As system design becomes more and more complicated, systematic, and organized, there is an increasingly large gap in how system design happens in the industry versus what is taught in academia. While the system design basics and fundamentals mostly remain the same, the process, flow, considerations, and tools applied in industry are far different than that in academia. Designing Drone Systems takes you through the entire flow from system conception to design to production, bridging the knowledge gap between academia and the industry as you build your own drone systems. What You’ll LearnGain a high level understanding of drone systems Design a drone systems and elaborating the various aspects and considerations of design Review the principles of the industrial system design process/flow, and the guidelines for drone systems Look at the challenges, limitations, best practices, and patterns of system design Who This Book Is For Primarily for beginning or aspiring system design experts, recent graduates, and system design engineers. Teachers, trainers, and system design mentors can also benefit from this content.