Guía de aplicacion de la ISO 9001:2015

Guía de aplicacion de la ISO 9001:2015
Author: Icontec Internacional
Publisher: ICONTEC
Total Pages: 337
Release: 2017-04-30
Genre: Technology & Engineering
ISBN: 9267106945

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

Guía para la aplicación de ISO 9001 2015
Author: José Antonio Gómez Martínez
Publisher: Alpha Editorial
Total Pages: 313
Release: 2016-07-30
Genre: Technology & Engineering
ISBN: 9587782283

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:

The ISO 9001:2015 Implementation Handbook:
Author: Milton P. Dentch
Publisher: Quality Press
Total Pages: 119
Release: 2016-05-02
Genre: Business & Economics
ISBN: 1951058925

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.

ISO 9001

ISO 9001
Author: Itay Abuhav
Publisher: CRC Press
Total Pages: 444
Release: 2021-12-13
Genre:
ISBN: 9781032240428

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

ISO 9001:2015 Internal Audits Made Easy

ISO 9001:2015 Internal Audits Made Easy
Author: Ann W. Phillips
Publisher: Quality Press
Total Pages: 95
Release: 2015-09-21
Genre: Business & Economics
ISBN: 1951058968

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.

9001 for Manufacturing Or Assembly

9001 for Manufacturing Or Assembly
Author: Fred Dobb
Publisher:
Total Pages:
Release: 2017-01-08
Genre:
ISBN: 9780995678507

EDITION-2: Seeking ISO 9001:2015 certification: This is the book you have been waiting for. Feeling bamboozled and confused by the "experts," who expand a few lines of the standard into a 3 page academic assay? . Then this book is for you ! Ideal for: precision machinists, plastic injection moulders, toolmakers, foundries, forges, fabricators, sheet metal workers, printers, garment manufacturers, carpet manufacturers, paper and cardboard manufacturers, instrument makers, food and drink manufacturers, toy manufactures, electrical goods manufacturers, jewellery manufactures, Vehicle repair or bodyshops, ammunitions factory, assembly or filling contractors, etc. A successful large or small organisation is already meeting 70-80% of the ISO 9001 requirements. This book provides step-by-step instructions and includes a, complete proven and best-practice template documented Quality Management System (manual, procedures and over 60 optional forms), so that implementing ISO 9001:2015 becomes simple and straightforward. As an option, the complete template of manual, procedures and forms (formatted, pre-typed and "ready-to-go" in WORD(TM) 97-2003 for maximum compatibility) can be purchased directly by a link provided in the book. Updating from ISO 9001:2008 to ISO 9001:2015: The 2015 edition of ISO 9001 is NOT a MAJOR CHANGE. An analogy would be "The same cake or gateau with the layers in a different order, with a couple of extra cherries and some fairy-dust sprinkled on the top." However, because the order of the clauses has been completely reformatted and requirements moved from one clause to another, to restructure an existing 9001:2008 quality management system can be a nightmare. The templates provided within the book make this update simple. Other unique features in this book: - Choosing the certification body; - Preparation for the ISO 9001 external audit; - Advice on consultants; - Handling the external auditor; - How to eliminate an unfair nonconformity. Over 50 Years' direct experience in one book. Practical, common sense, fool-proof and torment free. Save $1000's year-on-year. This book is your easiest and cheapest route to 9001:2015 certification.

Managing Medical Devices within a Regulatory Framework

Managing Medical Devices within a Regulatory Framework
Author: Beth Ann Fiedler
Publisher: Elsevier
Total Pages: 382
Release: 2016-09-10
Genre: Law
ISBN: 0128041927

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

The Gougeon Brothers on Boat Construction

The Gougeon Brothers on Boat Construction
Author: Meade Gougeon
Publisher:
Total Pages: 406
Release: 2005
Genre: Boatbuilding
ISBN: 9781878207500

An illustrated guide to wooden boat construction using WEST SYSTEM epoxy by pioneers in the field of wood/epoxy composite construction. Subjects include Fundamentals of Wood/Epoxy Composite Construction, Core Boatbuilding Techniques, First Production Steps, Hull Construction Methods, and Interior and Deck Construction.

CMMI Survival Guide

CMMI Survival Guide
Author: Suzanne Garcia
Publisher: Addison-Wesley Professional
Total Pages: 374
Release: 2006-10-20
Genre: Computers
ISBN: 0768685141

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.

ISO 9001, ISO 14001, and New Management Standards

ISO 9001, ISO 14001, and New Management Standards
Author: Iñaki Heras-Saizarbitoria
Publisher: Springer
Total Pages: 218
Release: 2017-10-10
Genre: Business & Economics
ISBN: 3319656759

This book is a comprehensive reference on ISO management system standards and their implementation. The impacts that ISO 9001 and ISO 14001 have had on business performance are analyzed in depth, and up-to-date perspectives are offered on the integration of these and other management standards (e.g. SA8000, ISO/TS 16949). Detailed information is provided on the signaling value of different management standards and on the new ISO standards for management systems, such as ISO 50001 and ISO 45001, relating to energy management and occupational health and safety. The role of audits in ensuring compliance with the standards and achievement of objectives is also carefully considered. The volume examines avenues for further research and emerging challenges. In offering an integrated, holistic perspective on ISO management system standards, this book will have wide appeal for academics, public decision-makers, and practitioners in the field of quality and environmental management.