how to establish a document control system for compliance with iso 9001 2015 iso 13485 2016 and fda requirements

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How To Establish A Document Control System For Compliance With Iso 9001 2015 Iso 13485 2016 And Fda Requirements

Author : Stephanie L. Skipper
ISBN : 9780873899178
Genre : Business & Economics
File Size : 63. 30 MB
Format : PDF, ePub, Mobi
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This book explains the requirements for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls, and presents a methodology for compliance. The document control system (DCS), or documented information control system (DICS), is the foundation of a quality management system. It is the first quality system element that must be implemented because the establishment and control of documented processes and information in a quality-controlled environment is dependent on the ability to proactively manage access to documents and the movement of documents through the document life cycle. A well-developed document control system benefits business by: Improving knowledge retention and knowledge transfer within and across business units Improving access to knowledge-based information Improving employee performance by providing standardized processes and communicating clear expectations Improving customer communication and satisfaction by providing documented information from which common understanding can be achieved Providing traceability of activities and documentation throughout the organization Improving organization of and access to documents and data Sample documents are included in the appendixes of this book to help clarify explanations, and a full set of formatted procedures and document templates are available for download to get you off to an even faster start. This book provides a process-based approach that can be used for controlling all forms of documented information that are required to be managed under the quality management system.

The Fda And Worldwide Quality System Requirements Guidebook For Medical Devices

Author : Amiram Daniel
ISBN : 9780873897402
Genre : Medical
File Size : 79. 7 MB
Format : PDF
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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.

Iso 13485 2016

Author : Itay Abuhav
ISBN : 9781351000772
Genre : Medical
File Size : 25. 23 MB
Format : PDF, ePub
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This book will be a substantial revision, which will reflect the new version of the ISO 13485:2016. This represents the standard protocols that all medical device manufacturers must follow, in the fabrication of their products. It will focus on changes in the structure of the quality management system; change in the documentation for quality managemeent systems and finally, present the different methods of implementation of the standard requirements within the organization.This new version was initiated in 2016, thus all apprpriate enterprises using the old standard must convert to the new version, now available.The Second Edition will clarify, explain and demonstrate the new version.

How To Audit Iso 9001 2015

Author : Chad Kymal
ISBN : 9780873899277
Genre : Business & Economics
File Size : 53. 56 MB
Format : PDF, Docs
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ISO 9001:2015 includes many changes that not only affect the companies aiming to achieve certification to it, but also auditors. This book is the resource auditors need to fully understand ISO 9001:2015 and help them perform audits to it. This book integrates two different types of audit strategies, conformance audits and performance audits, into one process approach audit. Conformance audits confirm that the organization is meeting the requirements of the standard, while performance audits confirm that the QMS is achieving its intended results. The book includes: An introduction to ISO 9001:2015 An auditing strategy for ISO 9001:2015 How to conduct a Stage 1 audit for ISO 9001:2015 How to conduct a Stage 2 on-site audit for ISO 9001:2015 Appendices include an introduction to process focus, an assessment report template for Stage 1 audits, a confidential assessment report template for Stage 2 audits, and an ISO 9001:2015 conformance checklist.

Document Control

Author : Dawit Kassa
ISBN : 1519760450
Genre :
File Size : 41. 23 MB
Format : PDF, ePub
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This book presents nine chapters covering essential topics in document control. It provides important insights into document control principles, processes and practices. It addresses strategic issues as well as daily governance challenges in document control, and provides practical advice on a number of topics including project document control.

Document Control

Author : Denise Robitaille
ISBN : 9781932828436
Genre : Business & Economics
File Size : 47. 87 MB
Format : PDF, ePub, Mobi
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They’re supposed to be useful tools, but whether they’re printouts, computer files, flowcharts, or forms, documents can often give more headaches than help. And yet without them, most organizations couldn’t function. ISO 9001 and other quality management systems place great emphasis on documents, and for good reason. Documents aren’t individual, stand-alone elements of the management process. They’re interrelated, formatted in different media, and controlled by various and distinct functions. Keeping critical information current and in the right hands requires more than just signing off on procedures. Document control is essential, but where should you begin? Inside you’ll find clear explanations about the document control process as well as practical solutions for creating, organizing, and maintaining documents, including: A discussion of different kinds of documents, including electronic media and QMS requirements Identifying and defining responsibility Understanding the relationship between documents and records Tips for document writers Managing and maintaining documents Issues of accessibility Handling revisions and deviations Writing document control procedures

Practical Engineering Process And Reliability Statistics

Author : Mark Allen Durivage
ISBN : 9780873898898
Genre : Business & Economics
File Size : 58. 56 MB
Format : PDF, ePub, Docs
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This book was written to aid quality technicians and engineers. It is a compilation of 30 years of quality-related work experience and the result of frustration at the number of books necessary, at times, to provide statistical support. To that end, the intent of this book is to provide the quality professional working in virtually any industry a quick, convenient, and comprehensive guide to properly utilize statistics in an efficient and effective manner. This book will be a useful reference when preparing for and taking many of the ASQ quality certification examinations, including the Certified Quality Technician (CQT), Certified Six Sigma Green Belt (CSSGB), Certified Quality Engineer (CQE), Certified Six Sigma Black Belt (CSSBB), and Certified Reliability Engineer (CRE). This book is an expansion of the work of Robert A. Dovich in his books Quality Engineering Statistics and Reliability Statistics. It builds on and expands Dovich's method of presenting statistical applications in a simple, easy-to-follow format.

Effective Document Management

Author : Bob Wiggins
ISBN : 0566081482
Genre : Language Arts & Disciplines
File Size : 81. 24 MB
Format : PDF, Kindle
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Document management is a key to business success. It has a major contribution to play in delivering effective enterprise knowledge management. This book suggests how this can be achieved in the context of knowledge management and improvement approaches such as business process re-engineering, quality management and Investors in People.

Medical Device Regulations

Author : Michael Cheng
ISBN : 9789241546188
Genre : Medical
File Size : 37. 72 MB
Format : PDF, ePub, Mobi
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The term 'medical devices' covers a wide range of equipment essential for patient care at every level of the health service, whether at the bedside, at a health clinic or in a large specialised hospital. Yet many countries lack access to high-quality devices, particularly in developing countries where health technology assessments are rare and there is a lack of regulatory controls to prevent the use of substandard devices. This publication provides a guidance framework for countries wishing to create or modify their own regulatory systems for medical devices, based on best practice experience in other countries. Issues highlighted include: the need for harmonised regulations; and the adoption, where appropriate, of device approvals of advanced regulatory systems to avoid an unnecessary drain on scarce resources. These approaches allow emphasis to be placed on locally-assessed needs, including vendor and device registration, training and surveillance and information exchange systems.

Software Process Improvement And Capability Determination

Author : Paul M. Clarke
ISBN : 9783319389806
Genre : Business & Economics
File Size : 41. 54 MB
Format : PDF, Docs
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This book constitutes the refereed proceedings of the 16th International Conference on Software Process Improvement and Capability Determination, SPICE 2016, held in Dublin, Ireland, in June 2016. The 28 full papers presented together with 5 short papers were carefully reviewed and selected from 52 submissions. The papers are organized in the following topical sections: SPI in regulated and safety critical domains; gamification and education issues in SPI; SPI in agile and small settings; SPI and assessment; SPI and project management concerns; empirical research case studies of SPI; knowledge and human communications issues in SPI.

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