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 : 36. 82 MB
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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.

How To Audit Iso 9001 2015

Author : Chad Kymal
ISBN : 9780873899277
Genre : Business & Economics
File Size : 29. 28 MB
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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.

A Practical Field Guide For Iso 9001 2015

Author : Erik V. Myhrberg
ISBN : 9780873899406
Genre : Business & Economics
File Size : 88. 28 MB
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The intent of this field guide is to assist organizations, step by step, in implementing a QMS in conformance with ISO 9001:2015, whether “from scratch” or by transitioning from ISO 9001:2008. Within the guide each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill the requirements listed below. This book examines each sub-clause of clauses 4–10 of ISO 9001:2015, which contain the requirements, with a visual representation provided in flowchart format on the facing page. This field guide will: - Provide a user-friendly guide to ISO 9001:2015’s requirements for implementation purposes - Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 9001:2015 implementation - Guide internal auditor(s) regarding what to ask to verify that a conforming and effective QMS exists - Direct management on what it must do and should consider to satisfy ISO 9001:2015’s enhanced requirements and responsibilities for top management - Depict step by step what must occur to create an effective, conforming QMS What separates this field guide from most other books on ISO 9001:2015 and its implementation are the flowcharts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. As the flowcharts themselves can be overwhelming when you first look at them, a text box appears with each flow chart that explains pertinent facts and/or what the flowchart represents and how it is to be used.

Cracking The Case Of Iso 9001 2015 For Service Third Edition

Author : Charles A. Cianfrani
ISBN : 9780873899086
Genre : Business & Economics
File Size : 40. 33 MB
Format : PDF, Docs
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This guide is intended to help everyone in a service organization participate in creating and sustaining a foundation of integrity, meet requirements and customer expectations, and support robust processes, to the advantage of everyone in the organization and to each of its customers. It provides a simplified explanation of the clauses of ISO 9001:2015, including: - What’s required - Why to do it - Implementation tips - Questions to ask to assess conformity Also included is a chapter that answers the question “Why do ISO 9001:2015?” and a chapter that summarizes the key differences with past editions of ISO 9001. To assist the user in implementation of QMS processes, this guide also includes a chapter that describes 12 quality tools. For each tool, the authors describe (1) what it is, (2) where it’s used, (3) how it’s done, and (4) cautions to be considered when using the tool. The contents of this book can help organizations save time in achieving compliance with the ISO 9001 requirements and also facilitate effective implementation. This has the potential to lower internal costs and to improve customer satisfaction.

Cracking The Case Of Iso 9001 2015 For Manufacturing Third Edition

Author : Charles A. Cianfrani
ISBN : 9780873899079
Genre : Business & Economics
File Size : 46. 76 MB
Format : PDF, Mobi
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The Fda And Worldwide Quality System Requirements Guidebook For Medical Devices

Author : Amiram Daniel
ISBN : 9780873897402
Genre : Medical
File Size : 48. 33 MB
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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.

Document Management For The Enterprise

Author : Michael J. D. Sutton
ISBN : STANFORD:36105019223432
Genre : Computers
File Size : 23. 75 MB
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A complete blueprint for planning, building, and maintaining fast, efficient, automated document management systems In Document Management for the Enterprise, Michael Sutton clearly defines and simplifies the principles of document engineering and management. He arms you with a set of proven techniques and methods for planning, building, and maintaining automated systems for fast and efficient storage and retrieval of documents and forms. And, with the help of numerous case studies, he shows you how to avoid common pitfalls and how to overcome frequently encountered obstacles. The most up-to-date, comprehensive, hands-on guide to the engineering and management of enterprise document management systems, Document Management for the Enterprise: * Clearly defines the goals and uses of document management and engineering * Provides expert assessments of risks, costs, and benefits of creating an enterprise-wide document management system * Outlines a document engineering life cycle and framework for rolling out document management applications * Identifies available software products and describes a method for evaluating their functions and features

Document Control

Author : Dawit Kassa
ISBN : 1519760450
Genre :
File Size : 88. 23 MB
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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 : 74. 76 MB
Format : PDF, ePub
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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 : 36. 63 MB
Format : PDF, Kindle
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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.

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