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

Author : Stephanie L. Skipper
Publisher : Quality Press
Page : 156 pages
File Size : 55,8 Mb
Release : 2015-10-14
Category : Business & Economics
ISBN : 9780873899178

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How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements by Stephanie L. Skipper Pdf

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.

Author : Chad Kymal
Publisher : Quality Press
Page : 156 pages
File Size : 42,9 Mb
Release : 2016-04-22
Category : Business & Economics
ISBN : 9780873899277

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How to Audit ISO 9001:2015 by Chad Kymal Pdf

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.

Author : Erik V. Myhrberg
Publisher : Quality Press
Page : 170 pages
File Size : 40,8 Mb
Release : 2016-10-20
Category : Business & Economics
ISBN : 9780873899406

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A Practical Field Guide for ISO 9001:2015 by Erik V. Myhrberg Pdf

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.

Author : Charles A. Cianfrani,John E. (Jack) West
Publisher : Quality Press
Page : 296 pages
File Size : 48,9 Mb
Release : 2016-09-08
Category : Business & Economics
ISBN : 9780873899086

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Cracking the Case of ISO 9001:2015 for Service, Third Edition by Charles A. Cianfrani,John E. (Jack) West Pdf

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.

Author : Charles A. Cianfrani,John E. (Jack) West
Publisher : Quality Press
Page : 298 pages
File Size : 54,8 Mb
Release : 2016-09-08
Category : Business & Economics
ISBN : 9780873899079

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Cracking the Case of ISO 9001:2015 for Manufacturing, Third Edition by Charles A. Cianfrani,John E. (Jack) West Pdf

Author : Milton P. Dentch
Publisher : Quality Press
Page : 138 pages
File Size : 52,7 Mb
Release : 2018-06-05
Category : Technology & Engineering
ISBN : 9781953079374

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The ISO 45001:2018 Implementation Handbook by Milton P. Dentch Pdf

Guidance on how an organization can build and use a management system to both control and improve its safety or occupational health and safety performance in alignment with the requirements of ISO 45001:2018.

Author : Erik V. Myhrberg,Brandon L. Myhrberg
Publisher : Quality Press
Page : 84 pages
File Size : 46,8 Mb
Release : 2017-01-01
Category : Business & Economics
ISBN : 9780873899635

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A Practical Field Guide for ISO 14001:2015 by Erik V. Myhrberg,Brandon L. Myhrberg Pdf

The field guide depicts step by step what must occur for organizations to create an effective environmental management system (EMS) in conformance with ISO 14001:2015, whether “from scratch” or by transitioning from ISO 14001:2004. In keeping with ISO 9000:2015’s definition of environmental as the “degree to which a set of inherent characteristics fulfills requirements,” the authors have identified the requirements and inherent characteristics (distinguishing features) for this field guide. Within the guide, each sub-clause containing requirements is the focus of a two-page spread that consistently presents features that fulfill ISO 14001’s requirements. What separates this field guide from most other books on ISO 14001:2015 and its implementation are flowcharts showing the steps to be taken in implementing an EMS to meet a sub-clause’s requirements. This field guide has been created to foster an inner reliance between senior management, middle management, functional teams, and the individual. Users of the field guide will find within it practical tools, tips, and techniques useful for not only implementing an environmental management system (EMS) but also maintaining one. The revised ISO 14001:2015 standard is both useful to the organization and here to stay. May this logistical field guide serve you and your organization well!

Author : John F. Graham
Publisher : Quality Press
Page : 45 pages
File Size : 40,8 Mb
Release : 2017-05-19
Category : Business & Economics
ISBN : 9780873899598

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The Magic of ISO 9001 by John F. Graham Pdf

Author : J.P. Russell
Publisher : Quality Press
Page : 102 pages
File Size : 55,9 Mb
Release : 2016-07-18
Category : Business & Economics
ISBN : 9780873899031

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ISO Lesson Guide 2015 by J.P. Russell Pdf

The ISO Lesson Guide translates ISO 9001 into easy-to-understand words. This pocket guide was designed as a quick reference for anyone to carry around conveniently. Each element containing requirements is discussed and key concepts are highlighted at the beginning of each section. In the ISO Lesson Guide: Quality is defined The ISO process approach is explained Key concepts are accompanied by an illustration Risk-based thinking is introduced Concepts are described in easy-to-understand words A brief conspectus summarizes ISO 9001 requirements Quality management principles are described in easy-to-understand words An entertaining fable explains the difference between ISO 9001 and ISO 9004 Ideal for handing out to existing and new employees, this pocket guide can also be used as supplemental study material for ISO 9001 training courses.

Author : J.B. Smith
Publisher : Quality Press
Page : 216 pages
File Size : 40,9 Mb
Release : 2016-03-08
Category : Business & Economics
ISBN : 9780873899253

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The Art of Integrating Strategic Planning, Process Metrics, Risk Mitigation, and Auditing by J.B. Smith Pdf

The author’s lessons learned—during more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, military, aerospace, automotive, and logistics—are condensed in this book to provide reference material to both beginners and seasoned professionals in the development and sustainability of an effective quality and operational system. Experiences shared in this book include the design from ground zero-to-deployment, risk mitigation, and maintenance of quality standards such as ISO 9001, AS9100, ISO/TS 16949, TL 9000, FDA/GMP and C-TPAT standard, and Lean Six Sigma principles. The main focus of this book is to promote the use of the internal auditing tool as a feedback mechanism not only for compliance verification but also for the measurement and enhancement of the system’s effectiveness. The catalysts for this goal are: Auditing beyond compliance to include identification of improvement opportunities Use of process metrics as feedback mechanism in the discovery of hidden factories and risks Concepts and models discussed in this book are clearly illustrated using anonymous real-life examples encountered in day-to-day operations. These examples include lessons learned associated with compliance, continuous improvement, and techniques in the conversion of performance metrics as process indicators, savings’ generators, and risk mitigation. The examples and models are simple and easy to understand accompanied with templates for quick application on the creation of problem statements, root cause analysis methods, and design of action plans with measurement of success. Workshop modules for ‘training the trainers’ are included in this book with practical hands-on exercises on the different tools associated with problem solving, development of process metrics for risk mitigations and auditing.

Author : Mark Allen Durivage
Publisher : Quality Press
Page : 404 pages
File Size : 47,6 Mb
Release : 2016-05-23
Category : Technology & Engineering
ISBN : 9781951058906

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The Certified Pharmaceutical GMP Professional Handbook by Mark Allen Durivage Pdf

The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.

Author : Philip S. Cosgriff,Matthew J. Memmott
Publisher : CRC Press
Page : 223 pages
File Size : 47,9 Mb
Release : 2024-03-26
Category : Science
ISBN : 9781040002353

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Writing In-House Medical Device Software in Compliance with EU, UK, and US Regulations by Philip S. Cosgriff,Matthew J. Memmott Pdf

This book is a comprehensive guide to producing medical software for routine clinical use. It is a practical guidebook for medical professionals developing software to ensure compliance with medical device regulations for software products intended to be sold commercially, shared with healthcare colleagues in other hospitals, or simply used in-house. It compares requirements and latest regulations in different global territories, including the most recent EU regulations as well as UK and US regulations. This book is a valuable resource for practising clinical scientists producing medical software in-house, in addition to other medical staff writing small apps for clinical use, clinical scientist trainees, and software engineers considering a move into healthcare. The academic level is post-graduate, as readers will require a basic knowledge of software engineering principles and practice. Key Features: Up to date with the latest regulations in the UK, the EU, and the US Useful for those producing medical software for routine clinical use Contains best practice

Author : Vinny R. Sastri
Publisher : William Andrew
Page : 525 pages
File Size : 46,7 Mb
Release : 2021-11-24
Category : Technology & Engineering
ISBN : 9780323851275

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Plastics in Medical Devices by Vinny R. Sastri Pdf

Plastics in Medical Devices: Properties, Requirements, and Applications, Third Edition provides a comprehensive overview on the main types of plastics used in medical device applications. The book focuses on the applications and properties that are most important in medical device design, such as chemical resistance, sterilization capability and biocompatibility. The roles of additives, stabilizers and fillers as well as the synthesis and production of polymers are covered and backed up with a wealth of data tables. The book also covers other key aspects in detail, including regulations, compliance, purchasing controls and supplier controls, and process validation. This updated edition has been thoroughly revised with regard to new plastic materials, applications and requirements. This is a valuable resource for engineers, scientists and managers involved in the design and manufacture of medical devices. Presents detailed coverage of commercially available plastics used in medical device applications, organized by polymer type and supported by data Includes up-to-date regulatory requirements and practical information on purchasing and supplier controls, process validation and risk management Supports the development, marketing and commercialization of medical devices and materials for use in medical devices

Author : Amiram Daniel
Publisher : Quality Press
Page : 355 pages
File Size : 48,9 Mb
Release : 2008-01-01
Category : Medical
ISBN : 9780873897402

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The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by Amiram Daniel Pdf

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.

Author : Michael Cheng,World Health Organization
Publisher : World Health Organization
Page : 54 pages
File Size : 41,6 Mb
Release : 2003-09-16
Category : Medical
ISBN : 9789241546188

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Medical Device Regulations by Michael Cheng,World Health Organization Pdf

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.