How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements PDF Download
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Author: Stephanie L. Skipper
Publisher: Quality Press
ISBN: 0873899172
Category : Business & Economics
Languages : en
Pages : 155
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Book Description
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: Stephanie L. Skipper
Publisher: Quality Press
ISBN: 0873899172
Category : Business & Economics
Languages : en
Pages : 155
Get Book Here
Book Description
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: Stephanie L. Skipper
Publisher: Quality Press
ISBN: 1953079504
Category : Business & Economics
Languages : en
Pages : 159
Get Book Here
Book Description
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. 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
ISBN: 1953079547
Category : Business & Economics
Languages : en
Pages : 161
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Book Description
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 example of the format for an ISO 9001:2015 conformance checklist.
Author: Erik V. Myhrberg
Publisher: Quality Press
ISBN: 0873899407
Category : Business & Economics
Languages : en
Pages : 166
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Book Description
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 410 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 9001:2015s 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 9001:2015s 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-clauses 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
Publisher: Quality Press
ISBN: 0873899083
Category : Business & Economics
Languages : en
Pages : 135
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Book Description
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: - Whats 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 its used, (3) how its 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
Publisher: Quality Press
ISBN: 0873899075
Category : Business & Economics
Languages : en
Pages : 135
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Book Description
Author: Milton P. Dentch
Publisher: Quality Press
ISBN: 1953079377
Category : Technology & Engineering
Languages : en
Pages : 144
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Book Description
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: John F. Graham
Publisher: Quality Press
ISBN: 0873899598
Category : Business & Economics
Languages : en
Pages : 47
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Book Description
Author: Erik V. Myhrberg
Publisher: Quality Press
ISBN: 0873899636
Category : Business & Economics
Languages : en
Pages : 104
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Book Description
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 9000:2015s 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 14001s 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-clauses 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: J.P. Russell
Publisher: Quality Press
ISBN: 0873899032
Category : Business & Economics
Languages : en
Pages : 83
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Book Description
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.
