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A Practical Field Guide for ISO 9001:2015
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...
A Practical Field Guide for ISO 14001:2015
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...
A Practical Field Guide for ISO 13485:2016
The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requiremen...
Beyond Compliance Design of a Quality System
Next Level Results for Your QMS You don't just want a compliant quality management system, you want a robust one a QMS that's easy to implement and maintain. Beyond Compliance Design merges two sets of experiencess that of a quality system designer/auditee and that of an external auditor to help you make that possible. Move beyond a focus on checking all the right boxes to the opportunities for continuous improvement, waste reduction, employee engagement, and customer satisfaction and delight. Author Janet Bautista Smith, with the contributions of external auditor, Robert Alvarez, guides you in this process with her models, case studies, lessons learned, and an array of simple tools and temp...
A Practical Field Guide for AS9100C
The purpose of this field guide is to assist the reader, step-by-step, in implementing a Quality Management System (QMS) in conformance with AS9100C. This field guide has been created in order 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 a QMS but also for maintaining one. What separates this field guide from most other books on AS9100 and its implementation are the flow charts showing the steps to be taken in implementing a QMS to meet a sub-clause’s requirements. You need to turn out aerospace conforming parts on time, every time, and at a competitive cost, as that's exactly what the companies that can compete now and in the future will do. A Practical Field Guide for AS9100 will help to get you there.
How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements
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...
A Practical Field Guide for ISO 13485:2016
The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishing features) for this expanded field guide. Within the guide, each subclause containing requirements is the focus of a two-page visual spread that consistently presents features that fulfill the requiremen...
A Practical Field Guide for AS9100
What separates this field guide from most other books on AS9100 are the flowcharts showing the steps to be taken in implementing a QMS to meet subclause requirements, and the process control tips that assist the reader to meet the intent of AS9100 and gain competitive advantage."--Jacket.
Advanced Quality Auditing
Auditors from any industry must "learn the language of upper management" if they truly want to effect positive change throughout their environments. If quality auditors want to remain relevant and keep from becoming marginalized, they need to add new skills and credentials, and even more importantly, move beyond conformance monitoring to determine how their work might impact the corporate bottom line. The purpose of this book is to accept that challenge in presenting two ways that auditors can "learn [to speak] the language of upper management"-either by helping to drive continuous improvement or by helping to manage risk. This book has essential information that will help guide an organizat...
