Bøker av Erik V. Myhrberg

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 requirements listed below.This guide will:Provide a user-friendly guide to ISO 13485:2016's requirements for implementation purposes-Identify the documents/documentation required, along with recommendations on what to consider retaining/adding to a QMS during ISO 13485:2016 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 13485:2016's enhanced requirements, as well as on the responsibilities for top management-Depict step-by-step in flowchart form what must occur to create an effective, conforming QMS

The field guide depicts step by step what must occur for organizations to create an effective environmental management system (EMS) in conformance with a ISO 14001:2015/a, 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!

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 QMSWhat 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.