5,638円 Quality has been around for years-why would it need to be unleashed? The truth is, the power of quality comes from actions that stem from behaviors-behaviors that apply to every department within a company. In other words, a company's culture. For years, these behaviors have been restrained. Qual...

8,457円 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 o...

18,888円 This new and expanded second edition maintains the organizational approach of the first and includes the requirements and guidance contained in the Quality System Regulation (QSReg), the ISO 13485:2003 standard, the ISO/TR 14969:2004 guidance document, and, as appropriate, a number of the FDA an...

4,934円 Has your organization tried Lean already? If so, you surely see and feel the Joy of Lean in your workplace now, right? Don't worry. If you're not quite to joy yet, you're not alone. As it attracts more and more attention as a successful business philosophy that can improve results in any type of ...

10,571円 The focus of this book is to demystify the requirements delineated within ISO/IEC 17025:2017, while providing a road map for organizations wishing to receive accreditation for their laboratories. AS9100, ISO 9001:2015, and ISO 13485:2016 are standards that have been created to support the develop...

7,048円 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...

21,143円 This handbook is a helpful guide to Six Sigma process improvement and variation reduction. Individuals studying to pass the ASQ Certified Six Sigma Yellow Belt (CSSYB) exam will find this comprehensive text invaluable for preparation, and it is also a handy reference for those already working in ...

8,457円 Implementing the requirements of ISO 9001 can be a daunting task for many organizations. In an attempt to develop a system that will pass the registration audit, we are tempted to establish processes with the primary purpose of conforming to the requirements of ISO 9001. In doing so, however, it ...

14,801円 The ASQ Certified Quality Improvement Associate (CQIA) certification introduces the basics of quality to organizations and individuals who are new to quality. This book, and the Body of Knowledge (BoK) it supports, form a foundation for applying proven quality principles and practices that are us...

7,048円 Competitive advantage as it existed in the 1970s and 1980s is no longer valid. Leaders must be ready to adopt the thinking that there is no such thing as long-term competitive advantage anymore, due to the constantly changing landscape, and they will have to repeatedly redefine and redesign busin...

6,485円 Healthcare providers deal with quality concepts and tools on a regular basis, but the idea of a quality system or quality management system (QMS) is not a familiar term. Most are familiar with control charts, Lean, the PDSA cycle, Six Sigma, and the Baldrige criteria, but ISO 9001 is not usually ...

4,088円 This guide is intended to help everyone in an 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 simp...