5,638円 This primer was written to promote the application of basic and sound supply chain management principles. It was written for a global audience of practitioners and their managers. Authors and reviewers were chosen from around the world to capture these accepted methods used in national and intern...

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...

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...

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 All organizations experience unintended variation and its consequences. Such problems exist within a broad range of scope, persistence, and severity across different industries. Some problems cause minor nuisances, others leads to loss of customers or money, others yet can be a matter of life and...

13,954円 In order for organizations to have high confidence in the reliability of their medical devices, they must ensure that each and every component or service meets requirements, including quality requirements. In that light, supplier management is not only a regulatory requirement but also a business...

6,343円 In 1917, we split the atom and released an incredible force for destruction. In 2019, we split the DMAIC and released an even bigger force for improvement. There is no doubt that the various improvement methods work. Whether it is PDCA or 7-Step problem-solving or A3 or IIs Not or DMAIC or any ot...

20,438円 Many reliability engineers are gainfully employed in considerations of the physical nature of components and systems-bringing to bear theories and methodologies of physics, electronics, mechanics, material science, chemistry, and so on. But when a product has been designed and manufactured, its p...

11,276円 The 2015 edition of ISO 9001 has been modernized to update terminology and content to meet current and anticipated user needs. The major emphasis of ISO 9001:2015 is still consistent provision of products and services that meet customer and applicable statutory and regulatory requirements. This b...

8,175円 The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as...