The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQs Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.
The ASQ Certified Medical Device Auditor Handbook (formerly The Biomedical Quality Auditor Handbook) was developed by the ASQ Medical Device Division (formerly Biomedical Division) in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the medical device community. It principally serves as a resource to candidates preparing for the Certified Medical Device Auditor (CMDA) certification exam. The fourth edition of this handbook has been reorganized to align with the 2020 certification exam Body of Knowledge (BoK) and reference list. The combination of this handbook with other reference materials can provide a well-rounded background in medical device auditing. Updates to this edition include: • A discussion of data privacy, data integrity principles, and the Medical Device Single Audit Program (MDSAP) • Current information about federal and international regulations • New content regarding human factors and usability engineering, general safety and performance requirements, labeling, validation, risk management, and cybersecurity considerations • A thorough explanation of quality tools and techniques
This new handbook is an excellent resource to support the body of knowledge for the Quality Auditor-Biomedical Certification. it serves as a reference to the application of quality auditor principles to the biomedical industry including coverage of medical devices. Content focuses on the understanding of domestic and international concepts and principles of biomedical quality auditing and includes related regulations, directives, standards, and guidance. Preview a sample chapter from this book along with the full table of contents by clicking here. You will need Adobe Acrobat to view this pdf file.
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans
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 ISO 9001:2015 conformance checklist.
The authors lessons learnedduring more than 25 years of hands-on quality management experience in environments including manufacturing, medical devices, military, aerospace, automotive, and logisticsare condensed in this book to provide reference material to both beginners and seasoned professionals in the development and sustainability of an effective quality and operational system. Experiences shared in this book include the design from ground zero-to-deployment, risk mitigation, and maintenance of quality standards such as ISO 9001, AS9100, ISO/TS 16949, TL 9000, FDA/GMP and C-TPAT standard, and Lean Six Sigma principles. The main focus of this book is to promote the use of the internal auditing tool as a feedback mechanism not only for compliance verification but also for the measurement and enhancement of the systems effectiveness. The catalysts for this goal are: Auditing beyond compliance to include identification of improvement opportunities Use of process metrics as feedback mechanism in the discovery of hidden factories and risks Concepts and models discussed in this book are clearly illustrated using anonymous real-life examples encountered in day-to-day operations. These examples include lessons learned associated with compliance, continuous improvement, and techniques in the conversion of performance metrics as process indicators, savings generators, and risk mitigation. The examples and models are simple and easy to understand accompanied with templates for quick application on the creation of problem statements, root cause analysis methods, and design of action plans with measurement of success. Workshop modules for training the trainers are included in this book with practical hands-on exercises on the different tools associated with problem solving, development of process metrics for risk mitigations and auditing.
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.
The Handbook of Data Recording, Maintenance, and Management for the Biomedical Sciences explains how to maintain a scientific log that will withstand peer, federal, and other reviewing agencies' scrutiny. This is a timely publication as the maintenance of a log becomes an increasingly more important issue. It covers data monitoring, recording and maintenance; quality assurance; and printed forms, and the laws and regulations that impact their design and use.
The quality inspector is the person perhaps most closely involved with day-to-day activities intended to ensure that products and services meet customer expectations. The quality inspector is required to understand and apply a variety of tools and techniques as codified in the American Society for Quality (ASQ) Certified Quality Inspector (CQI) Body of Knowledge (BoK). The tools and techniques identified in the ASQ CQI BoK include technical math, metrology, inspection and test techniques, and quality assurance. Quality inspectors frequently work with the quality function of organizations in the various measurement and inspection laboratories, as well as on the shop floor supporting and interacting with quality engineers and production/service delivery personnel. This handbook supports individuals preparing to perform, or those already performing, this type of work. It is intended to serve as a ready reference for quality inspectors and quality inspectors in training, as well as a comprehensive reference for those individuals preparing to take the ASQ CQI examination. Examples and problems used throughout the handbook are thoroughly explained, are algebra-based, and are drawn from real-world situations encountered in the quality profession. To assist readers in using this book as a ready reference or as a study aid, the book has been organized to conform explicitly to the ASQ CQI BoK. Each chapter title, all major topical divisions within the chapters, and every main point has been titled and then numbered exactly as they appear in the CQI BoK.
