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The ASQ Certified Medical Device Auditor Handbook
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
The ASQ Certified Quality Engineer Handbook
The ASQ Certified Quality Engineer Handbook, Fifth Edition, covers a wide range of topics in the quality engineering field and is organized to align with the 2022 ASQ Certified Quality Engineer (CQE) Body of Knowledge (BoK). This handbook is essential for candidates preparing for the ASQ CQE examination. For working engineers, it is a convenient and thorough guide to the profession. In addition to providing detailed explanations of each section of the 2022 CQE BoK, this current edition includes: • An explanation of cost-benefit analysis (CBA) and the RACI matrix; critical to quality as a design input; hazard analysis and FMEA; overall equipment effectiveness (OEE); 5 Whys analysis; data au...
The ASQ Certified Quality Engineer Study Guide, Second Edition
This study guide is helpful for anyone planning to take the ASQ Certified Quality Engineer (CQE) exam. The book has been developed specifically to address the 2022 CQE Body of Knowledge (BoK). Every practice question includes an explanation of the correct answer along with the corresponding section of the BoK for further study, and over half of the 600+ questions have been revised and improved. New topics include data automation and database integration, cost-benefit analysis, the RACI matrix, assessing risks in auditing, overall equipment effectiveness, critical-to-quality concepts, 5 Whys, and a much more intensive treatment of risk management.
Mastering Safety Risk Management for Medical and In Vitro Devices
When it comes to medical and in vitro devices, risk management starts with a design assurance process that helps practitioners identify, understand, analyze, and mitigate the risks of the healthcare product design for favorable benefit-risk assessment. Risk management actively follows the product’s life cycle into production and post-market phases. This book offers a blueprint for implementing an effective risk management system. It provides risk management tools and a compliance framework for methods in conformance to ISO 13485:2016, ISO 14971:2019, European Union MDR, IVDR, and US FDA regulations (including the new FDA QMSR).
The ASQ Certified Medical Device Auditor Handbook
This latest edition replaces the former handbook, The ASQ Biomedical Quality Auditor Handbook. General editor, Scott Laman, collaborated closely with Quality experts in the medical device industry to align the new handbook's content to ASQ's Body of Knowledge (BoK) for the CMDA (Certified Medical Device Auditor) certification exam. New to the latest edition: ?New chapter covering the EU medical device regulations?Updated content about In Vitro Diagnostic (IVD) devices?Updated content about quality risk management (ISO 14971 and ISO 13485) ?Improved quality tools and techniques
The Book of Laman
Mette Harrison is one of the best-known Mormon authors currently writing about Mormonism for a national audience. Her Linda Wallheim mystery series (The Bishop's Wife, His Right Hand, For Time and All Eternities, and, one hopes, many more to come) marks the first time ever that a strong and intelligent Mormon woman (or any other kind of Mormon woman for that matter) has had a starring role in a nationally marketed mystery series. In The Book of Laman, Harrison takes a concept that others have used for a quick joke-the idea of narrating the first part of the Book of Mormon from Laman's perspective-and turns it into a serious and profoundly moving story of redemption that has the ability to ma...
The ASQ Certified Food Safety and Quality Auditor Handbook
Federal regulatory agencies have embraced Hazard Analysis Critical Control Point (HACCP) as the most effective method to offer farm-to-table food safety and quality in the United States-but it is important to look beyond HACCP. The ASQ Certified Food Safety and Quality Auditor (CFSQA) Handbook serves as a baseline of knowledge for auditors of food safety and quality systems that covers other aspects of food production, including preventive controls. This handbook assists certification candidates in preparing for the ASQ Certified Food Safety and Quality Auditor (CFSQA) examination. Its chapters cover the HACCP audit and auditor, preventive principles, and quality assurance analytical tools. ...
