The Biomedical Quality Auditor Handbook, Third Edition PDF Download
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Author: Heather Crawford
Publisher: Quality Press
ISBN: 0873899628
Category : Business & Economics
Languages : en
Pages : 271
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Book Description
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.
Author: Heather Crawford
Publisher: Quality Press
ISBN: 0873899628
Category : Business & Economics
Languages : en
Pages : 271
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Book Description
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.
Author: Scott A Laman
Publisher: Quality Press
ISBN: 1953079970
Category : Medical
Languages : en
Pages : 372
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Book Description
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
Author: Chad Kymal
Publisher: Quality Press
ISBN: 087389927X
Category : Business & Economics
Languages : en
Pages : 136
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Book Description
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.
Author: J.B. Smith
Publisher: Quality Press
ISBN: 0873899253
Category : Business & Economics
Languages : en
Pages : 171
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Book Description
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.
Author: ASQ's Food, Drug, and Cosmetic Division
Publisher: Quality Press
ISBN: 0873898680
Category : Business & Economics
Languages : en
Pages : 221
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Book Description
This handbook is intended to serve as a baseline of hazard analysis critical control point (HACCP) knowledge for quality auditors. HACCP is more than just failure mode and effect analysis (FMEA) for food: it is a product safety management system that evolved and matured in the commercial food processing industry allowing food processors to take a proactive approach to prevent foodborne diseases. Both the FDA and the USDA have embraced HACCP as the most effective method to ensure farm-to-table food safety in the United States. This handbook also assists the certification candidate preparing for the ASQ Certified HACCP Auditor (CHA) examination. It includes chapters covering the HACCP audit, the HACCP auditor, and quality assurance analytical tools.
Author: Stephanie L. Skipper
Publisher: Quality Press
ISBN: 0873899172
Category : Business & Economics
Languages : en
Pages : 155
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Book Description
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.
Author: Charles H. Moseley
Publisher: Quality Press
ISBN: 1636940080
Category : Business & Economics
Languages : en
Pages : 393
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Book Description
Initially developed as a tool for training lead auditors of nuclear quality systems, the Nuclear Auditing Handbook has also been used as a reference by quality managers who plan quality system audits. It provides detailed material in such aspects as the development, administration, planning, preparation, performance, and reporting of quality system audits in energy-related fields. ASQ's Nuclear Committee of the Energy and Environment Division gathered a team of highly seasoned experts in the nuclear auditing field to expand this new edition's content and bring it current to modern-day best practices and standards. This book introduces updated information about requirements and standards, including the 2019 editions of the American Society of Mechanical Engineers (ASME) NQA-1 Quality Assurance Program Requirements for Nuclear Facility Applications and ASME BPVC Sections I; IV; and VIII, Divisions 1 and 2. The authors and editors have also added helpful tools to aid nuclear auditors, including case studies suitable for training auditors, blank forms for convenient use, and samples of completed forms.
Author: Marie Teixeira
Publisher: CRC Press
ISBN: 9780203909386
Category : Medical
Languages : en
Pages : 258
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Book Description
This reference provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations-offering product development models for the production of safe, durable, and cost-efficient medical devices and systems. Details procedures utilize
Author: Jose (Pepe) Rodriguez-Perez
Publisher: Quality Press
ISBN: 1636940129
Category : Business & Economics
Languages : en
Pages : 152
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Book Description
Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.
Author: Roderick A. Munro
Publisher: Quality Press
ISBN: 0873898915
Category : Business & Economics
Languages : en
Pages : 693
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Book Description
This reference manual is designed to help those interested in passing the ASQ's certification exam for Six Sigma Green Belts and others who want a handy reference to the appropriate materials needed to conduct successful Green Belt projects. It is a reference handbook on running projects for those who are already knowledgeable about process improvement and variation reduction. The primary layout of the handbook follows the ASQ Body of Knowledge (BoK) for the Certified Six Sigma Green Belt (CSSGB) updated in 2015. The authors were involved with the first edition handbook, and have utilized first edition user comments, numerous Six Sigma practitioners, and their own personal knowledge gained through helping others prepare for exams to bring together a handbook that they hope will be very beneficial to anyone seeking to pass the ASQ or other Green Belt exams. In addition to the primary text, the authors have added a number of new appendixes, an expanded acronym list, new practice exam questions, and other additional materials
