Title: The Biomedical Quality Auditor Handbook, 3rd Edition Author: ASQ Biomedical Division, Heather Crawford ISBN: 0873899628 / 9780873899628 Format: Hard Cover Pages: 264 Publisher: ASQ Year: 2017 Availability: Out of Stock
Description
Contents
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 ASQ’s 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.
List of Figures and Tables
Preface
Acknowledgments
Part I : Auditing
Chapter 1 : Auditing Fundamentals Chapter 2 : Auditing and Inspection Processes Chapter 3 : Audit Procedural References
Part II : Biomedical Quality Management System Requirements
Chapter 4 : US Requirements - Federal Food, Drug, and Cosmetic Act (FDCA) Chapter 5 : US FDA Code of Federal Regulations (CFR) Title 21 Chapter 6 : The EU Medical Device Directives Chapter 7 : Other International Regulations Chapter 8 : FDA Guidance for Manufacture of In Vitro Diagnostic (IVD) Products Chapter 9 : International Standards for Quality Systems Chapter 10 : Quality System Regulation (QSR) Requirements Chapter 11 : Postmarket Surveillance
Part III : Technical Biomedical Knowledge
Chapter 12 : Risk Management Chapter 13 : Sterilization Chapter 14 : Biocompatibility Chapter 15 : Controlled Environments and Utility Systems Chapter 16 : Software Development and Maintenance for Products Chapter 17 : Laboratory Testing and Failure Analysis Chapter 18 : Sources for New and Evolving Standards Chapter 19 : Common Medical Device Directives and Standards Chapter 20 : Packaging Chapter 21 : Reprocessing/Reuse and Cleaning of Medical Devices
Part IV : Quality Tools and Techniques Chapter 22 : Quality Control and Problem-Solving Tools Chapter 23 : Process Improvement Techniques Chapter 24 : Data Types and Sampling
Part V : Appendices
Appendix A : Glossary of Terms
Appendix B : Certified Biomedical Auditor (CBA) Body of Knowledge (2013)
Appendix C : Certified Biomedical Auditor (CBA) Refereces (2013)
Endnotes
Index