The Biomedical Quality Auditor Handbook, 3rd Edition

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