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. A specific listing of each requirement is provided along with observations concerning compliance and adherence to the rules.