Certified Biomedical Auditor (CBA)
Certification Provider
American Society for Quality (ASQ)
Best For
Quality Assurance Auditor - Biomedical, Regulatory Affairs Specialist, Biomedical Quality Manager, Medical Device Auditor, Biomedical Compliance Officer, Quality Systems Coordinator - Biomedical
Description
The Certified Biomedical Auditor (CBA) is a professional credential offered by the American Society for Quality (ASQ) that validates an individual's expertise in auditing biomedical systems. This certification focuses on the principles of biomedical quality auditing, including regulations, standards, and guidance specific to the biomedical field. Candidates will demonstrate their knowledge of quality tools and processes, risk management, and the ability to assess compliance with biomedical industry practices. The CBA is ideal for professionals seeking to ensure the efficacy and safety of biomedical products and services.
Includes Certification
Yes
Prerequisites
A minimum of five years of on-the-job experience in one or more of the areas of the Certified Biomedical Auditor Body of Knowledge.
A minimum of an associate degree as the educational equivalent of two years of experience, with the degree being in a science, technology, engineering, or mathematics (STEM) field or in a field related to biomedical practice.
Candidates without a degree can have five additional years of work experience in the biomedical field, totaling ten years.
Experience must be in a full-time, paid role and can include roles in quality assurance, regulatory affairs, product development, manufacturing, or other areas relevant to biomedical auditing.
Agreement to abide by the ASQ Code of Ethics.
Passing the CBA examination, which covers topics such as auditing fundamentals, biomedical quality management systems, and biomedical product realization.
