CBA® Certified Biomedical Auditor
ABOUT:
The Certified Biomedical Auditor (CBA®) designation recognizes professionals skilled in auditing biomedical systems against industry standards and regulations. CBAs are adept at evaluating process safety and compliance using various auditing tools and techniques. They analyze system elements, assess adherence to quality management criteria, and report on system efficiencies and deficiencies.
CERTIFICATION BODY: ASQ® (American Society for Quality)
LEARNING OBJECTIVES:
- Audit Principles: Grasp audit types, roles, and related ethical and legal issues.
- Quality Management Systems: Apply biomedical standards like ISO 9001 and ISO 13485.
- Quality Tools: Utilize Pareto charts, flowcharts, SPC charts, and PDCA.
- Risk Management: Implement standards for risk assessment and hazard detection.
- Regulatory Compliance: Evaluate risk management, complaint handling, and recalls.
- Biocompatibility and Validation: Understand biocompatibility testing and environmental controls.
- Software Development: Recognize quality system elements in the software lifecycle.
- Industry Standards: Ensure compliance with standards using tools like FDA QSIT.EXAM
EXAM INFORMATION:
- Computer-Based: 145 questions (135 scored). Duration: 4.5 hours (4 hours 18 minutes). English only.
- Paper-Based: 135 questions. Duration: 4 hours. English only.
- Open Book: Bring your own reference materials. Calculators allowed.
RECERTIFICATION:
The CBA certification is valid for three years. Recertification requires maintaining professional development through continuing education or re-examination. Candidates must demonstrate ongoing competence in the field to retain their certification.
For More Information
Curriculum
- 1 Section
- 9 Lessons
- 40 Hours
- CONTENT:9
- 1.1Introduction: Overview of auditing principles and practices.
- 1.2Audit Types and Roles: Different audit methodologies and ethical considerations.
- 1.3Biomedical Quality Management: Requirements and regulations.
- 1.4Quality Tools and Techniques: Pareto charts, SPC, flowcharts, and more.
- 1.5Risk Management: Standards and practices for risk evaluation.
- 1.6Regulatory Compliance: FDA regulations, ISO standards, and quality systems.
- 1.7Biocompatibility and Validation: Testing and environmental controls.
- 1.8Software and Quality Systems: Understanding the software development life cycle.
- 1.9Case Studies and Practical Exercises: Real-world scenarios and applications.
Requirements
- Experience:
Five years of work experience in biomedical auditing, with at least one year in a decision-making role. - Education Waivers:
Associate’s Degree: One year of experience waived.
Bachelor’s Degree: Three years of experience waived.
Master’s or Doctorate Degree: Four years of experience waived.
Target audiences
- Biomedical Auditors
- Biomedical Engineers
- Project Managers
- Quality Audit Managers
- Quality Engineers
- Quality Managers
- Regulatory Experts
- Supplier Quality Engineers