Why Become A Certified Biomedical Auditor?: What Are The Core Competencies of A CBA?

WHY BECOME A
CERTIFIED BIOMEDICAL AUDITOR CBA
CERTIFIED BIOMEDICAL AUDITOR?

As a Certified Biomedical Auditor (CBA) you will be a professional who understands the principles of
standards, regulations, directives, and guidance for auditing a biomedical system while using various tools
and techniques to examine, question, evaluate, and report on that system’s adequacies and deficiencies. A
CBA analyzes all elements of the system and reports on how well it adheres to the criteria for management
and control of process safety.
What Are the Core Competencies of a CBA?

• Comprehend different types of audits, audit roles • Evaluate risk management programs and requirements
and responsibilities, and the ethical, legal, and for complaint handling, vigilance, medical device
professional issues associated with audits. reporting (MDR), and tracking and product recall
processes. Review validation procedures for laboratory
• Apply and understand a broad variety of biomedical
testing and use appropriate methods for analyzing,
quality management system requirements including
detecting, and controlling nonconformances.
U.S. and foreign regulatory laws and regulations
(e.g., Code of Federal Regulations, 21 CFR 820) and • Identify and describe biocompatibility terms and test
international standards for quality (e.g., ISO 9001, selection rationale in accordance with applicable
ISO 13485). standards and guidelines. Evaluate environmental
controls and determine whether utilities require
• Understand quality tools such as Pareto charts, cause
qualification, validation, or maintenance.
and effect diagrams, flowcharts, statistical process
control (SPC) charts, check sheets, scatter diagrams, • Recognize the elements of the software development
histograms, and plan-do-check-act (PDCA). life cycle for products, processes, and quality systems.
• Identify and apply standards related to risk manage-

ment, hazard detection, and sterilization for aseptically
processed and terminally sterilized products.
What Is the Value to Your Company? What Is the Value to You?

• Ensure conformity to industry standards and • An improved skill set qualifies you for more positions
compliance with regulations and requirements within modern business environments.
regarding quality systems, complaints, MDRs,
• CBAs make an average of $91,500 per year;
product classification, and more.
compared to those without certification, who make
• Understand industry auditing tools like FDA approximately $72,508.*
Quality System Inspection Technique (QSIT)
and risk-based auditing.
*Please see the current Quality Progress Salary Survey at:
• Mitigate expensive risks using appropriate asq.org/qualityprogress/.
sterilization methods and processes.
• Improve processes by implementing quality

tools and techniques.
CERTIFIED BIOMEDICAL AUDITOR CBA
Qualifications and Biomedical Auditor Learning
Requirements for CBA Certification Resources and Certification Preparation
Candidates must have five years of work • Biomedical Auditor Exam Preparation Class
experience in a full-time, paid role in the field
• The Biomedical Quality Auditor Handbook, Second Edition
of biomedical auditing, including one year in
a decision-making position. • Biomedical Division—an ASQ professional network
Education Recertification Required?

Candidates who have completed a degree from a Yes, every three years.
college, university, or technical school can waive
some part of the five-year experience requirement as
follows (only one of these waivers may be claimed): How to Enroll for Certification
• Associate’s degree—one year waived Visit asq.org/cert
• Bachelor’s degree—three years waived
• Master’s or doctorate degree—

four years waived
MARKETPLACE INFORMATION
COMMON JOB FUNCTIONS COMMON INDUSTRIES
Biomedical Auditor Cardiovascular Devices
Biomedical Engineer Consulting and/or Third-party Auditing
Project Manager General Hospital Devices
Quality Audit Manager Implants and Prosthetic Devices
Quality Engineer In Vitro and Diagnostic Devices
Quality Manager Manufacturing Equipment/Components for Biomedical Industries
Regulatory Expert Medical Device Industry
Regulatory Manager Pharmaceutical Industry
Supplier Quality Engineer Surgery and Life Support Devices
Key Markets
• Risk management (ISO 14971)
• Risk-based decision making
• FDA 21 CFR 820 compliance
• ISO 13485

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WHY BECOME A

CERTIFIED BIOMEDICAL AUDITOR CBA

CERTIFIED BIOMEDICAL AUDITOR?

What Are the Core Competencies of a CBA?

• Identify and apply standards related to risk manage-

What Is the Value to Your Company? What Is the Value to You?

• Improve processes by implementing quality

Education Recertification Required?

• Master’s or doctorate degree—

• Risk-based decision making

• FDA 21 CFR 820 compliance

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