Biomedical Auditor Certification

Step 1. Is this the right certification for you?

Here are the requirements and exam specifics for a Biomedical Auditor. If you already know this is the certification you want to pursue, move on to exam preparation.

Work Experience

You must have five years of on-the-job experience in one or more of the areas of the Certified Biomedical Auditor Body of Knowledge. At least one year must be in a decision-making role.

If you have completed a degree from a college, university or technical school with accreditation accepted by ASQ, part of the five-year experience requirement will be waived, as follows (only one of these waivers may be claimed):

• Associate degree—one year waived
• Bachelor’s degree—three years waived
• Master’s or doctorate—four years waived

Degrees or diplomas from educational institutions outside the United States must be equivalent to degrees from U.S. educational institutions.

Minimum Expectations of a Certified Biomedical Auditor

• Must be able to differentiate between the types of audits and how they are used for organizational effectiveness. Must be able to define and determine the roles and responsibilities of the audit participants, including the auditor’s role in terms of ethical and professional conduct. Must be able to distinguish between audit procedural references, regulatory requirements and guidance, and quality system regulations and standards.
• Must identify resource requirements in preparation and planning for an audit and be able to create an audit plan, select team members, identify necessary documentation and tools, determine a strategy, and ensure that logistics are organized. Must be able to manage and perform an audit, from the opening meeting to the exit meeting, and be able to document observations, collect objective evidence, use working papers, and classify nonconformances. Must be able to create an effective audit report, apply record retention requirements, and know when an audit can be closed. Must be able to evaluate corrective and preventive action plans and know how to negotiate with an auditee when corrective action is not appropriate or when audit follow-up is necessary. Must be able to use effective communication techniques, including interviewing auditees, resolving conflicts, and communicating with team members and various other stakeholders before, during, and after an audit.
• Must be able to analyze the effectiveness of management control processes, including personnel requirements, the corrective and preventive action (CAPA) process, and production and process controls (P&PC), including document control, purchasing controls, handling and storage, and packaging and labeling controls. Must know the definitions, standards, and methods of sterilization, and the standards related to sterile product packaging. Must be able to evaluate the design control process, including compliance to the Medical Device Directive (MDD) and harmonized standards.
• Must be able to evaluate risk management programs and identify methods and tools used for risk estimation. Must be able to evaluate requirements for complaint handling, vigilance, medical device reporting (MDR) and medical device tracking, and evaluate product recall, correction, and removal processes. Must be able to review validation procedures for laboratory testing methods to ensure that procedures are appropriate. Must be able to analyze methods for detecting and controlling nonconformances, evaluate trending data, and validation and process controls. Must be able to apply sampling and statistical techniques used in the biomedical field.
• Must be able to identify and use biocompatibility terms, associated tests, and test selection rationale in accordance with applicable standards and guidelines. Must be able to evaluate environmental controls and determine whether utilities require qualification, validation, or maintenance.
• Must recognize the elements of the software development life cycle for products, processes, and quality systems.
• Must be able to define, analyze, and apply quality control tools, quality improvement tools, and qualitative and quantitative analysis methods. Must understand the basic process capability measures and cost of quality principles.

Examination

Each certification candidate is required to pass a written exam that consists of multiple-choice questions that measure comprehension of the Body of Knowledge. The Biomedical Auditor examination is a one-part, 135-question, four-hour exam and is offered in English only.

Examinations are conducted twice a year, in March and October, by local ASQ sections and international organizations. All examinations are open-book. Each participant must bring his or her own reference materials. Use of reference materials and calculators is explained in the seating letter provided to applicants.

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