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 must be in a full time, paid role. Paid intern, co-op or any other course work cannot be applied towards the work experience requirement.
The CBA requires FIVE years of work experience including ONE year in a decision-making position. See the CBA Body of Knowledge here.
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
- Will be able to differentiate between various audit types and determine the roles and responsibilities of the audit participants, and will be able to respond appropriately to situations in terms of ethical and professional conduct. Will be able to distinguish between audit procedural references, regulatory requirements and guidance, and quality system regulations and standards.
- Will be able to identify resource requirements in preparation and planning for an audit and will be able to manage and performan audit, from the opening meeting to the exit meeting. Will be able to document observations, collect objective evidence, use working papers, and classify nonconformances. Will be able to create an effective audit report,apply record retention requirements, and know when an audit can be closed. Will be able to evaluate corrective and preventive action plans.
- Will be able to distinguish between audit procedural references and guidance's (such as ISO 19011 and GHTF SG4) and the FDA Quality System Inspection Technique (QSIT).
- Will be able to analyze the effectiveness of a biomedical quality management system in relation to those national and international regulations and standards for production and process controls, document andchange control systems, purchasing controls, and product identification andtraceability.
- Will be able to identify and apply standards related to risk management and hazard detection. Will be able to identify andapply standards related to methods of sterilization for aseptically processedand terminally sterilized products.
- Will be able to evaluate risk management programs evaluate requirements for complaint handling, vigilance, medical device reporting (MDR) and tracking, and evaluate product recall processes. Will be able to review validation procedures for laboratory testing and use appropriate methods for analyze, detect and control nonconformances. Will apply appropriate standard driven data analysis and statistical technique's used for sampling.
- Will identify and describe biocompatibility terms, associated tests, and test selection rationale in accordance with applicable standards and guidelines. Will be able to evaluate environmental controls and determine whether utilities require qualification, validation, or maintenance.
- Will be able to recognize the elements of the software development life cycle for products, processes, and quality systems. Will be able to identify sources for new and evolving standards and guidance documents and recognize common medical device directives and standards.
- Will be able to apply quality tools and process improvement techniques using qualitative and quantitative
Each certification candidate is required to pass a written exam that consists of multiple-choice questions that measure comprehension of the Body of Knowledge. See the CBA Body of Knowledge here. The CBA examination is a one-part, 145-question*, four and a half hour exam.
*All CBT delivered certification exams include unscored items in addition to BoK classified items. For more information please click here
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