CDG proudly presents the ISO 15189:2022 Lead Auditor Course, an advanced, self-paced online training and certification program designed for professionals seeking to develop or enhance their expertise in auditing medical laboratories against the latest version of ISO 15189:2022. This course delivers a robust, flexible, and in-depth learning experience, empowering individuals to lead and conduct audits aligned with global best practices in medical laboratory quality and competence.

Built around the updated requirements of ISO 15189:2022, this course reflects the evolution of laboratory quality systems and risk-based thinking, as well as the increasing integration of digital technologies in healthcare and diagnostic environments. Whether you are an internal auditor, quality manager, laboratory professional, or aspiring third-party auditor, this training is tailored to equip you with the comprehensive knowledge, skills, and practical tools necessary for conducting professional audits with precision, objectivity, and technical integrity.

The ISO 15189:2022 standard emphasizes quality and competence in medical laboratories, aligning with ISO/IEC 17025 and ISO 9001 principles. This revision reflects a more integrated approach to laboratory operations, placing strong focus on risk-based decision-making, information systems, personnel competence, ethical behavior, patient safety, confidentiality, and continual improvement. The CDG Lead Auditor course has been meticulously developed to encompass all these evolving requirements, providing learners with the clarity and confidence to interpret and apply the standard in real-world audit scenarios.

One of the most distinguishing features of this course is its self-paced structure, allowing learners to access the material on-demand, from any location, and complete the course at their convenience. With no time-bound restrictions or physical attendance required, participants enjoy maximum flexibility without compromising on content depth or learning outcomes. This makes the course ideal for working professionals, busy laboratory personnel, consultants, or those managing multiple responsibilities while pursuing career development.

The curriculum of the course has been crafted by experienced auditors and laboratory compliance experts, blending technical detail with practical audit methodologies. It begins by introducing learners to the core concepts of ISO 15189:2022, including its scope, structure, and terminology. Special attention is given to the intent and interpretation of each clause, ensuring learners not only understand the literal requirements but also the broader context in which these requirements are applied within laboratory environments.

Throughout the training, participants will explore essential auditing concepts such as audit principles, auditor roles and responsibilities, audit planning and scheduling, opening and closing meetings, evidence collection techniques, reporting of findings, nonconformity classification, and follow-up audits. The course also includes guidance on preparing audit checklists, conducting remote audits, interacting with auditees, and ensuring impartiality and confidentiality—all aligned with ISO 19011 principles and ISO/IEC 17021-1 guidance.

What sets the CDG ISO 15189:2022 Lead Auditor course apart is its inclusion of realistic case studies, scenario-based exercises, and document samples that mirror actual audit challenges faced in medical laboratories. These practical insights foster critical thinking, risk identification, and evidence-based evaluation—skills vital for effective auditing in complex healthcare systems. Additionally, the course highlights the growing role of digital tools and laboratory information management systems (LIMS), and how to audit their compliance with ISO 15189's data integrity, traceability, and security requirements.

Participants will also be trained in how to assess laboratory personnel competence, evaluate quality indicators, review method validation and verification processes, and ensure the reliability of laboratory reports, all within the compliance framework. The course emphasizes the importance of patient focus, ethical behavior, risk management, and continual improvement—key pillars of the revised ISO 15189 standard.

Once participants have completed the learning modules, they will be eligible to appear for the online final examination. This exam is structured to evaluate both theoretical understanding and practical audit competence. It includes multiple-choice questions, compliance analysis, and situational judgment scenarios based on the ISO 15189:2022 standard. The exam can be taken anytime, with no external scheduling or travel needed. Upon successful completion, candidates will immediately receive a digital certificate of achievement issued by CDG. This certificate confirms their competence as an ISO 15189:2022 Lead Auditor and can be downloaded, printed, or shared with employers and professional bodies.

The course is particularly beneficial for:

• Professionals working in or auditing medical laboratories
• Quality managers and compliance officers
• Internal auditors seeking lead auditor roles
• Laboratory consultants and technical experts
• Certification body auditors transitioning to ISO 15189:2022
• Healthcare regulatory and accreditation professionals

By completing this course, participants will gain:

• A thorough understanding of ISO 15189:2022 requirements and interpretations
• Competence in planning, conducting, reporting, and following up on audits
• Insight into risk-based and evidence-based auditing techniques
• Confidence in evaluating quality and technical operations of laboratories
• Recognition through certification as a qualified ISO 15189:2022 Lead Auditor

The CDG ISO 15189:2022 Lead Auditor course is more than just a certification—it is a gateway to advancing your professional credibility, expanding your career opportunities, and contributing meaningfully to the enhancement of quality and patient safety in medical laboratory services. Our intuitive learning platform, expert-curated content, and commitment to excellence ensure that you receive the highest quality education in a format that fits your life.

Enroll today and take your auditing capabilities to the next level—on your own schedule, at your own pace, with CDG.