Understanding ISO 15189:2022 for Medical Laboratories with Point of Care Testing
This interactive training course provides a foundational understanding of ISO 15189:2022, the internationally recognized standard for quality and competence in medical laboratories. Accreditation to ISO 15189 is acknowledged globally, with approximately 60 countries incorporating it into their mandatory medical laboratory accreditation requirements.
Tailored for professionals in medical laboratories and point-of-care testing environments, this course guides participants through the key clauses of the standard, including quality management principles, personnel competence, metrological traceability, and risk management. Through interactive lectures and practical exercises, attendees will learn to implement ISO 15189:2022 requirements effectively, enhancing laboratory operations to improve patient outcomes and ensure data integrity.
Prerequisites
Fundamental quality concepts are strongly recommended.
Target Attendees
Clinical and Point of Care Testing management, i.e., directors, managers, and supervisors.
Learning Outcomes
Upon successful completion of this course, participants will be able to:
- Explain the purpose and scope of ISO 15189:2022 and its role in supporting quality and competence in medical laboratory services.
- Implement practical steps to establish or enhance a quality management system in compliance with ISO 15189:2022.
- Interpret the structure and requirements of the standard, including updated focus areas such as risk-based thinking and information management.
- Estimate and apply measurement uncertainty in a medical testing context to support accurate and confident decision-making.
- Ensure traceability of patient test results by applying standardized calibration procedures, reference materials, and documentation practices—whether in centralized clinical labs or decentralized point-of-care settings.
- Apply quality management principles to align laboratory operations with accreditation expectations.
- Recognize the importance of staff competence, equipment calibration, and traceability in producing valid and reliable test results.
- Validate and verify analytical methods to ensure test procedures are fit for purpose and meet clinical and regulatory expectations.
- Implement internal quality control and participate in external quality assessment to monitor and sustain performance.
- Apply risk management strategies and corrective actions to reduce process variability and drive continuous improvement.
CEUs Awarded
1.4 CEUs*, 14 Training Hours
Presentation Style
This course will use lecture, discussion, and interactive exercises.
Reference
Students are required to bring a copy of the ISO 15189 standard with them furnished by their company or purchase them directly from ISO or other approved document provider prior to the class.
*A2LA WorkPlace Training is accredited by the International Association for Continuing Education and Training (IACET) and is authorized to issue the IACET CEU.
Course Content
- Course Introduction
- Mutual Recognition Agreements
- The A2LA Accreditation Process
- ISO 15189-What the Standard Requires
- Management requirements and responsibility
- Quality management system
- Document control
- Service agreements
- Examination by referral laboratories
- External services and supplies
- Advisory services
- Resolution of complaints
- Identification and control of nonconformities
- Corrective and preventive action
- Continual improvement
- Control of records
- Evaluation and audits
- Management review
- Technical requirements
- Personnel
- Accommodation and environmental conditions
- Laboratory equipment, reagents, and consumables
- Pre-examination, examination, and post-examination processes
- Ensuring quality of examination results
- Reporting and release of results
- Laboratory information management
- A2LA Specific Requirements
- Advertising accreditation and reporting accredited results
- Traceability requirements for measurement equipment
- Participation in proficiency testing
- Implementing IQCP
- Risk and risk management
- Risk estimation and evaluation
- Failure Mode and Effects Analysis (FMEA)