- ISO 15189 is an international standard that specifies requirements for quality and competence in medical laboratories. This standard provides a comprehensive framework for laboratory management systems and technical requirements to ensure reliable laboratory services and patient care.
- The standard establishes requirements for quality management systems in medical laboratories, including organizational structure, policies, processes, and procedures. It emphasizes the importance of laboratory services in patient care and medical decision-making.
- Leadership and governance requirements specify responsibilities for laboratory management, including strategic planning, resource allocation, and oversight of quality systems. This includes requirements for defining organizational roles, responsibilities, and authorities.
- Document control requirements detail how laboratories should manage and control their quality management system documentation, including policies, procedures, and records. This ensures that current versions of documents are available and used appropriately.
- Service agreements requirements specify how laboratories should establish and maintain agreements with users of laboratory services, including requirements for test ordering, sample collection, and results reporting.
- Examination procedures requirements detail how laboratories should select, validate, and implement testing methods. This includes specifications for method verification, measurement uncertainty, and quality control procedures.
- Personnel requirements specify qualifications, training, and competency assessment for laboratory staff. This includes ongoing professional development and regular evaluation of staff performance.
- Equipment requirements detail specifications for laboratory equipment selection, validation, maintenance, and calibration. This includes requirements for monitoring equipment performance and addressing malfunctions.
- Pre-examination processes are addressed comprehensively, including requirements for test ordering, patient identification, sample collection, handling, and transportation. This ensures sample integrity from collection to analysis.
- Examination processes requirements specify how laboratories should perform testing, including quality control procedures, results validation, and documentation of analytical procedures.
- Post-examination processes detail requirements for results reporting, interpretation, and communication with healthcare providers. This includes specifications for timely reporting of critical results.
- Quality assurance requirements specify how laboratories should monitor and evaluate their performance, including internal quality control and external quality assessment programs.
- Information management requirements detail how laboratories should handle patient data, test results, and quality records. This includes specifications for laboratory information systems and data security.
- Nonconforming event management requirements specify how laboratories should identify, control, and address nonconforming work, including corrective and preventive actions.
- Continual improvement requirements detail how laboratories should monitor, measure, and improve their processes and services. This includes requirements for management review and quality indicators.
- Risk management requirements specify how laboratories should identify and address potential risks to patient safety and service quality. This includes both analytical and operational risks.
- Resource management requirements detail how laboratories should ensure adequate resources for service delivery, including personnel, equipment, and supplies.
- Facility requirements specify necessary environmental conditions and workspace organization for safe and effective laboratory operations. This includes requirements for sample storage and processing areas.
- Safety requirements detail how laboratories should maintain a safe working environment for staff and visitors. This includes specifications for biological, chemical, and physical safety measures.
- Environmental conditions requirements specify how laboratories should monitor and control environmental factors that could affect test results or staff safety.
- Quality control requirements detail how laboratories should ensure the reliability of examination results through appropriate quality control measures and monitoring.
- Method validation requirements specify how laboratories should validate and verify examination procedures to ensure accurate and reliable results.
- Measurement uncertainty requirements detail how laboratories should determine and document the uncertainty associated with their examination results.
- Reference intervals requirements specify how laboratories should establish and verify biological reference intervals for their test results.
- Results reporting requirements detail how laboratories should communicate examination results to healthcare providers, including formatting, content, and critical value notification.
- Customer service requirements specify how laboratories should interact with users of their services, including handling complaints and measuring customer satisfaction.
- Ethics requirements detail how laboratories should maintain ethical practices in all aspects of their operations, including patient privacy and confidentiality.
- The standard promotes harmonization of laboratory practices globally, facilitating international recognition of laboratory results and supporting patient care across borders.
- Accreditation requirements specify how laboratories can demonstrate compliance with the standard through external assessment and accreditation processes.
- Internal audit requirements detail how laboratories should evaluate their own compliance with the standard and identify opportunities for improvement.
- The standard addresses the specific needs of medical laboratories while maintaining alignment with other relevant quality management system standards.
- Updates and revisions to the standard reflect evolving laboratory practices and technologies, ensuring continued relevance to modern laboratory operations.
