Here are key aspects of ISO 29990:2010:

1. Scope: ISO 15189 applies to medical laboratories, regardless of their size or the scope of their testing activities. The standard covers a wide range of medical laboratory services, including clinical chemistry, microbiology, hematology, immunology, and other fields.
2. Quality Management System (QMS): One of the central aspects of ISO 15189 is the establishment and maintenance of a quality management system within the medical laboratory. This includes documentation of policies, procedures, and processes to ensure the consistent delivery of accurate and reliable results.
3. Competence of Personnel: The standard emphasizes the importance of having competent personnel within the laboratory. This involves ensuring that staff members have the necessary qualifications, training, and experience to perform their tasks effectively.
4. Equipment and Facilities: ISO 15189 sets requirements for the calibration and maintenance of laboratory equipment to ensure accurate and reliable results. The standard also addresses the need for appropriate facilities, including environmental conditions and safety measures.
5. External Quality Assurance: Laboratories are encouraged to participate in external quality assurance programs, such as proficiency testing, to validate and benchmark their performance against other laboratories.
6. Documented Procedures: ISO 15189 mandates the development and maintenance of documented procedures for all critical laboratory processes, including sample handling, analysis, reporting, and corrective actions.
7. Quality Control and Assurance: The standard requires laboratories to establish and maintain a program of quality control and assurance to monitor the accuracy and reliability of test results. This includes regular calibration and verification of equipment and instruments.
8. Proficiency Testing: Laboratories are encouraged to participate in proficiency testing programs to verify the accuracy and reliability of their testing processes and to compare their performance with other laboratories.
9. Handling of Laboratory Samples: ISO 15189 outlines specific requirements for the collection, handling, transportation, and storage of laboratory samples to ensure their integrity and prevent contamination.
10. Reporting of Results: The standard defines the criteria for reporting test results, ensuring that results are accurate, complete, and timely. It also emphasizes the importance of clear and concise communication with healthcare providers and patients.
11. Risk Management: ISO 15189 encourages laboratories to implement risk management processes to identify and mitigate potential risks to patient safety and the quality of laboratory services.
12. Continuous Improvement: The standard promotes a culture of continuous improvement within the laboratory, with regular reviews of processes and performance to identify opportunities for enhancement.