ISO 15189: introduction, advantages, principles, practicing, documentation, stabilization
- 2 days
- Course fee
- Medical Laboratory directors.
- Quality officers & Quality managers in medical laboratories.
- Medical Laboratory supervisors.
- Medical laboratory technicians & technologists with a minimum of 3 years of work experience
- Laboratory services are the cornerstone of health care programs as 70% of clinical decision making is directly influenced by laboratory test results.
- The importance of quality medical laboratory services is recognized globally; quality and reliability are important for ensuring appropriate case management.
- Poor quality of laboratory services and unreliable test results can lead to inappropriate action or inaction such as over- or under-treatment when health care providers act upon inaccurate laboratory results.
- ISO 15189 was created specifically for Medical Laboratories & written by medical laboratory professionals.
- It is stated the specific requirements for quality and competence in medical laboratories to be used for accreditation, not certification.
- This International Standard is based upon ISO/IEC 17025 and ISO 9001.
- ISO 15189 is focused on assisting health care testing facilities in achieving Laboratory quality.
- By implementing a quality system, laboratories can reduce or eliminate medical error, standardize consistent work processes and procedures, reduce costs, satisfy regulatory requirements & achieve quality objectives.
- It is one of the fastest-growing international quality standards in the world for the medical field and very comprehensive.
Objectives and Expected Results
- Terms and definitions
- Normative references
- Management requirements which include:
- Organization & management responsibility.
- Quality management system, Quality Manual.
- Document control
- Continual Improvement.
- Technical requirements which include:
- Accommodation and environmental conditions.
- Laboratory equipment, Reagents, and consumables
- Pre-examination processes.
- Examination processes: Including Selection, Verification & Validation of Examination procedures, Measurement uncertainty, Biological reference intervals, Documentation (Writing Standard Operating procedures).
- Ensuring quality of examination results: Including Internal Quality Control, Interlaboratory comparisons (Proficiency testing), Comparability of examination results.
- Post-examination processes.
- Reporting of results.
- Release of results.
- Lab information management.
- Exercises, examples, case studies will be used in this course to enrich the knowledge & help the trainee to get the best benefit.
Others Training Materials
Workshop, Sheets, and case studies paper will be conducted and implemented during training.