ISO 15189: introduction, advantages, principles, practicing, documentation, stabilization

Quality Management Training Courses

2 days
Course fee

Program Description

Target Level

  • 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

  1. Scope
  2. Terms and definitions
  3. Normative references
  4. Management requirements which include:
  • Organization & management responsibility.
  • Quality management system, Quality Manual.
  • Document control
  • Continual Improvement.
  1. Technical requirements which include:
  • Personnel:
  • 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.
  1. 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.

Target group

  • Trainer Languages

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