Importance of Quality Management Systems in Laboratories

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Learn why establishing Quality Management Systems (QMS) is crucial in laboratory settings to avoid errors and ensure efficient patient services. Explore the necessity, solutions, and standardization associated with QMS models like ISO and CLSI guidelines.

  • QMS
  • Laboratory Quality
  • ISO Standards
  • CLSI Guidelines
  • Quality Control

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Presentation Transcript


  1. Quality Management Systems OVERVIEW OF QMS

  2. WHY DO WE NEED TO HAVE QMS IN A LAB? To avoid any error or any mismanagement in laboratory during patient services we need to establish QMS

  3. IS 1% ERROR ACCEPTABLE?

  4. WHAT IS THE SOLUTION? LABORATORY QUALITY MANAGEMENT SYSTEMS

  5. STANDARDISE

  6. STANDARDISE

  7. SYNCHRONISE

  8. SYNCHRONISE

  9. STANDARDIZE, SYNCHRONIZE Competency and efficiency of lab staff Environmental Conditions Quality of reagents and equipment. Pre- analytical, analytical and post analytical processes Quality control procedures Advocacy Services Resolution of complaints Procedure of documentation and record keeping

  10. PROCESS WORKFLOW IN A LABORATORY

  11. QMS MODELS (ISO & CLSI) ISO Standards CLSI Guidelines (International Organization for Standardization) (Clinical and Laboratory Standards Institute) -GP26 (Application of Quality Management System Model for Laboratory Services) -ISO 15189 (Laboratory Quality and Competence) ISO 9001 (QMS) + ISO/IEC 17025 (Competence of Testing) -Specific Guidelines for each QSE Followed in India for Accreditation of Laboratories

  12. Quality As per ISO definition quality is the degree to which a set of inherent characteristics fulfils requirements Competence As per ISO definition competence demonstrated ability to apply knowledge and skills

  13. Thanks

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