Description

The Standard ISO 15189:2022 specifies requirements for quality and competence in medical laboratories. This course gives a structured and comprehensive approach on interpretation of the requirements of ISO 15189:2022 for implementation in a Medical Laboratory. This course includes aspects on planning, managing, conducting and leading the internal audits of in a Medical Laboratory. The revised Standard notably includes perspectives of Risk Management and Point-of-Care Testing (POCT), placing emphasis on effective, timely and efficient Patient Care.

What You'll Learn

  • Grasping the fundamental concepts of accreditation.
  • Acquiring knowledge and expertise in documenting and implementing management systems in medical testing laboratories, aligning with the ISO 15189:2022 standard.
  • Understanding and interpreting the requirements of ISO 15189:2022
  • Understanding the requirements for accrediting medical testing laboratories.
  • Implementing ISO 15189 requirements, including NABL 112 Specific Criteria for Accreditation of Medical Laboratories, within your laboratory.
  • Recognizing the purpose and synergy of a quality management system, encompassing both managerial and technical aspects.
  • Implementing these requirements to enhance service quality and instil greater confidence in your laboratory’s results.
  • Developing and implementing a system as per ISO 15189:2022 for a Medical Laboratory
  • Planning, managing, conducting and leading the internal audit of Medical Laboratory as per ISO 15189:2022
  • Improving the laboratory’s operations and management system
  • Preparing the Medical Laboratory for the NABL accreditation in a structured way

Curriculum

Module 1
  • Introduction
  • Objective of the module
  • ISO 15189:2022 Medical Laboratories: Requirements
  • Clause 1 Scope
  • Clause 2 Normative Reference
  • Summary
  • Takeaway from the Module
Module 2
  • Introduction
  • Objective of the Module
  • Clause 3 Terms and Definitions
  • Summary
  • Take away from the module
Module 3
  • Introduction
  • Objective of the Module
  • Clause 4 General Requirements
  • Clause 4.1 impartiality
  • Clause 4.2 Confidentiality
  • Clause 4.3 Requirements regarding Patients
  • Summary
  • Takeaway from the Module
Module 4
  • Introduction
  • Objective of the Module
  • Structural and Governance Requirements
  • Clause 5.1 Legal Identity
  • Clause 5.2 Laboratory Director
  • Clause 5.3 Laboratory Activities
  • Clause 5.4 Structure And Authority
  • Clause 5.5 Objectives and Policies
  • Summary
  • Takeaway form the Module
  • Clause 5.6 Risk Management
Module 5
  • Introduction
  • Objectives
  • Clause 6 Resource Requirements
  • Clause 6.1 General
  • Clause 6.2 Personnel
  • Clause 6.2.1
  • Clause 6.2.2
  • Clause 6.2.3
  • Clause 6.2.4
  • Clause 6.2.5
  • Clause 6.3 Facilities and Environmental Conditions
  • Clause 6.3.1
  • Clause 6.3.2
  • Clause 6.3.3
  • Clause 6.3.4
  • Course 6.3.5
  • Summary
  • Takeaway from the Module
Module 6
  • Introduction
  • Objectives of the Module
  • Clause 6.4 Equipment
  • Clause 6.4.1
  • Clause 6.4.2
  • Clause 6.4.3
  • Clause 6.4.4
  • Clause 6.4.5
  • Clause 6.4.6
  • Clause 6.4.7
  • Clause 6.5 Equipment Calibration And Metrological
  • Clause 6.5.1
  • Clause 6.5.2
  • Clause 6.5.3
  • Clause 6.6 Reagents And Consumables
  • Summary
  • Takeaway from the Module
Module 7
  • Introduction
  • Clause 6.7 Service Aggrements
  • Clause 6.8 Externally Provided and Service
  • Summary
  • Takeaway from the Module
  • 1.2 Objective of the Module
Module 8
  • Introduction
  • Objective of the Module
  • Clause 7 process Requirements
  • Clause 7.1 General
  • Clause 7.2 Pre-examination Processes
  • Clause 7.2.1
  • Clause 7.2.2
  • Clause 7.2.3
  • Clause 7.2.4
  • Clause 7.2.5
  • Clause 7.2.6
  • Clause 7.2.7
  • Summary
  • Takeaway from the Module
Module 9
  • Introduction
  • Objective of the Module
  • Clause 7.3 Examination Processes
  • Clause 7.3.1
  • Clause 7.3.2
  • Clause 7.3.3
  • Clause 7.3.4
  • Clause 7.3.5
  • Clause 7.3.6
  • Clause 7.3.7
  • Summary
  • Takeaway from the Module
Module 10
  • Introduction
  • Objective of the Module
  • Clause 7.4 Post Examination Processes
  • Clause 7.4.1
  • Clause 7.4.2
  • Summary
  • Takeaway from the Module
Module 11
  • Introduction
  • Objective of the Module
  • Clause 7.5 Nonconforming Work
  • Clause 7.6 Control of Data and information Managem
  • Clause 7.7 Complaints
  • Clause 7.8 Continuity and Emergency Preparedness P
  • Takeaway from the Module
Module 12
  • Introduction
  • Objective of the Module
  • Clause 8 Management Sysatem Requirements
  • Clause 8.1 General Requirements
  • Clause 8.2 Management System Documentation
  • Clause 8.3 Control of Management Syatem Documents
  • Clause 8.4 Control of Records
  • Summary
  • Takeaway from the Module
Module 13
  • Introduction
  • Objective of the Module
  • Clause 8.5 Actions to address risks and oppornutie
  • Clause 8.5.1
  • Clause 8.5.2
  • Clause 8.6 Improvement
  • Clause 8.6.1
  • Clasuse 8.6.2
  • Clause 8.7 Nonconformities and corrective actions
  • Clause 8.7.1
  • Clause 8.7.2
  • Clause 8.7.3
  • Summary
  • Takeaway from the Module
Module 14
  • Introduction
  • Objectives of the Module
  • Clause 8.8 Evaluations
  • Clause 8.8.1 General
  • Clause 8.8.2 Quality Indicators
  • Clause 8.8.3 Internal Audits
  • Clause 8.9 Management Reviews
  • Clause 8.9.1 General
  • Clause 8.9.2 Review Input
  • Clause 8.9.3 Review Output
  • Summary
  • Takwaway form the Module