Description

Medical Laboratory System and Internal Audit as per ISO 15189:2022

 Master the International Standard for Quality and Competence in Medical Laboratories

 

In the critical field of medical diagnostics, the accuracy, reliability, and timeliness of laboratory results are fundamental to patient care and safety. The ISO 15189:2022 standard is the globally recognized benchmark for the quality management and technical competence of medical laboratories. This comprehensive course is your definitive guide to understanding, implementing, and auditing a robust Quality Management System (QMS) in accordance with ISO 15189:2022. By focusing on the key requirements including risk management, Point-of-Care Testing (POCT), and the structured approach to internal auditing, you will gain the knowledge to ensure your laboratory operates at the highest standard, fosters continual improvement, generates reliable results that clinicians can trust and successfully navigate the accreditation process with NABL.

 

Actionable takeaways for your Job Role

By the end of this course, you will be able to confidently:

  • Interpret the Standard with a clear, structured understanding of all clauses, from management and governance requirements to pre-examination, examination, and post-examination processes .
  • Develop & Implement a QMS tailored for a medical laboratory, ensuring it is effective, efficient, and patient-focused with effective documentation and control of records .
  • Ensure Technical Competence by mastering the critical requirements for personnel, equipment, reagents and consumables, facilities and environmental conditions, and service agreements .
  • Apply a Risk-Based Approach to laboratory operations, identifying, analyzing, and mitigating risks to enhance patient safety and reduce errors .
  • Plan and Conduct Internal Audits specific to the medical laboratory environment, employing proven methodology to assess compliance, identify nonconformities, and drive process improvement .
  • Facilitate Management Reviews that ensure the continual suitability, adequacy, and effectiveness of the QMS, and prepare the laboratory for accreditation assessments .

 

Quality & Excellence Performance Metrics

Post-training, you will drive these quality parameters to ensure operational excellence, in your job-role:

  • Successfully map existing systems to the ISO 15189:2022 requirements.
  • Thoroughly identify all gaps against the new and revised clauses.
  • Plan and execute internal audits focused on high-impact areas including patient safety and risk.
  • Implement robust procedures for managing personnel competence, equipment calibration, and quality control.
  • Update all critical documents to reflect the standard's terminology and requirements.
  • Investigate nonconformities, perform root cause analysis, and implement corrective actions to prevent recurrence.
  • Proactively integrate risk management and Point-of-Care Testing (POCT) considerations into the QMS.

 

Course Curriculum

The course is structured into digestible modules, designed for optimal learning flow:

  • Module 1: Introduction and Comprehensive Interpretation of ISO 15189:2022 Requirements: Scope, Normative References, and Terms & Definitions 
  • Module 2: General and Structural Requirements: Impartiality, Confidentiality, Legal Identity, and Laboratory Director Responsibilities 
  • Module 3: Resource Requirements: Personnel, Facilities, Equipment, Reagents, Consumables, and Service Agreements 
  • Module 4: Process Requirements: Pre-examination, Examination, and Post-examination Processes, including Control of Nonconforming Work and Data Management 
  • Module 5: Management System Requirements: Documentation, Records, Risk Management, Corrective Actions, and Improvement 
  • Module 6: Internal Auditing for Medical Laboratories: Principles, Planning, Execution, Reporting, and Follow-up, including Preparation for NABL/EIAC/GAC Accreditation 

 

Job Roles That Will Benefit

This course is essential for professionals involved in the management, operation, and quality assurance of medical laboratories, including:

  • Laboratory Directors, Quality Managers, and Technical Managers
  • Pathologists, Clinical Biochemists, and Microbiologists
  • Medical Laboratory Technologists and Technicians
  • Internal Auditors and Aspiring Assessors for medical laboratories
  • Regulatory and Accreditation Personnel involved in NABL, EIAC, or GAC processes
  • Consultants and Professionals supporting medical laboratory accreditation

 

Prerequisites

While there are no formal prerequisites, it is highly recommended that participants have a fair knowledge of medical laboratory operations and the concept of accreditation to maximize their learning from this course .

 

Course Features & Included Materials

  • Focused Content: Concentrate on the specific requirements of ISO 15189:2022, including risk management, POCT, and audit methodology .
  • Interactive Sessions: Engage in practical exercises, case studies, and role-play simulations tailored to medical laboratory operations .
  • Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced accreditation and medical laboratory professionals.
  • Comprehensive Learning Materials: Digital Learning Materials and a copy of ISO 15189:2022 (For Training Purposes only).
  • Knowledge Evaluation: Gauge your understanding with Pre and Post-training Evaluation.
  • Certificate of Training: Earn a verifiable, with a unique ID and QR code, soft-copy certificate issued via the QCI training portal. Validate your achievement anytime at https://pathshala.qcin.org/.

 

Enroll Today and Elevate the Quality and Competence of Your Medical Laboratory!

Invest in your skills to implement a world-class quality system, enhance patient safety, and achieve international recognition for your laboratory's services.

 

For more information, please contact:

Rohit Varshney at rohit.varshney@qcin.org, Ph. 9773500376