ISO 15189: 2022 Medical laboratories - Requirements for Quality and Competence

Master the International Standard for Quality and Competence in Medical Testing

In the critical field of medical diagnostics, the accuracy, reliability, and timeliness of results are paramount to patient care and safety. ISO 15189:2022 is the globally recognized standard specifying the quality management and technical competence requirements for medical laboratories. This comprehensive course is your definitive guide to understanding, implementing, and maintaining a robust Quality Management System (QMS) in accordance with ISO 15189:2022. Through detailed interpretation and practical scenarios, you will gain the knowledge to ensure your laboratory operates at the highest standard of quality, fosters continual improvement, and generates reliable results that clinicians can trust.

What You Will Learn

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

• Interpret the Standard with a clear, structured understanding of all clauses, from management 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.

• Ensure Technical Competence by understanding critical requirements for personnel, equipment, reagents, and quality assurance of examination processes.

• Manage the Examination Process effectively, covering pre-analytical, analytical, and post-analytical phases to guarantee result validity.

• Plan and Conduct internal audits specific to the medical laboratory environment to assess compliance and drive improvement.

• Facilitate Management Reviews that ensure the continual suitability, adequacy, and effectiveness of the QMS.

Course Curriculum

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

• Module 1: Introduction to ISO 15189:2022 and its Importance in Healthcare

• Module 2: Management Requirements: Building the Framework of Your QMS

• Module 3: Resource and Process Requirements: Ensuring Technical Competence

• Module 4: The Examination Process: Pre-examination, Examination, and Post-examination Phases

• Module 5: Evaluation and Improvement: Internal Audits, Management Review, and Corrective Action

• Module 6: Practical Application: Case Studies and Scenarios for Medical Laboratories

Who Is This Course For?

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

• Quality and Regulatory Affairs Professionals in healthcare

Prerequisites

While there are no formal prerequisites, it is highly recommended that participants have a basic understanding of medical laboratory operations and quality management concepts to maximize their learning.

Course Features & Included Materials

• Interactive Learning: Engage in scenario-based exercises and knowledge checks to reinforce understanding.

• Expert-Designed Content: Learn from curriculum developed by industry specialists with direct experience in medical laboratory accreditation.

• Comprehensive Learning Materials: Digital Learning Materials including a detailed participant handbook and key reference documents.

• Certificate of Completion: 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 and your laboratorys commitment to patient safety. Gain the confidence to implement, maintain, and audit a world-class quality system that meets international standards.

For more information, please contact:

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