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 and reliability of laboratory results are fundamental to patient care and safety. The ISO 15189:2022 standard is the globally recognized benchmark for quality and competence in medical laboratories, ensuring consistent delivery of valid and reliable examination results. This comprehensive course is your definitive guide to understanding, implementing, and auditing a robust quality management system in line with this essential standard. Through real-life scenarios and practical workshops, you will gain the expertise to enhance your laboratory's operations, build stakeholder confidence, and successfully navigate the accreditation process with NABL.
What You Will Learn
By the end of this course, you will be able to:
-
Interpret the ISO 15189:2022 Standard with a clear, structured understanding of all requirements specific to medical laboratories.
-
Develop & Implement a QMS tailored for a medical laboratory, ensuring effective management of quality, personnel, and equipment.
-
Ensure Technical Competence by mastering the critical processes of the examination procedure, from pre-examination to post-examination phases.
-
Plan and Conduct Effective Internal Audits to assess compliance, identify improvement opportunities, and facilitate management reviews.
-
Navigate the NABL Accreditation Process and understand the international framework for laboratory recognition.
-
Apply Knowledge Practically through interactive case studies that simulate common challenges in medical laboratory settings.
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
-
Module 2: Developing and Implementing the Medical Laboratory Management System
-
Module 3: Technical Requirements and Examination Process Management
-
Module 4: Conducting Internal Audits, Management Reviews, and Preparing for NABL Accreditation
-
Module 5: Real-Life Scenarios, Case Studies, and Interactive Q&A Sessions
Who Is This Course For?
This course is essential for professionals dedicated to excellence in medical laboratory services, including:
-
Medical Professionals, Pathologists, and Laboratory Technicians
-
Owners, Directors, and Management Personnel of Medical Laboratories
-
Quality Managers and Quality Professionals in healthcare
-
Internal Auditors, Assessors, and Consultants
-
Regulators and Personnel involved in 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.
Course Features & Included Materials
- Interactive Learning: Engage in hands-on exercises and scenario-based workshops to reinforce understanding.
- Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced assessors 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 assessments.
- 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