About the Program:

This blended learning program is designed to provide a comprehensive understanding of the implementation and practical challenges of ISO 15189:2022 standards for medical laboratories. It covers essential principles, operational frameworks, and best practices to ensure quality and competence in medical testing.

Program Structure

This program follows a blended structure, incorporating e-learning, classroom sessions, and real-world laboratory exposure to ensure a comprehensive learning experience. The structure is as follows:

1. E-Learning:

• Participants will receive access to the e-learning course material 07 days prior to the program date.
• The course will cover ISO 15189:2022 fundamentals, including its requirements and practical applications.
• It is mandatory for participants to complete the e-learning module and pass the associated exam before proceeding to the onsite sessions.

2.    Classroom Sessions:

• The onsite sessions will focus on practical implementation and advanced concepts related to ISO 15189:2022.
• Key activities include:
• Recap and Discussions: Reviewing the e-learning content and clarifying any doubts.
• Workshops and Exercises: Hands-on activities such as preparing quality management documents, performing gap analyses, and conducting internal audits.
• Expert Lectures: In-depth sessions on documentation, roles and responsibilities, accreditation scope, and gap analysis techniques.
• Interactive Q&A sessions and group discussions to provide opportunities for collaborative learning.

3.    Laboratory Visit:

• Participants will visit an accredited medical laboratory to observe good practices related to the implementation of ISO 15189:2022 requirements.
• Activities during the visit include:
• Understanding real-world applications of laboratory management systems.
• Observing operational workflows, quality controls, and compliance mechanisms.
• Discussions with laboratory personnel to gain insights into challenges and best practices.
• A post-visit debriefing session will be held to address queries and summarize key learnings.

Program Broadly Covers:

• ISO 15189:2022 Fundamentals: Comprehensive understanding of the requirements, implementation, and operational benefits for medical laboratories.
• Strategic Problem-Solving: Identifying and addressing key challenges in accreditation, compliance, and quality management systems.
• Hands-On Expertise: Developing real-world skills in creating, implementing, and auditing quality management systems.
• Significance of ISO 15189: The role of standardized practices in ensuring accurate, reliable, and timely medical testing results.
• Global and Local Context: Adapting laboratory practices to meet international standards while addressing specific regional challenges.
• Documentation Essentials: Step-by-step guidance on preparing quality documents, standard operating procedures, and retained records to meet ISO 15189 standards.
• Roles and Responsibilities: Clearly defining and delegating responsibilities among quality managers, technical heads, authorized signatories, and laboratory staff.
• Scope and Gap Analysis: Techniques to identify gaps, define the scope of accreditation, and implement targeted corrective actions for laboratory compliance.
• Measurement Reliability: Understanding measurement uncertainty evaluation and participation in proficiency testing for consistent and traceable results.

What’s Included:

• Course Material: Participants will receive soft copies of the learning materials covering ISO 15189.
• Interactive Exercises and Workshops: Real-life case studies and hands-on group exercises ensure an engaging learning experience.
• Q&A Sessions: Dedicated time to address participant questions, fostering a deeper understanding through discussions.
• Certificate: A 'Certificate of Competency' will be issued to participants who attend the program & pass the final exam. Those who do not pass the exam can attempt the exam once more. If they cannot pass on the second attempt, they will receive a 'Certificate of Participation'.The certificate includes a unique ID or QR code for verification on the program portal.
• Pre and Post Evaluation: Tools to quantify knowledge improvement and align learning outcomes effectively.

Prerequisites: No formal prerequisites are required. However, a basic understanding of laboratory quality management, medical testing, and accreditation principles will be beneficial.

Who Should Attend?

• Quality/Technical Managers in medical laboratories
• Medical laboratory technicians
• Pathologists and laboratory scientists
• Healthcare quality professionals
• Accreditation assessors
• Regulatory personnel
• Internal auditors

Enquire Now:

Rohit Varshney, Project Manager, TCB/QCI, rohit.varshney@qcin.org, Ph. 9773500376