Training Program on ISO 15189:2022

Training Program on ISO 15189:20222

Learning Objectives:

Understanding ISO 15189:2022

NABL Specific Criteria

NABL Documentation

Implementation of Laboratory Quality Management Systems

Who should attend:

Those who are engaged in Diagnostic/Hospital Laboratory or Clinical Research Laboratory

Pathologists, Microbiologists, Biochemists, Geneticists

Lab Director, Lab Manager/Supervisor/Coordinator, Lab Technologists, Lab Technicians

Application specialist for Medical Equipments

Clinical Research personnel

What is going to happen?

Group Discussion

Q & A

Trainers:

Prof. Dr. CN Srinivas - MD(Path), DNB(Path), PhD, FCAP, PGDHRM.eMBA

Chief Advisor - Product Innovation, Matrix Labs Diagnocare Pvt. Ltd.

Dr. Zubair Hasan - MD (Pathology), DNB (Pathology), MNAMS, International fellow of College of American Pathologists, Executive Alumnus IIM - Calcutta

Lab Director, Central Lab, Syngene International, Bengaluru

General Instructions for Participants

• All participants must assemble at the venue by 8:30 AM on both days.

• Full-day attendance (8:30 AM – 5:30 PM) on both days is mandatory for certificate eligibility.

• Be punctual for all sessions and return promptly after breaks.

• Snacks and tea will be provided during morning and afternoon breaks.

• Food is to be consumed only during break timings and not inside the training hall.

• Notebook and pen shall be provided; keep your ID card visible throughout the program.

• Keep mobile phones in silent mode. Avoid phone use during sessions.

• Actively participate in discussions, group exercises, and mock audits.

• Dress code: formal or institution-appropriate attire.

• Follow the seating arrangement provided.

• Cooperate with your assigned group during practical audit sessions.

• Maintain respectful and professional behaviour at all times.

• Submit the feedback form on Day 2 to receive your certificate.

ISO 15189:2022 Revision Training Schedule 

(9:00 AM - 5:30 PM Daily)

 DAY 1: Core Requirements (Clauses 4, 5, & 6)

9:00 AM - 10:45 AM

Topic: Intro & Core Changes (Rationale for 2022 Revision, Alignment with ISO/IEC 17025)

Speaker: Dr. Srinivas CN

10:45 AM - 11:00 AM: Morning Coffee Break

11:00 AM - 12:45 PM

Topic: Clause 4 & 5 (General, Structural, Impartiality, Ethical Conduct, and Laboratory Director's Expanded Role)

Speaker: Dr. Zubair Hasan

12:45 PM - 1:45 PM: Lunch Break

1:45 PM - 3:30 PM

Topic: Clause 6.1, 6.2, & 6.8 (Personnel Competence, Training, and Point-of-Care Testing (POCT) Governance)

Speaker: Dr. Srinivas CN

3:30 PM - 3:45 PM: Afternoon Coffee Break

3:45 PM - 5:30 PM

Topic: Clause 6.3 - 6.7 (Facilities, Environmental Conditions, Equipment Management, Calibration, and External Suppliers)

Speaker: Dr. Zubair Hasan

DAY 2: Processes, Risk, & QMS (Clauses 7 & 8)

9:00 AM - 10:45 AM

Topic: Clause 7.1 - 7.5 (Pre-examination Processes: Planning, Review of Requests, Sample Collection/Handling)

Speaker: Dr. Zubair Hasan

10:45 AM - 11:00 AM: Morning Coffee Break

11:00 AM - 12:45 PM

Topic: Clause 7.6 - 7.10 (Examination Procedures, Results Validity (IQC/EQA), Reporting, Information Management, and Complaints)

Speaker: Dr. Srinivas CN

12:45 PM - 1:45 PM: Lunch Break

1:45 PM - 3:30 PM

Topic: Clause 8.1 - 8.6 (Management System, Document Control, and core implementation of Actions to address Risks and Opportunities (Clause 8.5))

Speaker: Dr. Zubair Hasan

3:30 PM - 3:45 PM: Afternoon Coffee Break

3:45 PM - 5:30 PM

Topic: Clause 8.7 - 8.9 (Internal Audits, Management Review (MRM) updates, Continual Improvement, and the 2012-to-2022 Gap Analysis Strategy) Speaker- Dr Srinivas CN