ISO 15189 Module 2 - Method and Processes requirements

Method and Processes requirements

ISO 15189 - MODULE 2. Method and Processes requirements for competence in a medical/clinical laboratory.

Course Objectives

This module covers clauses 5.4, 5.5 and 5.7 of the standard and will take up to 3 hours to complete.

Once the resources and infrastructure are in place, medical/clinical laboratory staff are required to develop, validate and implement the processes to be used in the laboratory under controlled conditions so as to produce technically valid results that will affect patient outcomes.

Both pre-analytical (pre-examination) and post-analytical (post examination) sets of processes are examined in this Module. Exercises are designed to help participants understand their roles and responsibilities in the lab. The focus is on assuring the quality of examination results and this is covered in significant depth in Module 3 which follows, on Clause 5.6-Ensuring the quality of examination results.

Module 2 also introduces the concepts and disciplines of evidence-based medicine.

Your Instructor

Dr.  Thuppil Venkatesh
Dr. Thuppil Venkatesh

Dr Thuppil Venkatesh, Ph.D, FACBI, FABMS.

CEO & Director, Foundation for Quality India

Dr Thuppil Venkatesh, more popularly known as the Lead Man of India, is Professor Emeritus at St John's Medical College in Bangalore. He is an adviser to the Association of Health Care Providers of India (AHPI), an adviser to the Consortium of Accredited Health Care Organizations (CAHO), and National Chairman of the Indian Society for Lead Awareness and Research (InSLAR). He also serves as President of the International Society for Chronic Hypoxia (ISCH) located in LaPaz Bolivia). In his spare time, he serves as National Director to National Referral Centre for Lead Projects in India (NRCLPI), the Chairman of the Accreditation body in Nepal (AERSSC), and a GDG member of World Health Organization (WHO) in developing treatment protocols for lead poisoning. He is a Visiting professor of Zubeita University Bolivia and Past-President of The Association of Clinical Biochemists of India (ACBI).

Within the accreditation and clinical laboratory community, Dr Thuppil has served NABL as a lead assessor for ISO 15189 (clinical labs) and ISO/IEC 17043 (proficiency testing providers/external quality assurance providers – PTP/EQA) for over 15 years and serves NABH in the capacity of Principal assessor for the past 8 years. He is an Accreditation committee member of Emirates International Accreditation committee (EIAC) and has taught medical students and provided guidance to MD and PhD candidates for over 40 years. Has served in both UNIDO and the EU. He currently serves as the Principal Trainer on ISO 15189 for the International Accreditation Service (IAS), an ILAC-Signatory Accreditation Body.

Dr Thuppil has published over 350 scientific papers and has contributed to the content of many text books related to medicine and clinical practice.

Dr Thuppil is the first Asian to receive International science Truth and Honor award in 2010. He is a recipient of Arya Bhatta and Lifetime Achievement Awards.

Course Curriculum

  ISO 15189 - MODULE 2. Method and Processes requirements
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