ISO 15189 Module 1 -Resource and infrastructure requirements for competence in a medical/clinical laboratory.
Resource and infrastructure requirements for competence in a medical/clinical laboratory.
ISO 15189 - MODULE 1. Resource and infrastructure requirements for competence in a medical/clinical laboratory.
This module covers clauses 5.1 to 5.3 of the standard.
Medical laboratory infrastructure and resources are within eight broad classes covering competent personal, quality material, the testing environment, the testing equipment and all types of supplies used to support competent testing. This is in addition to requirements for metrological traceability of clinical measurements and the measurement equipment that is used to produce results and control the testing environment.
Accreditation of medical/clinical laboratories by ILAC-recognised accreditation bodies includes examination of these resources.
Associated policies, procedures and records are discussed in this Module with examples. This session is 90 minutes in duration and is delivered in two Parts:
Part 1: Resource procurement, management and continual improvement
Part 2: Policies processes and records requirements for conformity assessment bodies (in this case medical testing laboratories)
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.