ISO 15189 - MODULE 7. Auditing Clinical Lab Processes
Auditing Clinical Lab Processes
ISO 15189 – MEDICAL LABORATORIES-REQUIREMENTS FOR QUALITY AND COMPETENCE
MODULE 7. Auditing Clinical Lab Processes – Techniques, Documentation and Evaluation
In Module 7, the importance of both audits and evaluation are discussed, with emphasis on the importance of continual improvement.This Module is based primarily on Clauses 4.12 and 4.14 which demonstrates the link between continual improvement and the internal audit tool used to help implement it.
Examples of various QMS tools are highlighted and the importance of taking appropriate action following both evaluation and audit are demonstrated. Module 6 is divided into the following Parts:
Part 1: Understanding of the requirements contained in 15189
Part 2: Audit and evaluation tools and techniques in the clinical lab.
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.