ISO 15189 - MODULE 6. QA and QC in the Clinical Lab
QA and QC in the Clinical Lab
ISO 15189 – MEDICAL LABORATORIES-REQUIREMENTS FOR QUALITY AND COMPETENCE
MODULE 6.Quality assurance and quality control – Requirements and Importance
In Module 6, Quality assurance and Quality control requirements for ensuring the quality of examination results are discussed. Examples of various quality tools will be highlighted including the importance of appropriate action to be taken when a quality control result or the results in quality assurance are questionable.
The focus is on assuring the quality of examination results and this is covered in Clause 5.6 - Ensuring the quality of examination results.
Module 6 is divided into the following Parts:
Part 1:Understanding of the requirements contained in 15189
Part 2:Quality control approaches used in clinical 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.