ISO 15189 - MODULE 5. Requirements and Procedures for Records

System Management Policies - What is required?


MODULE 5.Requirements and Procedures for Records

MODULE V. Procedures and records requirements from all parts of 15189

Course Objectives

This Module examines ISO 15189 records requirements, from all relevant Clauses including 4.13.

The clinical laboratory is required to exercise good control of the records it generates, and this module examines this concept as described throughout the standard.Examples of record control processes are discussed.

Control of records is explicitly or implicitly stated throughout all parts of 15189 and there are no requirements that do not imply sufficient control of the records that demonstrate fulfillment of requirements.

Module 5 is divided into the following Parts:

Part 1:Understanding of the requirements contained in 15189

Part 2:Samples of requisite laboratory control of records.

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 5. ISO 15189 Module 05 – Requirements and Procedures for Records
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