NABL Accreditation - Advantages and Disadvantages and Its Process in India

Abstract

BACKGROUND Accreditation is a means of self-regulation and peer review adopted by an institution or an organization. It is a voluntary process of being certified as meeting minimum requirements designated by an accrediting agency. ISO 15189 standard is an international standard that specifies requirements for quality management in medical laboratories. It is intended to promote the quality and competence of medical laboratories and to provide a framework for continual improvement. The National Accreditation Board for Testing and Calibration Laboratories (NABL) operates as an autonomous organization functioning under the governance of the Department of Science and Technology, Government of India. The primary objective of this initiative is to offer an independent evaluation of the proficiency and excellence in testing and calibration laboratories affiliated with governmental authorities, industry associations, and the private sector. The NABL provides laboratory accreditation services adhering to the ISO 15189 guidelines. Although there exist certain limitations to the accreditation process such as financial expenses, time constraints, stringent regulations, and an emphasis on adherence rather than enhancement, the advantages of accreditation generally outbalance these challenges. Accreditation serves as a means of providing guarantee with respect to the dependability and precision of laboratory outcomes, a fundamental imperative for a multitude of crucial purposes which include but are not limited to the realm of healthcare, environmental evaluation, and product safety assessment.