Availability of Reference Materials for Improving Quality of Life within Scientific and Industrial Framework

Abstract

Established metrological traceability to SI (system international) is the strength of any reliable quality management system. Accreditation of facilities and Good laboratory practices in conducting studies drives all measurement involved in the system with traceability either through calibration or by use of Reference Material (RM). Whenever the process of calibration become not convenient, RMs could take up the role for assuring reliability in results with stated level of confidence with minimum possible uncertainty in results. Standardizing clinical diagnostics, qualifying different developmental stages of bio-medical devices and biomaterials, development and constructive use of radio nuclear techniques, control of environmental pollution, etc invites special attention in improving quality of life. Onsets of pandemic conditions like SARS – CoV 2 (severe acute respiratory syndrome -Corona Virus 2) triggers emergencies for regulatory approvals. Availability of certified property values of RMs has significant role in qualifying such tests and evaluations. They may support quick release of products like medical devices into market for routine use. Property value of RMs could be quantitative or qualitative. Even though a large quantum of work has established RMs with quantitative property value, the other type still remains as minimally addressed in many countries. Remarkable efforts done at international research laboratories supplies RMs traceable to NIST (National Institute Standards and Technology, USA), USP (United States Pharmacopeia), NPL (National Physical Laboratory) India etc. RM requirements in critical application areas like healthcare are not sufficiently visible to the scientific community and hence do not satisfy global demands. This feature presents an overview of present status on the issue.