Quality Management System at NPLI: Transition of ISO/IEC 17025 From 2005 to 2017 and Implementation of ISO 17034: 2016

Abstract

ISO/IEC 17025 is the single most popular and well adopted international standard which is applicable for any testing and calibration laboratories irrespective of size of the laboratories. Similarly, ISO 17034 is also very important international standard for development/production of reference materials (RMs) by competent producers. CSIR-National Physical Laboratory of India (NPLI) was one of the 38 National Metrology Institutes (NMIs) those who signed International Committee for Weights and Measures Mutual Recognition Arrangement (CIPM MRA) during 21st General Conference on Weights and Measures (CGPM) meeting in Paris, France on 14th October, 1999. NPLI has been maintaining quality system based on ISO/IEC 17025 for more than two decades to fulfil the requirements of CIPM MRA. NPLI has participated in 130 international inter-comparisons so far; some of them were also piloted by NPLI. NPLI has also undergone International Peer Reviews through Asia Pacific Metrology Programme (APMP) to register 236 Calibration and Measurement Capabilities (CMCs) on various parameters in International Bureau of Weights and Measures Key Comparison Database (BIPM KCDB). However, NPLI for the first time implemented uniform quality system based on ISO 17034 in 2020. In this direction, NPLI for the first time prepared integrated Quality Manual to make policies, objectives and procedures addressing all the requirements of both the standards. Presently, 28 Sub-Divisions of NPLI follow quality system. Some of the Sub-Divisions are involved only in calibration/testing activities maintain only ISO/IEC 17025: 2017. Similarly, some of the Sub-Divisions are involved only in development/production of RMs/certified reference materials (CRMs) (Bharatiya Nirdeshak Dravya, BND®–Indian Reference Material) maintain only ISO 17034. On the other hand, few Sub-Divisions are involved both in calibration/testing as well as BND activities and accordingly follow both the standards. It is an extraordinary challenge for implementation and monitoring of quality system in such a big organization like NPLI. In this article, authors have highlighted preparation process of integrated quality manual based on ISO/IEC 17025: 2017 and ISO 17034: 2016 including policies, objectives & procedures adopted and its implementation process at NPLI. In November, 2020, NPLI has undergone on-site peer review of quality system of 23 Sub-Divisions through APMP.