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Quality Management System at NPLI: Transition of ISO/IEC 17025 From 2005 to 2017 and Implementation of ISO 17034: 2016
MAPAN ( IF 1 ) Pub Date : 2021-07-24 , DOI: 10.1007/s12647-021-00490-w
Goutam Mandal 1 , M. A. Ansari 1 , D. K. Aswal 1
Affiliation  

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.



中文翻译:

NPLI 的质量管理体系:ISO/IEC 17025 从 2005 年到 2017 年的过渡和 ISO 17034:2016 的实施

ISO/IEC 17025 是最流行和广泛采用的单一国际标准,适用于任何测试和校准实验室,无论实验室规模如何。同样,ISO 17034 也是主管生产商开发/生产参考材料 (RM) 的非常重要的国际标准。CSIR-印度国家物理实验室 (NPLI) 是在第 21 届度量衡大会 (CGPM) 会议期间签署国际度量衡委员会互认安排 (CIPM MRA) 的 38 个国家计量研究所 (NMI) 之一。 1999 年 10 月 14 日,法国巴黎。 20 多年来,NPLI 一直在维护基于 ISO/IEC 17025 的质量体系,以满足 CIPM MRA 的要求。迄今为止,NPLI已参与130次国际比对;其中一些还由 NPLI 试行。NPLI 还通过亚太计量计划 (APMP) 进行了国际同行评审,在国际度量衡局关键比较数据库 (BIPM KCDB) 中注册了 236 项关于各种参数的校准和测量能力 (CMC)。然而,NPLI 在 2020 年首次实施了基于 ISO 17034 的统一质量体系。在这个方向上,NPLI 首次编制了综合质量手册,以制定政策、目标和程序,以满足两个标准的所有要求。目前,NPLI的28个分部遵循质量体系。一些子部门只涉及校准/测试活动,只维护 ISO/IEC 17025: 2017。同样,® –印度参考材料)仅维护 ISO 17034。另一方面,很少有分部同时参与校准/测试以及 BND 活动,因此遵守这两个标准。在像NPLI这样的大型组织中,质量体系的实施和监控是一项非凡的挑战。在本文中,作者重点介绍了基于 ISO/IEC 17025: 2017 和 ISO 17034: 2016 的综合质量手册的编制过程,包括所采用的政策、目标和程序及其在 NPLI 的实施过程。2020年11月,NPLI通过APMP对23个分部的质量体系进行了现场同行评审。

更新日期:2021-07-24
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