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Competence assessment of management and technical for inspection body and laboratory - Requirements for verification and validation
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Basic data
| Standard ID | RB/T 063-2021 (RB/T063-2021) |
| Description (Translated English) | Competence assessment of management and technical for inspection body and laboratory - Requirements for verification and validation |
| Sector / Industry | Chinese Industry Standard (Recommended) |
| Classification of Chinese Standard | A00 |
| Word Count Estimation | 10,180 |
| Issuing agency(ies) | National Certification and Accreditation Administration |
RB/T 063-2021: Competence assessment of management and technical for inspection body and laboratory - Requirements for verification and validation
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Competence assessment of management and technical for inspection body and laboratory - Requirements for verification and validation
ICS 03.120.20
CCSA00
People's Republic of China Certification and Accreditation Industry Standards
Inspection and testing organization management and technical ability evaluation
Method validation and validation requirements
Published on 2021-11-04
2022-01-01 Implementation
Released by the National Certification and Accreditation Administration of the People's Republic of China
foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents"
drafted.
Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents.
This document is proposed and managed by the National Certification and Accreditation Administration.
This document is drafted by. Beijing Guoshi Testing Technology Research Institute, Dalian Customs Technology Center, China Automotive Engineering Research Institute Co., Ltd.
Company, Guangdong Provincial Food Industry Research Institute Co., Ltd. (Guangdong Provincial Quality Supervision Food Inspection Station), Anhui Provincial Public Inspection Research Institute Co., Ltd.,
Shaanxi Provincial Institute of Product Quality Supervision and Inspection, Shanghai Electric Tools Research Institute (Group) Co., Ltd., China Center for Disease Control and Prevention, Guangzhou
Zhongke Testing Technology Service Co., Ltd., Nanjing Product Quality Supervision and Inspection Institute, Zhejiang Medical Device Inspection and Research Institute, Henan Wanguo Technology
Co., Ltd., Guangzhou Huibiao Testing Technology Center, Hainan Provincial Product Quality Supervision and Inspection Institute, Zhejiang Zhonghe Engineering Testing Co., Ltd., Zhuanghe
Municipal Market Supervision Service Center (Zhuanghe Food Inspection and Testing Center), Guangxi Zhuang Autonomous Region Analysis, Testing and Research Center, China Railway Third Bureau Group
Tuan Electric Engineering Co., Ltd., China Northern Vehicle Research Institute Test Center, Guangzhou Harbor Engineering Quality Inspection Co., Ltd., Guangxin Testing and Certification
Group Co., Ltd., Boxing County Traffic Vehicle Comprehensive Performance Testing Co., Ltd., Hebei Zhongdian Kehang Testing Technology Service Co., Ltd., Jilin Province
Chadwick Technology Co., Ltd., Henan Provincial People's Hospital (Henan Integrity Forensic Clinical Judicial Appraisal Institute), Xi'an Product Quality Supervision and Inspection
Institute, Shandong Lukan Engineering Inspection and Appraisal Co., Ltd., National Nuclear Security Technology Center, and Fujian Provincial Institute of Product Quality Inspection.
The main drafters of this document. Wei Feng, Huang Tao, Yang Chunrong, Li Shaolian, Pan Shunfang, Yang Jiaolan, Wang Huifang, Feng Zhiqiang, Li Na, Ma Li, Cheng Xiucai,
Yang Jianxi, Li Feng, Gao Ruifeng, Huang Yan, Wu Yongcun, Hong Aizhu, Zhu Jinyan, Xie Tao, Tong Chengliang, Guo Sihong, Zhang Li, Guo Qiang, Liu Jun, Zhou Fangmei,
Gu Jianhua, Mi Weihui, Yang Qunhua, Zhang Xiangwen, Zhang Guimei, Chen Xia, Cui Lin, Zhang Zeju, Kang Bing, Wei Gang, Liu Shunshun, Zhang Yaowu, Zhao Eryu, Yu Chunlai,
Tian Huanrong, Chen Xiaojia, Bao Qianxiang, Pu Weihua, Bai Huiqing, Yang Jun.
Inspection and testing organization management and technical ability evaluation
Method validation and validation requirements
1 Scope
This document specifies requirements for standard method validation and non-standard method validation.
This document is applicable to the evaluation of the qualification accreditation capacity of inspection and testing institutions that issue data and results with a proving role to the society.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations
documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to
this document.
GB/T 19000 Quality Management System Fundamentals and Terminology
GB/T 19011 Management System Audit Guidelines
GB/T 27000 Conformity Assessment Vocabulary and General Principles
GB/T 27020 Conformity Assessment Operational Requirements for Various Inspection Agencies
GB/T 27025 General requirements for the competence of testing and calibration laboratories
JJF1001 General Metrology Terms and Definitions
3 Terms and Definitions
GB/T 19000, GB/T 19011, GB/T 27000, GB/T 27020, GB/T 27025, JJF1001 and the following techniques
terms and definitions apply to this document.
3.1
standardmethod
International standards, regional standards, national standards,
Technical operation methods specified in documents such as industry standards.
Note. Metrological verification procedures and calibration specifications are also standard methods.
3.2
non-standard method
A documented method of technical operation not approved by the appropriate standardization organization.
NOTE. Non-standard methods include but are not limited to.
a) well-known technical organizations or methods published in relevant scientific books and journals;
b) methods developed/developed by inspection and testing institutions;
c) the method specified by the equipment manufacturer;
d) standard methods, extended and modified standard methods used beyond their intended scope;
e) other methods.
3.3
method verification methodverification
The inspection and testing agency shall provide objective and valid evidence to prove that the requirements specified by the inspection and testing methods are met.
...