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GB/Z 27426-2022Guidance on monitoring validity of the results for chemical analysis laboratory (English PDF)

化学分析实验室结果有效性监控指南

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Issued by

State Administration for Market Regulation; Standardization Administration of China

Level / Type

National · Recommended

Issue date

October 12, 2022

Implementation date

October 12, 2022

Scope

GB/Z 27426-2022 is the English-translated version of 化学分析实验室结果有效性监控指南.

GB/Z 27426-2022 is the Chinese national standard on guidance on monitoring validity of the results for chemical analysis laboratory, in the field of services and company organization. The /Z suffix marks it as a guiding technical document: it does not prescribe requirements that can be certified against, but sets out the technique, the method or the state of the art that the standards bodies recommend following. It was issued on 12 October 2022 by the State Administration for Market Regulation; Standardization Administration of China. As a guiding technical document it carries no separate date of entry into force: it applies from publication. Classification: ICS 03.120.20, CCS A00. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

Document preview — GB/Z 27426-2022

National Standard of the People's Republic of China

ICS
03.120.20
Classification
A00

Issued by: State Administration for Market Regulation; Standardization Administration of China

Contents

  • ForewordI
  • IntroductionII
  • 1 Scope1
  • 2 Normative references1
  • 3 Terms, definitions and symbols1
  • 3.1 Terms and definitions1
  • 3.2 Symbols3
  • 4 General rules3
  • 5 Planning of the monitoring3
  • 6 Internal monitoring4
  • 6.1 Use of reference materials, standard samples or quality control samples4
  • 6.2 Spiked recovery7
  • 6.3 Use of blank samples8
  • 6.4 Plotting control charts9
  • 6.5 Intermediate checks of equipment10
  • 6.6 Repeat analysis11
  • 6.7 Intralaboratory comparison11
  • 6.8 Analysis of the correlation of the results13
  • 7 External monitoring13
  • 7.1 Proficiency testing13
  • 7.2 Interlaboratory comparison14
  • Annex A (informative) Examples16
  • Bibliography19

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 Standardization Technical Committee (SAC/TC261). This document is drafted by: China National Accreditation Center for Conformity Assessment, National Geological Experiment and Testing Center, Shenzhen Customs Food Inspection and Quarantine Technology Technology Center, China Petroleum and Chemical Industry Federation, China Petroleum & Chemical Corporation Petrochemical Research Institute, China Medical Science Institute of Pharmacy, China Standard Technical Service (Shanghai) Co., Ltd., Institute of Testing and Analysis of Guangdong Academy of Sciences (Guangzhou, China Analysis and Testing Center), Industrial Analysis and Testing Center of Guangdong Academy of Sciences, China Certification and Accreditation Association, National Environmental Analysis and Testing Center, Steel Research Nanogram Testing Technology Technology Co., Ltd. The main drafters of this document. Zhao Bingnan, Wang Suming, Wang Shanshan, Sun Peiqin, Dong Fuyin, Wei Jing, Zhou Yongyun, Yang He, Ma Yuan, Zhang Jinlan, Liu Fufang, Wu Huiqin, Ma Yanfang, Wang Yaning, Du Bing, Hu Jingyu, He Zhaowei.

Chemical analysis involves many industries and fields such as chemical industry, petroleum, geology, environment, food and medicine, and the validity of laboratory test results is monitored especially important. With the wide application of the international standard ISO /IEC 17025 and the continuous enhancement of laboratory quality awareness, laboratory managers have More and more attention has been paid to the monitoring of the validity of the test results, and the monitoring of the validity of the test results has become an important part of laboratory management. Although ISO /IEC 17025 gives general requirements for laboratories to ensure the validity of results, and applies to all testing laboratories carrying out test results with The organization and management of effectiveness monitoring, however, due to the uneven level of laboratory capacity, many laboratories are carrying out results effectiveness monitoring and management. There is still a lot of confusion. According to the technical characteristics of chemical analysis laboratories, this document clarifies the general principles of monitoring and management of the effectiveness of results, and guides the risk-based The basic method of analyzing and evaluating results is used for monitoring and planning, and the selection and evaluation of internal monitoring methods, external monitoring methods and their results are given. The specific guidance for application is aimed at improving the quality of laboratory test results and improving the validity and reliability of laboratory test results. Guidelines for Monitoring the Validity of Chemical Analysis Laboratory Results

1 Scope

GB/Z 27426-2022 is the Chinese national standard on guidance on monitoring validity of the results for chemical analysis laboratory, in the field of services and company organization. The /Z suffix marks it as a guiding technical document: it does not prescribe requirements that can be certified against, but sets out the technique, the method or the state of the art that the standards bodies recommend following. It was issued on 12 October 2022 by the State Administration for Market Regulation; Standardization Administration of China. As a guiding technical document it carries no separate date of entry into force: it applies from publication. Classification: ICS 03.120.20, CCS A00. This page is published from the official record of the standard held by the Chinese standards administration: the identification, the dates, the classification and the issuing body are taken from there. The clause text, the tables and the numeric limits are in the document itself, which is delivered complete in English translation.

This document provides general principles, monitoring planning, internal and external monitoring methods and implementation requirements for the effectiveness of monitoring results in chemical analysis laboratories. Points and results evaluation and other guidance. This document is intended to guide the monitoring of the validity of chemical analysis laboratory results.

2 Common Terms and Definitions

GB/T 19000-2016 Quality Management System Fundamentals and Terminology

GB/T 27025-2019 General requirements for the competence of testing and calibration laboratories

JJF1001-2011 General Metrology Terms and Definitions

JJF1033-2016 Measurement Standard Assessment Specification

JJF1059.1-2012 Evaluation and representation of measurement uncertainty

3 Terms, Definitions and Symbols GB/T 6379.1-2004, GB/T 15000.2-2019, GB/T 19000-2016, JJF1001-2011,

JJF1033-2016 Terms and definitions defined in

JJF1059.1-2012 apply to this document. For convenience, this document repeats the following terms and definitions.

3.1 Terms and Definitions

3.1.1 effectiveness The extent to which planned activities are completed and planned results are obtained. [Source: GB/T 19000-2016, 3.7.11]

3.1.2 calibration A set of operations under specified conditions, the first step of which is to determine the relationship between the magnitude provided by the measuring standard and the corresponding indication, the second step It is to use this information to determine the relationship between the measurement results obtained from the indication value, where both the quantity provided by the measurement standard and the corresponding indication value have measurement uncertainty. fixed. [Source: JJF1001-2011, 4.10]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 23 pages — is available in the English PDF.

Referenced standards

Normative references

GB/T 6379.1-2004 · GB/T 15000.2-2019 · GB/T 19000-2016 · GB/T 27025-2019 · JJF1001-2011 · JJF1033-2016 · JJF1059.1-2012

Similar standards

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