GB/T 15000.5-2023 English PDFUS$874.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 15000.5-2023: Directives for the work of reference materials - Part 5: The in-house preparation of quality control materials(QCMs) Status: Valid GB/T 15000.5: Historical versions
Basic dataStandard ID: GB/T 15000.5-2023 (GB/T15000.5-2023)Description (Translated English): Directives for the work of reference materials - Part 5: The in-house preparation of quality control materials(QCMs) Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: A00 Classification of International Standard: 01.120 Word Count Estimation: 50,511 Date of Issue: 2023-08-06 Date of Implementation: 2023-08-06 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 15000.5-2023: Directives for the work of reference materials - Part 5: The in-house preparation of quality control materials(QCMs)---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. ICS 01.120 CCSA00 National Standards of People's Republic of China Standard sample work guide Part 5.Internal Development of Quality Control Samples [ISO Guide80.2014,Guidanceforthein-housepreparationof Published on 2023-08-06 2023-08-06 Implementation State Administration for Market Regulation Released by the National Standardization Administration Committee Table of contentsPreface III Introduction IV 1 Scope 1 2 Normative reference documents 1 3 Terms and Definitions 1 4 Quality Control Samples (QCM) 2 5 Purposes of Quality Control Samples (QCM) 2 6 Step 3 of in-house development of quality control samples (QCM) 7 Technical requirements for raw materials 3 7.1 Substrate type, compatibility and interchangeability3 7.2 Characteristics and characteristic values 4 7.3 Unit specifications 4 7.4 Total sample size 4 8 Preparation of quality control samples (QCM) 4 8.1 Raw material collection 4 8.2 Processing and Preparation 5 8.3 Dispensing and packaging 6 9 Uniformity 7 9.1 Overview 7 9.2 Analysis methods 8 9.3 Statistical processing of uniformity data 8 10 Determination and Assignment10 11 Stability10 11.1 Overview10 11.2 Stability assessment 11 11.3 QCM validity period assessment 11 12 Transportation11 13 Quality Control Sample (QCM) Documentation 11 13.1 Overview 11 13.2 Information required for quality control samples (QCM)11 13.3 QCM unit label 12 13.4 Other useful information12 14 save 12 14.1 Overview 12 14.2 Monitoring of storage conditions 12 15 Use of quality control samples (QCM) 13 15.1 Overview 13 15.2 Minimum sampling volume13 15.3 Mixing procedures 13 15.4 Dry basis calibration 13 15.5 Storage of QCM containers after unsealing 13 Appendix A (informative) Case 1 Development of coal quality control sample (QCM) 14 Appendix B (Informative) Case 2 Development of Geological and Metallurgical Quality Control Samples (QCM) 16 Appendix C (informative) Case 3 Development of quality control sample (QCM) of folic acid fortified flour 22 Appendix D (Informative) Case 4 Development of Bauxite Quality Control Samples (QCM) 27 Appendix E (informative) Case 5 Development of drug quality control samples 32 Appendix F (informative) Case 6 Development of quality control samples for “bromate in water” 36 Reference 42ForewordThis document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. This document is Part 5 of GB/T 15000 "Guidelines for Standard Sample Work". GB/T 15000 has released the following parts. ---Part 1.General provisions for standard samples stated in technical standards; ---Part 2.Commonly used terms and definitions; ---Part 3.Standard sample determination and uniformity and stability evaluation; ---Part 4.Contents of certificates, labels and accompanying documents; ---Part 5.Internal development of quality control samples; ---Part 6.General rules for standard sample packaging; ---Part 7.General requirements for the capabilities of standard sample producers; ---Part 8.Use of standard samples. This document is equivalent to ISO Guide80.2014 "Guidelines for the Internal Development of Quality Control Samples". The file type is determined by the ISO guideline document. The parts are adjusted to my country's national standards. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed and coordinated by the National Standard Sample Technical Committee (SAC/TC118). This document was drafted by. China Standardization Association, Wuhan University of Science and Technology, Dalian University for Nationalities, China Jiliang University, China Inspection and Certification Group Tuan Liaoning Co., Ltd., Shandong Analysis and Testing Center, Winning Energy Efficiency Technology (Qingdao) Co., Ltd., Beijing Huasu Chenguang Technology Co., Ltd. The main drafters of this document. Xu Jianping, Xu Dajun, He Ping, Tian Wen, Chen Ying, Li Jinxia, Yang Chunsheng, Tang Benling, Hu Xiaoyan, An Ziyi, Shi Yuting, Cao Jijuan, Zi Zihong, Wu Bin, Wang Xiao, Chen Jian, Chen Hongyuan.IntroductionReference samples (RM) are widely used in measurement laboratories because of their multiple uses. Laboratories recognize that depending on the specific use It is important to choose the appropriate sample. Certified reference samples (CRM), i.e. those whose characteristic values and associated uncertainties are determined by metrologically valid Samples determined by procedures are mainly used for method validation and calibration to provide metrological calibration traceability. The development of standard samples for metrological quality control (that is, the control of measurement quality rather than product quality) is an important activity and provides the basis for the measurement system. Routine monitoring under statistical control provides suitable samples. This sample is not required to be determined through metrological verification procedures and can be determined by actual Developed by laboratory personnel familiar with sample characteristics within the laboratory (hereinafter referred to as "in-house"), it can meet specific quality control needs. A sufficiently uniform and stable RM is necessary for metrological quality control purposes such as. certifying the measurement system It is under statistical control, performs as expected and provides reliable results; the accuracy of the measurement results is not critical here. Collect from different fields Use different terms to describe these samples (e.g., internal standards, quality control samples, check samples, etc.). To simplify and avoid duplication Note, this document uses the term “quality control sample (QCM)” uniformly. In the standard sample technology system, GB/T 15000 "Guidelines for the Work of Standard Samples" is the basic and general guide for the work of standard samples in our country. Usability standards. GB/T 15000 aims to establish a standard that is universally applicable to the preparation, valuation, packaging, storage, distribution and application of standard sample producers. The guidelines consist of 8 parts. ---Part 1.General provisions for standard samples stated in technical standards. The purpose is to provide for the statement of standards in the formulation of technical standards General requirements for samples, the relationship between standard samples and technical standards, technical criteria for selecting standard samples, etc. ---Part 2.Commonly used terms and definitions. The purpose is to specify terms and definitions related to standard samples, especially those used for standard samples. terminology in product product instructions, certificates and corresponding development reports. ---Part 3.Standard sample determination and uniformity and stability evaluation. The purpose is to provide more specific guidance on technical issues Guide, and provide a basic model for the homogeneity, stability evaluation and setting process of standard samples. ---Part 4.Contents of certificates, labels and accompanying documents. The purpose is to establish standards applicable to the preparation of standard sample certificates, labels and attachments. Relevant requirements that need to be followed when bringing file content. ---Part 5.Internal development of quality control samples. The purpose is to standardize and guide the development and use of quality control samples. ---Part 6.General rules for standard sample packaging. The purpose is to establish basic rules applicable to standard sample packaging, storage and transportation. ---Part 7.General requirements for the capabilities of standard sample producers. The purpose is to stipulate relevant organizational management and operational requirements to ensure Standard sample producers can produce standard samples that meet the requirements. ---Part 8.Use of standard samples. The purpose is to provide guidance for the correct use of standard samples. Typically, QCMs are only available within a limited range (limited characteristic values) for use by specific laboratories when performing measurements. QCM in this document It is RM, according to which the requirements of ISO Guide341)[1] for RM development are applicable. However, if the sample is restricted to the laboratory in which it was developed, For partial use, certain requirements (e.g., transport stability) may be relaxed. When the development of QCM is related to CRM, developers can refer to ISO Guide34 and ISO Guide35[2] provide further guidance. Where applicable, this document will refer directly to the relevant part. 1) ISO Guide34.2000 was replaced by ISO 17034.2016, and the original guide document was abolished. ISO 17034.2016 has been equivalent to GB/T 15000.7-2021. As we all know, CRM is developed by recognized standard sample producers and sold on the market. QCM is often performed by a laboratory Developed for internal use. The reason for developing quality control samples may be one or more of the following. ---An RM that is as close as possible to daily samples is needed for quality control; ---Need a RM suitable for daily use to supplement CRM; ---No suitable CRM; --- Scenarios that do not require the use of all features of CRM (i.e. traceability and uncertainty of specified feature values). Therefore, many laboratories require QCM in order to minimize the time and effort required to develop samples. The appendix to this document gives Many research cases are provided to illustrate how to process these data to confirm the applicability of QCM. Standard sample work guide Part 5.Internal Development of Quality Control Samples1 ScopeThis document provides the basic characteristics of standards for use in quality control (QC), suitable for use in laboratories developed by competent personnel. Process for standard samples (to avoid instabilities due to shipping conditions). This document also applies to very stable samples (during transport There is no risk of significant changes in the value of the characteristic of interest). The primary users of this document are laboratory personnel who need to develop specific quality control samples (QCM). If there are transport requirements, e.g. Laboratories have different application locations or proficiency testing plans. The development of QCM should refer to the relevant ISO Guide34 and ISO Guide35. Require. The detailed description of the development of reference samples (RM) in ISO Guide34 and ISO Guide35 also applies to the development of QCM. But for "internal The requirements for "Part 1" QCM are lower than those for certified reference samples (CRM). The development of QCM includes uniformity and stability assessment, providing tables Indicative values of relevant characteristics and their changes for ease of use. This document provides the quality standards that samples should meet to demonstrate that the measurement system performs under statistical control. Guidance on the application of QCM, such as drawing quality control charts, has been included in references [3], [4], [5], [6]. cover, so it is not included in this document. The framework and structure of this document provide general information on developing QCM in the main chapters and include some industry-specific information in the appendices. case study. The case studies are not intended to be complete "how-to manuals" but highlight key considerations when developing a QCM. case study Studies vary in complexity and detail and contain industry-specific terminology, but provide a range of Information. All parties involved in the development of QCM need to have a certain understanding of the type of sample being developed, and must pay attention to aspects such as matrix effects and contamination. potential problems.2 Normative reference documentsThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. ISO 3534-1 Statistical vocabulary and notation Part 1.General statistical terminology and terms used in probability (Statistics-Voca- Note. GB/T 3358.1-2009 Statistical vocabulary and symbols Part 1.General statistical terms and terms used in probability (ISO 3534-1.2006, IDT) Note. GB/T 15000.2-2019 Standard Sample Work Guide Part 2.Common Terms and Definitions (ISO Guide30.2015, IDT) ISO /IEC Guide99 International Vocabulary of Metrology Basic and Common Concepts and Related Terms (VIM) [Internationalvocabu-3 Terms and definitionsThe terms and definitions defined in ISO Guide30, ISO /IEC Guide99, ISO 3534-1 and the following apply to this document. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 15000.5-2023_English be delivered?Answer: Upon your order, we will start to translate GB/T 15000.5-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 15000.5-2023_English with my colleagues?Answer: Yes. 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