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JJF 1342-2022 English PDF

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JJF 1342-2022: General Requirements for the Competence of Reference Material Producers
Status: Valid

JJF 1342: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
JJF 1342-2022English749 Add to Cart 5 days [Need to translate] General Requirements for the Competence of Reference Material Producers Valid JJF 1342-2022
JJF 1342-2012EnglishRFQ ASK 5 days [Need to translate] General Requirements for Reference Material Producers Obsolete JJF 1342-2012
JJF 1342-1990English199 Add to Cart 2 days [Need to translate] O.T.N. of 4πα.4πβ Primary Standard for Low-Level Radipactivity Obsolete JJF 1342-1990

Standard similar to JJF 1342-2022

JJF 1033   JJF 1030   JJF 1343   

Basic data

Standard ID JJF 1342-2022 (JJF1342-2022)
Description (Translated English) General Requirements for the Competence of Reference Material Producers
Sector / Industry Metrology & Measurement Industry Standard
Word Count Estimation 34,376
Date of Issue 2022-04-29
Date of Implementation 2022-10-29
Issuing agency(ies) State Administration for Market Regulation

JJF 1342-2022: General Requirements for the Competence of Reference Material Producers

---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.
General Requirements for the Competence of Reference Material Producers National Metrology Technical Specifications of the People's Republic of China General requirements for reference material development (production) institutions (ISO 17034.2016, MOD) Released on 2022-04-29 Implementation on 2022-10-29 Released by the State Administration for Market Regulation Standard material development (production) General Institutional Requirements Replace JJF 1342-2012 Responsible unit. National Standard Substance Metrology Technical Committee Main drafting unit. China Institute of Metrology Participating in the drafting unit. Steel Research Nanoco Testing Technology Co., Ltd. National Geological Experiment and Testing Center This specification entrusts the National Standard Substance Metrology Technical Committee to be responsible for interpretation The main drafters of this specification. Kan Ying (National Institute of Metrology) Li Hongmei (National Institute of Metrology) Zheng Shuwen (National Institute of Metrology) Lu Xiaohua (National Institute of Metrology) Guo Jing (National Institute of Metrology) Participating drafters. Tang Benling (Steel Research Nanoco Testing Technology Co., Ltd.) Xu Chunxue (National Geological Experiment and Testing Center)

Table of contents

Introduction (Ⅲ) 1 Scope(1) 2 Normative references (1) 3 Terms and Definitions(1) 3.1 Fairness(1) 3.2 Reference material documents (2) 3.3 Operationally defined measurand(2) 4 General Requirements(2) 4.1 Fairness(2) 4.2 Confidentiality(2) 4.3 Contractual matters(2) 5 Structural Requirements(3) 6 Resource Requirements(4) 6.1 Personnel(4) 6.2 Subcontracting(4) 6.3 Procurement of equipment, services and supplies(5) 6.4 Facilities and environmental conditions (5) 7 Technology and R&D (production) requirements (6) 7.1 General (6) 7.2 Development (production) planning (7) 7.3 Development (production) control (7) 7.4 Material handling and storage (8) 7.5 Preparation (9) 7.6 Measurement procedure (10) 7.7 Measuring equipment(10) 7.8 Data integrity and evaluation (11) 7.9 Metrological traceability of certified values (12) 7.10 Homogeneity Evaluation(12) 7.11 Stability assessment and monitoring (13) 7.12 Fixed value measurement (14) 7.13 Determination of characteristic values and their uncertainties (15) 7.14 Reference material documentation and labeling (16) 7.15 Sales and after-sales service (17) 7.16 Control of records(17) 7.17 Management of Nonconforming Work (18) 7.18 Complaints(19) 7.19 Storage and transport(19) 8 Management System Requirements(19) 8.1 Alternatives (19) 8.2 Quality Policy (20) 8.3 General management system documentation (20) 8.4 Control of management system documentation (20) 8.5 Internal Audit(21) 8.6 Management Review (21) 8.7 Actions to address risks and opportunities (22) 8.8 Corrective Actions (23) 8.9 Improvements(23) 8.10 Customer Feedback(24) Appendix A Comparison between this specification and ISO 17034 (25) Appendix B Requirements for Research and Development (Production) of Reference Materials and Certified Reference Materials (27)

Introduction

Reference materials can be used in various stages of the measurement process, including method validation, calibration, and quality control. they also use Interlaboratory comparisons for the purpose of method validation and evaluation of laboratory capability. It is a basic requirement to ensure the quality of reference materials to prove the scientific and technological capabilities of reference material development (production) institutions beg. At the same time, with the continuous improvement of the precision of measuring equipment and the demand for more accurate and reliable data in the field of science and technology, There is also an increasing demand for new reference materials of higher quality. Standard material development (production) organization does not It is only necessary to provide product information in the form of standard material documents, and it is also necessary to prove that it has qualified standard material for production Ability. This specification replaces JJF 1342-2012 "General Requirements for Standard Material Development (Production) Institutions" and specifies the standard The general requirements for the ability of substance research and development (production) institutions to engage in the research and development (production) of national standard substances, combined with GB/T 27025 Purchasing, metrological traceability, etc. related requirements. When it comes to the medical field, relevant requirements should refer to GB/T 22576.1. The technical requirements of this specification and ISO 17034.2016 "General requirements for the ability of reference material developers (producers)" Be consistent and cover all the requirements of this International Standard. Compared with ISO Guide 34.2009, the main The modification is as follows. ---According to the general structure developed by the ISO Committee for Conformity Assessment (CASCO) and adopted by other international standards structure has been rearranged; --- Increase the general requirements of impartiality and confidentiality; ---Includes the production requirements of all types of reference materials, as well as the specific requirements of certified reference materials; --- Consistent with the revision of ISO Guide 31 and ISO Guide 35; ---Includes more detailed requirements for the preparation of documents required for reference materials; --- Including the response to risks and opportunities; --- Enhanced and improved according to ISO /CASCOPROC33. Considering the applicability and operability to the national standard material research and development (production) institutions, without violating On the basis of the requirements of ISO 17034, the specification retains some clauses in the previous version of JJF 1342 that are suitable for my country's national conditions, such as 7.19 Storage and transportation, etc. According to the drafting rules of ISO international standards, "shal" is a mandatory requirement, translated as "should"; "should" is a suggestion, Translated as "should", this specification maintains consistency with this rule. General requirements for reference material development (production) institutions

1 Scope

This standard stipulates that the research and development (production) institutions of reference materials are engaged in national standard materials (hereinafter referred to as reference materials) General requirements for the capabilities required for research and development (production), applicable to the establishment and operation of reference material research and development (production) institutions The quality management system for the developed (produced) reference materials. Note. This specification can also be used by management departments, accreditation institutions and other institutions to confirm or identify the ability of reference material development (production) institutions. provide a basis for reference.

2 Normative references

This specification references the following documents. JJF 1001 General Metrology Terms and Definitions General terms and definitions of JJF 1005 reference materials JJF 1186 Standard substance certificate and label requirements JJF 1218 Standard material development report preparation rules JJF 1343 Determination, homogeneity and stability evaluation of reference materials JJF 1854 Establishment, Evaluation and Expression of Metrological Traceability of Standard Substances GB/T 27025 General requirements for the competence of testing and calibration laboratories ISO Guide 31 Contents of reference materials certificates, labels and accompanying documents (Referencematerials- ISO Guide 35 Guidelines for Valuation and Homogeneity and Stability Evaluation of Standard Substances (Referencematerials- For dated references, only the dated version applies to this specification; for undated references document, its latest version (including all revisions) applies to this specification.

3 Terms and Definitions

JJF 1005 and the following terms apply to this specification. 3.1 impartiality Objectivity that actually exists and is perceived. Note. 1 Objectivity means that the conflict of interest does not exist or has been resolved, and will not affect the follow-up activities of the reference material development (production) organization. Negative Effects. 2 Other terms that may be used to denote the element of impartiality are. objective, independent, free from conflict of interest, free from prejudice, free from bias, neutral

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