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JJF 1645-2017 English PDF

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US$374.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
JJF 1645-2017: In-house Preparation of Quality Control Materials(QCMs)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
JJF 1645-2017	374	Add to Cart	4 days	In-house Preparation of Quality Control Materials(QCMs)	Valid

Similar standards

JJG 1094 JJF 1441 JJF 1507

Basic data

Standard ID: JJF 1645-2017 (JJF1645-2017)
Description (Translated English): In-house Preparation of Quality Control Materials(QCMs)
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A67
Classification of International Standard: 17.020
Word Count Estimation: 19,118
Date of Issue: 2017-09-26
Date of Implementation: 2017-12-26
Quoted Standard: JJF 1001; JJF 1005; JJF 1343; JJF 1507; GB/T 3358.1
Adopted Standard: ISO Guideline 80-2014, IDT
Regulation (derived from): General Administration of State Quality Inspection Announcement 2017 No. 78
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine
Summary: This standard stipulates the basic characteristics of the quality control material, and provides the basic procedures for the internal development of the quality control material, as well as the basic principles of homogeneity assessment, stability assessment, and assignment in the development process. It is applicable to guiding the laboratory to carry out quality control. The internal development of the material.

JJF 1645-2017: 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.
(Technical specification for internal development of quality control substances) People's Republic of China National Measurement Specifications Internal Control of Quality Control Materials In-housePreparationofQualityControlMaterials (QCMs) 2017-09-26 Posted 2017-12-26 Implementation General Administration of Quality Supervision, Inspection and Quarantine released Internal Control of Quality Control Materials ControlMaterials (QCMs) Focal point. National Standard Material Measurement Technical Committee The main drafting unit. China Institute of Metrology Participate in the drafting unit. Shanghai Institute of Measurement and Testing Technology Chinese Center for Disease Control Occupational Health and Poison Control This specification entrusts the national standard material measurement technical committee to be responsible for explaining The main drafters of this specification. Kan Ying (China Institute of Metrology) Li Hongmei (China Institute of Metrology) Guo Jing (China Institute of Metrology) Participate in the drafters. Wu Limin (Shanghai Institute of Measurement and Testing Technology) Yan Huifang (China Center for Disease Control and Prevention Occupational Health and Poison Control)

Introduction (Ⅲ) 1 Scope (1) 2 References (1) 3 Terms and Definitions (1) 3.1 Quality Control Substance (1) 4 quality control material development steps (1) 5 material technical requirements (2) 5.1 substrate type, matching and interchangeability (2) 5.2 Characteristics and characteristic values (3) 5.3 Unit Specifications (3) 5.4 Batch (3) Preparation of 6 quality control substances (3) 6.1 Collection of raw materials (3) 6.2 Materials Processing (4) 6.3 packaging and packaging (5) 7 Uniformity (6) 7.1 Overview (6) 7.2 Analysis Methods (7) 7.3 Statistical Analysis of Uniformity Data (7) 8 assignment (9) 9 Stability (9) 9.1 Overview (9) 9.2 Stability Assessment (10) 9.3 to determine the validity of quality control substances (10) 10 Transport (10) 11 Preparation of relevant documents for quality control substances (11) 11.1 General (11) 11.2 Information to be Provided for Quality Control Substance (11) 11.3 Labeling of quality control substance units (11) 11.4 Archive Information (11) 12 Storage (12) 12.1 General (12) 12.2 Monitoring of storage conditions (12) 13 Use of quality control substances (12) 13.1 General (12) 13.2 Minimum Sampling Quantity (12) 13.3 Mixing Procedure (12) 13.4 Dry Mass Correction (12) 13.5 Storage of quality control substances after opening (13)

Introduction

As the market demands for testing and product quality expand rapidly, the demand for quality control substances continues to grow. quality Use of controlled substances include but are not limited to. 1) Make a quality control chart to prove that the measurement process is controllable and effective; 2) compare the results, confirm the equivalence of the measurement results or normalize the result; 3) Method development to establish consistency; 4) instrument performance check; 5) Repeatability/Reproducibility studies; 6) as a verification sample, such as the equivalence of two or more laboratory measurements confirmed; 7) operator change monitoring; 8) Monitoring of the impact of changes in environmental conditions. The application of quality control substances is of great significance to promote the detection quality and product quality in various fields. The quality control substance is only a supplement to the certified reference substance, not an alternative. Usually there is no suitable standard Quality, or the need for large quantities of standard material, the cost is high, the laboratory needs to develop quality control substances. This specification is equivalent to the ISO Guide 80.2014 "internal control of quality control materials", elaborated the quality control Material internal research and development processes and uniformity assessment, stability assessment, assignment and other technical requirements to promote China's high water Quality control of the development and application of substances to ensure that the laboratory developed quality control material can effectively play a "quality control System "role. This specification is first released. Internal Control of Quality Control Materials

1 Scope

This Code outlines the basic characteristics of quality control of raw materials, and gives the quality control of the internal development of the material base This procedure, as well as the development of uniformity assessment, stability assessment, the basic principles of assignment, suitable for guiding experiment Room to carry out internal control of quality control material.

2 reference documents

JJF 1001 common measurement terms and definitions JJF 1005 standard terms and definitions commonly used General Principles and Statistical Principles of JJF 1343 Standard Substance Setting Selection and Application of JJF 1507 Standard Substance GB/T 3358.1 statistical terms and symbols - Part 1. General statistical terms and terms used in probability (ISO 3534-1, IDT) ISO Guide 80 Internal Development of Quality Control Materials [ISO Guide80.Guidanceforin-house Preparation of Quality Control Materials (QCMs)] For dated references, only the dated version applies to this specification. For undated references The latest version (including all amendments) applies to this specification.

3 Terms and definitions

JJF 1001 "Common measurement terms and definitions", JJF 1005 "common terms and definitions of standard substances" and GB/T 3358.1 "Glossary and symbols of statistics Part 1. General statistical terms and terms used in probability" Chinese regulations The term applies to this specification. 3.1 Quality Control Materials QualityControlMaterials (QCMs) [ISO Guide 302.1.22] The standard substance used to measure quality control. Notes 1. "Quality control" refers to the use of such substances and not to another category of reference substances. Note 2. Quality control standards do not require evaluation results have traceability and measurement uncertainty, but must have to meet the pre- Period of use of the uniformity and stability. Note 3. Certified Reference Materials can also be used for measurement quality control.

4 quality control material development steps

The basic use of quality control substances is to detect changes in order to measure repeatability, measure the precision during or Recurring assessment, etc. (but not limited to). The assessment of uniformity and stability is usually based on the actual situation Achieve the balance between R & D costs and intended use. Figure 1 shows the key steps in a typical quality control material development process. However, not all steps It will be done by the agency that needs the substance. Materials procurement, handling, packaging and packaging can be a matter of experience ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of JJF 1645-2017_English be delivered?

Answer: Upon your order, we will start to translate JJF 1645-2017_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of JJF 1645-2017_English with my colleagues?

Answer: Yes. The purchased PDF of JJF 1645-2017_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.