GB/T 32467-2015 English PDF

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GB/T 32467-2015: Verification and validation of methods and internal quality control on chemical analysis -- Terms and definitions
Status: Valid

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Basic data

Standard ID: GB/T 32467-2015 (GB/T32467-2015)
Description (Translated English): Verification and validation of methods and internal quality control on chemical analysis -- Terms and definitions
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A00
Classification of International Standard: 03.120.10
Word Count Estimation: 26,224
Date of Issue: 2015-12-31
Date of Implementation: 2016-07-01
Regulation (derived from): State Standard Announcement 2015 No.43
Issuing agency(ies): General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China

GB/T 32467-2015: Verification and validation of methods and internal quality control on chemical analysis -- Terms and definitions

---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.
Verification and validation of methods and internal quality contorl on chemical analysis - Terms and definitions ICS 03.120.10 A00 National Standards of People's Republic of China Chemical analysis method validation confirmation and internal quality control Terms and definitions Verification and validationofmethodsandinternalqualitycontorlonchemical 2015-12-31 released 2016-07-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Management Committee released

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and centralized by the National Standardization Technical Committee for Quality Supervision and Testing of Key Products (SAC/TC374). The standard drafting unit. Sichuan Province Product Quality Supervision, Inspection and Testing Institute, in the inspection Warner (Beijing) Quality Technology Center Co., Ltd., Luzhou (Beijing) Quality Inspection Technology Research Institute Co., Ltd., Sichuan Province Food and Drug Inspection and Testing Institute, Guangyuan City Quality Supervision and Inspection Institute, Chengdu Hong billion Industrial Group Limited. The main drafters of this standard. Zheng Weidong, Wang Ming, Yin Jianjun, Li Wei, Hu Dan, Zhang Xicui, Zhang Shanyi, Cheng Guihong, Fan Zhigang.

Introduction

This standard is a chemical analysis laboratory test method validation and internal quality control (InternalQualityControl, IQC) series One of the standards. It is recommended that the Chemical Analysis Laboratory use this standard and other criteria in the standard. This standard gives a series of definitions and terms for the validation of chemical analysis methods and internal quality control. In the definition, Examples and notes are given in the form of explanatory information and precautions. This standard is intended to facilitate the validation and validation of chemical analysis methods in our laboratory Consistency of quality control terminology. The terms and definitions given in this standard and the following standards constitute the terms and definitions of chemical analysis methods for validation and internal quality control. The chemical analysis methods presented in this standard validate the terminology and definitions of validation and laboratory internal quality control. First, the existing standard discomfort With the use of individual terms and definitions, modified after the inclusion of this standard; the second is the current chemical analysis method validation and internal quality control is missing Terminology, defined definitions, and incorporated into this standard. GB/T 3358.1-2009 Statistical terms and symbols - Part 1. General statistical terms and terms for probabilities Statistical vocabulary and symbols - Part 2. Application statistics GB/T 3358.2 Statistical vocabulary and symbols - Part 3. Experimental design GB/T 3358.3 GB/T 6379.1-2006 Accuracy of measurement methods and results (accuracy and precision) Part 1. General and definitions Analytical chemistry terms GB/T 14666-2003 GB/T 15000.2-1994 Working Guidelines for Standard Samples (2) Terms and Definitions for Standard Samples GB/T 17378.2-2007 Marine monitoring specification - Part 2. Data processing and analysis - Quality control Quality management systems - Fundamentals and terminology GB/T 19000-2008 Standard Terminology and Definitions for JJF1001-2011 ISO 11843-1..1997 Detection Capability - Part 1. Terms and Definitions (Capabilityofdetection-Part 1. Terms anddefinitions) Domestic and international analytical chemistry in the use of the series of terms "accuracy", "correctness", "bias", "precision" is more chaotic, and international standards ISO 5725 (Internationally Modified to GB/T 6379) series published by International Standardization Organization (ISO ) The definition given by the standard has a large gap. It is important to emphasize the importance of this series of terms in validation and validation of chemical analysis methods Nature, specification and harmonization in the field of chemical analysis of the correct use of this standard directly quoted GB/T 6379.1 (IDTISO 5725-1) given the Terms and definitions. This appendix is an informative appendix to the terms and definitions of test terminology and definitions that are commonly used in chemical analysis and definitions. The purpose of this appendix is to assist the Chemical Analysis Laboratory in understanding and using the ISO 11843 series of standards. Chemical analysis method validation confirmation and internal quality control Terms and definitions

1 Scope

This standard specifies the chemical analysis and testing process, method detection capability, recovery rate, linearity and calibration, quality control samples, detection methods, management, Chemical analysis methods Verification and terminology and definitions of internal quality control. This standard applies to laboratory chemical analysis methods to verify and internal quality control.

2 Test procedure terms and definitions

2.1 Inspection inspection Through the test, test or estimate, combined with the observation and judgment of the compliance evaluation. Note. rewrite GB/T 19000-2008, defined 3.8.2. 2.2 Test test The technical operation of a given product, in accordance with the prescribed procedure, determines one or more characteristics, processing or provision of services. Note. rewrite JJF1001-2011, defined 9.46. 2.3 Target analyte objectiveanalytes Analyte Target component objectivecomponents Present in the test sample, the detected component specified by the method. Note. The target analyte can be a single component or a mixed component. 2.4 Analysis sequence analyticalseries Analysis of batchrun A set of regular and quality control samples. Note. see GB/T 3358.2-2009, definition 3.5.11. 2.5 Analysis program analyticalprocedures The test program determinationprocedures A detailed description of the steps/procedures for detection (analysis, testing). 2.6 Standard operating procedures standardoperationprocedure; SOP The standard operational procedures and requirements for a particular activity are described in a uniform format to guide and standardize the specific activity. Procedures to ensure consistency of the document. 2.7 Independent repetitive detection of independentrepeatedtest In the chemical analysis test, the current test is not affected by the same or similar sample detection in the past, including the independent preparation of the test sample, random ......

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