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GB/T 27403-2026: Criterion on quality control of laboratories - Molecular biological testing of food
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GB/T 27403: Evolution and historical versions
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Criterion on quality control of laboratories - Molecular biological testing of food
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| GB/T 27403-2008 | English | 515 |
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Criterion on quality control of laboratories -- Molecular biological testing of food
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Standard similar to GB/T 27403-2026 GB/T 27400 | GB/T 27207 | GB/T 27404 | GB/T 27402 | GB/T 27401 | Basic data | Standard ID | GB/T 27403-2026 (GB/T27403-2026) | | Description (Translated English) | Criterion on quality control of laboratories - Molecular biological testing of food | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A00 | | Classification of International Standard | 03.120.10 | | Date of Issue | 2026-01-28 | | Date of Implementation | 2026-03-01 | | Older Standard (superseded by this standard) | GB/T 27403-2008 | GB/T 27403-2026: Criterion on quality control of laboratories - Molecular biological testing of food
---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 03.120.10
CCSA00
National Standards of the People's Republic of China
Replaces GB/T 27403-2008
Laboratory quality control standards for food molecular biology testing
Published on 2026-01-28
Implemented on 2026-03-01
State Administration for Market Regulation
The State Administration for Standardization issued a statement.
Table of contents
Preface III
Introduction IV
1.Scope 1
2 Normative References 1
3.Terms and Definitions 1
4 General Requirements 3
5.Structural Requirements 4
6.Resource Requirements 4
7.Process Requirements 9.
8.Management System Requirements 16
Appendix A (Informative) Regional Division of Gene Amplification Laboratories 19
Appendix B (Informative) Hazardous Waste Management 22
Appendix C (Informative) Commonly Used Equipment in Molecular Biology Laboratories 23
Appendix D (Informative) Principles for the Prevention and Handling of PCR Contamination in Nucleic Acid Testing 24
Appendix E (Informative) Prevention of RNase Contamination in RNA Detection 27
Appendix F (Normative) Management Requirements for Mobile Molecular Biology Laboratories 28
References 29
Foreword
This 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 supersedes GB/T 27403-2008 "Laboratory Quality Control Standards for Molecular Biological Testing of Food", and is consistent with GB/T 27403-
Compared to.2008, aside from structural adjustments and editorial changes, the main technical changes are as follows.
a) The scope has been changed (see Chapter 1, Chapter 1 of the.2008 edition);
b) The requirements for terms and definitions have been changed, and some terms have been modified and added (see Chapter 3, Chapter 3 of the.2008 edition);
c) The general requirements have been revised, clarifying the requirements related to impartiality and confidentiality (see Chapter 4, 4.1.4 and 5.2.4 of the.2008 edition);
d) The structural requirements have been changed (see Chapter 5, 4.1 and 5.5.1.3 of the.2008 edition);
e) Resource requirements have been revised, specifying requirements related to personnel, facilities and environment, equipment, metrological traceability, and externally provided products and services.
See Chapter 6 (Chapter 5 in the.2008 edition);
f) Process requirements were modified, subcontracting elements were removed, and the changes were incorporated into the requirements, tender documents, and contract review. The requirements, tender documents, and contract review were further refined.
Technical requirements related to contract review, method selection, verification and validation, sampling, and handling of test samples (see Chapter 7).
Chapter 6 of the.2008 edition);
g) The management system requirements were changed, the preventive action element was removed, and the risk and opportunity response element was added (see 8.5,.2008).
Version 4.9);
h) Added management requirements for mobile molecular biology laboratories (see Appendix F).
Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.
This document was proposed and is under the jurisdiction of the National Technical Committee on Standardization of Certification and Accreditation (SAC/TC261).
This document was drafted by. China Customs Science and Technology Research Center, China National Accreditation Service for Conformity Assessment, and Inner Mongolia Yili Industrial Group.
Joint-stock company, Linyi University, Institute of Agricultural Product Processing, Chinese Academy of Agricultural Sciences, Anhui Kebo Product Testing and Research Institute Co., Ltd., Yantai
Jieke Testing Service Co., Ltd., Shanghai Miaokelanduo Food Technology Co., Ltd., Chongqing Tianyou Dairy Co., Ltd., and Zhongnongwei
Real Testing Technology (Weifang) Co., Ltd., and Chaji (Shanghai) Brand Management Co., Ltd.
The main drafters of this document are. Zhang Huiyuan, Zhang Haiyan, Wu Xiaoli, Liu Yunguo, Song Yiyun, Ma Dan, Yang Xiangying, Duan Jianhua, Chen Sheng, and Lin Chiyu.
Liu Shuyan, Hao Jianliang, Zhang Qingping, Li Mei, Zhi Lihui, Rong Jia.
The release history of this document and the document it replaces is as follows.
---GB/T 27403-2008;
---This is the first revision.
Introduction
This document outlines the specific applications of GB/T 27025 "General Requirements for the Competence of Testing and Calibration Laboratories" in the field of food molecular biology testing.
This document serves as a useful supplement, aiming to standardize, guide, and assist relevant laboratories in meeting the requirements of GB/T 27025 and the quality control standards specific to this professional field.
The requirements are clear and understood regarding the implementation of relevant quality control measures.
All clauses of GB/T 27025 apply to this document. It is recommended that relevant laboratories familiarize themselves with and understand GB/T 27025 before using this document.
Related content.
Although this document includes some current Chinese regulations applicable to this professional field and some safety-related content, it is not intended as a judgment.
The basis for determining whether a diagnostic laboratory meets relevant regulations and safety requirements.
Laboratory quality control standards for food molecular biology testing
1 Scope
This document specifies the general requirements, structural requirements, resource requirements, process requirements, and management requirements for quality control in food molecular biology testing laboratories.
The system requirements.
This document applies to laboratories that primarily use molecular biology techniques to test food and related products.
Quality control activities and competency assessments. This should be used as a reference for molecular biology testing laboratories in other fields.
2 Normative references
The contents of the following documents, through normative references within the text, constitute essential provisions of this document. Dated citations are not included.
For references to documents, only the version corresponding to that date applies to this document; for undated references, the latest version (including all amendments) applies.
This document.
GB 7258 Technical Conditions for Safe Operation of Motor Vehicles
GB/T 19000 Quality Management Systems. Fundamentals and Vocabulary
GB/T 27000 Conformity Assessment Vocabulary and General Principles
GB/T 27025 General requirements for the competence of testing and calibration laboratories
GB/T 27043 General requirements for conformity assessment and proficiency testing
GB 27421 Biosafety Requirements for Mobile Laboratories
GB/T 29471 General Technical Specification for Mobile Laboratories for Food Safety Testing
GB/T 29475 Design Principles and Basic Requirements for Mobile Laboratories
GB/T 29476 General Technical Specifications for Mobile Laboratory Instruments and Equipment
GB/T 37868 Technical Specification for Traceability of Nucleic Acid Detection Kits
JJF1265 Biometric Terminology and Definitions
3 Terms and Definitions
The terms and definitions defined in GB/T 19000, GB/T 27000, GB/T 27025 and JJF1265, as well as the following terms and definitions, apply to this document.
3.1
A laboratory that uses molecular biology detection technology as its main method and focuses on food and related products for testing.
3.2
The enzymatic reaction process of in vitro DNA amplification.
[Source. ISO 22174.2024, 3.1.17]
3.3
A procedure that combines PCR amplification with the detection and/or quantification of specific amplification products during the amplification process.
[Source. ISO 22174.2024, 3.1.19]
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