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GB/T 27403-2008 English PDF

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GB/T 27403-2008: Criterion on quality control of laboratories -- Molecular biological testing of food
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Standard similar to GB/T 27403-2008

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Basic data

Standard ID GB/T 27403-2008 (GB/T27403-2008)
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
Word Count Estimation 33,348
Date of Issue 2008-05-04
Date of Implementation 2008-10-01
Quoted Standard GB/T 15483.1; GB/T 19000; GB 19489; GB/T 27000; VIM common international metrology basic terminology [ by the BIPM (BIPM), the International Electrotechnical Commission (IEC), the International Federation of Clinical Chemistry and Laboratory Medicine (IF
Regulation (derived from) Announcement of Newly Approved National Standards No. 7 of 2008 (No. 120 overall)
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
Summary This standard specifies the molecular biology laboratory of food quality control management requirements, technical requirements, test procedures and test results of the control requirements for quality control requirements. This standard applies to engage in molecular biology techniques as the main means for the detection of objects in food quality control laboratories. Other areas of molecular biology testing laboratory also refer to the use.

GB/T 27403-2008: Criterion on quality control of laboratories -- Molecular biological testing of food


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Criterion on quality control of laboratories. Molecular biological testing of food ICS 03.120.10 A00 National Standards of People's Republic of China Laboratory quality control standards Molecular biology Food Posted 2008-05-04 2008-10-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Introduction Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms, Definitions and Abbreviations 1 4 Management Requirements 3 4.1 Organization 3 4.2 Management System 3 4.3 Document control 3 4.4 Quality and technical records 4 4.5 5 customer service 4.6 Complaints 5 4.7 Control of nonconforming work 5 4.8 Corrective Action 5 4.9 Precautions 5 4.10 Internal Audit 6 4.11 Management Review 6 4.12 Continuous Improvement 6 5 Technical requirements 7 5.1 Procurement Service 7 5.2 7 persons 5.3 Accommodation and environmental conditions 8 9 5.4 Device 5.5 Reagents and hazardous waste management 10 5.6 Traceability 11 6 Process control requirements 12 6.1 General 12 6.2 Contract Review 12 6.3 Sampling 12 6.4 Disposal of the test sample 13 6.5 methods and method validation 13 6.6 Subcontracting 16 6.7 Results Report 16 6.8 Emergency preparedness and response 18 7 18 Quality Control Results 7.1 Internal Quality Control 18 19 7.2 External Quality Control Appendix A (informative) This standard and GB/T 27025-2008 Table of Articles 20 Annex B (informative) Laboratory of Molecular Biology zoning 21 Annex C (informative) Laboratory of Molecular Biology 22 commonly used equipment Annex D (informative) nucleic acid detection and prevention of pollution of the principles involved in PCR 23 Appendix E (Informative Appendix) RNA detected in RNase contamination prevention 25 References 26

Foreword

This standard is one of the series of standard laboratory quality control practices, which currently includes the following criteria. --- GB/T 27401 "Laboratory Quality Control Standards of Animal Quarantine"; --- GB/T 27402 "Laboratory Quality Control Standards for Phytosanitary"; --- GB/T 27403 "food quality control laboratory of molecular biology norms"; --- GB/T 27404 "laboratory quality control practices physical and chemical testing of food"; --- GB/T 27405 "laboratory microbiological testing of food quality control standards"; --- GB/T 27406 "Laboratory quality control standards of food toxicology." Please note that some of the content of this standard may involve patents. The standard release mechanism should not bear the responsibility to identify these patents. The Standard Appendix A, Appendix B, Appendix C, Appendix D and Appendix E is an informative annex. This standard certification and accreditation by the National Standardization Technical Committee (SAC/TC261) and focal points. The standard by the China National Accreditation Center is responsible for drafting. Participated in the drafting of this standard. China National Accreditation Center, People's Republic of China Beijing Entry-Exit Inspection and Quarantine Bureau. The main drafters of this standard. Chan Kwong-chuen, to Liu Fu, Zhang Huiyuan, CAO, THE ACADEMY, Hezhao Wei, Zeng Jing, Rao red, Wang Qi, Zhang Xin.

Introduction

This standard mainly in the preparation of GB/T 27025 "testing and calibration laboratories General requirements" based on the absorption of the GB/T 19001-2000 "Quality Management System requirements," the content, and reference documents relevant international professional organizations, domestic and international industry standards and professional Industry literature applicable content, and the full integration of management experience in domestic laboratories. This standard is intended to regulate, guide and help related laboratory, to meet the GB/T 27025 and the professional in the field of quality control of concrete Claim. In addition to GB/T 27025, the standard reference in the art including the main professional document SN/T 1193-2003 "genetic testing real Laboratory technical requirements ", GB 19489-2004" General requirements for laboratory biosafety "and so on. Furthermore, although this includes the standard applicable to this part of our current areas of expertise as well as part of the safety regulations related content, but this standard Motion does not determine whether the laboratory as to meet the relevant regulations and safety requirements basis. Food testing laboratory of molecular biology refers to molecular biology techniques (such as nucleic acid technology, etc.) as the main means for the detection of food Like laboratory for detecting process including contract review, sampling, disposal methods and methods for detecting samples confirmed the detection of subcontracting. This standard applies to food molecules in biology laboratories engaged in molecular biology laboratory food of this standard can be Reference. Recommendations related laboratory before using this standard should be familiar with and master the GB/T 27025 relevant content. This standard GB/T 27025-2008 terms of control see Appendix A. Laboratory quality control standards Molecular biology Food

1 Scope

This standard specifies requirements for the management of food molecular biology laboratory quality control, technical requirements, testing and inspection requirements for process control Measurement results of the quality control requirements. This standard applies to engage in molecular biology techniques (such as nucleic acid technology, etc.) as the main means for the detection of objects in food laboratories QC. Molecular biology laboratories in other fields may also refer to use.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 15483.1 ability to use inter-laboratory comparison of verification - Part 1. Development and operation of proficiency testing schemes (GB/T 15483.1-1999, idt ISO /IEC Guide 43-1.1997) GB/T 19000 Quality management systems - Fundamentals and vocabulary (GB/T 19000-2000, idt ISO 9000.2000) GB 19489 General requirements for laboratory biosafety GB/T 27000 Conformity assessment - Vocabulary and general principles (GB/T 27000-2006, ISO /IEC 17000.2004, IDT) VIM internationally accepted basic metrology terminology [by the Bureau of Weights and Measures (BIPM), the International Electrotechnical Commission (IEC ), and the International Clinical Chemistry Federation of Experimental Medicine (IFCC), the International Organization for Standardization (ISO ), the International Federation of the theory of Pure and Applied Chemistry (IUPAC), International Theory Federation of Physical and Applied Physics (IUPAP) and the International Organization of Legal Metrology (OIML) Post] 3 Terms, definitions and abbreviations 3.1 Terms and Definitions GB/T 19000, GB/T 27000 and VIM are established and the following terms and definitions apply to this standard. Note. GB/T 19000 specifies the quality-related common definitions, GB/T 27000 devoted to the provision of laboratory accreditation and certification and related definitions. If the GB/T 19000 and GB/T 27000 and there are differences in the definition of VIM given priority GB/T 27000 and VIM are defined. 3.1.1 In molecular biology techniques (such as nucleic acid technology, etc.) as the main means of food for the laboratory testing of the object. 3.1.2 At the highest level of command and control laboratory of a person or group of people. 3.1.3 In the personnel responsible for managing laboratory activities laboratory top management leadership. 3.1.4 Laboratory materials, environment, information resources, personnel, technology and expertise needed for the corresponding detection.

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