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GB/T 27401-2008 English PDF

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GB/T 27401-2008: Criterion on quality control of laboratories -- Animal quarantine
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PDF similar to GB/T 27401-2008


Standard similar to GB/T 27401-2008

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Basic data

Standard ID GB/T 27401-2008 (GB/T27401-2008)
Description (Translated English) Criterion on quality control of laboratories -- Animal quarantine
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard A00
Classification of International Standard 03.120.10
Word Count Estimation 32,330
Date of Issue 2008-05-04
Date of Implementation 2008-10-01
Quoted Standard GB/T 15483.1; GB/T 18088; GB/T 19000; GB 19489; GB/T 27000; GB/T 27025; JJF 1059; VIM common international metrology basic terminology [ measured by the International Bureau, the International Electrotechnical Commission, International Clinical Chemistry and Experimental Medicine Federation, the International Organization for Standardization
Regulation (derived from) Announcement of Newly Approved National Standards No. 7, 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 animal quarantine laboratory quality control management requirements, technical requirements, process control requirements and the results of quality control requirements. This standard applies in animal and animal products and quarantine harmful organisms laboratory.

GB/T 27401-2008: Criterion on quality control of laboratories -- Animal quarantine

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Criterion on quality control of laboratories. Animal quarantine ICS 03.120.10 A00 National Standards of People's Republic of China Laboratory quality control norms of Animal Quarantine 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 and definitions 4 Management Requirements 2 4.1 Organization 2 4.2 Management System 3 4.3 Document control 3 4.4 quality control and technical recording 3 4.5 4 customer service 4.6 Complaints 4 4.7 Control of nonconforming work 4 4.8 Corrective Action 5 4.9 Precautions 5 4.10 Internal Audit 5 4.11 Management Review 6 4.12 Continuous Improvement 6 5 Technical requirements 6 5.1 Procurement Services 6 5.2 7 persons 5.3 Accommodation and environmental conditions 8 9 5.4 Device 5.5 Reagents and waste management 10 5.6 Traceability 11 5.7 biological model 12 6 Process control requirements 12 6.1 General 12 6.2 Contract Review 12 6.3 Sample Collection, storage, transport and disposal 13 6.4 quarantine methods and method validation 14 6.5 quarantine process 16 6.6 Subcontracting 17 6.7 Results Report 18 6.8 19 outbreaks have been reported 6.9 Emergency preparedness and response 19 7 19 Quality Control Results 7.1 Internal Quality Control 19 20 7.2 External Quality Control Appendix A (informative) This standard and GB/T 27025-2008 Table of Articles 21 Annex B (informative) Transfer of 22 samples processed animal quarantine Annex C (informative) reagents, consumables inspection methods and quality assurance 25

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. This standard Annex A, Annex B and Annex C is informative appendix. 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. This standard drafting units. China National Accreditation Center, People's Republic of China Beijing Entry-Exit Inspection and Quarantine Bureau. The main drafters of this standard. Liu Lai Fu, Song Guilan, Zhang Lifeng, Liu Yanhua, Zhang Hexiao, Di Peijun, Li Bingling, He Ping, Liu Chuan.

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 of professional major document including the World Organisation for Animal Health (Worldor- ganisationforanimalhealth, OIE) "Terrestrial Animals Manual of diagnostic tests and vaccines (mammals, birds and bees)" Fifth Edition (2004) The first part of Subjects, fifth edition (2006) of the first part of the "Aquatic Animal Disease Diagnostic Manual", GB/T 18088 "Entry and Exit Animal Quarantine sampling ", GB 19489" General requirements for laboratory biosafety. " 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. Animal Quarantine means within a predetermined range of laws and regulations, technical norms and standards, a variety of veterinary diagnostic, testing technology, timely Found in animals and animal products harmful organisms, in order to control the proliferation of animal diseases, protect animal breeding, animal and animal product safety. its The main process includes sample collection, quarantine, results analysis and results reporting. This standard is mainly applied in animal, animal products and quarantine Laboratory animal disease diagnosis. Engaged in animal disease research laboratory can use this as a reference standard. Recommendations related laboratory before using this standard should be familiar with and master the GB/T 27025 relevant content. This standard and GB/T 27025- 2008 control provisions in Appendix A. Laboratory quality control norms of Animal Quarantine

1 Scope

This standard specifies requirements for the management of Animal Quarantine laboratory quality control, technical requirements, process control requirements and quality control results Claim. This standard applies to engage in animal and animal product quarantine harmful organisms in the laboratory.

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 18088 Entry and Exit Animal Quarantine sampling 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) GB/T 27025 testing and calibration laboratories General requirements (GB/T 27025-2008, ISO /IEC 17025.2005, IDT) JJF1059 Evaluation and Expression of Uncertainty in Measurement 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 and Definitions

GB/T 27025, GB/T 15483.1, GB/T 19000, GB/T 27000 and VIM established and the following terms and definitions apply To this standard. 3.1 In animal and animal product quarantine harmful organisms in the laboratory. 3.2 At the highest level of command and control laboratory of a person or group of people. 3.3 Management of laboratory activities in the laboratory top management leadership. 3.4 Laboratory work specific embodiments, methods and procedures detailed instructions or guidance documents. 3.5 It can be used to prevent the failure detection operation or activity.

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