Food toxicology testing refers to the testing and evaluation of food-related substances through toxicological methods. Food-related substances may include food and its raw materials, food additives, and food containers and packaging materials that may be ingested through food. The process mainly includes application acceptance, test system preparation, sample collection, transportation and storage, sample processing and inspection, result interpretation and reporting, as well as making recommendations and providing consultation. This standard is mainly applicable to the professional field of food toxicology safety evaluation, and can also be used as a reference for similar work in other toxicology testing fields. In addition, organizations that evaluate and accredit the capabilities of food toxicology testing laboratories can also use this standard as the basis for their work. This standard specifies the management requirements, technical requirements, process control requirements and result quality control requirements for food toxicology testing laboratories. This standard includes the quality control requirements of food toxicology testing laboratories from application acceptance, sample collection, sample processing and sample inspection to issuing inspection reports, interpreting results and making recommendations. This standard is applicable to food toxicology testing laboratories and can also be used as a reference for other professional toxicology testing laboratories. This standard is intended to regulate, guide and help relevant laboratories to meet the specific requirements of GB/T27205 and quality control in this professional field. GB/T 27406-2008 Laboratory Quality Control Specification Food Toxicology Testing GB/T27406-2008 Standard Download Decompression Password: www.bzxz.net
Food toxicology testing refers to the detection and evaluation of food-related substances by toxicological methods. Food-related substances may include food and its raw materials, food additives, and food containers and packaging materials that may be ingested through food. The process mainly includes acceptance of applications, preparation of test systems, sample collection, transportation and storage, sample processing and inspection, interpretation and reporting of results, and making recommendations and providing consultations. This standard is mainly applicable to the professional field of food toxicology safety evaluation, and can also be used as a reference for similar work in other toxicology testing fields. In addition, organizations that evaluate and accredit the capabilities of food toxicology testing laboratories can also use this standard as the basis for their work. This standard specifies the management requirements, technical requirements, process control requirements and result quality control requirements for food toxicology testing laboratories. This standard includes the quality control requirements for the entire process of food toxicology testing laboratories from application acceptance, sample collection, sample processing and sample testing to issuing test reports, interpreting results and making recommendations. This standard applies to food toxicology testing laboratories and can also be used as a reference for other professional toxicology testing laboratories. This standard aims to standardize, guide and help relevant laboratories to meet the specific requirements of GB/T 27205 and quality control in this professional field.

The clauses in the following documents become the clauses of this standard through reference. For all dated referenced documents, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties to an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all undated referenced documents, the latest versions are applicable to this standard.
GB/T1.1 Guidelines for standardization Part 1: Structure and rules for the preparation of standards (GB/T1.1-2000, ISO/IEC Directives, Part 3, 1997, NEQ)
GB15193.2 Standard practice for food toxicology laboratories
GB/T15483.1 Proficiency testing using inter-laboratory comparisons Part 1: Establishment and operation of proficiency testing schemes
(GB/T15483.1-1999, idtISO/IEC Guide 43-1:1997)
GB/T19000 Quality management system fundamentals and vocabulary (GB/T 19000-2000, idt ISO 9000: 2000)
GB/T 27025 General requirements for the competence of testing and calibration laboratories (GB/T 27025-2008, ISO/IEC 17025: 2005, IDT) OECD Principles for laboratory competence
VIM Internationally used basic terminology of metrology [published by the International Bureau of Weights and Measures (BIPM), the International Electrotechnical Commission (IEC), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the International Organization for Standardization (ISO), the International Union of Pure and Applied Chemistry (IUPAC), the International Union of Theoretical and Applied Physics (IUPAP) and the International Organization of Legal Metrology (OIML ) ]
Foreword
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... 4.1 Organization……………………………………………………………………………… ３ 4.2 Management system…………………………………………………………………… ３ 4.3 Document control…………………………………………………………………… ４ 4.4 Quality and technical records…………………………………………………… ４ 4.5 Customer service……………………………………………………………… ５ 4.6 ４．７ Nonconforming work control…………………………………………………………………………５ ４．８ Corrective actions………………………………………………………………………………６ ４．９ Preventive measures……………………………………………………………………………６ ４．１０ Internal audit…………………………………………………………………………６ ４．１１ Management review………………………………………………………………６ ４．１２ Continuous improvement……………………………………………………………………７















5. Technical requirements………………………………………………………………………… ７
5.1 Procurement services…………………………………………………………………… ７
5.2 Personnel…………………………………………………………………………………… ７
5.3 Facilities and environmental conditions………………………………………………… ９ 5.4
Laboratory equipment…………………………………………………………… １０
5.5 Test system……………………………………………………………………… １１
5.6 Traceability………………………………………………………………………… １１
６
６．１ General Principles ……………………………………………………………………………… １１ ６．２
Inspection Acceptance and Contract Review ……………………………………………… １２
６．３ Sample Collection, Storage, Transportation and Disposal …………………… １２
６．４ Test Plan ………………………………………………………………………… １３
６．５ Validation of Test Methods and SOP …………………………………… １４
６．６ Preparation and Grouping of Test Systems ………………………… １４
６．７
６．８ Experimental operation…………………………………………………………………………１６
６．９ Data statistical analysis and result evaluation………………………………１８
６．１０ Subcontracting………………………………………………………………………１８
６．１１ Result reporting and interpretation………………………………………１８ ６．１２
Supervision and inspection……………………………………………………１９ ７ Result quality control
…………………………………………………………２０
７．１ Internal quality control…………………………………………………………………………………… ２０
7.2 External quality control………………………………………………………………………… ２２
Appendix A (informative) Comparison table between this standard and GB/T 27025-2008 and OECD GLP clauses… ２３
Appendix B (informative) Principles for the application of animal experiment ethics in toxicology… ２５
Appendix C (informative) Quarantine of experimental animals……………………… ２７

ICS 03. 120, 10
National Standard of the People's Republic of China
GB/T27406—2008
Criterion on guality control of laboratoriesFood toxicology test2008-05-04Release
Digital Anti-Counterfeiting
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaStandardization Administration of China
2008-10-01Implementation
Normative Reference Documents
3Terms and Definitions
Management Requirements
Management System
Document Control
Quality and Technical Records
Customer Service
Complaint Handling
Non-Conformance Work Control
Corrective Action
Preventive Measures
Internal Audit
Management review
Continuous improvement·
5 Technical requirements
5.1 Procurement services
5.2 Personnel
Facilities and environmental conditions
Laboratory equipment
5.5 Test system·
5.6 Traceability·
6 Process control requirements
General principles·
6.2 Inspection acceptance and contract review
6.3 Sample collection, storage, transportation and disposal6.4
Test plan
Confirmation of test method and SOF
6. 6 Test system standard and grouping - Sample pretreatment and reagent preparation Test operation Data statistical analysis and result evaluation Result reporting and interpretation Supervision and inspection GB/T 27406-2008 GB/T 27406-2008 7 Result quality control 7.1 Internal quality control 2 External quality control Appendix A (informative) This standard is consistent with GB/T 27025-2008 and 0ECD GLP Appendix B (Informative Appendix) Principles for the Application of Animal Experiment Ethics in Toxicology Appendix C (Informative Appendix) Laboratory Animal Quarantine This standard is one of the laboratory quality control specification series, which currently includes the following standards: Animal Quarantine; GB/T27401 Laboratory Air Quality Control Specification Plant Quarantine, GB/T27402 Laboratory Quality Control Specification GB/T27403 Laboratory Quality Control Specification - GB/T27404 Laboratory Quality Control Specification - GB/T27405 Laboratory Quality Control Specification - GB/T27406 Laboratory Quality Control Specification Food Molecular Biology Testing: Food Physical and Chemical Testing; Food Microbiology Testing: Food Toxicology Testing. The drafting unit is not responsible for identifying any patent rights that may be involved in this standard. Appendices A, B and C of this standard are informative appendices. This standard was proposed and managed by the National Technical Committee for Certification and Accreditation (SAC/TC261). The China National Accreditation Service for Conformity Assessment is responsible for drafting this standard. GB/T27406—2008
The drafting units of this standard: Guangdong Provincial Center for Disease Control and Prevention, China National Accreditation Service for Conformity Assessment. State Food and Drug Administration.
The main drafters of this standard: Yang Xingfen, Wei Hao, Luo Jianbo, Lv Jing, Wu Youtong, Mi Guilan, Huang Junming, Chen Bifeng, Xiong Xikun, He Xiwen, Cai Mei, Hu Hanyan, He Ping, Liu Liping, Huang Zhibiao. Shan
GB/T27406--2008
The preparation of this standard is mainly based on GB/T27025 "General requirements for the competence of testing and calibration laboratories", while absorbing the contents of GB/T19001-2000 "Quality Management System Requirements", and referring to the applicable contents in the documents of relevant international professional organizations, domestic and foreign industry standards and professional literature, and fully integrating the management experience of relevant domestic laboratories: This standard aims to standardize, guide and help relevant laboratories to meet the specific requirements of GB/T 27205 and quality control in this professional field.
In addition to CB/T27205, the main documents related to this professional field that this standard refers to include ISO15189 Special requirements for quality and competence of medical laboratories, GB15193.2 Code of practice for food toxicology laboratories and OECD Principles of good laboratory practice (GLP). In addition, although this standard includes some of the current laws and regulations in my country applicable to this professional field and some safety-related content, this standard is not used as a basis for judging whether the laboratory meets the relevant laws and regulations and safety requirements. Food toxicology testing refers to the detection and evaluation of food-related substances by physiology methods. Food-related substances may include food and its raw materials, food additives, and food containers and packaging materials that may be ingested through food. The process mainly includes application acceptance, test system preparation, sample collection, transportation and storage, sample processing and inspection, result interpretation and reporting, as well as making suggestions and providing consultation. This standard is mainly applicable to the professional field of food toxicology safety evaluation, and can also be used as a reference for similar work in other toxicology testing fields. In addition, organizations that evaluate and accredit the capabilities of food toxicology testing laboratories can also use this standard as the basis for their work. It is recommended that relevant laboratories should be familiar with and master the relevant contents of GB/T27205 before using this standard. For the comparison of this standard with the provisions of GB/T270252008 and OECD GLP, please refer to Appendix A. 1 Scope
Laboratory quality control specification Food toxicology testing GB/T 27406—2008
This standard specifies the management requirements, technical requirements, process control requirements and result quality control requirements for the quality control of food toxicology testing laboratories. This standard includes the quality control requirements of food toxicology testing laboratories from the acceptance of application sample collection, sample processing and sample testing to the issuance of test reports, interpretation of results and recommendations. This standard is applicable to food toxicology testing laboratories and can also be used as a reference for other professional toxicology testing laboratories. 2 Normative references
The provisions in the following documents become the provisions of this standard through reference. For all referenced documents with dates, all subsequent amendments (excluding errata) or revisions are not applicable to this standard. However, parties that reach an agreement based on this standard are encouraged to study whether the latest versions of these documents can be used. For all referenced documents without dates, the latest versions are applicable to this standard. GB/T1.1 Guidelines for standardization Part 1: Structure and rules for writing standards (GB/T1.1-2000, ISO/IEC Directives, Part 3, 1997, NEQ)
GB15193.2 Code of practice for food toxicology laboratories GB/T15483.1 Proficiency testing using inter-laboratory comparisons Part 1: Establishment and operation of proficiency testing schemes (GB/T15483.1-1999, idt ISO/IFC Guide 43-1:1997) GB/T19000 Quality management system foundation and terminology (GB/T19000-2000, id1 ISO9000:2000) GB/T27025 General requirements for the competence of testing and calibrating laboratory procedures (GB/T27025-2008, ISO/IEC17025.2005 IDT)
OFCD Principles far good laboratory practiceVIM International General Metrology Basic Terms are issued by the International Bureau of Metering and Recording (BIPM), the International Electrotechnical Commission (IEC), the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), the International Organization for Standardization (ISO), the International Union of Pure and Applied Chemistry (IUPAC), the International Union of Theoretical and Applied Physics (IUPAP) and the International Organization of Legal Metrology (OIML) 3 Terms and definitions
GB/T1.1, GB/T15481, GB/T15483.1. The terms and definitions established in GB/T19000 and VIM and the following terms and definitions apply to this standard.
Food toxicology testing laboratory is a laboratory that tests and evaluates food-related substances through toxicological methods. Food-related substances may include food and its raw materials, food additives, and food containers and packaging materials that may be ingested through food. The laboratory can provide consulting services within the scope of its inspection, including interpretation of results and provision of suggestions. 3.2
Food safety
In the discipline of toxicology, food safety refers to a food that does not cause any harm to human health under the prescribed range of consumption, method of consumption and amount of consumption, that is, it does not cause acute or chronic diseases, nor does it cause potential harm to contacts and future generations. 3.3
Procedure for toxicological safety evaluationThe principle of phased testing adopted in toxicological safety evaluation, as well as the order in which various tests are conducted.1
GB/T 27406-2008
Top management of laboratoryOne or a group of people who direct and control the laboratory at the highest level. 3.5
Study directorStudy directorCctor
The person responsible for carrying out a certain test.
Quality inspectorQuality inspector
Some specific personnel who do not participate in or partially participate in the test, and ensure that the laboratory work meets the standard requirements by supervising the entire test process.
Standard operating procedure, standard operating procedure; SOPDetailed rules for the implementation of routine test operations.
Study protocol
A document that defines the experimental design, including the purpose of the experiment, the basis of the experiment, the experimental items, the experimental animals and their sources, the animal breeding conditions, the dosage design, the sample processing, the sampling plan, the experimental methods and the observation indicators. 3.9
Test system
The animals, microorganisms, cells and sub-cells and other biological, chemical and physical systems used for the experiment. 3.10
Test material
All kinds of samples to be tested within the scope of this standard. 3.11
Sample
One or more parts taken from a whole, aiming to provide relevant information about the whole, usually as the basis for judging the whole. 3.12
Batch
A certain batch of test or reference materials produced in a specified production cycle, which are considered to have consistent characteristics and are marked. 3.13
vehicle
Material that can mix, disperse, or dissolve the test substance or reference substance without affecting the test results. 3.14
reference material
Material used in the test system to identify the biological characteristics of the test organism and the sensitivity and specificity of the test system, as well as a material used in the test system to compare with the test substance when judging the results. 3.15
specimen
Material used for testing or obtained from the test system for inspection, analysis, or preservation. 3.16
administration
The operation of giving the test substance to the test system in a certain way. 2
dose
The amount of the test substance given to the test system in the test. 3.18
dose-effect relationship
dose-effect relationship
indicates the relationship between the dose of the test substance and the intensity of the toxic effect occurring in the individual or group of the test system. 3.19
dose-response relationship
indicates the relationship between the dose of the test substance and the incidence of a certain toxic effect occurring in the group of the test system. 3.20
customercustomer
the institution, organization or individual who entrusts the laboratory to carry out the test. 3.21
control samplecunirul sample
the sample with known sample component content, which can be used for repeatability test and control test process accuracy. 4 Management requirements
4.1 Organization
GB/T27406—2008
4.1.1 Food toxicology laboratory or its organization should have a clear legal status. The laboratory is generally an independent legal person, and the laboratory that is not an independent legal person must be authorized by the legal person.
4.1.2 Laboratory testing services should be able to meet the work needs of customers and their institutions. 4.1.3 When the experimental case is carried out at a location inside or outside its fixed organization, it should comply with the relevant provisions of this standard. 4.1.4 The top management should be responsible for the design, establishment, maintenance and improvement of the management system, including at least the following aspects: a) Allocate sufficient personnel for the laboratory and provide all personnel with the authority and resources required to perform their duties; 1) Formulate policies and procedures to prevent the organization and personnel from being involved in any activities that may reduce their judgment, technical skills, honesty and impartiality;
Formulate policies and procedures to ensure that customer confidential information is protected; c
Clearly define the organizational and management structure of the experimental case, as well as the relationship between the laboratory and other relevant organizations; d)
c) Specify the responsibilities and powers of all personnel f)
, establish a technical management team responsible for technical operations (the person in charge of the technical management team is also called the technical responsible person) and assign corresponding responsibilities and powers, appoint a quality manager who is fully responsible for the operation of the quality system; g) establish an animal ethics committee to review and approve relevant animal experiments; h) personnel familiar with the purpose of inspection, procedures, operations and result evaluation shall provide corresponding training and supervision to other laboratory personnel according to their experience, capabilities and responsibilities. The top manager directly appoints and manages the quality supervisor, and appoints agents for key personnel. In some small laboratories, one person may assume multiple positions. 4.1.5 The top manager, technical person in charge, quality person in charge and other key quality personnel of the laboratory may authorize capable personnel to exercise corresponding powers in professional laboratories.
4.1.6 The top manager, technical person in charge, quality responsible person and heads of various professional laboratories in the laboratory shall have appointment documents. 4.2 Management System
4.2.1 Policies, processes, plans, procedures, instructions and operating procedures shall be documented and communicated to all relevant personnel. It should be ensured that the relevant personnel are familiar with, understand and implement them.
4.2.2 The management system should include internal quality control and external quality control. 3
GB/T 27406--2008
4.2.3 The top management should preside over the formulation of quality policies, objectives and commitments, and form documents and write them into the quality manual. The top management or quality manager shall publicize the quality policy and objectives to all employees. The quality policy, objectives and commitments should be concise and clear, and be easily accessible to the relevant personnel at the lower level, and should also be understood by the customers. They should include the following: a) The scope of services provided by the laboratory
Commitment to service standards;
The quality management level and technical standards of the laboratory, and the requirements for relevant personnel to be familiar with, understand and implement quality documents; e) The laboratory's commitment in terms of professional behavior, inspection quality, and compliance with the management system and relevant laws and regulations. 4.2.4 The quality manual should describe the management system and document structure, and indicate the referenced supporting procedures; the quality manual should also specify the responsibilities of personnel in various important positions. All personnel should be instructed in the use of the quality manual and all referenced documents and in the implementation of these requirements. 4.3 Document Control
4.3.1 The laboratory should develop and implement special procedure documents to meet the requirements of document management, back up and archive the documents, and clearly define their retention period. These controlled documents can be stored in paper or paperless media and should comply with national, regional and local regulations.
The document control procedures implemented should ensure that:
The management system related documents issued to laboratory personnel are approved by authorized personnel before release: a)
A record of the name, validity status and issuance status of the documents in use is established, which is also called the document control record; In the corresponding places, only the current and confirmed document versions are used; c)
Documents should be evaluated and revised regularly and approved by authorized personnel: d)
Invalid and obsolete documents should be immediately removed from all places of use or appropriately marked to prevent misuse: If the laboratory allows handwritten modifications to documents before the document is reprinted, the modification procedures and authorities should be determined. The modifications should be clearly marked, initialed and dated, and the revised documents should be officially released as soon as possible; g
A procedure should be established to describe how to change and control files running in computer systems. 4.3.3
All documents related to the management system shall have unique identification, in short: a)
Title and document number;
Revision or revision number;
Number of pages (if applicable);
Issuing agency:
Source identification.
4.4 Quality and technical records
4.4.1 The laboratory shall establish and implement a set of procedures for identifying, collecting, indexing, retrieving, storing, maintaining and safely handling quality and technical records.
4.4.2 All quality and technical records shall be clear and easy to retrieve, and shall comply with relevant regulations. A suitable storage environment shall be provided and they shall be stored in an appropriate form to prevent damage, destruction, leakage, loss or theft. 4.4.3 The laboratory shall clearly define the retention period of various quality and technical records. The retention period should be determined based on the nature of the inspection or the authenticity of each record, and in some cases it should also comply with applicable laws and regulations. The quality and technical records room shall at least include:
a) inspection application form or sampling record;
inspection results and reports;
results printed out by the instrument;
inspection plan:
original work record book or record sheet;Www.bzxZ.net
test data statistical record;
g) quality control records;
complaints and measures taken;
i) internal and external audit records;
i) proficiency testing or inter-laboratory comparison records;k) quality improvement records;
instrument use and maintenance records, including internal and external calibration records;m)
environmental monitoring records of experimental animal rooms;
ethical review records for animal experiments:n)
relevant records of external service supply, including the source and quality records of experimental animal supply;o)
GB/T 27406—2008
Records of acceptance of equipment and consumables, records of regular testing of feed and drinking water, records of acceptance, quarantine and adaptation of experimental animals; p)
Records of errors or accidents and countermeasures;
) Records of personnel training and competence.
4.4.4 When errors occur in the records, each error should be crossed out and the correct value filled in next to it, and the content before the change should be identifiable. All changes to the records should be signed or signed by the person making the change. The same measures should be taken for electronically stored records to avoid loss or modification of original data.
4.5 Customer Service
4.5.1 The laboratory should authorize senior personnel to provide customers with appropriate professional consulting services before delivery. 4.5.2 Authorized professionals in the laboratory can provide advice on the selection of inspections and services at the request of customers, including inspection items, inspection methods, required sample conditions, etc. The laboratory shall clarify the requirements of the customer and allow the customer to enter the laboratory to monitor the operations related to their work while ensuring the confidentiality of the laboratory and other customers. It may also provide services such as sample preparation, packaging and delivery to customers. 4.5.3 The laboratory shall maintain contact with customers, especially customers of large business, throughout the work process. 4.5.4 When appropriate, authorized professional and technical personnel in the laboratory can provide interpretation of the test results. 4.5.5 The laboratory shall notify the customer of any delays and major deviations in the testing process. 4.5.6 The laboratory shall solicit feedback from customers, whether positive or negative. These feedback shall be used and analyzed and applied to improve the management system, testing activities and service levels. Complete records of feedback and corresponding measures taken shall be kept during the experiment, and the feedback and measures can be used as input to the management evaluation market [see 4.11, 2h)]. 4.6 Complaint handling
4.6.1 The laboratory shall have policies and procedures for handling complaints from customers or other parties, and the methods and channels shall be diverse and multi-channel. The laboratory shall keep records of complaints and investigations and corrective actions taken in response to complaints. Customer complaints and their handling shall be one of the inputs to management review (see 4.5.6).
4.6.2 The laboratory is encouraged to survey its service customers to obtain positive and negative feedback information and improve and perfect the laboratory management system. 4.7 Control of nonconforming work
The laboratory shall have special procedures and regulations to identify and control nonconforming work during the inspection process. These procedures and regulations should ensure that: a) a specific person is designated to handle nonconforming work issues; b) clearly specify the measures to be taken; c) consider the possible impact of nonconforming work and notify the customer if necessary; d) immediately correct and take corrective measures if necessary; e) if the inspection results have been released, consider whether they need to be recalled or handled in an appropriate manner; designate a specific person with the authority to suspend (terminate) the inspection and approve the resumption of the inspection work; g) record each occurrence of nonconforming work and keep it in archives. These records should be evaluated regularly to detect trends and take preventive measures (see 4.9).
GB/T 27406—2008
4.7.2 After the non-conforming work is controlled, the root cause of the non-conforming items should be analyzed and eliminated to prevent similar non-conforming work from recurring.
4.7.3 The laboratory should formulate and implement relevant procedures to specify how to review and issue inspection reports on non-conforming work, and keep these work records.
4.8 Corrective measures
After the non-conforming work found is controlled and corrected, it should also be analyzed and considered whether corrective measures need to be implemented. a) The corrective action procedure should include an investigation process to determine the root or potential cause of the problem. Corrective measures should be commensurate with the severity of the problem and the size of the risk it brings to avoid waste of resources. b)
If the corrective measures taken involve a change, these changes should be documented and issued to relevant personnel for implementation. c) The results of each corrective action should be monitored to determine whether these measures are effective. d) If the investigation and analysis of nonconforming work indicates that there may be problems in the management system, the laboratory shall conduct additional audits of the management system or management reviews aimed at solving the problems. The results of corrective actions shall be reviewed. 4.9 Preventive measures
The laboratory shall establish specific procedures to detect potential nonconforming work and prevent its occurrence. a) Potential nonconformities and required improvements, including technical aspects and related management system aspects, shall be identified. If preventive measures are taken, these measures shall be developed, implemented and monitored to reduce the possibility of similar nonconformities and take the opportunity to improve. b) The preventive measures procedure shall include the conditions for initiation and application. Preventive measures may also involve data analysis, trend and risk analysis, etc.
c) All operating procedures shall be reviewed regularly to detect potential nonconforming work, propose technical improvements, develop and implement improvement measures, and archive relevant documents and records. d) After the review is completed and the corresponding measures are implemented, the laboratory shall evaluate the effectiveness of the above measures by focusing on the relevant aspects of the review or audit.
c) The results of the implementation of preventive measures should be analyzed and judged, including whether the management system needs to be changed and how to change it. 4.10 Internal Audit
4.10.1 In order to check and verify the compliance of inspection and related work with the management system, the implementation of each element of the quality system should be checked and audited regularly (at least once a year), that is, internal audit. The internal audit should include all elements of the quality system and all relevant departments and personnel. Additional audits can be carried out when necessary [see 4.8d)]. 4.10.2 The person responsible for quality or a designated qualified person shall be responsible for planning, organizing and conducting internal audits. Auditors shall have no direct connection with the work being audited, as long as resources permit. A procedure document for internal audits shall be established, including personnel responsibilities, audit types, frequencies, bases, work processes, methods used and relevant documents. 4.10.3 If non-conforming work is found during the audit, the laboratory shall correct it and take appropriate corrective or preventive measures when necessary. These measures shall be documented and sent to the relevant departments for rectification and completed within the agreed time. A designated person shall be responsible for follow-up audits to verify the effectiveness of the rectification. If the problems found may affect the test results that have been issued, the customer shall be notified in writing. 4.10.4 The audit results shall be issued to all relevant departments and personnel in a documented form. 4.10.5 The audit results and the follow-up verification of problem rectification shall be recorded and used as one of the inputs to the management review [see 4.11.2d)]. 4.11 Management Review
4.11.1 The laboratory shall review the management system and other related work, including inspection and consulting work, to ensure the suitability of the management plan and the external conditions such as the resources required for effective operation, and make necessary changes or improvements in a timely manner. Management review should be conducted at least once a year, and may be conducted temporarily when necessary [see 4,8d). 4.11.2 The management review shall be chaired by the top management. The management review should at least consider the following aspects: a) Implementation of the last management review; b) Applicability of policies and procedures; Corrective measures taken, preventive measures and other quality system improvement methods and other improvement suggestions; d) Reports from management or supervisory personnel; e) Results of recent internal audits; f) Results of external reviews and participation in proficiency testing and inter-laboratory comparisons; g) Changes in the workload and type of work undertaken, and financial situation; h) Quality of inspection services, including complaints or related information from customers, internal employees and other parties; i) Personnel training and effectiveness evaluation; Internal quality control results report; k) Evaluation of suppliers and service providers; I) Suitability of the quality policy and analysis of achievement of quality objectives. GB/T 27406—2008
4.11.3 The results of the management review shall include an evaluation of the suitability of the management system, solutions to problems that affect the suitability and effectiveness of the management system, and follow-up on the implementation of the solutions. 4.11.4 The results of the management review shall be communicated to relevant personnel, and the documents and records shall be archived. 4.12 Continuous Improvement
4.12.1 The laboratory shall continuously improve the laboratory's management system by meeting the requirements of the quality of testing and customers. 4.12.2 The laboratory shall continuously improve the effectiveness of the laboratory management system through the use of quality policy, quality objectives, data analysis, communication, management review, internal audit capability verification, preventive and corrective measures, customer complaints and other channels. 4.12.3 The laboratory shall establish a quality indicator system to monitor and evaluate the effectiveness of the inspection work. If the evaluation results of the indicator indicate that there is a possibility of improvement, it should be considered so that the quality of the experimental work can be continuously improved. 5 Technical requirements
5.1 Purchasing services
5.1.1 The laboratory should formulate special procedures and documents to regulate and control the use of external services, equipment and consumables that may affect the quality of the test. The purchased items should meet the quality requirements of the laboratory. There should be procedures and work records for the inspection, acceptance (rejection) and recommendation of consumables.
5.1.2 When the purchased equipment and consumables may affect the quality of the test, they shall not be used before it is determined that these items meet the standard specifications. The decision can be made by inspecting the quality control samples and evaluating the acceptability of the results. The information provided by the supplier can also be used for confirmation. 5.1.3 When purchasing experimental animals, the qualifications of the animal supplier should be confirmed, and the animal quality certificate should be obtained from the supplier. Each batch of animals should be inspected as necessary, and they can only be accepted after confirmation of compliance.
5.1.4 Appropriate quality records should be established for external services and supplies and maintained for a certain period of time. The records should include the batch number of reagents, quality control materials and calibrators, the date of receipt in the laboratory and the date of commissioning. 5.1.5 The laboratory shall regularly evaluate suppliers of consumables and service providers that affect the quality of inspection, establish a list of qualified suppliers and service providers and keep records of these evaluations, and shall promptly remove unqualified suppliers from the list. 5.2 Personnel
5.2.1 The laboratory shall keep job descriptions of personnel in various positions, including records of qualifications, responsibilities, and related organizational plans and policies.
5.2.2 The laboratory shall keep records of the relevant educational background, professional qualifications, training, work experience and capabilities of all personnel. The records shall include the following:
a) Education, degree and qualification certificates, appointment letters; b) Technical work resume and corresponding employer evaluation (when applicable); c) Job description,
d) Records of continuing education and achievements;
e) Records of relevant scientific activities, including published academic papers, research projects participated in and results certificates, etc.; [Capacity assessment and evaluation;2 When the purchased equipment and consumables may affect the quality of the test, they shall not be used before it is determined that these items meet the standard specifications. The decision can be made by testing the quality control samples and evaluating the acceptability of the results. It can also be confirmed by using the information provided by the supplier. 5.1.3 When purchasing experimental animals, the qualifications of the animal supplier should be confirmed, and the animal quality certificate should be obtained from the supplier. Each batch of animals should be inspected as necessary, and they can only be accepted after confirmation of qualification.
5.1.4 Appropriate quality records should be established for external services and supplies and maintained for a certain period of time. The records should include the batch number of reagents, quality control materials and calibrators, the date of laboratory receipt and the date of use. 5.1.5 The laboratory should regularly evaluate the suppliers of consumables and service providers that affect the quality of the test, establish a list of qualified suppliers and service providers, and keep records of these evaluations. Unqualified suppliers should be deleted from the list in a timely manner. 5.2 Personnel
5.2.1 The laboratory should keep job descriptions of personnel in various positions, including records of qualifications, responsibilities and related organizational plans and policies.
5.2.2 The laboratory should keep records of all personnel's relevant educational background, professional qualifications, training, work experience and capabilities. The records should include the following:
a) Education, degree and qualification certificates, appointment letters; b) Technical work resume and corresponding employer evaluation (when applicable); c) Job description,
d) Records of continuing education and achievements;
e) Records of relevant scientific activities, including published academic papers, research projects participated in and results certificates, etc.; [Capacity assessment and evaluation;2 When the purchased equipment and consumables may affect the quality of the test, they shall not be used before it is determined that these items meet the standard specifications. The decision can be made by testing the quality control samples and evaluating the acceptability of the results. It can also be confirmed by using the information provided by the supplier. 5.1.3 When purchasing experimental animals, the qualifications of the animal supplier should be confirmed, and the animal quality certificate should be obtained from the supplier. Each batch of animals should be inspected as necessary, and they can only be accepted after confirmation of qualification.
5.1.4 Appropriate quality records should be established for external services and supplies and maintained for a certain period of time. The records should include the batch number of reagents, quality control materials and calibrators, the date of laboratory receipt and the date of use. 5.1.5 The laboratory should regularly evaluate the suppliers of consumables and service providers that affect the quality of the test, establish a list of qualified suppliers and service providers, and keep records of these evaluations. Unqualified suppliers should be deleted from the list in a timely manner. 5.2 Personnel
5.2.1 The laboratory should keep job descriptions of personnel in various positions, including records of qualifications, responsibilities and related organizational plans and policies.
5.2.2 The laboratory should keep records of all personnel's relevant educational background, professional qualifications, training, work experience and capabilities. The records should include the following:
a) Education, degree and qualification certificates, appointment letters; b) Technical work resume and corresponding employer evaluation (when applicable); c) Job description,
d) Records of continuing education and achievements;
e) Records of relevant scientific activities, including published academic papers, research projects participated in and results certificates, etc.; [Capacity assessment and evaluation;
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