Plant quarantine refers to laboratories engaged in the detection, identification, evaluation and treatment of plant or plant product pests. The process mainly includes on-site sampling, indoor detection and identification, isolated planting, harmless treatment, etc. This standard is mainly applicable to laboratories engaged in plant quarantine activities. This standard specifies the management requirements, technical requirements, detection process control requirements and result quality control requirements for plant quarantine laboratory quality control. This standard is applicable to plant quarantine laboratories engaged in plant pest detection, identification, treatment and other activities. If the plant quarantine laboratory does not engage in one or more activities included in this standard, such as sampling, isolated planting, harmless treatment, etc., the requirements of the relevant clauses are not applicable. The preparation of this standard is mainly based on GB/T 27025 "General Requirements for the Competence of Testing and Calibration Laboratories", and at the same time absorbs the content of GB/T 19001-2000 "Quality Management System Requirements", and refers to the documents of relevant international professional organizations, domestic and foreign industry standards and applicable contents in professional literature, and fully integrates 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 27025 and quality control in this professional field. GB/T 27402-2008 Laboratory Quality Control Specification for Plant Quarantine GB/T27402-2008 Standard Download Decompression Password: www.bzxz.net
Plant quarantine refers to laboratories engaged in the detection, identification, evaluation and treatment of pests of plants or plant products. Its processes mainly include on-site sampling, indoor detection and identification, isolated planting, harmless treatment, etc. This standard is mainly applicable to laboratories engaged in plant quarantine activities. This standard specifies the management requirements, technical requirements, detection process control requirements and result quality control requirements for plant quarantine laboratory quality control. This standard applies to plant quarantine laboratories engaged in the detection, identification and treatment of plant pests. If the plant quarantine laboratory does not engage in one or more activities included in this standard, such as sampling, isolated planting, harmless treatment, etc., the requirements of the relevant clauses do not apply. The preparation of this standard is mainly based on GB/T27025 "General requirements for the competence of testing and calibration laboratories", and at the same time absorbs the content of GB/T19001-2000 "Quality Management System Requirements", and refers to the documents of relevant international professional organizations, domestic and foreign industry standards and professional literature, and fully integrates the management experience of relevant domestic laboratories. This standard aims to standardize, guide and help relevant laboratories to meet the specific requirements of GB/T27025 and quality control in this professional field.

The preparation of this standard is mainly based on GB/T27025 "General requirements for the competence of testing and calibration laboratories", and at the same time absorbs
the content of GB/T19001-2000 "Quality Management System Requirements", and refers to the documents of relevant international professional organizations, domestic and foreign industry standards and professional literature, and fully integrates the management experience of relevant domestic laboratories.
This standard aims to regulate, guide and help relevant laboratories to meet the specific
requirements of GB/T 27025 and quality control in this professional field.
In addition to GB/T 27025, the main documents related to this professional field referenced by this standard include the International Plant Protection Convention (IPPC) International Standards for Phytosanitary Measures Publication No. 5 "Glossary of Phytosanitary Terms".
In addition, although this standard includes some of the current laws and regulations in China 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. Plant quarantine refers to laboratories engaged in the detection, identification, evaluation and treatment of pests of plants or plant products. Its process mainly includes on-site sampling, indoor detection and identification, isolated planting, harmless treatment, etc. This standard is mainly applicable to laboratories engaged in plant quarantine activities.
It is recommended that relevant laboratories should be familiar with and master the relevant contents of GB/T 27025 before using this standard. For a comparison of the clauses between this standard and
GB/T 27025-2008, see Appendix A.
Foreword………………………………………………………………………………………………………III
Introduction………………………………………………………………………………………………………IV
1 Scope…………………………………………………………………………………………………… １
2 Terms and definitions…………………………………………………………………… １
3 Management requirements……………………………………………………………… １
3.1 Organization……………………………………………………………………………… １
3.2 Management system…………………………………………………………………… ２
3.3 3. Document control……………………………………………………………………………………３
3.4 Record control……………………………………………………………………………３
3.5 Subcontracting……………………………………………………………………………４
3.6 Customer service……………………………………………………………………………４
3.7 Complaint handling……………………………………………………………………４
3.8 Control of non-conforming work…………………………………………４
3.9 Improvement…………………………………………………………………………４
3.10 Internal audit………………………………………………………………………… ５
３．１１ Management review……………………………………………………………… ５
４ Technical requirements………………………………………………………………… ６
４．１ Procurement services…………………………………………………………… ６
４．２ Personnel………………………………………………………………………… ６
４．３ Facilities and environmental conditions……………………………………… ７
４．４ Equipment………………………………………………………………………… ７
４．５ Specimens……………………………………………………………………………………８
４．６ Traceability………………………………………………………………………………８
５ Process control requirements………………………………………………………………… ９
５．１ General………………………………………………………………………………… ９
５．２ Contract review process control………………………………………………………… ９
５．３ Sampling process control………………………………………………………… １０
５．４ Laboratory testing and identification process control…………………… １１
５．５ ５．５ Control of quarantine planting process……………………………………………………………………１２
５．６ Control of harmless treatment process…………………………………………………………１３
５．７ Control of review process……………………………………………………………………１３ ５．８
Control of result reporting process………………………………………………………１３
６ Control of result quality……………………………………………………………………１４
６．１ General principles………………………………………………………………………………１４
６．２ Internal quality control……………………………………………………………………１４
６．３ External quality control………………………………………………………………………………………１５
Appendix A (Informative Appendix) Comparison table between this standard and GB/T 27025-2008 clauses………………………………１６

ICS 03. 120. 10
National Standard of the People's Republic of China
GB/T27402—2008
Criterion on quality control of lahoratories---Plant quarantine
Criterion on quality control of lahoratories---Plant quarantine2008-05-04Issued
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaAdministrative Committee of Standardization of the People's Republic of China
Implemented on 2008-10-01
2 Terms and Definitions
3 Management Requirements
3.1 Organization
3.2 Management System
3.3 Document Control
Record Control
Customer Service
3.7 Complaint Handling
3. 8 Non-conformance to T work control
3.9 Improvement
Internal audit,
Management review
4 Technical requirements
Procurement services
Facilities and environmental conditions
4.4 Equipment
4.6 Traceability
Process control requirements
Contract review process control
Sampling process control…
5.4 Laboratory testing and identification Process control*
Isolation planting process control
Harmless treatment process control·
Review process control··
5.8 Result reporting process control
6 Result quality control
6.2 Internal quality control.
6.3 External quality control..
Appendix A (Informative Appendix) Comparison table between this standard and GB/T27025-2008 clauses GB/T 27402—2008
This standard is one of the laboratory quality control specification series standards, which currently includes the following standards: -GB/T27401 "Laboratory Quality Control Specification Animal Quarantine"; GB/T27402 Laboratory Quality Control Specification Plant Quarantine;
-GB/T27403 "Laboratory Quality Control Specification Food Molecular Biology Testing":
-GB/T27404 "Laboratory Quality Control Specification Food Physical and Chemical Testing":
-CB/T27405 "Laboratory Quality Control Specification Food Microbiology Testing";
GB/T27406 "Laboratory Quality Control Specification Food Toxicology Testing".
Appendix A of this standard is an informative appendix.
This standard is proposed and managed by the National Technical Committee for Certification and Accreditation of Standardization (SAC/TC261). This standard is drafted by the China National Accreditation Service for Conformity Assessment. GB/T27402—2008
This standard was drafted by: Liaoning Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, China Institute of Inspection and Quarantine, Shanghai Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Shenzhen Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Shanxi Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, China National Accreditation Service for Conformity Assessment, Heilongjiang Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Jiangsu Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China, Jilin Exit-Entry Inspection and Quarantine Bureau of the People's Republic of China. The main contributors to this standard: Wang Youfu, Cao Zhihan, Zhang Le, Yin Liping, Zhang Chaming, Li Lianping, Tang Danzhou, Bi Yuchun, Niu Xingrong, Shang Lan. An Yulin, Fan Chunyan, Zhang Hongxiang, Liu Pubin, Wu Cuizang. GB/T27402--2008
This standard is mainly based on GB/T 27025 General requirements for the competence of testing and calibration laboratories. It also absorbs the content of GB/T19001·2000≤Quality Management System Requirements, and refers to the documents of relevant international professional organizations, domestic and foreign industry standards and applicable content in professional literature, and fully integrates 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 27025 and quality control in this professional field.
In addition to GB/T27025, the main documents related to this professional field referenced by this standard include the International Plant Protection Convention (IPPC) International Standard for Phytosanitary Measures No. 5 "Glossary of Phytosanitary Terms". 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. Plant quarantine refers to laboratories engaged in the detection, identification, evaluation and treatment of pests of plants or plant products. The process mainly includes on-site sampling, indoor detection and identification, isolated planting, harmless treatment, etc. This standard is mainly applicable to laboratories engaged in plant quarantine activities. It is recommended that relevant laboratories should be familiar with and master the relevant contents of GB/T27025 before using this standard. The comparison of the clauses of this standard and GB/T27025:-2008 is shown in Appendix A. 1 Scope
Laboratory quality control specification plant quarantine
GB/T 27402—2008
This standard specifies the management requirements, technical requirements, detection process control requirements and result quality control requirements for plant quarantine laboratory quality control.
This standard is applicable to plant quarantine laboratories engaged in the detection, identification and treatment of plant pests. If the plant quarantine laboratory does not engage in one or more activities included in this standard, such as sampling, isolated planting, harmless treatment, etc., the requirements of the relevant clauses are not applicable.
2 Terms and definitions
The following terms and definitions apply to this standard. 2.1
Phytosanitary laboratory Phytosanitary laboratory is an experimental space engaged in the detection, identification, evaluation and treatment of pests of plants or plant products. Its activities generally include on-site sampling, indoor detection and identification, isolated planting, chemical treatment, etc. 2.2
Top management of laboratory A person or a group of people who direct and control the laboratory at the highest level. 2.3
Identification
The process of distinguishing and determining the category of pests based on their characteristics. 2.4
Specimen
Part or all of any organism used for scientific research or comparative identification. 2.5
Operating instructions Detailed description or guidance document on the specific implementation plan, methods and procedures of laboratory work. 2.6
Contrast
In the process of testing and identification in plant quarantine laboratories, the reference objects used for result judgment include: standard bacteria (virus) strains, specimens, pictures, etc. 2.7
Harmless Lreaiment
The process of treating plants or plant products and their packaging or waste. 2.8
Isolated planting
The process of cultivating and planting plant propagation materials in a controllable area or environment. 3 Management requirements
3. 1 Organization
3.1.1 The plant quarantine laboratory (hereinafter referred to as the laboratory) or its organization shall have a legal status or be an entity that can bear legal responsibilities1
GB/T 27402--2008
.
3.1.2 The laboratory shall ensure that the testing work it performs complies with the requirements of this standard, perform the corresponding legal functions, and meet the needs of customers, statutory management agencies or organizations that provide recognition to it. 3.1.3 The laboratory's management system should cover its laboratory work in fixed locations and outside fixed locations, including all activities such as sampling, isolation planting, and harmless treatment.
3.1.4 If the organization in which the laboratory is located is also engaged in activities other than testing and identification, in order to identify potential conflicts of interest and ensure the impartiality of the laboratory, the laboratory should define the responsibilities of personnel in the organization who are involved in or have an impact on testing and identification. 3.1.5 The organizational and management structure of the experimental case and its position in the parent organization, as well as the relationship between quality management, technical work and support services should be clear.
3.1.6 The laboratory should have a top manager and ensure that he/she: a) can control all laboratory activities; b) can implement necessary measures to achieve quarantine process control and continuous improvement of these processes, and manage these processes in accordance with this standard; c) can take measures to ensure that the confidential information and proprietary rights of customers are protected, including the protection of electronic storage and transmission results; d) can take measures to avoid any activities that may reduce the ability, impartiality, judgment or work integrity of laboratory personnel.
Note: The top manager of the laboratory should have appropriate training and education background to be able to perform the following duties: organize the formulation of laboratory work plans and development goals, and be responsible for resource allocation, maintain effective contact and work with relevant parties, including: 1) relevant departments of the government management agency; 2) laboratory accreditation bodies and authorized bodies; 3) other industries and departments engaged in plant quarantine-related businesses and technologies; 4) suppliers of essential products.
Establish and operate a laboratory management system.
1. Provide efficient administrative management for all the work within the laboratory. 2. Ensure that the human resources of the laboratory can receive timely and effective training to meet the needs of the laboratory's work. 3. Responsible for the safety management of dangerous and harmful organisms found during laboratory inspections, organize review and verification, and report to relevant departments. 4. Ensure good professional ethics. 5.
3.1.7 The laboratory should have management personnel and technical personnel who should be familiar with the relevant laws and regulations involved in the activities they are engaged in, and have the necessary power and resources to perform their duties. 6. 3.1.8 The laboratory should have a technical person in charge who is fully responsible for technical work and the supply of required resources to ensure the quality of laboratory technical work; there should be a quality person in charge, with clear responsibilities and powers to ensure the effective operation of the management system, and stipulate that he can report the operation of the system directly to the laboratory's top management. 7.1.9 The laboratory should make detailed provisions for the professional background, training experience or qualifications and responsibilities of key personnel and result evaluation personnel.
3. 1. 10 bzxz.net
The laboratory should have quality supervisors who are familiar with the testing and identification methods and procedures to fully supervise the laboratory personnel. 3.1.11 Personnel in key positions of the laboratory plan should have representatives. 3.2 Management system
3.2.1 The laboratory should establish, operate and maintain a management system that is appropriate to the intended scope of activities. The laboratory's policies, systems, plans, procedures and operating instructions should be documented and ensure that they meet work needs and are easily accessible to laboratory personnel. 3.2.2 The laboratory should establish a management system in the form of process control, and each identifiable necessary process of the laboratory management system should ensure effective control.
3.2.3 Policies related to quality in the laboratory management system, including a statement of the quality policy, should be specified in the quality manual (regardless of how it is named). The quality policy statement shall be issued by the top management and shall include at least the following:2
a) Quality commitment regarding laboratory service standards b) Purpose of the management system related to quality assurance; GB/T27402-2008
Requires all personnel involved in testing and identification work to be familiar with and understand the management system documents and implement its policies and procedures in their work,
d) Commitment to implement relevant laws, regulations and agreements and comply with this standard,3.2.4 The quality manual shall include supporting procedures including technical procedures and outline the structure of the management system documents. 3.2.5 The quality manual shall clearly define the responsibilities of the technical person in charge and the person in charge of quality, including the responsibility for ensuring compliance with this standard. 3.2.6 The laboratory shall establish overall objectives, which shall be reviewed by management and documented. 3.2.7 When planning and implementing changes to the management system, the top management shall ensure that the integrity of the management system is maintained. 3.3 Document Control
3.3.1 The laboratory should develop and implement special procedure documents to meet the requirements of document management, and the documents should be backed up and archived, and their retention period should be clearly specified. These controlled documents can use paper or paperless media and should be preserved, and should also comply with national, regional and local regulations.
3.3.2 The document control procedure implemented should ensure: a) Management system related documents issued by laboratory personnel are approved by authorized personnel before release; establish records of the names, validity status and issuance of documents in use, which are also called document control records; b)
Only current and confirmed document versions are used in corresponding places; Documents should be reviewed and revised regularly and approved by authorized personnel; d)
Invalid or obsolete documents should be immediately removed from all places of use or properly marked to prevent misuse; If the laboratory allows handwritten modifications to documents before they are reprinted, the modification procedures and authorities should be determined, and the modifications should be clearly marked, initialed and dated, and the revised documents should be officially released as soon as possible; Procedures should be established to describe how to change and control files running in computer systems. g
3.3.3 All documents related to the management system shall be uniquely identified, including: a) title and document number;
revision date or revision number:
tribute number (if applicable);
issuing agency;
e) identification of the source.
3.4 ​​Record control
3.4.1 The laboratory shall have procedures for collecting, identifying, using, preserving, maintaining and safely disposing of various quality and technical records. Quality records include internal audit reports, external review reports, alternative review reports, document issuance records, non-conforming work records, customer complaint records, customer opinion solicitation records, corrective action reports, preventive action reports, etc. Technical records include sampling records, original test and identification records, personnel training records, equipment maintenance and use records, calibration records, harmless treatment records, environmental monitoring records, instrument equipment and reagent procurement records, isolation and planting records, sample preservation and disposal records, test and identification method confirmation records, contract review records, instrument printing records, pictures, images, result reports, etc. 3.4.2 The laboratory shall ensure that the quality and technical records maintained contain sufficient information to make the recorded work traceable. Whenever possible, technical records shall include factors that affect the identification of uncertainty. 3.4.3 Laboratory personnel shall record observations, data and calculation results in a timely, objective and accurate manner and sign them. 3.4.4 All records shall be clear and stored in an easily retrievable manner. The storage facilities and environment shall be suitable to prevent damage, deterioration, loss or unauthorized access to the records.
3.4.5 The laboratory shall have corresponding regulations for the modification and preservation of records and the transfer of data information. 3.4.6 The laboratory shall have procedures or measures to protect and back up records stored in electronic form and prevent unauthorized activation or modification.
GB/T 27402—2008
3.5 Subcontracting
3.5.1 When the laboratory needs to subcontract work due to unforeseen reasons, or subcontract work in a long-term continuous situation, the laboratory should have an effective way to evaluate and select subcontracting laboratories to ensure that the projects that the laboratory needs to subcontract are subcontracted to capable subcontractors. 3.5.2 The laboratory should evaluate the subcontracting laboratories and keep evaluation records to ensure: a) The capabilities of the subcontracting laboratories meet the requirements of the subcontracting! b) There is no conflict between the subcontracting laboratories and the parties. 3.5.3 The laboratory should notify the client of the subcontracting arrangement in an appropriate manner and obtain its consent. 3.5.4 Unless the subcontractor is designated by the customer or the regulatory agency, the laboratory shall be responsible for the test and identification results provided by the subcontractor. Note 1: If the subcontractor is designated by the customer or the regulatory agency, the laboratory shall keep objective evidence of the customer or the regulatory agency designating the subcontractor. Note 2: The responsibilities, rights and obligations between the laboratory and the subcontractor are defined by both parties in the form of a subcontracting contract or subcontracting agreement. 3.6 Customer Service
3.6.1 The laboratory should maintain good cooperation with customers. On the premise of ensuring the confidentiality of other customers, the laboratory should allow customers to visit the laboratory to observe operations related to their work.
3.6.2 The laboratory's top management should authorize competent professional and technical personnel to provide customers with appropriate relevant business consulting services. The laboratory should make oral or written explanations to customer inquiries. 3.6.3 The laboratory should collect customer feedback as much as possible in order to find opportunities to improve the laboratory case management system and improve the laboratory's testing and identification level.
3.7 Complaint Handling
The laboratory should have policies and measures to handle complaints from customers and other parties, and should keep records of all complaints as well as records of investigations and corrective measures taken by the laboratory in response to complaints.
When applicable, the laboratory may establish a responsible department for complaint handling and a complaint registry.The person in charge of the investigation shall set up an investigation team when necessary. If the complaint is established, the client shall be notified of the handling results as soon as possible. If the complaint is not established, the laboratory shall explain the reasons to the client. 3.8 Control of non-conforming work
3.8.1 When the laboratory's work does not meet the requirements of the management system documents, the requirements of the client or the requirements of laws and regulations, the laboratory shall have procedures to control the work that produces non-conforming work, implement it when non-conforming work is found, and ensure that: a) the responsibilities and powers for managing non-conforming work are clearly defined, and the measures to be taken when it is determined to be non-conforming work (including suspending work and withholding result reports when necessary): b) the severity of the consequences of non-conforming work is evaluated, and the content of the evaluation should include the consequences of the spread of dangerous pests; c) immediate correction is taken;
d) if necessary, notify the client and cancel the work; c) the responsibility for approving the resumption of work is specified.
3.8.2 When the laboratory finds that the test and identification results are wrongly judged, the laboratory shall re-test and identify while executing the non-conforming work control procedures, report the possible epidemic situation to the relevant departments, and take corresponding measures. 3.8.3 After evaluation, if it is considered that non-conforming work may occur again or there is doubt about the compliance of the laboratory's operation with its prescribed procedures, the corrective action procedure specified in 3.9.2 shall be immediately initiated. If the non-conforming work found leads to the laboratory's non-compliance with its own prescribed procedures, or the laboratory does not comply with the provisions of this standard, the laboratory shall audit the relevant activity areas as soon as possible. 3.8.4 The laboratory shall record the non-conforming work and its handling, and provide a basis for the improvement of the laboratory management system. 3.8.5 The laboratory shall submit the severity evaluation report of non-conforming work to management review in a timely manner. 3.9 Improvement
3.9.1 Continuous Improvement
The laboratory shall continuously improve the management system through the determined quality policy and quality objectives, based on the audit results, statistical analysis, corrective and preventive measures and the results of management evaluation.
3.9.2 Corrective action
GB/T 27402--2008
3.9.2.1 The laboratory shall take action to eliminate the causes of nonconformities and prevent the recurrence of nonconformities. Corrective actions shall be commensurate with the impact of the nonconformities that have occurred.
3.9.2.2 The laboratory shall establish procedures to specify requirements for the following aspects: a) Evaluate nonconforming work;
b) Determine the causes of nonconformities;
Propose measures to avoid the recurrence of nonconformities and evaluate them: d) Determine and implement the necessary measures:
e) Record the results of the measures taken;
Verify the corrective actions taken.
3.9.3 Preventive measures
The laboratory shall take action to eliminate the causes of potential nonconformities and prevent the recurrence of nonconformities. Preventive measures shall be commensurate with the impact of potential problems.
3.9.3.2 The laboratory shall establish procedures to specify requirements for the following aspects: a) Identify potential nonconformities and their causes;
Propose measures to prevent nonconformities from occurring and evaluate them; b)
Identify and implement necessary measures;
Record the results of the measures taken;
Evaluate the preventive measures taken.
3.10 Internal Audit
3.10.1 The laboratory shall establish an internal audit procedure and conduct internal audits at appropriate intervals to determine whether the management system:) complies with the requirements of this standard and the requirements of the management system established by the laboratory case; b) is effectively implemented and maintained.
3, 10.2 The laboratory case quality manager shall organize an audit team to plan, organize and implement internal audits. Internal auditors shall be qualified personnel and as independent of the audited department as possible. Auditors from the same industry may also be hired when necessary. 3.10.3 If the audit results cause doubts about the reliability of the system operation or the accuracy of the test and identification results, the laboratory shall take corrective measures in a timely manner. If the investigation shows that the test and identification results of the laboratory may have been affected, the laboratory shall notify the customer in writing.
The laboratory shall record the scope, audit results and improvement measures proposed for each audit activity. 3. 10.4
3.10.5 Follow-up audit activities shall verify and record the implementation and reliability of the improvement measures taken. 3. 11 Management Review
3.11.1 The top management of the laboratory shall have plans or measures to regularly review the laboratory's management system and testing activities to ensure the continued suitability and reliability of the quality policy, quality objectives and management system, and make timely improvements and enhancements. 3.11.2 The input to the management review shall generally include the following: a) The suitability of the quality policy and procedures;
Requirements and changes in national policies, laws, regulations, agreements and standards; h) Changes in the workload and type of work undertaken by the laboratory; d) Changes in the last management Implementation of the review,
Results of recent internal audits;
Reviews conducted by external organizations;
Implementation of corrective measures;
Results of inter-laboratory comparisons and proficiency testing; Detected hazardous pests and statistical analysis of the results;5
GB/T27402—-2008
Report of quality supervisor:
k) Personnel training needs analysis and plan
Evaluation of non-conforming work:
Complaints from customers or feedback from laboratory personnel and other parties. m)
The output of management review should include the following:a)
Improvement of the reliability of the management system and its control processb)
Improvement of customer-related requirements:
Voluntary requirements.
3.11.4 The laboratory should record the results of the management review and the measures taken thereby, and the management should ensure that these measures are implemented within an appropriate time. 4 Technical requirements
4. 1 Procurement services
4.1.1 The laboratory should have a procurement procedure to ensure that the reagents, drugs, consumables and other supplies purchased meet the requirements of testing and identification. The procurement procedure should include the following:
a) Procurement authority and scope of different types of supplies; b)
Evaluation and selection of suppliers;
c) Preparation of procurement documents;
d) Acceptance, storage and use of supplies; Before the supplies are put into use, they must be inspected or confirmed to meet the relevant requirements. e)
4.1.2 The procurement documents prepared by the laboratory should include the technical requirements of the supplies. The technical content of these procurement documents shall be evaluated and approved before implementation.
4.1.3 The laboratory shall keep records of verification that the supplies meet the specified requirements. 4.4 The laboratory shall keep records of investigations and periodic evaluations of suppliers to list qualified suppliers that have been approved. Note: The evaluation of suppliers can directly use the results of system certification or product certification. 4.2 Human Resources
4.2.1 The laboratory should have sufficient human resources with corresponding technical capabilities to meet the needs of testing and identification work, and should set up management, technical and key support positions for specific testing and identification work. 4.2.2 The laboratory should retain descriptions of the current work of management personnel, technical personnel and related chain personnel related to testing and identification. Note: Job descriptions can be expressed in a variety of ways. Generally, the following content can be specified: Required professional knowledge and experience
Qualification requirements and training plans:
Management responsibilities.
4,2.3 The laboratory should formulate education and training plans for personnel at different levels. The training plan should be adapted to the current and expected tasks of the laboratory. At the same time, the effectiveness of these training activities should be evaluated. 4.2.4 Laboratory personnel should have relevant biosafety knowledge, especially knowledge of preventing the escape and spread of harmful organisms during quarantine.
4.2.5 Laboratory technicians should have professional backgrounds in relevant disciplines, master certain professional skills, have practical experience, be able to master relevant testing and identification methods or standards proficiently, and can work independently after passing the assessment. 4.2.6 The laboratory shall authorize personnel engaged in special work, including operating special instruments and equipment, sampling, hazard treatment and result evaluation personnel, etc.
4.2.7 If the laboratory uses external technical personnel, they should be properly evaluated and their qualifications should be confirmed and filed. Note: When the laboratory uses external technical personnel (including experts), it can establish a personnel file, including professional background, years of professional experience, technical titles, achievements in the field, etc., and update its content regularly to ensure the authority of the test and identification results. 6
GB/T 27402-2008
4.2.8 When there may be doubts about the ability of the experimental personnel, the laboratory's top management should authorize qualified quality supervisors to conduct appropriate supervision and assessment.
Note: The personnel who need supervision include: personnel in training;
— new employees;
— personnel in probation;
personnel working in new positions;
— personnel who have been working in fixed positions for a long time and have not received regular training. 4.2.9 The laboratory should keep archive records of laboratory personnel including reviewers, including relevant educational background, professional qualifications, training, work experience, performance results, etc.
4.3 Facilities and environmental conditions
4.3.1 The laboratory should ensure that the configured experimental site, water source, energy, lighting, isolation, harmless treatment and other facilities as well as temperature, humidity, ventilation and other environmental conditions are conducive to the normal conduct of testing. For the environment outside the fixed facilities of the laboratory, including sampling sites and isolation planting sites, the corresponding requirements should also be met.
4.3.2 When the relevant specifications, methods and procedures have requirements for the test environment, or when the facility environment has an impact on the test and identification results, the laboratory case should monitor, control and record the environmental conditions. When the environmental conditions endanger the test and identification results, the test activities should be stopped. 4.3.3 The overall layout of the laboratory should prevent the spread, escape and spread of harmful organisms during the quarantine process. If there are incompatible business activities between adjacent laboratories, they should be effectively isolated to avoid cross-contamination between areas. 4.3.4 The sterile area of ​​the laboratory should be clearly marked and can be effectively controlled and monitored. Sterile blood should be stored separately and easily distinguished. 4.3.5 When the laboratory is engaged in isolated planting, it should have the environment or facilities required to meet the requirements of isolated planting to ensure that it is not invaded by external organisms that affect the results, and prevent the escape and spread of dangerous harmful organisms. 4.3.6 The laboratory should have the facilities and environment required to meet the requirements of harmless treatment to ensure the effectiveness of harmless treatment, and at the same time ensure the safety of personnel and the environment during the harmless treatment process. 4.3.7 The laboratory shall have special storage facilities for standard samples, specimens, and standard bacteria (virus) strains, and ensure that they are stored under the required environmental conditions.
4.3.8 The laboratory shall have facilities and environment suitable for sample storage to avoid contamination of samples during storage and the escape and spread of harmful organisms. 4.3. During the sample transfer process, special instruments shall be used to prevent the possible escape and spread of dangerous harmful organisms during the transfer of samples. 4.3.10 The laboratory shall have facilities or measures for the treatment of quarantine waste to ensure the safe disposal of waste that may contain dangerous harmful organisms. 4.3.11 The laboratory shall control the entry or use of areas that may affect the quality of work and cause personal injury. 4.3.12 The laboratory shall take measures to ensure that the laboratory has good housekeeping. 4.4 Equipment
4.4.1 The laboratory shall be equipped with equipment required for testing and identification work. If the laboratory needs to use equipment outside the control scope, it shall ensure that it meets the requirements of this standard.
4.4.2 The equipment and software used in the laboratory shall meet the requirements required for testing and identification. The laboratory should formulate a verification or calibration plan for instruments and equipment that have a certain impact on the test and identification results, so that the instruments and equipment are verified or calibrated before being put into use to prove that they meet the laboratory's test and identification requirements.
4.4.3 Equipment that has an important impact on the test and identification results should be operated by designated personnel. The instructions for the use and maintenance of the equipment should be convenient for the relevant personnel in the experiment.
4.4.4 Each device that has an impact on the test and identification results should have a unique identification. 4.4.5 The laboratory should keep records of each device and its software that have an impact on the test and identification results. The records should include the following: a) Identification of the equipment and its software;
b) Manufacturer's name, model identification, serial number or other unique identification; Equipment installation date and commissioning date: c) Equipment installation date and commissioning date; e) Equipment installation date and commissioning date; f) Equipment installation date and commissioning date; g ...
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