Documents of China National Certification and Accreditation Administration Committee
Notice on printing and distributing the accreditation criteria for laboratory qualifications
Bureau of Quality and Technical Supervision of all provinces, autonomous regions and municipalities directly under the Central Government:
In order to implement the Measures for the Administration of Accreditation of Laboratories and Inspection Institutions, according to the provisions of relevant laws and regulations such as People's Republic of China (PRC) Metrology Law, People's Republic of China (PRC) Standardization Law, People's Republic of China (PRC) Product Quality Law, and People's Republic of China (PRC) Certification and Accreditation Regulations, combined with the actual situation of laboratories in China and the management experience of laboratories at home and abroad, we hereby print and distribute them to you, please follow them.
In order to ensure the smooth implementation of the evaluation criteria, relevant matters are hereby notified as follows:
First, seriously organize and study the Evaluation Standard, strengthen publicity and guidance, publicize the new evaluation standard in time, and urge the laboratory to change the edition in time.
Two, in People's Republic of China (PRC), engaged in the laboratory qualification certification (measurement certification/approval) released to the public shall abide by this standard.
Three, CNCA will compile training materials according to the "assessment standards", and organize the training, assessment and certification of national and provincial examiners. The provincial quality and technical supervision bureaus are responsible for organizing the training, assessment and certification of examiners below the provincial level. Personnel who perform on-site laboratory evaluation tasks must pass the examination and have the qualification of registered evaluator.
Four, by the National Certification and Accreditation Supervision and Management Committee to obtain the accreditation of laboratories (measurement certification/examination and accreditation), only the specific provisions of this standard different from the accreditation standard (bold) are reviewed. Applications for laboratory accreditation and qualification accreditation (measurement accreditation/examination accreditation) shall be reviewed in accordance with the laboratory accreditation standards and the special provisions of this standard.
Five, the relevant provisions of this standard are inconsistent with the provisions of the original relevant documents, the provisions of this standard shall prevail.
The evaluation standard of intransitive verbs has been implemented since June 5438+1 October12007, and all metrological certification/examination and accreditation laboratories should complete the translation work before February 3, 2007. At that time, the former State Bureau of Quality and Technical Supervision issued the Evaluation Standard for Metrology Certification/Examination and Accreditation (Acceptance) of Product Quality Inspection Institutions (Trial).
I hereby inform you.
Attachment: Laboratory Qualification Accreditation Standards
July 27(th), 2006
Attachment:
Accreditation and evaluation criteria of laboratory qualifications
1. General
1. 1 In order to implement the Administrative Measures for Accreditation of Laboratories and Inspection Institutions, ensure the scientificity and standardization of laboratory accreditation (metrological certification/approval) evaluation, and provide a reliable basis for the administrative licensing of laboratory qualifications, according to the Metrology Law of People's Republic of China (PRC), the Standardization Law of People's Republic of China (PRC) and the Standardization Law of People's Republic of China (PRC).
1.2 within the territory of People's Republic of China (PRC), the evaluation (metrological certification, authorization and acceptance) of laboratory qualifications that produce data and results with proof function to the society shall abide by this standard.
1.3 The accreditation and evaluation of laboratory qualifications mentioned in this standard refers to the evaluation and accreditation activities conducted by the National Certification and Accreditation Administration and the quality and technical supervision departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government on whether the basic conditions and capabilities of laboratories comply with laws, administrative regulations and the implementation of relevant technical specifications or standards.
1.4 laboratory accreditation should follow the principles of objectivity, fairness, science, accuracy, unity and standardization, which is conducive to the enjoyment of testing resources and avoids unnecessary duplication.
1.5 Accreditation of laboratories accredited by accredited institutions determined by CNCA, and evaluation of specific clauses of this specification (bold only). At the same time, according to the laboratory accreditation criteria and the specific provisions of this standard, the application for laboratory accreditation and qualification recognition is reviewed.
2. Reference documents
GB/T 1548 1: 2000 general requirements for testing and calibration laboratories.
ISO/IEC 17025: 2005 "general requirements for testing and calibration laboratories"
Measures for the Administration of Accreditation of Laboratories and Inspection Institutions (Order No.86 of the Director of the General Administration of Quality Supervision, Inspection and Quarantine)
Evaluation Standard for Metrology Certification/Examination and Accreditation (Acceptance) of Product Quality Inspection Institutions (Trial) (Confirmation Letter of Quality and Technical SupervisionNo. [2000]046)
3. Terms and definitions
This standard uses the related terms and definitions given in the Administrative Measures for Accreditation of Laboratories and Inspection Institutions and GB/T15481:1999 General Requirements for Testing and Calibration Laboratories.
4. Management requirements
4. 1 organization
Laboratories should be established or registered according to law, be able to bear corresponding legal responsibilities, and ensure that they engage in testing or calibration activities objectively, fairly and independently.
4. 1. 1 The laboratory is generally an independent legal person; The laboratory of a non-independent legal person shall be authorized by the legal person, be able to independently undertake the impartial inspection of a third party, conduct independent external writing and business activities, and have independent accounts and independent accounting.
4. 1.2 The laboratory should have a fixed workplace, and should have fixed, temporary and movable testing and/or calibration equipment and facilities required for correct testing and/or calibration, and can be deployed and used independently.
4. 1.3 The laboratory management system should cover the work carried out in all places.
4. 1.4 The laboratory should have professional technicians and managers suitable for its testing and/or calibration activities.
4. 1.5 The laboratory and its personnel shall not be interested in the detection and/or calibration activities and the data and results issued by them; Do not participate in any activities that undermine the independence and integrity of detection and/or calibration judgment; Do not participate in product design, development, production, supply, installation, use or maintenance activities related to testing and/or calibration projects or similar competitive projects.
The laboratory should take measures to ensure that its personnel are free from any improper commercial, financial and other pressures and influences from inside and outside, and prevent commercial bribery.
4. 1.6 The laboratory and its personnel have the obligation to keep confidential the state secrets, commercial secrets and technical secrets they know during the testing and/or calibration activities, and take corresponding measures.
4. 1.7 The laboratory should clarify its organizational and management structure, its position in the superior organization and the relationship among quality management, technical operation and support services.
4. 1.8 The top manager, technical manager, quality supervisor and department head of the laboratory shall have their employment documents, and the top manager of the independent legal person laboratory shall be appointed by its superior unit; Changes in senior management and technical management personnel shall be reported to the issuing authority or its authorized department for confirmation.
4. 1.9 The laboratory shall specify the responsibilities, powers and relationships of all management, operation and verification personnel that have an impact on the quality of testing and/or calibration. When necessary, appoint agents of key management personnel.
4. 1. 10 The laboratory shall supervise the key links of testing and/or calibration by personnel familiar with the methods, procedures, objectives and results evaluation of various testing and/or calibration.
4. 1. 165438+
4. 1. 12 The mandatory inspection task assigned by the government shall be completed on time with good quality and quantity (applicable to authorized/accepted laboratories).
4.2 Management System
The laboratory shall establish and maintain a management system, which can ensure its impartiality and independence and is suitable for testing and/or calibration activities according to these standards. The management system shall be documented to clarify the quality-related policies, including quality policies, objectives and commitments, so that all relevant personnel can understand and effectively implement them.
4.3 Document control
The laboratory shall establish and maintain control procedures for document preparation, review, approval, identification, distribution, storage, revision and abolition to ensure the validity of documents.
4.4 Testing and/or Calibration Subcontracting
If the laboratory subcontracts part of the testing and/or calibration work, the subcontracted laboratory must meet the requirements of this specification; The subcontracting ratio must be controlled (limited to low frequency, high price, special project instruments and equipment). The laboratory shall ensure and prove that the subcontractor has the ability to complete the subcontracting task. The laboratory shall obtain the written consent of the customer before subcontracting.
4.5 Procurement of Services and Supplies
The laboratory shall establish and maintain procedures for the selection, procurement, acceptance and storage of services and supplies that affect the quality of testing and/or calibration, so as to ensure the quality of services and supplies.
4.6 Contract review
The laboratory shall establish and maintain procedures for reviewing customer requirements, tenders and contracts, and clarify customer requirements.
4.7 Complaints and Complaints
The laboratory should establish a perfect complaint and complaint handling mechanism to handle the objections raised by interested parties to its testing and/or calibration conclusions. Records of all complaints and appeals and their handling results shall be kept.
4.8 Corrective measures, preventive measures and improvement
When the laboratory confirms that it is unqualified, corrective measures should be taken; When the causes of potential nonconformities are determined, preventive measures should be taken to reduce the possibility of similar nonconformities. The laboratory should continuously improve its management system by implementing corrective and preventive measures.
4.9 records
The laboratory should have a recording system suitable for its own specific situation and in line with the current quality system. The preparation, filling, alteration, identification, collection, indexing, filing, maintenance and cleaning of laboratory quality records shall be carried out in accordance with appropriate procedures.
All work should be recorded on time. Effective measures should also be taken for electronically stored records to avoid the loss or change of original information or data.
All quality records and original observation records, calculated and exported data, records, certificates/copies of certificates and other technical records shall be filed and kept within an appropriate time limit. The record of each test and/or calibration shall contain enough information to ensure its reproducibility. Records shall include the identities of personnel involved in sampling, sample preparation, testing and/or calibration. All records, certificates and reports shall be safely stored, properly kept and kept confidential for customers.
4. 10 internal audit
The laboratory shall regularly conduct internal audit on its quality activities to verify that its operation continuously meets the requirements of the management system and this standard. The annual internal audit activities shall cover all elements and activities of the management system. Auditors should receive training and confirm their qualifications. As long as resources permit, auditors should be independent of the work being audited.
4. 1 1 management review
The top management of the laboratory shall regularly review the management system and testing and/or calibration activities according to the predetermined plans and procedures to ensure their continuous applicability and effectiveness and make necessary improvements.
Management review should consider: the adaptability of policies and procedures; Reports of management and supervision personnel; The results of the recent internal audit; Corrective measures and preventive measures; Reviews conducted by external agencies; The results of inter-laboratory comparison and capability verification; Changes in workload and type of work; Complaints, complaints and customer feedback; Suggestions for improvement; Quality control activities, resources and personnel training, etc.
5. Technical requirements
5. 1 personnel
5. 1. 1 The laboratory shall have professional technicians and managers suitable for its testing and/or calibration activities. The laboratory should use formal personnel or contract personnel. When using contract personnel, other technical personnel and key support personnel, the laboratory should ensure that these personnel are competent and supervised and work in accordance with the requirements of the laboratory management system.
5. 1.2 All personnel engaged in sampling, testing and/or calibration, issuing test/calibration reports and operating equipment shall be qualified according to the corresponding education, training, experience and/or provable skills as required, and hold relevant certificates. Professional and technical personnel and laboratory management personnel engaged in special product testing and/or calibration shall also meet the requirements of relevant laws and administrative regulations.
5. 1.3 The laboratory shall determine the training requirements, and establish and maintain personnel training procedures and plans. Laboratory personnel should receive education and training according to their tasks and have corresponding technical knowledge and experience.
5. 1.4 When using the trained personnel, they should be properly supervised.
5. 1.5 The laboratory shall keep the documents of personnel qualification, training, skills and experience.
5. 1.6 The technical director and authorized signatory of the laboratory shall have the technical title of engineer or above, be familiar with the business and pass the examination.
5. 1.7 The authorized signatory of a legally established and authorized quality supervision and inspection institution shall have the technical title of engineer or above, be familiar with the business and have been engaged in the professional field for more than 3 years.
5.2 Facilities and environmental conditions
5.2. 1 The testing and calibration facilities and environmental conditions of the laboratory shall meet the requirements of relevant laws, regulations, technical specifications or standards.
5.2.2 When the facilities and environmental conditions affect the quality of the results, the laboratory shall monitor, control and record the environmental conditions. Pay special attention to the influence of environmental conditions when testing in non-fixed places.
5.2.3 The laboratory shall establish and maintain a management procedure for safe operation, so as to ensure that dangerous chemicals, drugs, harmful organisms, ionizing radiation, high temperature, high pressure, shock, water, gas, fire and electricity and other factors and environments that endanger safety are effectively controlled, and corresponding emergency measures can be taken.
5.2.4 The laboratory shall establish and maintain environmental protection procedures, have corresponding facilities and equipment, and ensure that the treatment of waste gas, waste liquid, dust, noise and solid waste generated by testing/calibration meets the requirements of environment and health, and have corresponding emergency treatment measures.
5.2.5 Effective isolation measures should be taken when the work between regions adversely affects each other.
5.2.6 Areas and facilities that affect work quality and involve safety shall be effectively controlled and correctly identified.
5.3 Detection and calibration methods
5.3. 1 The laboratory shall adopt appropriate methods and procedures to carry out testing and/or calibration activities according to relevant technical specifications or standards. Laboratories should give priority to national standards, industry standards and local standards; If the lack of instructions may affect the test and/or calibration results, the laboratory shall formulate corresponding work instructions.
5.3.2 The laboratory should confirm whether the selected new method can be used correctly. If the method changes, it should be reconfirmed. The laboratory should ensure that the latest and effective standard version is used.
5.3.3 Standards, manuals and instructions related to laboratory work shall be effective and convenient for staff to use.
5.3.4 When necessary, the laboratory can adopt international standards, but it can only be commissioned by a specific client.
5.3.5 After confirmation, the non-standard methods developed by the laboratory can be used as identification items, but only for the testing of specific customers.
5.3.6 The deviation of detection and calibration methods shall be verified by relevant technical units or approved by relevant competent departments, and then approved by the head of the laboratory and accepted by customers. The deviation of this method shall be documented.
5.3.7 The laboratory shall have appropriate regulations for calculation, data conversion and processing, and effectively implement them. When using computers or automatic equipment to collect, process, record, report, store or retrieve test or calibration data, the laboratory shall establish and implement data protection procedures. The plan shall include (but not limited to) the integrity and confidentiality of data input or acquisition, data storage, data transmission and data processing.
5.4 Equipment and Reference Materials
5.4. 1 The laboratory shall be equipped with sampling, measuring and testing equipment (including software) and standard materials required for correct detection and/or calibration (including sampling, sample preparation, data processing and analysis), and all instruments and equipment shall be maintained normally.
5.4.2 If the equipment is overloaded or misoperated, or the display result is suspicious, or it is defective by other means, it should be stopped immediately and marked clearly. If possible, it should be stored in a specified place until it is repaired. After maintenance, the instruments and equipment must be verified and calibrated to prove that their functional indicators have been restored. The laboratory should check the influence of this defect on previous tests and/or calibrations.
5.4.3 If you want to use instruments and equipment beyond the permanent control scope of the laboratory (rent, borrow or use the customer's equipment), it is limited to some testing facilities and equipment with low frequency, high price or special requirements, and ensure to meet the relevant requirements of this standard.
5.4.4 Equipment shall be operated by authorized personnel. Technical data related to the use and maintenance of equipment shall be easy for relevant personnel to obtain.
5.4.5 The laboratory shall keep the documents of the equipment and its software which have important influence on the detection and/or calibration. This document shall at least include:
A) Name of the equipment and its software;
B) Manufacturer's name, model identification, serial number or other unique identification;
C) Verification records of equipment compliance with specifications (if applicable);
D) Current location (if applicable);
E) Description of the manufacturer (if any), or indicate its location;
F) All verification/calibration reports or certificates;
G) Date and acceptance record of equipment receiving/debugging;
H) Equipment use and maintenance records (if applicable);
I) Records of any damage, failure, modification or repair of the equipment.
5.4.6 All instruments and equipment (including reference materials) shall be clearly marked to indicate their status.
5.4.7 If the equipment is not under the direct control of the laboratory, the laboratory shall ensure that after the equipment returns, it shall check its function and calibration status before use, and can display satisfactory results.
5.4.8 When it is necessary to use interim verification to maintain the reliability of equipment calibration status, it shall be carried out in accordance with the prescribed procedures.
5.4.9 When calibration produces a set of correction coefficients, the laboratory shall ensure that these coefficients are correctly applied.
5.4. 10 The special testing instruments and equipment for non-type shall provide the verification certificates of relevant technical units.
5.5 Traceability of values
5.5. 1 The laboratory shall ensure that its relevant testing and/or calibration results can be traced back to the national basic standards. The laboratory shall formulate and implement general requirements for calibration and/or verification (verification) and confirmation of instruments and equipment. For equipment calibration, a value transfer block diagram traceable to national measurement standards should be drawn (if applicable) to ensure that the value of measuring instruments and equipment in use conforms to the provisions of the measurement law.
5.5.2 If the test results cannot be traced back to the national basic standards, the laboratory shall provide satisfactory evidence of the results of equipment comparison and capability verification.
5.5.3 The laboratory shall formulate the equipment verification/calibration plan. Before use, the measuring and test equipment that affects the accuracy of detection and calibration shall be verified/calibrated according to the relevant national technical specifications or standards to ensure the accuracy of the results.
5.5.4 The laboratory shall have a reference standard verification/calibration plan. Before and after any adjustment, the reference standard should be calibrated. Unless it can be proved that the performance of the reference standard will not fail, the measurement reference standard held by the laboratory can only be used for calibration and cannot be used for other purposes.
5.5.5 If possible, the laboratory should use certified reference materials. When there is no certified reference material (reference material), the laboratory should ensure the accuracy of the value.
5.5.6 The laboratory shall conduct interim verification of reference standards and reference substances (reference substances) according to the prescribed procedures to maintain the credibility of their calibration status.
5.5.7 The laboratory shall have procedures for safe handling, transportation, storage and use of reference standards and reference substances (reference substances) to prevent pollution or damage and ensure their integrity.
5.6 Sampling and sample processing
5.6. 1 The laboratory shall have procedures for extracting, transporting, receiving, disposing, protecting, storing, retaining and/or cleaning the test and/or calibration samples to ensure the integrity of the test and/or calibration samples.
5.6.2 The laboratory shall carry out sample extraction, preparation, transmission, storage and treatment in accordance with relevant technical specifications or standards. In the absence of relevant technical specifications or standards, the laboratory should make a sampling plan according to appropriate statistical methods. In the process of sampling, we should pay attention to the factors that need to be controlled to ensure the validity of the detection and/or calibration results.
5.6.3 The laboratory sampling record shall include the sampling plan, sampler, environmental conditions, graphical representation of sampling location (if necessary) or other equivalent methods, and if possible, the statistical method on which the sampling plan is based.
5.6.4 The laboratory shall record the customer's requirements for deviation, addition or deletion of the sampling scheme in detail, and notify relevant personnel.
5.6.5 The laboratory shall record the status of samples received for testing or calibration, including deviations from normal (or specified) conditions.
5.6.6 The laboratory shall have an identification system for testing and/or calibrating samples to avoid confusion of samples or records.
5.6.7 The laboratory should have appropriate equipment and facilities to store and process samples to ensure that the samples are not damaged. The laboratory shall keep the circulation records of samples.
5.7 Results Quality Control
5.7. 1 The laboratory shall have quality control procedures and quality control plans to monitor the effectiveness of the test and calibration results, which may include (but not limited to) the following:
A) Regularly use certified standard substances (reference substances) for monitoring and/or use sub-standard substances (reference substances) for internal quality control;
B) Participate in comparison or capability verification between laboratories;
C) Repeated detection or calibration with the same or different methods;
D) Retest or recalibrate the remaining samples;
E) Analyze the correlation of the results of different characteristics of the sample.
5.7.2 The laboratory should analyze the quality control data. When it is found that the quality control data will exceed the predetermined judgment basis, it should take planned measures to correct the problem and prevent the wrong results from being reported.
5.8 Results Report
5.8. 1 The laboratory shall timely issue testing and/or calibration data and results according to the requirements and prescribed procedures of relevant technical specifications or standards, and ensure that the data and results are accurate, objective and true. Reports should use legal units of measurement.
5.8.2 The inspection and/or calibration report shall at least include the following information:
A) title;
B) The name and address of the laboratory, and the testing and/or calibration location different from the laboratory address;
C) Unique identification (such as serial number) of the test and/or calibration report, identification on each page and clear identification at the end of the report;
D) Name and address of the customer (if necessary);
E) Identification of standards or methods used;
F) State description and identification of samples;
G) Date of sample receipt and date of test and/or calibration (if necessary);
H) Description of the sampling scheme used, if related to the validity or application of the results;
I) Results of testing and/or calibration;
J) Signature or equivalent identification of testing and/or calibration personnel and their report approvers;
K) Declare that, if necessary, the results are only related to the tested and/or calibrated samples.
5.8.3 If it is necessary to explain the test and/or calibration results, the report may also include the following contents:
A) Deviation, addition or deletion of detection and/or calibration methods, and information on specific detection and/or calibration conditions;
B) Statement of compliance (or non-compliance) with requirements and/or specifications;
C) When the uncertainty is related to the validity or application of the test and/or calibration results, or when the customer requests it, or when the uncertainty affects the judgment of the conformity of the results, the report also needs to include uncertainty information;
D) Additional information required by specific methods, customers or customer groups.
5.8.4 The sampling inspection report shall also include the following contents:
A) sampling date;
B) Standards or specifications related to sampling methods or procedures, and deviations, additions or deletions to these specifications;
C) Sampling location, including any sketches, sketches or photographs;
D) sampler;
E) List the sampling scheme used;
F) Details of environmental conditions that may affect the interpretation of test results during sampling.
5.8.5 If the inspection report contains subcontracting results, these results shall be clearly marked. The subcontractor shall report the results in writing or electronically.
5.8.6 When the test and/or calibration results are transmitted by telephone, telex, fax or other electronic/electromagnetic means, the requirements of this standard shall be met.
5.8.7 Substantive modification of published reports shall be implemented in the form of supplementary documents or alternative reports; It should also include the following statement: "Report supplement, serial number ... (or other identification)", or other equivalent text forms. The modification of the report shall meet all requirements of this specification. If a new report needs to be issued, it should have a unique logo and indicate the original replacement.