![<?echo $_SERVER['SERVER_NAME'];?>](/template/twentyseventeen/skin/images/header.jpg)
1. General
1.1 In order to implement the "Administrative Measures for Qualification Certification of Laboratories and Inspection Institutions", to ensure the scientific and standardized implementation of laboratory qualification certification (measurement certification / examination approval) review, to provide a reliable basis for laboratory qualification administrative licensing The Metrology Law, the Standardization Law of the People ’s Republic of China, the Product Quality Law of the People ’s Republic of China, the Certification and Accreditation Regulations of the People ’s Republic of China, and other relevant laws and regulations stipulate this Code.
1.2 Within the territory of the People ’s Republic of China, the assessment of laboratory qualifications (measurement certification, authorization, acceptance) engaged in the issuance of data and results that prove to the society shall comply with these guidelines.
1.3 The accreditation of laboratory qualifications referred to in these guidelines refers to the National Certification and Accreditation Administration Committee and
The basic conditions and capabilities of the laboratories of the quality and technical supervision departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government
Whether the power complies with laws, administrative regulations and relevant technical specifications or standard implementation evaluation and commitment
Recognition activities.
1.4 The qualification assessment of the laboratory should be objective and fair, scientifically accurate, uniform and standardized, and beneficial
The principle of detecting resource sharing and avoiding unnecessary duplication.
1.5 Qualify the laboratories that have been accredited by the accreditation body determined by the National Accreditation Regulatory Commission, and only review the specific provisions of this Code (parts in bold). Those applying for laboratory accreditation and qualification accreditation at the same time shall be evaluated in accordance with the laboratory accreditation criteria and the specific provisions of this standard.
2. Reference documents
GB / T15481: 2000 (GB / T27025 :: 208) "General requirements for the ability of testing and calibration laboratories" ISO / IEC17025
: 2005 "General Requirements for the Ability of Testing and Calibration Laboratories" and "Administrative Measures on the Qualification Certification of Laboratories and Inspection Institutions" (State Administration of Quality Supervision, Inspection and Quarantine No. 86 Order of the Director) Guidelines (Trial Implementation) Quality and Technical Supervision Recognition Letter [2000] 046)
3. Terms and definitions
This standard uses the relevant terms and definitions given in the "Administrative Measures for Qualification Certification of Laboratories and Inspection Institutions" and GB / T 15481: 1999 "General Requirements for the Capability of Testing and Calibration Laboratories."
4. Management requirements
4.1 The organization laboratory shall be established or registered in accordance with the law and be able to bear the corresponding legal responsibilities to ensure objective, fair and independent inspection or calibration activities.
4.1.1 The laboratory is generally an independent legal person; the laboratory of a non-independent legal person needs to be authorized by the legal person, can independently undertake third-party fair inspection, independently write foreign documents and carry out business activities, and have independent accounts and independent accounting.
4.1.2 The laboratory shall have a fixed working place, and shall be equipped with fixed, temporary and movable testing and / or calibration equipment and facilities required for proper testing and / or calibration and capable of independent deployment.
4.1.3 The laboratory management system shall cover all the work performed in its premises.
4.1.4 The laboratory shall have professional technicians and management personnel who are suitable for their testing and / or calibration activities.
4.1.5 The laboratory and its personnel shall not have an interest in the testing and / or calibration activities and the data and results they produce; they shall not participate in any activities that detract from the independence and integrity of the testing and / or calibration judgment; 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 shall have measures to ensure that its personnel are not subject to any unfair commercial, financial and other pressures and influences from inside and outside, and to prevent commercial bribery.
4.1.6 The laboratory and its personnel shall be obliged to keep confidential the state secrets, trade secrets and technical secrets known in the testing and / or calibration activities, and shall take corresponding measures.
4.1.7 The laboratory should clarify its organization and management structure, its position in the parent organization, and the relationship between quality management, technical operations, and support services.
4.1.8 The top management of the laboratory, technical management, quality supervisors and heads of departments should have appointment documents, and the top management of the independent legal person laboratory should be appointed by its superior; the changes of top management and technical management need to be reported Confirmed by the certification authority or its authorized department.
4.1.9 The laboratory shall specify the responsibilities, powers, and interrelationships of all management, operation, and verification personnel that have an impact on the quality of testing and / or calibration. If necessary, appoint an agent for key management personnel.
4.1.10 The laboratory shall be supervised by personnel familiar with various testing and / or calibration methods, procedures, objectives and evaluation of results on the key links of testing and / or calibration.
4.1.11 The laboratory shall be fully responsible for technical operations by the technical manager, and appoint a quality supervisor to give him the responsibility and authority to ensure the effective operation of the management system.
4.1.12 For the mandatory inspection tasks issued by the government, a plan should be prepared and the quality and quantity should be completed on time (applicable to authorized / accepted laboratories).
4.2 Management system
The laboratory shall establish and maintain a management system that can ensure its impartiality and independence and is compatible with its testing and / or calibration activities in accordance with these guidelines. The management system shall be documented to clarify the policies related to quality, including quality policies, objectives and commitments, so that all relevant personnel understand and implement them effectively.
4.3 File control
The laboratory shall establish and maintain control procedures for document preparation, review, approval, identification, issuance, storage, revision, and abolition to ensure that the documents are currently valid.
4.4 Subcontracting for testing and / or calibration
If the laboratory subcontracts part of the testing and / or calibration work, the subcontracted laboratory must meet the requirements of this standard; the subcontracting ratio must be controlled (limited use of instruments and equipment, low frequency, expensive and special projects). The laboratory shall ensure and confirm that the subcontractor is capable of completing the subcontracting tasks. The laboratory shall subcontract the subcontracting matters in written form with the consent of the client. The laboratory shall periodically conduct internal audits of its quality activities to verify that its operations continue to meet the requirements of the management system and this Code. The annual internal audit activities shall cover all elements and all activities of the management system. The auditors should be trained and qualified, and as long as resources permit, the auditors should be independent of the work being audited.
4.11 Management review
The top management of the laboratory shall periodically review the management system and testing and / or calibration activities according to predetermined plans and procedures to ensure its continued application and effectiveness, and make necessary improvements. The management review should take into account: the adaptability of policies and procedures; the reports of management and supervisory personnel; the results of recent internal audits; corrective and preventive measures; reviews by external agencies; the results of inter-laboratory comparisons and proficiency tests; Changes in workload and job types; appeals, complaints, and customer feedback; suggestions for improvement; quality control activities, resources, and personnel training.
5. Technical requirements
5.1 Personnel
5.1.1 The laboratory shall have professional technicians and management personnel who are suitable for their testing and / or calibration activities. The laboratory should use formal personnel or contract personnel. When using contract personnel and 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, issuance of testing / calibration reports and operating equipment shall be qualified and held as required according to the corresponding education, training, experience and / or provable skills Card. For laboratories engaged in the testing and / or calibration of special products, their professional technicians and managers shall also comply with the requirements of relevant laws and administrative regulations.
5.1.3 The laboratory shall determine the training needs and establish and maintain personnel training procedures and plans. Laboratory personnel should undergo education and training appropriate to the tasks they undertake, and have corresponding technical knowledge and experience.
5.1.4 When using personnel in training, they should be appropriately supervised.
5.1.5 The laboratory shall keep files of personnel qualifications, training, skills and experience.
5.1.6 The laboratory technical supervisor and authorized signatory should have the technical titles of engineers or above (including engineers), be familiar with the business, and pass the assessment.
5.1.7 The quality supervision and inspection agency established and authorized according to law shall have an authorized signatory with the technical title of engineer or above (including engineer), be familiar with the business, and have worked in this field for more than 3 years.
5.2 Facilities and environmental conditions
5.2.1 Laboratory testing and calibration facilities and environmental conditions should meet the requirements of relevant laws, regulations, technical specifications or standards.
5.2.2 When facilities and environmental conditions have an impact on the quality of the results, the laboratory shall monitor, control and record the environmental conditions. Special attention should be paid to the impact of environmental conditions when testing in non-stationary locations.
5.2.3 The laboratory should establish and maintain safe operation management procedures to ensure that chemical hazards, drugs, harmful organisms, ionizing radiation, high temperature, high voltage, impact, and water, gas, fire, electricity and other factors that endanger safety and the environment can be Effective control and corresponding emergency treatment measures.
5.2.4 The laboratory shall establish and maintain environmental protection procedures and have corresponding facilities and equipment to ensure that the treatment of exhaust gas, waste liquid, dust, noise, solid waste, etc. generated by testing / calibration meets environmental and health requirements, and has corresponding Emergency measures.
5.2.5 When the work between the areas has adverse effects on each other, effective isolation measures should be taken.
5.2.6 Areas and facilities that affect work quality and involve safety should be effectively controlled and correctly identified.
5.3 Testing and calibration methods
5.3.1 The laboratory shall perform testing and / or calibration activities using appropriate methods and procedures in accordance with relevant technical specifications or standards. Laboratories should prefer to choose national standards, industry standards, and local standards; if the lack of instructions may affect the test and / or calibration results, the laboratory should develop corresponding operation instructions.
5.3.2 The laboratory shall confirm whether the new method selected can be used correctly. If the method changes, you should reconfirm it. The laboratory should ensure that the latest valid version of the standard is used.
5.3.3 Standards, manuals, instructions, etc. related to laboratory work should be in effect and convenient for staff to use.
5.3.4 When necessary, the laboratory may adopt international standards, but only limited to the commissioned testing of specific commissioners.
5.3.5 The non-standard method formulated by the laboratory itself can be used as a qualification certification project after confirmation, but only for testing by a specific client.
5.3.6 The deviation of the detection and calibration methods must be verified by the relevant technical unit or approved by the relevant competent authority.
Approved by the person in charge of the laboratory and accepted by the customer, and the method is deviated from the documentation requirements.
5.3.7 The laboratory shall have appropriate calculation and data conversion and processing regulations and implement them effectively. When using computers or automated equipment to collect, process, record, report, store, or retrieve test or calibration data, the laboratory shall establish and implement data protection procedures. The procedure shall include (but not limited to): the integrity and confidentiality of data input or collection, data storage, data transfer and data processing.
5.4 Equipment and reference materials
5.4.1 The laboratory shall be equipped with the sampling, measuring and testing equipment (including software) and reference materials required for proper testing and / or calibration (including sampling, sample preparation, data processing and analysis), and normalize all instruments and equipment maintain.
5.4.2 If the instrument and equipment are overloaded or erroneously operated, or the displayed results are suspicious, or indicate defects by other means, they should be immediately stopped and clearly marked, and if possible, they should be stored in the specified place until repair; The repaired instruments and equipment must prove that their functional indexes have been restored through verification, calibration, etc. The laboratory shall check the effect of such defects on the tests and / or calibrations carried out in the past.
5.4.3 If you want to use instruments and equipment beyond the permanent control of the laboratory (rented, borrowed, or use customer equipment), it is limited to certain low-frequency, expensive, or specific testing facilities and equipment, and should be guaranteed to meet the relevant requirements of this standard Claim.
5.4.4 The equipment should be operated by authorized personnel. Relevant technical information on equipment use and maintenance should be accessible to relevant personnel.
5.4.5 The laboratory shall keep files of equipment and its software that have an important influence on testing and / or calibration. The file should include at least:
a) The name of the device and its software;
b) Manufacturer's name, type identification, serial number or other unique identification;
c) Verification records of equipment compliance with specifications (if applicable);
d) current location (if applicable);
e) the manufacturer's instructions (if any), or indicate their location;
f) All verification / calibration reports or certificates;
g) Equipment receiving / commissioning date and acceptance record;
h) Equipment use and maintenance records (when appropriate);
i) Any damage, malfunction, modification or repair records of the equipment.
5.4.6 All instruments and equipment (including reference materials) should be clearly marked to indicate their status.
5.4.7 If the equipment deviates from the direct control of the laboratory, the laboratory should ensure that after the equipment is returned, the function and calibration status of the equipment are checked before use and satisfactory results can be displayed.
5.4.8 When the period verification is required to maintain the reliability of the calibration status of the equipment, it shall be carried out in accordance with the prescribed procedures.
5.4.9 When calibration produces a set of correction factors, the laboratory shall ensure that it is applied correctly.
5.4.10 Special testing instruments and equipment that have not been finalized shall provide verification certificates from relevant technical units.
5.5 Traceability
5.5.1 The laboratory shall ensure that the relevant testing and / or calibration results can be traced back to the national standard. The laboratory shall formulate and implement the general requirements for the calibration and / or verification (verification) and validation of equipment. For the calibration of equipment, a block diagram of the transfer of values ​​that can be traced to the national metrological reference (when applicable) should be drawn to ensure that the values ​​of the measuring instruments and equipment in use comply with the legal requirements of metrology.
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 a plan for equipment verification / calibration. Before using measuring and testing equipment that affects the accuracy of testing and calibration, verification / calibration should be performed in accordance with relevant national technical specifications or standards to ensure the accuracy of the results.
5.5.4 The laboratory should have a verification / calibration plan for reference standards. The reference standard should be calibrated before and after any adjustment. The measurement reference standards held by the laboratory should only be used for calibration and not for other purposes unless it can be demonstrated that the performance as a reference standard will not fail.
5.5.5 When possible, the laboratory should use certified reference materials (reference materials). When there is no certified reference material (reference material), the laboratory shall ensure the accuracy of the measured value.
5.5.6 The laboratory shall periodically check the reference standards and reference materials (reference materials) according to the prescribed procedures to maintain the confidence of its calibration status.
5.5.7 The laboratory shall have procedures to safely handle, transport, store and use reference standards and reference materials (reference materials) to prevent contamination or damage and ensure its integrity.
5.6 Sampling and sample disposal
5.6.1 The laboratory shall have the facilities for sampling, transportation, reception, disposal, protection, storage, retention and maintenance of testing and / or calibration samples.
/ Or cleaning procedures to ensure the integrity of the testing and / or calibration samples.
5.6.2 The laboratory shall implement the sampling, preparation, transmission, storage, and disposal of samples in accordance with relevant technical specifications or standards. If there is no relevant technical specification or standard, the laboratory shall formulate a sampling plan according to appropriate statistical methods. The sampling process should pay attention to the factors that need to be controlled to ensure the validity of the test and / or calibration results.
5.6.3 Laboratory sampling records should include the sampling plan used, the sampler, the environmental conditions, if necessary, a diagram of the sampling location or other equivalent methods, and if possible, the statistical method on which the sampling plan is based.
5.6.4 The laboratory shall record in detail the customer's requirements for deviation, addition or deletion of the sampling plan, and inform the relevant personnel.
5.6.5 The laboratory shall record the status of receiving test or calibration samples, including deviations from normal (or specified) conditions.
5.6.6 The laboratory shall have an identification system for testing and / or calibration samples to avoid confusion in samples or records.
5.6.7 The laboratory shall have appropriate equipment and facilities to store and process samples to ensure that the samples are not damaged. The laboratory shall keep records of the flow 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 testing and calibration results, which may include (but not limited to) the following:
a) Periodically use certified reference materials (reference materials) for monitoring and / or use secondary reference materials (reference materials) for internal quality control;
b) Participate in inter-laboratory comparison or proficiency testing;
c) Use the same or different methods for repeated testing or calibration;
d) Retest or recalibrate the remaining samples;
e) Analyze the correlation of different characteristics of a 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 problems and prevent the reporting of erroneous results.
5.8 Results report
5.8.1 The laboratory shall promptly issue test and / or calibration data and results in accordance with relevant technical specifications or standard requirements and prescribed procedures, and ensure that the data and results are accurate, objective and true. The report should use the legal unit of measurement.
5.8.2 The test and / or calibration report should include at least the following information:
a) title;
b) The name and address of the laboratory, and the location of testing and / or calibration different from the laboratory address;
c) The unique identification of the test and / or calibration report (such as the serial number) and the identification on each page, as well as the clear identification of the end of the report;
d) Customer's name and address (if necessary);
e) identification of the standard or method used;
f) State description and identification of the sample;
g) The date of receipt of the sample and the date of testing and / or calibration (if necessary);
h) if relevant to the validity or application of the results, a description of the sampling plan used;
i) Results of testing and / or calibration;
j) The signature or equivalent identification of the testing and / or calibration personnel and their report approvers;
k) If necessary, the results are only related to the test and / or calibration samples.
5.8.3 If the test and / or calibration results need to be explained, the report may also include the following:
a) Deviations, additions or deletions to the testing and / or calibration methods, and information about specific testing and / or calibration conditions;
b) Declaration 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 the customer requires it, or the uncertainty affects the judgment of the conformity of the results, the report also needs to include the information of the uncertainty;
d) Additional information required by specific methods, customers or customer groups.
5.8.4 The test report with sampling shall also include the following:
a) Date of sampling;
b) Standards or specifications related to sampling methods or procedures, and deviations, additions or deletions from these specifications;
c) sampling location, including any sketches, sketches or photos;
d) sampler;
e) List the sampling plan used;
f) Detailed information on the environmental conditions that may affect the interpretation of the test results during the sampling process.
5.8.5 If the subcontracting results are included in the test report, these results shall be clearly marked. The subcontractor shall report the results in writing or electronically.
5.8.6 When transmitting test and / or calibration results by telephone, telex, fax or other electronic / electromagnetic methods, the requirements of this standard shall be met.
5.8.7 Substantial amendments to the issued report shall be implemented in the form of additional documents or replacement reports; and shall include the following statement: "Supplement to the report, serial number (or other identification)", or other equivalent Text form. The report modification shall meet all the requirements of this standard. If it is necessary to issue a new report, it shall have a unique identification and indicate the original to be replaced.
Rechargeable Hair Clipper,Rechargeable Hair Trimmer,Hair Clippers,Rechargeable Hair Clippers
Zhejiang Hisun Electrical Appliance Co.,Ltd , https://www.cn-hisun.com