ISO17025 standard is a laboratory management standard formulated by the international organization for Standardization ISO / Casco (International Organization for Standardization / conformity assessment committee). The predecessor of this standard is ISO / IEC Guide 25:1990 requirements for the ability of calibration and testing laboratories. The international organization that manages laboratory accreditation is the International Laboratory Accreditation Cooperation Organization (ILAC), which is attended by 44 laboratory accreditation institutions, including China National Accreditation Commission for laboratories (CNACL).
ISO17025 standard mainly includes: definition, organization and management, quality system, audit and review, personnel, facilities and environment, equipment and reference materials, quantity traceability and calibration, calibration and testing methods, sample management, records, certificates and reports, subcontracting of calibration or testing, external assistance and supply, complaints, etc. The core contents of the standard are equipment and reference materials, quantity traceability and calibration, calibration and testing methods, and sample management. These contents focus on evaluating whether the laboratory calibration or testing ability meets the expected requirements.
China National Laboratory Accreditation Commission (CNAs) is the only laboratory accreditation institution in China, which undertakes the ISO17025 standard accreditation of all laboratories in China. All calibration and testing laboratories can adopt and implement ISO17025 standard. According to international practice, the data provided by laboratories that pass ISO17025 standard have legal effect and are internationally recognized. At present, more than 1000 laboratories in China have passed the ISO17025 standard certification. Through the implementation of the standard, the accuracy of experimental data and results has been improved, the popularity of the laboratory has been expanded, and the economic and social benefits have been greatly improved.
National requirements
Voluntary: the laboratory applies voluntarily according to its own development and needs.
A. The need to develop trade
B. The need of quality certification development
C. Needs of notarization activities
D. Government management needs
legal status
Non discrimination principle, laboratory of all sectors of society. It has the effect of international mutual recognition.
Implementation subject
China National Accreditation Commission for conformity assessment (CNAs) is the only organization to accept it.
Target object
Any kind of laboratory
charge
1. The recognition fee items are: application fee (collected during the application of initial review, re review and expansion review), review fee (collected during document review and on-site review of the applicant (including on-site witness such as initial review, re review, supervision review, expansion review and corrective action verification review) Approval and registration fee (collected during initial review, re review, expansion review, etc.), annuity and production cost fee.
The relevant accreditation fees for laboratories and inspection institutions in Hong Kong, Macao, Taiwan and foreign countries shall be negotiated by both parties and agreed in the contract in accordance with international practice.
2 CNAs determines the number of person days required for the review according to the size and review scope of the applicant or approved recognized laboratory and inspection institution, and in the principle of ensuring the quality of the review work.
3 the transportation and accommodation expenses of the reviewers shall be borne by the applicant or the approved institution.
Certificate period
6 years
Cnas-iso / IEC17025 certification process
Preparation - system establishment and operation - (at least 6 months) - satisfactory capability verification - Application - on-site review - certificate issuance
Function and significance of cnas-iso / IEC17025
1. It shows that the laboratory has the technical ability to carry out calibration / testing according to relevant international standards.
CNAs laboratory accreditation criteria is based on ISO / IEC17025, which is an international standard for laboratory quality and technical requirements. The recognition of the laboratory by CNAs indicates that it has established a set of quality management system according to international standards. As long as it works in strict accordance with the system, the technical capacity of the laboratory will be guaranteed, and the testing / calibration services provided by the laboratory to customers can be claimed to meet the requirements of international standards.
2. Enhance the competitiveness of the laboratory in the calibration / testing market and win the trust of government departments and all sectors of society.
The products of the laboratory are test reports or calibration certificates. The quality of test reports or calibration certificates plays an important role in the reputation and survival of the laboratory and determines the competitiveness of the laboratory. ISO / IEC17025 aims to help the laboratory carry out quality planning, quality control, quality assurance and quality improvement through various quality management activities during the production and formation of "products", so as to ensure the quality of laboratory "products" and services. For laboratory customers, selecting laboratories with recognized technical capabilities can reduce the risk of providing unqualified "products".
Laboratory is an important technical support organization for government departments to supervise and manage various products, which provides basis for the government to make relevant decisions and even decisions. When government departments, customers and interested parties choose laboratories, the ability and credit of laboratories are particularly important. Accreditation can help government departments, customers and interested parties build confidence in the laboratory.
National Laboratory Accreditation is consistent with the foreign laboratory accreditation system and is a voluntary application for capacity accreditation. Through the testing technology organization recognized by the National Laboratory, it is proved that it meets the internationally accepted standards for the accreditation of calibration and testing laboratory capabilities.
It can effectively improve the management level of the laboratory, ensure the fairness and effectiveness of the test data issued by the laboratory, fully show the testing ability and notarization of the laboratory to the society, improve the market share and customer satisfaction.
3. Participation in international laboratory accreditation, bilateral and multilateral cooperation, has been more widely recognized.
China's authorized institutions have signed the mutual recognition agreement (MRA) with APLAC and ILAC. The signing of the agreement has established a "highway" for China's laboratories to participate in international activities. After being recognized by CNAs, the laboratory can use this way to lead to other signatories of the agreement, so as to be more widely recognized. This can not only increase the communication between China's laboratories and international counterparts, but also attract more laboratory customers by taking advantage of mutual recognition and cooperation to reduce costs.
4. Included in the National Laboratory Accreditation directory to improve the popularity of the laboratory.
CNAs compiles and publishes the laboratory accreditation directory every year, which is a combined Chinese and English version, and provides it to domestic laboratories, relevant authorities and foreign accreditation institutions at the same time. This will undoubtedly have a positive advertising effect on the laboratories listed in the list, so as to improve the popularity of accredited laboratories.
5. The approval mark can be used within the scope of the approved project.
Accreditation Mark refers to the graphic mark issued by CNAs to the accredited laboratory and allowed to be used by the accredited laboratory within the specified range to indicate that its winner has obtained the CNAs accreditation qualification. In order to ensure the interests of CNAs and accredited laboratories, CNAs has formulated strict management requirements for accreditation marks in accordance with relevant international requirements, and stipulated corresponding treatment measures for fraudulent use and abuse, including litigation when necessary. These means can not only protect the legitimate interests of CNAs and accredited laboratories, but also reduce and reduce the infringement on the legitimate rights and interests of CNAs and accredited laboratories.
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