1, definition
1.1 Laboratory Accreditation
Laboratory Accreditation is an authoritative body for the testing/calibration laboratories and their personnel are capable of carrying out the specified types of testing/calibration to give a formal recognition of the process. In China, the "authority" is the China National Accreditation Service for Conformity Assessment (CNAS). Competence assessment and evaluation is based on the international standard ISO/IEC 17025, its organization and operation is also based on the implementation of the corresponding international standards, CNAS on behalf of our country to participate in the International Laboratory Accreditation Cooperation (ILAC) and the Asia-Pacific Laboratory Accreditation Cooperation (APLAC), and with the APLAC members of the mutual recognition of test results signed an agreement. Thus laboratory accreditation is an internationalized activity.
1.2 Accreditation
It is a comprehensive certification and evaluation of the testing ability and reliability of the testing organization by the measurement administrative department of the people's government at or above the provincial level in accordance with the provisions of the Measurement Law of the People's Republic of China*** and the State.
In the State Administration of Quality Supervision issued by the "Laboratory and inspection agency accreditation management approach" in the "laboratory qualification" and "recognized" two words to explain, from these explanations of the so-called accreditation in fact is a laboratory accreditation The so-called accreditation from these explanations is actually laboratory accreditation, only with Chinese characteristics of laboratory accreditation, or the Chinese version of laboratory accreditation. Its ability to assess and evaluate the standards based on the "Laboratory Accreditation Review Guidelines". The guidelines are based on the international standard ISO/IEC 17025 "General Requirements for the Competence of Testing and Calibration Laboratories", after simplification and according to China's national conditions to strengthen certain elements and produce. Accreditation is managed and implemented by AQSIQ, and its operation and organization are similar to laboratory accreditation, but only for domestic laboratories, and the test reports are only valid in China. Therefore, accreditation is a non-internationalized activity.
2. Nature
2.1 Laboratory Accreditation
1. Voluntary application principle: refers to the laboratory itself to decide whether to apply for laboratory accreditation.
2. Non-discriminatory principle: refers to any laboratory, regardless of its affiliation, level, size, nature of ownership, as long as it can meet the accreditation guidelines, can be recognized equally.
3. Principle of expert evaluation: means that in order to ensure the scientific and objective impartiality of the accreditation, the evaluation of laboratories applying for accreditation is to assign trained technical experts (the main body of the registered assessors) to undertake the evaluation work, rather than by government officials to complete.
4. National accreditation principle: refers to laboratory accreditation only by the CNAS on behalf of the state, the accredited laboratory, its technical capabilities and data can be recognized by the state.
5. Laboratory accreditation is market behavior, belonging to the category of social credibility.
2.2 accreditation
Mandatory, the community to issue notarized data laboratories must apply for and pass the accreditation.
Qualification is a government action, belongs to the category of administrative approval.
3, the implementation of the main
3.1 Laboratory Accreditation
By the China National Accreditation Service for Conformity Assessment (CANS) for the evaluation of the organization and operation.
3.2 accreditation
Accreditation is implemented at two levels: one for the national level, organized by the National Accreditation and Certification Administration of the implementation of the second level for the provincial level, by the provincial Quality and Technical Supervision is responsible for the implementation of the specific work undertaken by the Office of Metrology and Accreditation (Metrology Department).
4, based on the standard
4.1 Laboratory Accreditation
CNAS to carry out laboratory accreditation activities are mainly based on the following basic guidelines:
1, CNAS-CL01:2006 "Testing and Calibration Laboratory Competence Guidelines for Accreditation" (the content of the equivalent of the use of ISO/IEC 17025:2005)? - I0 s- f' e,
2, CNAS-CL02:2008 Guidelines for the Accreditation of Competence of Medical Laboratories (equivalent to ISO 15189:2007)
% {1 E1 c7 h- y# N- d3, CNAS-CL03:2006 Guidelines for the Accreditation of Providers of Proficiency Testing Schemes (equivalent to ILAC G13:2000)
4. CNAS-CL04:2006 Guidelines for the Recognition of Competence of Producers of Reference Standards/Samples (equivalent to ISO 34:2000 and ISO/IEC 17025:2005) . U$ z. x% n! @
4 a2 S& c) G9 [, f! tAs well as on the basis of the above basic accreditation guidelines, a series of application guides and application notes have been developed to address the specific situations in certain technical fields.?
GB/T15481 (idtISO/IEC 17025) "General Requirements for the Competence of Testing and Calibration Laboratories", which CNAS adopted as CNAS-CL01 "Guidelines for the Accreditation of Testing and Calibration Laboratory Competence" by CNAS as an equivalent, and the main body of the content of which *** 25 elements, 108 articles.
4.2 accreditation
Measurement certification assessment guidelines in 2001.12.1 before: is JJG1021-90 "Product Quality Inspection Organization Measurement Certification Technical Examination Specification"; 2002.12.1 to 2006.12.30 is the "Product Quality Inspection Organization Measurement Certification/Review of Accreditation (Acceptance) Review Guidelines (Trial)", currently is the Accreditation Guidelines for Laboratory Accreditation *** 19 elements;
The Accreditation Guidelines for Laboratory Accreditation, a simplified ISO/IEC 17025 standard, the main part of its content *** 19 elements, 75 articles, in which there are 19 specific clauses developed for China's national conditions.
5 Results and Role
5.1 Laboratory Accreditation
Laboratories can stamp the CNAS logo on their test reports, indicating that their test data and results are credible, and should be mutually recognized between laboratories. If an international mutual recognition agreement is then signed with CNAS, the MRA mark can also be affixed, and there should also be mutual recognition between international laboratories.
5.2 Accreditation
Laboratories can stamp the CMA or CAL logo on their test reports, again indicating that their test data and results are credible. The government or authorized agencies can cite these data and results to supervise, evaluate, and issue licenses for product or project quality, etc. However, it is only valid within the People's Republic of China*** and the country, and does not have the effect of international mutual recognition.
6 application conditions
6.1 Laboratory Accreditation
a. First party, second party, third party can voluntarily apply for;
b. Have a clear legal status, with the ability to assume legal responsibility;
c. Comply with the relevant laws and regulations;
d. Comply with the relevant provisions of CNAS accreditation specification provisions;
d. Provisions;
e. Compliance with CNAS-CL01 accreditation guidelines;
f. Quality management system in accordance with CNAS requirements, running more than 6 months, a complete internal audit and management review;
g. Participate in the proficiency testing;
h. Meet the qualifications and requirements of the authorized signatory;
i. Use of instrumentation for Measurement value traceability.
6.2 Accreditation
a. Established in accordance with the law to ensure objectivity, impartiality and independence to engage in testing, calibration and inspection activities, and to bear the corresponding legal responsibilities; third-party laboratories can apply, non-independent legal person laboratories refer to government agencies and subordinate units (such as metrology institutes, school laboratories) can apply. Valid business license, institutional legal person certificate or other legal person documents (the scope of business should include testing and inspection business, shall not include the design, development, production, supply, installation, use or maintenance of business;)
b. With its testing, calibration and inspection activities appropriate professional and technical personnel and management personnel; engaged in the testing, calibration and inspection activities of special products Laboratory, its professional and technical personnel and management personnel should also meet the requirements of relevant laws and administrative regulations; (...) (Professional and technical personnel and management personnel labor relations certificate, that is, the social security department seal confirmation of social security certificate).
c. Possess a fixed workplace, and its working environment shall ensure the truthfulness and accuracy of the testing, calibration and inspection data and results;
d. Possess fixed, temporary and movable testing, calibration and inspection equipment and facilities required for the proper conduct of testing, calibration and inspection activities and capable of being independently deployed for use;
e. Establish a system that can ensure its impartiality, independence and independence from its testing, calibration and inspection activities;
e. Establish a system that can ensure its impartiality, independence and independence from its testing, calibration and inspection activities.
e. Establish a quality system that can ensure its impartiality, independence and scope of testing, calibration and inspection activities appropriate to its commitment, in accordance with the basic norms or standards for the development of the corresponding quality system documents and effective implementation;
f. Meet the requirements of the "Laboratory Accreditation Review Guidelines", running for more than six months.
7, what circumstances apply
7.1 Laboratory Accreditation
a. Laboratories undertaking import and export commodity inspection, entry and exit personnel quarantine, entry and exit of animal and plant quarantine tasks;
b. Laboratories with international cooperation affairs;
c. Laboratories of companies contracting engineering and construction projects abroad;
d. .State, industry or departmental authority laboratories. All of these laboratories should apply for laboratory accreditation in order to achieve international standards.
7.2 Qualification Accreditation
a. Product or engineering quality inspection organizations;
b. Independent laboratories providing notarized data for the society;
c. Laboratories undertaking third-party testing tasks. These above laboratories must apply for and pass the qualification accreditation to obtain the status of legal testing laboratory.
7.3 When do I need to apply for both?
When both of the above situations exist, both accreditation and laboratory accreditation should be applied for.
What are the circumstances under which neither of them is required?
a. Laboratories within enterprises and institutions that only serve their own organizations and do not provide data or results to the public;
b. Laboratories that are purely scientific research or teaching laboratories.
The above difference between laboratory accreditation and qualification is caused by historical reasons, with the deepening of China's government system reform and development, laboratory accreditation and qualification will eventually merge.
8 metrological certification CMA and review the link and difference between accreditation CAL
Qualification includes metrological certification CMA and review the accreditation CAL, they are based on different laws and regulations.
Measurement certification based on:
Measurement of the provisions of Article 22 of the Law "for the community to provide notarized data on product quality inspection agencies, must be measured by the people's government at or above the provincial level administrative departments of its measurement of calibration, testing capacity and reliability of the assessment of the qualified", the key to the government measurement of the executive management department Implementation of the assessment
Review and approval based on:
Standardization Law, Article 19 of the provisions of the "standardization of government standardization administration at or above the county level, according to the need to set up inspection agencies, or authorize other units of the inspection agency, whether the product is in line with the standard for inspection, the key is by the government standardization administration for "Planning, review";
Product Quality Law, Article 19 provides that "the product quality inspection machine must have the appropriate conditions and capabilities, by the people's product quality supervision department above the provincial level or its authorized departments qualified to undertake product quality inspection work. The key is the government product quality supervision department to implement the assessment.
?A matter of three departments, the purpose of which is to assess and evaluate the ability of product quality inspection organizations, the content is similar. Therefore, later the two on-site review work into one, but the certificate is still issued by the two departments, respectively, the logo is different, measurement certification mark is CMA, review and approval mark is CAL
.