Laboratory Services
Laboratory accreditation is a common international accreditation system at present. It is an accreditation body that evaluates the management and technical capabilities of testing/calibration laboratories and publishes the evaluation results to the public to officially recognize its ability to carry out specified types of testing/calibration activities
Ii. Who is approved by the laboratory?
Conformity assessment bodies, including calibration and testing laboratories (bodies: third parties, i.e., authoritative or authorized organizations).
What is the purpose of laboratory accreditation?
1. Strengthen the capacity building of the laboratory, constantly improve the management and technical level, promote the laboratory with fair behavior, scientific means, accurate results, maintain and improve its social credibility, and serve customers more effectively.
2. The accreditation indicates that the laboratory has the technical ability to carry out testing/calibration in accordance with the requirements of international accreditation standards, enhances the market competitiveness, wins the trust of the government and all parties in the society, and obtains international recognition through signing mutual recognition agreements, thus promoting the development of industry, technology and commerce.
Iv. Historical background and current situation of laboratory accreditation?
1. Background:
In the 19th century, with the invention of steam engine, which marked industrial leather, and the use of electricity, along with the birth of modern standardization, industrial production took shape. Make the market economy develop gradually and mature with each passing day, however, bring such as: boiler explosion, electric appliance catch fire and so on a large number of wealth destruction accident. It has caused social unrest, public suffering and huge losses to insurers. People are aware of self-evaluation from the product provider (the first party) and acceptance evaluation from the product receiver (the second party). As they become increasingly unreliable for their own interests, the public strongly appeals to a third party independent of the producers and sellers and not dominated and influenced by their economic interests to evaluate and supervise the performance of products circulating on the market, especially those involving safety and health, in a scientific, independent and impartial way.
There were actually two ways to do it:
One is to wait for the government to legislate, namely set rules, after the establishment of institutions to implement;
The second is the creation of testing laboratories funded by the private sector, mainly insurers. That is, getting the ball rolling and pushing for government legislation and regulation. Most industrialized countries choose the latter, that is, third-party testing, inspection, certification and other conformity assessment activities first emerged spontaneously from the private sector to meet the market demand. Such institutions as Underwriters Laboratories (UL) and The German Association of Technical Supervisors (TUv) have emerged. They all started from the inspection of boilers, electrical appliances, fire resistant materials, etc., and now have become internationally famous inspection and certification groups.
In 1903, the British Government authorized the British Standards Institute (BSI) to use BS as the basis for the qualification certification of railway tracks and put the BSI kite mark (certification mark) on the qualified railway track, which was the first time that the government directly managed and organized the certification. As a result, third-party measurement, evaluation, certification and conformity assessment have been transformed from purely non-governmental to governmental legislative management and non-governmental activities.
Conformity assessment is to the product, process, system, person or organization concerned regulation requirement is satisfied proof. Industrial production has changed the form of Commodity Exchange from simple meeting of supply and demand, barter, to a business network in which the supply and demand can make a deal without directly meeting, thus promoting the development of conformity assessment. In the 1970s, the General Agreement on Tariffs and Trade (GATT) decided to sign the "Agreement on Technical Barriers to Trade (TBT)" worldwide, which took effect on the New Year of 1980 and stipulated technical regulations, standards and certification system.
The 1994 VERSION of TBT used by THE WTO, which was reorganized and established by GATT, changed the word "certification system" to "conformity assessment system" and extended its connotation in the definition to "the first party self-declaration, the second party acceptance, the third party certification and accreditation activities conducted to prove compliance with technical regulations and standards". At the same time, it is stipulated that the conformity assessment procedures shall include: sampling, testing and inspection procedures: conformity assessment, verification and assurance procedures; Registration, accreditation and approval procedures and their combined application. In recent years, with the in-depth development of quality certification, many systems such as product certification, system certification, personnel certification, accreditation of certification bodies, laboratory accreditation and inspection bodies have been gradually formed in the field of conformity assessment (see Figure 1).
In short, under the WTO/TBT framework, the international economic and technological system takes measurement, standardization and conformity assessment as technical support, coordinates related standards and quality evaluation activities, promotes mutual recognition of measurement results among countries, and reduces technical barriers that affect or hinder the development of global trade. There is a growing recognition in both developing and developed countries of the need to study and improve the technological base associated with economic efficiency and market access for products and services. Measurement, standardization, certification and accreditation and inspection and testing of the four closely combined. Constitute a national quality infrastructure that, in turn, safeguards sustainable development and full participation in global trade. With the deepening of reform and opening up and the enhancement of economic strength, China's total import and export trade has been growing rapidly, facing the new situation of economic globalization and WTO accession. On July 4, 2002, the former CNACL and the former CCIBLAC merged to form the National Accreditation Committee for Laboratories in China (CNAL), realizing the unified laboratory accreditation system in China. To further manage the "Laboratory Accreditation Topics" series.
On March 31, 2006, CNCA merged CNAB (China Certification Authority) in accordance with the regulations of the people's Republic of China on certification and accreditation. China National Accreditation Service for conformity assessment (CNAs) was established. It is responsible for the accreditation of
The purpose of the Accreditation Committee is to promote the construction of conformity assessment institutions in accordance with relevant standards and norms, to promote the conformity assessment institutions to effectively provide services to the society with fair behavior, scientific means and accurate results, and carry out accreditation work in accordance with relevant national laws and regulations, as well as international and national standards and norms, and to follow the objective, fair, scientific and standardized standards The work principle of authority, credibility, honesty and high efficiency is to ensure the fairness of the accreditation work and to be responsible for the recognition decisions made. China's accreditation work has made great progress. After joining the multilateral mutual recognition of ILAC and APLAC, the number of accredited laboratories accounts for 13% of the total number of international mutual recognition laboratories (more than 40000). The number of recognized inspection institutions accounts for 5% of the total number of international mutual recognition inspection institutions (6700), which are among the top.
In order to further simplify administration and decentralization, deepen the reform of qualification licensing of inspection and testing institutions, improve the management regulations on qualification accreditation, create a fair competition, orderly and open inspection and testing market environment, and promote the strong, large and healthy development of inspection and testing high-tech modern service industry, the AQSIQ issued the administrative measures for qualification accreditation of inspection and testing institutions (AQSIQ Order No 163) and will be implemented from August 1 this year.
According to the measures, inspection and testing institutions shall obtain qualification certification for the following activities: providing evidential data and results for judicial decisions; providing evidential data and results for administrative decisions made by administrative organs; providing evidential data and results for arbitration decisions made by arbitration institutions; and; Providing evidential data and results for social economic and public welfare activities.
5、 The role and significance of laboratory accreditation are reflected in the following six aspects
1. It shows that it has the technical ability to carry out detection or calibration services according to the corresponding accreditation criteria;
2. Enhance the market competitiveness and win the trust of government departments and all walks of life;
3. Be recognized by the national and regional accreditation institutions of the parties to the mutual recognition agreement;
4. Have the opportunity to participate in bilateral and multilateral cooperation and exchange on Accreditation of international conformity assessment bodies;
5. CNAs National Laboratory Accreditation Mark and ILAC international mutual recognition joint mark can be used within the scope of accreditation;
6. To be included in the list of approved institutions to improve the visibility of the laboratory.
6. Laboratory accreditation generally includes the following eight processes:
1. The laboratory establishes the quality management system and operates effectively;
2. The laboratory shall submit the application for accreditation and relevant materials as required;
3. The Secretariat of China National Accreditation Commission for conformity assessment (CNAs) reviews the application materials and makes a decision on acceptance. If necessary, arrange the first visit;
4. The Review Group reviews the application materials to determine whether to arrange on-site review. If necessary, arrange pre review.
5. According to the notice of on-site review plan, the review team shall carry out on-site review.
6. If necessary, the laboratory shall implement corrective / or corrective measures according to the non conformity items proposed by the review team. The review group shall carry out rectification and acceptance for the non conformity items.
7. The Secretary General of CNAs shall make the accreditation decision according to the evaluation conclusion of the assessment committee, and issue the accreditation certificate and the notice of accreditation decision to the approved accreditation laboratory.
8. Follow up work: Supervision, re evaluation, expansion or reduction of scope of field and approval change after CNAs approval.