title>Proficiency testing by interlaboratory comparisons--Part 2:Selection and use of proficiency testing schemes by laboratory accreditation bodies - GB/T 15483.2-1999 - Chinese standardNet - bzxz.net
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Proficiency testing by interlaboratory comparisons--Part 2:Selection and use of proficiency testing schemes by laboratory accreditation bodies
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Standard ID:
GB/T 15483.2-1999
Standard Name:Proficiency testing by interlaboratory comparisons--Part 2:Selection and use of proficiency testing schemes by laboratory accreditation bodies
Standard ICS number:Sociology, Services, Organization and Management of Companies (Enterprises), Administration, Transport>>Quality>>03.120.20 Product Certification and Agency Certification, Conformity Assessment
Standard Classification Number:General>>Standardization Management and General Regulations>>A00 Standardization, Quality Management
drafter:China National Accreditation Service for Laboratories
Drafting unit:China National Accreditation Service for Laboratories
Focal point unit:China National Accreditation Service for Laboratories and China Institute of Standardization and Information Classification and Coding
Proposing unit:China National Accreditation Service for Laboratories
Publishing department:State Administration of Quality and Technical Supervision
The purpose of this standard is to: a) establish the principles for the selection of proficiency testing schemes in laboratory accreditation programs. b) assist laboratory accreditation bodies in coordinating the use of proficiency testing results. GB/T 15483.2-1999 Proficiency testing using inter-laboratory comparisons Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies GB/T15483.2-1999 Standard download decompression password: www.bzxz.net
The purpose of this standard is to: a) establish the principles for the selection of proficiency testing schemes in laboratory accreditation programs. b) assist laboratory accreditation bodies in coordinating the use of proficiency testing results.
Some standard content:
GB/T15483.2-1999 This standard is equivalent to TS()/IFC Guide 43-2 (1997 Edition) "Proficiency testing using laboratory comparisons Part 2: Selection and use of proficiency testing plans by laboratory accreditation bodies". GB/T15483-1999 includes the following two parts under the general title "Proficiency testing using laboratory comparisons": - GB/T13483.1-1999 Proficiency testing using laboratory comparisons Part 1: Establishment and operation of proficiency testing plans GB/T15483.2-1999 Proficiency testing using laboratory comparisons Part 2: Selection and use of proficiency evidence plans by laboratory accreditation bodies This standard emphasizes the use of laboratory proficiency testing results by accreditation bodies, which is a revision of (B/T This standard and GB/T15483.J--1999 replace GB/T15483-1995 from the date of implementation. This standard is proposed by the China National Accreditation Board for Laboratories. This standard is under the jurisdiction of the China National Accreditation Board for Laboratory Accreditation and the China Institute of Standardization and Information Classification and Coding. The China National Accreditation Board for Laboratory Accreditation and the China Institute of Standardization and Information Classification and Coding are responsible for drafting this standard. The main drafting units of this standard are: China National Accreditation Board for Laboratory Accreditation, China Institute of Standardization and Information Classification and Coding, China Academy of Computer Science and Technology, National Standard Material Research Center, and China National Petroleum Corporation. The main drafters of this standard are: Liu Anping, Jia Ju, Zhai Peiche, Mao Zuxing, Li Renliang, Shi Changyan, Qi Xuewen, Liu Zhimin. GB/T15483.2—1999 ISO/IEC Former ISO (International Organization for Standardization) and IFC (International Electrotechnical Commission) are specialized systems formed for global standardization. National organizations that are members of ISO or IEC participate in the formulation of international standards through technical committees composed of individual organizations from specific technical fields. ISQ and IEC technical committees cooperate in areas of common interest. At the same time, other governmental and non-governmental international organizations cooperate with ISO through cooperation with ISO ISO/IEC Guide 43-2 was prepared by the ISO/CASCO Ad HOC (Conformity Assessment Committee Expert Group) and is a supplement to ISO/IEC Guide 43. The first draft was circulated among the members of the CASCO Conformity Assessment Committee and the IFC National Committee for comments. The final draft was approved by ISO/CASCO and the IEC Committee adopted it as the ISO/IEC Guide 43-2. The Guidelines are published. Parts 1 and 2 of ISO/EC Guide 43:1997 will replace ISO/IEC Guide 43:1984. ISO/IEC Guide 43:1997 contains the following two parts under the general title Proficiency testing using interlaboratory comparisons: Part 1: Introduction and operation of proficiency testing schemes - Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies. GB/T 15483.2-1999 GB/T 183.1-1999 provides guidance on how to establish and use interlaboratory comparison methods for proficiency testing. This standard provides a harmonious model for the selection and use of proficiency testing schemes, which will facilitate national and international coordination and acceptance of data from accredited laboratories in different regions. Proficiency testing schemes can be operated by laboratory accreditation bodies as well as other bodies. It is essential that the accreditation bodies are competent, effective and fair in operating proficiency testing schemes using the results of the participants in the proficiency testing schemes to judge their technical capabilities. The purpose of laboratory accreditation is to provide independent recognition of a laboratory's ability to perform specific tests, measurements, calibrations or sampling. The procedures used to determine capability include an independent technical assessment. The assessor not only judges the laboratory's technical capabilities, but also judges the comparability of the laboratory's case to the relevant technical and sensor system recommendations (such as (GB/T15483.1-1999). Most laboratory accreditation bodies complete their on-site assessments in various practical ways to judge the comparability of the laboratory's data to test data, or to data provided by laboratories that have been proven to be qualified in the relevant tests and measurements. Some practical tests and audits may be unique and involve only one laboratory, such as issuing a certified reference material or a reference calibration product to a laboratory: This standard does not include techniques for evaluating the capability of a single laboratory. Scope National Standard of the People's Republic of China Proficiency testing by interlaboratory comparisons-.Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies The only objectives of this standard are: a) to establish the principles for the selection of proficiency testing schemes for laboratory accreditation schemes; b) to assist laboratory accreditation bodies in the use of proficiency testing results. GB/T 15483.2—199S Substituted for GB/T 15483—1995 Because the results of proficiency testing can be used in the decision on accreditation, it is essential that the accreditation body and the participating laboratories have confidence in the design and operation of the scheme. It is also important for participating laboratories and laboratory accreditation assessors to understand the accreditation body's policies on proficiency testing programs, the principles for judging success or failure in the program, and the policies and procedures for subsequent handling of unsatisfactory results in proficiency testing programs. However, it should be recognized that laboratory accreditation bodies and their assessors may also consider the applicability of test data obtained from other activities outside the proficiency testing program. This includes the results obtained by the laboratory itself using control samples according to internal quality control procedures, the results of comparisons with split samples from other laboratories, and the results of audit tests using certified reference materials. The use of the above-mentioned sources of data by the laboratory accreditation body is not included in this standard. However, the principles for subsequent handling of unsatisfactory performance specified in this standard also apply to these activities. 2 Referenced standards The following standards contain provisions that constitute the provisions of this standard through their use in this standard: At the time of publication of this standard, the versions shown are valid. All standards are subject to revision. Parties using this standard should discuss the possibility of using the latest versions of the following standards: GB/T15481-1995 General requirements for the competence of calibration and testing laboratories GB/T15483.1-1999 Proficiency testing using inter-laboratory comparisons Part 1: Establishment and operation of proficiency testing schemes 3 Definitions This standard adopts the definitions used in GB/T15483.1. 4 Choice of proficiency testing schemes 4.1 In order to facilitate the evaluation of the competence of laboratories for laboratory accreditation, the accreditation body should adopt a proficiency testing scheme that conforms to the provisions of GB/T15483.1. 4.2 If the proficiency testing scheme is operated by a laboratory accreditation body, this body should regularly review and evaluate its scheme in accordance with GB/T15483.1. Approved by the State Administration of Quality and Technical Supervision on March 8, 1999 and implemented on September 1, 1999
GR/T 15483-2-1999 4.3 If the laboratory accreditation body uses a proficiency testing scheme operated by a subcontracted organization, then the laboratory accreditation body should seek documentary evidence to demonstrate that the subcontracted scheme complies with GB 15483-2 before recognizing the scheme. Such compliance must be confirmed by audit. 4.4 In selecting a validation program, the laboratory accreditation body shall consider the following factors: a) the tests, measurements, or calibrations involved shall be consistent with the types of tests, measurements, or calibrations performed by the laboratory to be considered or already accredited; b) the accreditation body shall have access to the test results of the accredited participants in accordance with the agreement with the accredited laboratory to improve the details of the program, the procedures for establishing the assigned values, the instructions for the participants, the statistical treatment of the data, and the final report for each selected laboratory to be validated; d) the rationale for the organization of the program, such as schedule, location, sample stability test, distribution arrangements, etc., which are all related to the group of accredited laboratories participating in the program; f) the cost of the selected program; g) the policy of confidentiality for participants in the program; b) the schedule for reporting results; i) the test materials used in the program.The reliability of the characteristics of the product after testing, such as homogeneity, stability and, where appropriate, the source of national or international standards. Note: Some proficiency testing provides test details that are not completely consistent with the test items in the test list of an accredited laboratory (for example, different standards are used for the same test), but if the processing of the data allows some major differences in the test method or other aspects, then it is technically possible to include these laboratories in the proficiency testing scheme. 4.5 The selection of a specific proficiency testing scheme by the laboratory accreditation body should be determined and supervised by personnel with appropriate qualifications in the accreditation body. 5 Policy on participation in proficiency testing schemes 5. The laboratory accreditation body should document its policy on accrediting and inviting laboratories to participate in proficiency testing. This documented policy should be made public to the laboratories or other relevant bodies. 5.2 The scope of the participation policy shall include: a) whether participation in a given proficiency testing scheme is mandatory or voluntary; b) the number of times the laboratory is expected or invited to participate in proficiency testing; the criteria by which the laboratory accreditation body will judge successful or unsatisfactory performance in a particular scheme; d) whether the laboratory will be required to participate in a subsequent proficiency testing scheme if the results are judged to be unsatisfactory in a specific scheme; and e) how the results of proficiency testing will be used in accreditation decisions. 5.2 The details of the policy to be specified by the laboratory accreditation body include: a) whether participation in a given proficiency testing scheme is mandatory or voluntary; b) the number of times the laboratory is expected or invited to participate in proficiency testing; c) the criteria by which the laboratory accreditation body will judge successful or unsatisfactory performance in a particular scheme; d) whether the laboratory will be required to participate in a subsequent proficiency testing scheme if the results are judged to be unsatisfactory in a specific scheme; and e) how the results of proficiency testing will be used in accreditation decisions. 5.3 The details of the policy to be specified by the laboratory accreditation body shall be given. In some cases, the laboratory accreditation body may have a policy of mandating the participation of laboratories in a small number of proficiency testing schemes, while allowing voluntary participation in any possible proficiency testing scheme. 2 The establishment of proficiency testing schemes varies according to the technology involved, and the acceptance criteria may also vary between schemes. In many cases, acceptable data are derived from the results of a specific proficiency testing scheme and are not available in advance to the laboratory. In such cases, the laboratory accreditation body shall provide the participating laboratories with detailed information on the source of the acceptance criteria. 6 Use of proficiency testing results by laboratory accreditation bodies 6.1 Proficiency testing results are useful to both participating laboratories and accreditation bodies. However, there are limitations when using these results to verify narrow ISO/IEC 15483.2-1999 capabilities. Success in a proficiency testing program may represent proficiency for only that one activity and may not reflect ongoing proficiency. Similarly, ineffective performance in a single program may reflect an occasional deviation from the laboratory's normal proficiency status. Because of this, proficiency testing cannot be used in isolation in the accreditation process. 6.2 If a result or results submitted by a laboratory exceed the acceptance criteria of a certain proficiency testing program, the laboratory accreditation body should have procedures for taking action on these results. 6.3 Such procedures should include early reporting of the results by the laboratory and recommending that the laboratory conduct an investigation and review of its proficiency. Note: Some proficiency testing programs require considerable time to complete, especially the continuous provision of test items to each participating laboratory for testing, quality or calibration. In this case, it is recommended that the laboratory provide an interim report of the results. In particular, they are published. When the results of a test are not satisfactory, this will allow for early investigation and subsequent corrective measures to be taken as soon as possible, rather than waiting for the publication of the final results of the program. 6.4 For laboratory cases reporting unsatisfactory results, the accreditation body should have the following policies: a) the laboratory investigates and assesses its capability within an agreed time frame; b) if necessary, the laboratory is subsequently required to conduct a possible proficiency test to confirm whether the corrective actions taken by the laboratory are effective; c) if necessary, an on-site evaluation of the laboratory by a suitable technical assessor to confirm whether the corrective actions are effective. 6.5 The laboratory accreditation body should inform participating laboratories of the possible consequences of unsatisfactory performance in the proficiency testing program, which include: If effective rectification is carried out within the specified period, accreditation can continue: suspend accreditation of the relevant items (require appropriate corrective measures); withdraw accreditation of the corresponding items. Usually, the laboratory accreditation body's choice of these measures will depend on the laboratory's consistent capabilities and the latest on-site assessment. 6.6 The laboratory accreditation body should have procedures to ensure that the records of competence (in the form of accreditation files or records) are kept for participating laboratories in the proficiency testing program and are available to technical assessors during on-site assessments. 6.7 The accreditation body should have a policy for accredited laboratories to provide feedback on the measures taken on the proficiency testing results, especially for laboratories with unsatisfactory performance. 7 Laboratory actions and feedback 7.1 Accredited laboratories should be required to keep records of their own performance in proficiency testing schemes, including the conclusions of investigations into unsatisfactory results and subsequent corrective and preventive actions. 7.2 Laboratories should draw conclusions about their own performance from the evaluation of the proficiency testing organization and design. Information to be considered includes: a) the source and characteristics of the test samples; 1) the measurement method used and, if possible, the value assigned to the results of a specific method; c) the organization of the proficiency testing (e.g. statistical model, number of replications, and the way the measured parameters are performed); the rules used by the organization to evaluate the performance of participants.5 The laboratory accreditation body shall inform participating laboratories of the possible consequences of unsatisfactory performance in proficiency testing schemes, which may include: suspension of accreditation for the relevant items (with the requirement to take appropriate corrective measures); withdrawal of accreditation for the relevant items. In general, the laboratory accreditation body's choice of these measures will depend on the laboratory's overall competence and the most recent on-site assessment. 6.6 The laboratory accreditation body shall have procedures to ensure that records of the competence of participating laboratories in proficiency testing schemes (in the form of accreditation files or records) are maintained for participating laboratories and are available to technical assessors during on-site assessments. 6.7 The accreditation body shall have a policy for providing feedback to accredited laboratories on the actions taken on proficiency testing results, especially for laboratories with unsatisfactory performance. wwW.bzxz.Net 7 Laboratory Actions and Feedback 7.1 Accredited laboratories shall be required to maintain records of their own competence in proficiency testing schemes, including the conclusions of investigations into unsatisfactory results and subsequent corrective and preventive actions. 7.2 Laboratories shall draw conclusions about their own competence from the evaluations of the proficiency testing organization and program. Information that should be considered includes: a) the source and characteristics of the test samples; c) the organization of the proficiency test (e.g. statistical model, number of repetitions, manner in which the measured parameters are implemented); and c) the rules used by the organization to evaluate the performance of the participants.5 The laboratory accreditation body shall inform participating laboratories of the possible consequences of unsatisfactory performance in proficiency testing schemes, which may include: suspension of accreditation for the relevant items (with the requirement to take appropriate corrective measures); withdrawal of accreditation for the relevant items. In general, the laboratory accreditation body's choice of these measures will depend on the laboratory's overall competence and the most recent on-site assessment. 6.6 The laboratory accreditation body shall have procedures to ensure that records of the competence of participating laboratories in proficiency testing schemes (in the form of accreditation files or records) are maintained for participating laboratories and are available to technical assessors during on-site assessments. 6.7 The accreditation body shall have a policy for providing feedback to accredited laboratories on the actions taken on proficiency testing results, especially for laboratories with unsatisfactory performance. 7 Laboratory Actions and Feedback 7.1 Accredited laboratories shall be required to maintain records of their own competence in proficiency testing schemes, including the conclusions of investigations into unsatisfactory results and subsequent corrective and preventive actions. 7.2 Laboratories shall draw conclusions about their own competence from the evaluations of the proficiency testing organization and program. Information that should be considered includes: a) the source and characteristics of the test samples; c) the organization of the proficiency test (e.g. statistical model, number of repetitions, manner in which the measured parameters are implemented); and c) the rules used by the organization to evaluate the performance of the participants. Tip: This standard content only shows part of the intercepted content of the complete standard. If you need the complete standard, please go to the top to download the complete standard document for free.