CNAS-RL02. Rules for Proficiency Testing

Transcription

1 CNAS-RL02 Rules for Proficiency Testing CNAS

2 CNAS-RL02:2010 Page 1 of 7 Rules for Proficiency Testing 1 Objective and scope 1.1 This Rules is established by China National Accreditation Service for Conformity Assessment (abbreviated in English as CNAS) to guarantee the effectiveness and safeguard the quality of CNAS accreditation and facilitate the capacity building of conformity assessment bodies. 1.2 Proficiency testing and onsite assessment are the 2 main ways in which CNAS conducts evaluation of the competence of conformity assessment bodies. This Rules expatiates on CNAS policy and requirements for proficiency testing, including CNAS policy for organizing, recognizing and using the results of proficiency testing and its requirements on participation in proficiency testing by conformity assessment bodies. 1.3 This Rules applies to the conformity assessment bodies engaged in testing, calibration and inspection activities that seek CNAS accreditation or have already been accredited by CNAS. 2 References The following documents contain provisions which, through reference in this text, constitute provisions of this Rules. All documents are subject to revision, and parties to agreements based on this Rules are encouraged to investigate the possibility of applying the most recent editions of the documents indicated below (including any amendments). 2.1 CNAS-R01 Rules for the Use of Accreditation Symbols and Reference to Accreditation 2.2 CNAS-CL01 Accreditation Criteria for the Competence of Testing and Calibration Laboratories 2.3 CNAS-CL02 Accreditation Criteria for the Quality and Competence of Medical Laboratories 2.4 CNAS-CI01 Accreditation Criteria for the Competence of Inspection Bodies 2.5 GB/T27011 Conformity assessment -- General requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC17011,IDT) 2.6 GB/T27000 Conformity assessment -- Vocabulary and general principles

3 CNAS-RL02:2010 Page 2 of 7 (ISO/IEC17000,IDT) 2.7 APLAC MR001 Procedures for Establishing and Maintaining Mutual Recognition Arrangements amongst Accreditation Bodies 2.8 ILAC-P9 ILAC Policy for Participation in Proficiency Testing Activities 2.9 ISO/IEC Conformity assessment General requirements for proficiency testing 3 Terms and Definitions For the purpose of this Rules, the definitions given in GB/T27000 and the following apply: 3.1 inter-laboratory comparison organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions (ISO/IEC17043, 3.4) 3.2 proficiency testing evaluation of participant performance against pre-established criteria by means of inter-laboratory comparisons(iso/iec17043, 3.7) Note 1: This definition includes the EQA (External Quality Assessment or inter-laboratory quality assessment) that is commonly used in the medical area and complies with this definition. Note 2: also called proficiency testing activities, including various proficiency testing schemes, measurement audits and comparison schemes complying with this definition. 3.3 proficiency testing scheme: proficiency testing designed and operated in one or more rounds for a specified area of testing, measurement, calibration or inspection(iso/iec 17043, 3.11) Note: A proficiency testing scheme might cover a particular type of test, calibration, inspection or a number of tests, calibrations or inspections on proficiency test items. 3.4 measurement audit: comparison of the result of the actual test conducted by a participant on the measured article (material or product) to the reference value. Note: measurement audit is a proficiency testing scheme where a single participant is

4 CNAS-RL02:2010 Page 3 of 7 tested. 4 Requirements 4.1 Requirements to CNAS CNAS shall require conformity assessment bodies to demonstrate their competencies through participation in proficiency testing CNAS uses, selects and operates proficiency testing according to international standards and related technical requirements CNAS establishes, maintains and publishes the list of proficiency testing, including those organized and recognized by CNAS so as to provide channels for conformity assessment bodies to participate in proficiency testing CNAS formulates, publishes and updates according to accreditation demand the requirements for proficiency testing areas and frequency CNAS will accept the accreditation application of or make an accreditation decision on a conformity assessment body after reviewing its compliance to this Rules and supervise its continual compliance to this requirement CNAS will consider simplifying the competence confirmation process of relevant items in various assessments of a conformity assessment body that has participated in proficiency testing organized and recognized by CNAS and has achieved satisfactory performance stably CNAS may withdraw the accreditation qualifications for corresponding items of the conformity assessment body that is unable to meet the proficiency testing area and frequency requirement or has achieved unsatisfactory result in the proficiency testing and failed to take and verify the corrective actions within 180 days (from the day of proficiency testing report issuance) CNAS assessment team will assess the appropriateness of the work plans developed by the conformity assessment body, satisfaction level of the scope and frequency of proficiency testing requirements published by CNAS as well as the results of proficiency testing activities participated by the conformity assessment body and report the assessment

5 CNAS-RL02:2010 Page 4 of 7 conclusion to CNAS CNAS encourages the development of proficiency testing providers. Proficiency testing organized by CNAS should not constitute a competitive relationship with the CNAS-accredited proficiency testing providers and should not affect the implementation of the schemes of the proficiency testing providers. 4.2 Requirements for conformity assessment bodies A conformity assessment body should take proficiency testing as an important external quality assessment activity, participate in and utilize the results of proficiency testing according to the requirements of this Rules and the corresponding accreditation criteria and report information of proficiency testing that it has participated in to CNAS as required. Note: Inter-laboratory comparison that is participated in by a conformity assessment body for purposes other than proficiency testing, e.g. validation of methods characteristics, characterization of reference materials and comparisons supporting statement of metrological equivalence between national metrological institutes, with satisfactory results may also be considered as a proof of its proficiency The quality management system documents of the conformity assessment body should have requirements for procedures and records of participation of proficiency testing, including work plans for participating in proficiency testing and measures for dealing with unsatisfactory results. The work plan for proficiency testing should consider (but not limited to ) the following factors: Methods of testing, calibration and inspection covered in the scope of accreditation; Information of training, knowledge level, experiences and changes of staff; Information of internal quality control; Intended use of testing, calibration and inspection results; Technical stability of testing, calibration and inspection. Note: The conformity assessment body should assure its competence in areas without appropriate proficiency testing by means of reinforced internal quality control and self-comparisons with other laboratories. Such actions should also be considered as a part of the quality control plan or work plan

6 CNAS-RL02:2010 Page 5 of 7 for participation of proficiency testing of the conformity assessment body The conformity assessment body should have participated in at least 1 proficiency testing with satisfactory results for each sub-area that it applies for initial accreditation so far as such a proficiency testing is available (and a proficiency testing participated within 3 years prior to the date of application for accreditation shall be deemed as valid). The sub-area classification and frequency requirements shall satisfy the table of proficiency testing areas and frequency published by CNAS. Note: The area (sub-area) and frequency of proficiency testing required by CNAS shall be the minimum requirements and the conformity assessment body should establish and execute stricter requirements based on factors such as its accreditation scope and quality needs The accredited conformity assessment body should meet the CNAS requirements of area and frequency of proficiency testing and achieve satisfactory results so far as such proficiency testing is available. For any area (sub-areas) not included in the CNAS table of proficiency testing areas and frequency, the accredited conformity assessment body should at least participate in 1 proficiency testing within each accreditation cycle so far as such proficiency testing is available When the conformity assessment body uses equipments of different models, multiple equipments of the same model and / or different methods to generate data for the same item (or parameter), at least one of such equipment or method shall participate in 1 proficiency testing and internal equipment or method comparisons should be implemented. Note: CNAS encourages such bodies to participate in different proficiency testing for each piece of equipment and method A multi-site conformity assessment body should make sure that each of its sites engaged in testing, calibration or inspection activities meets the requirements in at the time of application for accreditation and each of such sites should meet the requirements in after accreditation A conformity assessment body that achieves unsatisfactory results in a proficiency testing should take and verify the corrective actions as required in the accreditation criteria. Where such unsatisfactory results are also unable to comply with the technical standards or specifications, the conformity assessment body, in addition to taking and verifying the

7 CNAS-RL02:2010 Page 6 of 7 corrective actions, shall suspend the use of CNAS logo in the certificate / report for the corresponding items. After the corrective actions are verified, the conformity assessment body may resume the use of the accreditation logo. The conformity assessment body shall complete such corrective actions and verification activities within 180 days (from the date of receipt of the report of proficiency testing result). The conformity assessment body should retain the aforesaid records for inspection by the assessment team. Note 1: Methods for verification of the validity of corrective actions include: re-participating in a proficiency testing organized or recognized by CNAS, participating in a measurement audit or be confirmed the site assessment by the CNAS assessment team. Note 2: When the conformity assessment body uses the same equipment or method to generate data for different items of accreditation and achieves unsatisfactory results in a proficiency testing, its corrective actions should take account of all items related to such equipment or method. Note 3: CNAS may suspend and even withdraw the accreditation of an accredited conformity assessment body if it fails to achieve satisfactory result in the special proficiency testing program implemented by CNAS Conformity assessment bodies, whose results of proficiency testing are unsatisfactory but still comply with the judgment requirements included in the standards or specifications serving as the basis of the accredited items, or are doubtful or questionable, should take effective preventive actions, or even corrective actions when necessary The conformity assessment body should increase the frequency of proficiency testing participation to demonstrate its competence in case of any significant changes to its staff, equipments, methods and standards, scope of accreditation or other aspects influencing its competence. Note: In such cases, the requests for participating in additional proficiency testing may also come from CNAS Conformity assessment bodies undertaking the technical tasks in the CNAS proficiency testing program may, after appropriate technical judgment, be deemed as having participated in and achieved satisfactory results in this program in the corresponding sub-areas Accredited conformity assessment bodies are obliged to participate in proficiency

8 CNAS-RL02:2010 Page 7 of 7 testing schemes specified by CNAS, such as international proficiency testing program or CNAS special proficiency testing schemes. Note: Schemes specified by CNAS are usually free of charge. 5 CNAS policy for recognizing external proficiency testing 5.1 CNAS recognizes proficiency testing implemented by other bodies in accordance with ISO/IEC 17043, such as: a) Proficiency testing schemes operated by CNAS-accredited proficiency testing providers; b) Proficiency testing schemes organized by accreditation bodies with mutual recognition arrangement with CNAS; c) Proficiency testing schemes organized by proficiency testing providers accredited by an accreditation body having mutual recognition arrangement with CNAS, and also registered to CNAS;; d) Proficiency testing or comparison schemes with supporting documents submitted to and validated by CNAS. Note: refer to relevant CNAS provisions for documents and information to be submitted for registration of PTP accredited by an accreditation body having MRA with CNAS and for program validated by CNAS. 5.2 CNAS recognizes proficiency testing implemented by international authoritative organizations, such as: a) Proficiency testing schemes developed by the International Cooperations for Laboratory Accreditation, such as Asia Pacific Laboratory Accreditation Cooperation (APLAC), European Cooperation for Accreditation (EA); b) International or regional comparison activities implemented by international and regional metrological organizations, such as International Committee for Weights and Measures (CIPM) and Asia Pacific Metrology Programme (APMP); c) International proficiency testing schemes implemented by international authoritative trade organizations such as World Anti-Doping Agency (WADA). 6 Costs and expenses Proficiency testing activities organized by CNAS are non-profit activities, but participants should bear the corresponding cost of participation, which will be advised of by CNAS in advance.