ISO requirements and definitions of important terms.ppt
Download as PPT, PDF0 likes57 views
The document outlines the requirements and definitions related to proficiency testing and interlaboratory comparisons according to ISO/IEC 17043:2023. It details various types of proficiency testing schemes, their purposes, and critical terms such as assigned value, consensus value, and metrological traceability. Additionally, it emphasizes the importance of evaluating laboratory performance and providing confidence in measurement results through structured testing processes.
ISO requirements and definitions of important terms.ppt
- 1. 1 1. Scope 2. Normative Reference 3. Terms and definitions 4. General requirements – 2 5. Structural requirements – 1 6. Resources requirements – 4 7. Process requirements – 7 8. Management System requirements - 9 ISO/IEC 17043: 2023 Requirements S.SUBRAMANIAN 01/01/25
- 2. 2 DEFINITIONS OF IMPORTANT TERMS Inter Laboratory Comparisons Inter Laboratory Comparisons – – Design Design, performance and evaluation of , performance and evaluation of measurements or tests on the same or measurements or tests on the same or similar items by two or more similar items by two or more laboratories in accordance with laboratories in accordance with predetermined conditions predetermined conditions Proficiency Testing (PT) Proficiency Testing (PT) – Evaluation of – Evaluation of participant performance against pre participant performance against pre established criteria by means of inter established criteria by means of inter laboratory comparisons laboratory comparisons S.SUBRAMANIAN 01/01/25
- 3. 3 Types of proficiency testing Schemes (as per ISO 13528:2022) Quantitative Scheme: Quantification of one or more measurands of the Proficiency Test item Qualitative Scheme : Identification or description of one or more quality characteristics of PT item Sequential Scheme : One or more PT items distributed sequentially for testing or measurement and returned to the provider at intervals S.SUBRAMANIAN 01/01/25
- 4. 4 Types of proficiency testing Schemes Simultaneous Scheme : Distribution of PT items for concurrent testing or measurement within a defined time period Single occasion exercise: Provision of PT items on a single occasion Continuous Scheme : Provision of PT items at regular intervals S.SUBRAMANIAN 01/01/25
- 5. 5 Types of proficiency testing Schemes Sampling: samples are taken for subsequent analysis & the purpose of PT Scheme includes evaluation of the execution of sampling Data transformation and interpretation: data or other information are furnished and the information is processed to provide an interpretation S.SUBRAMANIAN 01/01/25
- 6. 6 Different purposes for interlaboratory comparisons, which can be addressed by PT schemes, including but not limited to a) Evaluation of the performance of laboratories for specific measurements, tests, calibrations, examinations, inspections or sampling; b) identification of problems in laboratories that, for example, can be related to measurement or test methods, effectiveness of training and supervision of personnel, or calibration of equipment S.SUBRAMANIAN 01/01/25
- 7. 7 Different purposes for interlaboratory comparisons c) establishment of the effectiveness of measurement or test methods and the comparability of measurement or test results d) provision of additional confidence to users of measurement or test results; e) identification of differences in measurement or test results; f) education of participating laboratories based on the outcomes of such comparisons; g) validation of measurement uncertainty claims; S.SUBRAMANIAN 01/01/25
- 8. 8 For the following types of interlaboratory comparisons, the term PT does not usually apply because laboratory competence must be established in advance, in order to ensure the validity of measurements or tests as well as the metrological traceability of assigned values h) evaluation of the performance characteristics of a measurement or test method (often described as collaborative trials); i) assignment of values to reference materials j) support for statements of the equivalence of measurements of National Metrology Institutes (NMIs), or their Designated Institutes (DIs) through “key and supplementary comparisons”, conducted on behalf of the International Bureau of Weights and Measures (BIPM) and associated Regional Metrology Organizations (RMOs). S.SUBRAMANIAN 01/01/25
- 9. 9 DEFINITIONS OF IMPORTANT TERMS Assigned value Assigned value – Value attributed – Value attributed to a particular property to a particular property or or characteristic characteristic of a PT item- of a PT item- x xpt pt Standard Deviation for Proficiency Standard Deviation for Proficiency Assessment (SDPA) Assessment (SDPA)- - Measure of Measure of dispersion used in the evaluation dispersion used in the evaluation of results of Proficiency Testing, of results of Proficiency Testing, based on available information – based on available information – σ σpt S.SUBRAMANIAN 01/01/25
- 10. 10 DEFINITIONS OF IMPORTANT TERMS Action Signal Action Signal – Indication of a need for – Indication of a need for action arising from a PT result action arising from a PT result Consensus Value Consensus Value – – Value derived from Value derived from a collection of results in an a collection of results in an interlaboratory comparisons interlaboratory comparisons Outlier Outlier – – A member of a set of values A member of a set of values which is inconsistent with other which is inconsistent with other members of that set members of that set S.SUBRAMANIAN 01/01/25
- 11. 11 DEFINITIONS OF IMPORTANT TERMS Participant Participant – – Person or organization that undertakes activities related to proficiency testing and submits their results for performance evaluation by the Proficiency Testing Provider Proficiency Test item Proficiency Test item (PT Item) - (PT Item) - S Sample, product, artefact, reference ample, product, artefact, reference material, piece of equipment, material, piece of equipment, measurement standard, measurement standard, object, image object, image, , data set or other information used for data set or other information used for proficiency testing proficiency testing S.SUBRAMANIAN 01/01/25
- 12. 12 DEFINITIONS OF IMPORTANT TERMS Proficiency Testing Provider (PT Proficiency Testing Provider (PT Provider) Provider) – Organization which takes – Organization which takes responsibility for all responsibility for all activities activities in the in the development and operation of a PT development and operation of a PT Scheme Scheme Proficiency Testing Scheme Proficiency Testing Scheme - - P Proficiency Testing designed and roficiency Testing designed and operated in operated in one or more one or more proficiency proficiency testing testing rounds for rounds for a specified area of a specified area of measurement, testing, calibration, measurement, testing, calibration, examination, sampling examination, sampling or inspection or inspection S.SUBRAMANIAN 01/01/25
- 13. 13 DEFINITIONS OF IMPORTANT TERMS Customer ( Customer (Client Client) ) - - Organization Organization or individual for which a PT or individual for which a PT Scheme is provided Scheme is provided through a contractual arrangement PT round PT round- - Single complete Single complete sequence of sequence of proficiency testing proficiency testing including the evaluation and including the evaluation and reporting of the reporting of the performance performance of of participants participants S.SUBRAMANIAN 01/01/25
- 14. 14 DEFINITIONS OF IMPORTANT TERMS Reference Material (RM) Reference Material (RM) – Material, – Material, sufficiently homogeneous & stable with sufficiently homogeneous & stable with respect to one or more specified properties, respect to one or more specified properties, which has been established to be fit for its which has been established to be fit for its intended use in a measurement process intended use in a measurement process Certified Reference Material (CRM) Certified Reference Material (CRM) – – Reference material characterized by a Reference material characterized by a metrologically valid procedure for one or metrologically valid procedure for one or more specified properties, accompanied by a more specified properties, accompanied by a certificate that provides the value of the certificate that provides the value of the specified property, its associated uncertainty, specified property, its associated uncertainty, and a statement of metrological traceability and a statement of metrological traceability S.SUBRAMANIAN 01/01/25
- 15. 15 DEFINITIONS OF IMPORTANT TERMS M Metrological Traceability etrological Traceability - Property of a - Property of a measurement result whereby the measurement result whereby the result can be related to a reference result can be related to a reference through a documented unbroken chain through a documented unbroken chain of calibrations, each contributing to of calibrations, each contributing to the measurement uncertainty the measurement uncertainty Measurement Uncertainty Measurement Uncertainty - - Non- Non- negative parameter characterizing the negative parameter characterizing the dispersion of the quantity values dispersion of the quantity values being being attributed to a measurand, based on attributed to a measurand, based on the information used the information used S.SUBRAMANIAN 01/01/25